m. pharm syllabus & regulations revised

GITAM UNIVERSITY (Declared as Deemed to be University u/s 3 of the UGC Act 1956)

ACADEMIC REGULATIONS

COURSE STRUCTURE & SYLLABUS OF

M.PHARMACY A Two Year P.G., Course under semester pattern

(w.e.f 2010 -11 admitted batch) Approved in the 6th Academic Council meeting held on 30th January, 2010

GITAM INSTITUTE OF PHARMACY (ISO 9001:2008 Certified)

Gandhinagar Campus, Rushikonda, Visakhapatnam – 530 045 Ph. No. 0891-2840550, 2840551, 2795315

E-mail: [email protected], Website: www.gitam.edu

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ACADEMIC REGULATIONS FOR MASTER OF PHARMACY (M. Pharm) PROGRAMME 1.0 ADMISSIONS

1.1 Admissions into M. Pharmacy programme of GITAM University are governed by GITAM

University admission regulations.

2.0 ELIGIBILTY CRITERIA

2.1 A pass in B. Pharm with 50% of marks

2.2 Admissions in to M. Pharm will be based on the following:

(i) Score obtained in GAT (PGP) (ii) The merit position of the candidate for admission will be based on the score obtained by the

candidate in GAT PGP

3.0 STRUCTURE OF THE M. Pharm PROGRAMME

3.1 Each academic year consists of two semesters. Every branch of the M. Pharm programme has a curriculum and course content (syllabi) for the subjects recommended by the Board of Studies and approved by the Academic Council.

3.2 The Programme of instruction consists of:

I. First semester programme containing theory & practical subjects which are common for all

specializations. II. The subjects in the second semester are based on the respective specializations. III. An assignment on the research paper published in journals on the subjects related to the field

of specialization shall be allotted to the students to develop a research analytical skills to analyze to various facets of the given research work.

IV. The candidate has to present seminar on the chosen/ allotted topics during the 1st & 2nd semesters.

V. There shall be a comprehensive viva voce at the end of 1st semester and 2nd semester respectively.

VI. 3rd & 4th semester shall be devoted for the project work for the respective specialization. VII. During the 3rd semester a candidate has to present a mid semester seminar on selected

topics of respective specialization. Subsequently a candidate has to present an end semester seminar on proposed project work progress of literature survey and methodology of the project work.

VIII. The 4th semester consists of submission of project dissertation followed by seminar and viva voce. The general parameters for evaluation of project dissertation are Preface, Objectives general introduction, Drug profile, Review of literature, Plan of work, Methodology/ experimental work and investigations, Interpretation and analysis of data, Results and Discussion, Publication/ Abstracts of the author, Mode of Presentation.

3.3 Project Dissertation has to be submitted by each student individually. The general guidelines

for evaluation of M. Pharm thesis/ project work shall include the following:

I. Whether the objectives of the project work has been clearly identified and defined. II. Whether it is relevant to the respective field. III. Whether it is likely to make a significant contribution to the advancement of the knowledge or

its usefulness from commercial viability. IV. Whether the investigator possesses the necessary expertise to accomplish the work V. Whether the instigator has published and presented any papers in the relevant field VI. Any other aspects which may be considered relevant

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4.0 CREDIT BASED SYSTEM

4.1 The course content of the individual subjects - theory and practicals – is expressed in terms of a specified number of credits. The number of credits assigned to a subject depends on the number of contact hours (lectures & tutorials) per week.

4.2 In general, credits are assigned to the subjects based on the following contact hours per week

per semester. One credit for each Lecture hour. One credit for two hours of Practicals. Two credits for three or more hours of Practicals.

4.3 The curriculum of M. Pharm programme is designed to have a total of 100 credits for the

award of M. Pharm degree. A student is deemed to have successfully completed a particular semester’s programme of study when he / she earns all the credits of that semester i.e., he / she has no ‘F’ grade in any subject of that semester.

5.0 MEDIUM OF INSTRUCTION

The medium of instruction (including examinations and project reports) shall be English.

6.0 REGISTRATION Every student has to register himself/herself for each semester individually at the time specified by the College / University.

9.0 CONTINUOUS ASSESSMENT AND EXAMINATIONS 7.1 The assessment of the student’s performance in each course will be based on continuous

internal evaluation and semester-end examination. The marks for each of the component of assessment are based on the assessment procedure shown in the Table 1:

Table 1: Assessment Procedure

Sl. No

Component of assessment

Marks allotted

Type of Assessment

Scheme of Examination

40

Continuous evaluation

(i) Two mid semester examinations shall be conducted for 10 marks each. (ii) Two quizzes/ MCQ tests shall be conducted for 5 marks each. (iii) 5 marks are allotted for assignments. (iv) 5 marks are allotted for attendance

60

Semester-end examination

The semester-end examination in theory subjects will be for a maximum of 60 marks.

1

Theory Total 100

2

Practicals

100

Continuous evaluation

(i) 40 marks are allotted for record work and day to day performance and viva voce of the student in each lab throughout the semester. The candidate shall lose the marks for the practical classes she/ he remains absent. (ii) One examination for a maximum of 20 marks shall be conducted by the teacher handling the lab course at the middle of the semester (iii) One examination for a maximum of 40 marks shall be conducted at the end of the semester (as scheduled by the Head of the institution.

3. Comprehensive Viva

100

Viva-voce

100 marks are allotted for comprehensive viva for the end semester comprehensive viva of 1st & 2nd semester programme.

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4. Third semester

seminars 100 Seminar Seminar 1: During the 3rd semester a candidate has to present a

mid semester seminar on selected topics of respective specialization which shall be evaluated by a committee nominated by the Principal for a maximum of 100 marks. Seminar 2: The candidate shall also present an end semester seminar on proposed project work progress of literature survey and methodology of the project work which shall be evaluated by a committee nominated by the Principal for a maximum of 100 marks.

5.

Project work

100

Project evaluation

Phase I: The dissertation work of the project shall be evaluated on the basis of the performance and presentation skills on parameters like Preface, Objectives general introduction, Drug profile, Review of literature, Plan of work, Methodology/ experimental work and investigations, Interpretation and analysis of data, Results and Discussion, Publication/ Abstracts of the author, Mode of Presentation etc. This shall be jointly evaluated by the internal examiner and an examiner appointed by the Principal. Phase II: The candidate has to present a seminar before the committee on the project work which shall be followed by viva voce which shall be evaluated for a maximum marks of 100.

* Principal shall appoint examiners for conduct of the examination.

8.0 REAPPEARANCE

8.1 A Student who has secured ‘F’ Grade in any theory course / Practicals of any semester shall have to reappear for the semester end examination of that course / Practicals along with his / her juniors.

8.2 A student who has secured ‘F’ Grade in Project work shall have to improve his report and

reappear for viva – voce Examination of project work at the time of special examination to be conducted in the summer vacation after the last academic year.

9.0 SPECIAL EXAMINATION 9.1 A student who has completed the stipulated period of study for the degree programme

concerned and still having failure grade (‘F’) in not more than 5 courses ( Theory / Practicals), may be permitted to appear for the special examination, which shall be conducted in the summer vacation at the end of the last academic year.

9.2 A student having ‘F’ Grade in more than 5 courses (Theory / Practicals) shall not be permitted to appear for the special examination.

10.0 ATTENDANCE REQUIREMENTS

10.1 A student whose attendance is less than 75% in all the courses put together in any semester

will not be permitted to attend the end - semester examination and he/she will not be allowed to register for subsequent semester of study. He /She has to repeat the semester along with his / her juniors.

10.2 However, the Vice Chancellor on the recommendation of the Principal / Director of the

University college / Institute may condone the shortage of attendance to the students whose attendance is between 66% and 74% on genuine medical grounds and on payment of prescribed condonation fee.

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11.0 GRADING SYSTEM

11.1 Based on the student performance during a given semester, a final letter grade will be

awarded at the end of the semester in each course. The letter grades and the corresponding grade points are as given in Table 2.

Table 2: Grades & Grade Points

11.2 A student who earns a minimum of 5 grade points (C grade) in a course is declared to

have successfully completed the course, and is deemed to have earned the credits assigned to that course. However, a minimum of 24 marks is to be secured at the semester end examination of theory courses in order to pass in the theory course.

12.0 GRADE POINT AVERAGE

12.1 A Grade Point Average (GPA) for the semester will be calculated according to the formula: Σ [ C x G ]

GPA = ---------------- Σ C

Where C = number of credits for the course, G = grade points obtained by the student in the course.

12.2 Semester Grade Point Average (SGPA) is awarded to those candidates who pass in all

the subjects of the semester. 12.3 To arrive at Cumulative Grade Point Average (CGPA), a similar formula is used

considering the student’s performance in all the courses taken in all the semesters completed up to the particular point of time.

12.4 The requirement of CGPA for a student to be declared to have passed on successful

completion of the M. Pharm programme and for the declaration of the class is as shown in Table 3.

Table 3: CGPA required for award of Degree

Distinction ≥ 8.0* First Class ≥ 7.0 Second Class ≥ 6.0 Pass ≥ 5.0

* In addition to the required CGPA of 8.0, the student must have necessarily passed all the courses of

every semester in first attempt.

Grade Grade points Absolute Marks O 10 90 and above A+ 9 80 – 89 A 8 70 – 79 B+ 7 60 – 69 B 6 50 – 59 C 5 40 – 49 F Failed, 0 Less than 40

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13.0 ELIGIBILITY FOR AWARD OF THE M. Pharm DEGREE 13.1 Duration of the programme:

A student is ordinarily expected to complete the M Pharm. programme in four semesters of two years. However a student may complete the programme in not more than four years including study period.

13.2 However the above regulation may be relaxed by the Vice Chancellor in individual cases

for cogent and sufficient reasons. 13.3 Project dissertation shall the submitted on or before the last day of the course. However, it

can be extended up to a period of 6 months maximum, with the written permission of the concerned guide.

13.4 A student shall be eligible for award of the M. Pharm degree if he / she fulfils all the

following conditions.

a) Registered and successfully completed all the courses and projects. b) Successfully acquired the minimum required credits as specified in the curriculum

corresponding to the branch of his/her study within the stipulated time. c) Has no dues to the Institute, hostels, Libraries, NCC / NSS etc, and d) No disciplinary action is pending against him / her.

13.5 The degree shall be awarded after approval by the Academic Council. RULES

1. With regard to the conduct of the end-semester examination in any of the practical

courses of the programme, the Principal shall appoint one examiner from the institute in addition to an external examiner in the said subject.

2. In respect of all theory examinations, the paper setting shall be done by an external paper setter having a minimum of three years of teaching experience. The panel of paper setters for each course is to be prepared by the Board of Studies of the department concerned and approved by the Academic Council. The paper setters are to be appointed by the Vice Chancellor on the basis of recommendation of Director of Evaluation / Controller of Examinations.

3. The theory papers of end-semester examination will be evaluated by two examiners. The examiners may be internal or external. The average of the two evaluations shall be considered for the award of grade in that course.

4. If the difference of marks awarded by the two examiners of theory course exceeds 12 marks, the paper will have to be referred to a third examiner for evaluation. The average of the two nearest evaluations of the three shall be considered for the award of the grade in that course.

5. Panel of examiners of evaluation for each course is to be prepared by the Board of Studies of the department concerned and approved by the Academic Council.

6. The examiner for evaluation should possess post graduate qualification and a minimum of three years teaching experience.

7. The appointment of examiners for evaluation of theory papers will be done by the Vice Chancellor on the basis of recommendation of Director of Evaluation / Controller of Examinations from a panel of examiners approved by the Academic Council.

8. Project work shall be evaluated by two examiners at the semester end examination. One examiner shall be internal and the other shall be external. The Vice Chancellor can permit

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appointment of second examiner to be internal examiner when an external examiner is not available.

9. The attendance marks (maximum 5) shall be allotted as follows:

Percentage of Attendance Marks 76% to 84% 1 85% to 89% 2 90% to 94% 3 95% to 99% 4 100% 5

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Scheme of Instruction for M. Pharm Specialization: Pharmaceutics

I Semester Theory

Subject Code Name of the Subject Prescribed

Hours Credits

PPRPH1001 Dosage Form Design 4 4 PPRPH1002 Instrumental Methods of Analysis 4 4 PPRPH1003 Biological Methods of Screening 4 4

PPRPH1004 Research Methodology and statistical Methods

4 4

Total 16 16

I Semester Practical

PPRPH1011 Dosage Form Design 6 2 PPRPH1012 Instrumental Methods of Analysis 6 2 PPRPH1013 Biological Methods of Screening 6 2 PPRPH1014 Seminar/ Assignment 8 2 PPRPH1015 Comprehensive Viva-Voce 2 Total 26 10 Grand Total (Theory + Practical) 42 26

II Semester Theory


Hours Credits

PPRPH2101 Novel Drug Delivery Systems 4 4 PPRPH2102 Advanced Physical Pharmaceutics 4 4

PPRPH2103 Biopharmaceutics and Clinical Pharmacokinetics

4 4

PPRPH2104 Industrial Pharmacy 4 4 Total 16 16

II Semester Practical

PPRPH2111 Novel Drug Delivery System 6 2 PPRPH2112 Advanced Physical Pharmaceutics 6 2 PPRPH2113 Biopharmaceutics and Pharmacokinetics 6 2 PPRPH2114 Seminar Presentation 8 2 PPRPH2115 Assignments on Research Paper 2 PPRPH2116 Comprehensive Viva-Voce 2 Total 26 12 Grand Total (Theory + Practical) 42 28

9

III Semester

Subject Code Name of the Subject Prescribed Hours

Credits

PPRPH3001 Seminar – I (Mid Semester Seminar on Selected Topics of respective specialization)

4

PPRPH3002 Seminar – II (End Semester Seminar on Proposed Project Work, Literature Survey, Plan of Work, Methodology)

8

Total -- 12

IV Semester


Credits

PPRPH4001

Project dissertation (Preface, Objectives General Introduction, Drug profile, Review of Literature, Plan of work, Methodology/ Experimental work and Investigations, , Interpretation and analysis of data, Results and Discussion, Publications/ Abstracts of the author, mode of Presentation)

24

PPRPH4002 Seminar and Viva – Voce 10 Total -- 34

10

Scheme of Instruction for M. Pharm Specialization: Pharmaceutical Analysis and Quality Assurance

I Semester Theory


Credits

PPRPH1001 Dosage Form Design 4 4 PPRPH1002 Instrumental Methods of Analysis 4 4 PPRPH1003 Biological Methods of Screening 4 4


4 4

Total 16 16


PPRPH1011 Dosage Form Design 6 2 PPRPH1012 Instrumental Methods of Analysis 6 2 PPRPH1013 Biological Methods of Screening 6 2 PPRPH1014 Seminar/ Assignment 8 2 PPRPH1015 Comprehensive Viva-Voce 2 Total 26 10 Grand Total (Theory + Practical) 42 26

II Semester Theory


Credits

PPRPH2201 Stability of Drugs and Drug Products 4 4

PPRPH2202 Advanced Instrumental Methods of Analysis

4 4

PPRPH2203 Chromatographic Methods of Analysis

4 4

PPRPH2204 Quality Assurance, GMP & Validation 4 4 Total 16 16

II Semester Practical PPRPH2211 Stability of Drugs and Drug Products 6 2 PPRPH2212 Advanced Instrumental Methods of Analysis 6 2 PPRPH2213 Chromatographic Methods of Analysis 6 2 PPRPH2214 Seminar Presentation 8 2 PPRPH2215 Assignments on Research Paper 2 PPRPH2216 Comprehensive Viva-Voce 2 Total 26 12 Grand Total (Theory + Practical) 42 28

11

III Semester


Hours Credits


4


8

Total -- 12

IV Semester


Hours Credits

PPRPH4001


24


12

Scheme of Instruction for M. Pharm Specialization: Pharmaceutical Chemistry

I Semester Theory


Hours Credits

PPRPH1001 Dosage Form Design 4 4

PPRPH1002 Instrumental Methods of Analysis

4 4

PPRPH1003 Biological Methods of Screening 4 4


4 4

Total 16 16




6 2

PPRPH1013 Biological Methods of Screening 6 2 PPRPH1014 Seminar/ Assignment 8 2 PPRPH1015 Comprehensive Viva-Voce 2 Total 26 10 Grand Total (Theory + Practical) 42 26

II Semester Theory


Hours Credits

PPRPH2301 Chemistry of Bulk Drugs 4 4

PPRPH2302 Advanced Medicinal Chemistry

4 4

PPRPH2303 Chemistry of Natural Products 4 4

PPRPH2304 Stereochemistry and Reaction Mechanism

4 4

Total 16 16

II Semester Practical-I

PPRPH2311 Chemistry of Bulk Drugs 6 2

PPRPH2312 Advanced Medicinal Chemistry 6 2

PPRPH2313 Chemistry of Natural Products 6 2 PPRPH2314 Seminar Presentation 8 2

PPRPH2315 Assignments on Research Paper 2

PPRPH2316 Comprehensive Viva-Voce 2 Total 26 12 Grand Total (Theory + Practical) 42 28

13

III Semester


Hours Credits


4

PPRPH3002

Seminar – II (End Semester Seminar on Proposed Project Work, Literature Survey, Plan of Work, Methodology)

8

Total -- 12

IV Semester

Subject Code Name of the Subject Prescribed Hours Credits

PPRPH4001


24


14

Scheme of Instruction for M. Pharm Specialization: Pharmacology

I Semester Theory


Hours Credits


PPRPH1002 Instrumental Methods of Analysis 4 4

PPRPH1003 Biological Methods of Screening 4 4

PPRPH1004 Research Methodology and statistical Methods 4 4

Total 16 16




6 2

PPRPH1013 Biological Methods of Screening 6 2 PPRPH1014 Seminar/ Assignment 8 2 PPRPH1015 Comprehensive Viva-Voce 2 Total 26 10 Grand Total (Theory + Practical) 42 26

II Semester Theory


Hours Credits

PPRPH2401 Pharmacokinetics and Drug Metabolism

4 4

PPRPH2402 Advanced Systemic Pharmacology

4 4

PPRPH2403 Cellular and Molecular Pharmacology

4 4

PPRPH2404 Clinical Pharmacology and Toxicology

4 4

Total 16 16


PPRPH2411 Pharmacokinetics and Drug Metabolism

6 2

PPRPH2412 Advanced Systemic Pharmacology

6 2

PPRPH2413 Bioassays and Screening Methods

6 2

PPRPH2414 Seminar Presentation 8 2

PPRPH2415 Assignments on Research Paper

2

PPRPH2416 Comprehensive Viva-Voce 2 Total 26 12 Grand Total (Theory + Practical) 42 28

15

III Semester


Credits


4

PPRPH3002

Seminar – II (End Semester Seminar on Proposed Project Work, Literature Survey, Plan of Work, Methodology)

8

Total -- 12

IV Semester


Hours Credits

PPRPH4001


24


16

Distribution of Credits for Pharmaceutical Technology

Theory Practical Credits Total Credits Semester

Hours Credits Hours Credits M. Pharm I Semester 16 16 26 10 26 M. Pharm II Semester 16 16 26 12 28 M. Pharm III Semester 12 M. Pharm IV Semester 34 Total 100

Distribution of Credits for Pharmaceutical Analysis & Quality Assurance



Distribution of Credits for Pharmaceutical Chemistry



Distribution of Credits for Pharmacology



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Scheme of Examination for Master of Pharmacy (M. Pharmacy) Pharmaceutics

I Semester –Theory

Subject Code Name of the Subject Mid

sem Quiz/ MCQ

Assign -ment

Atten-dance

End Sem

Grand total

PPRPH1001 Dosage Form Design 20 10 5 5 60 100 PPRPH1002 Instrumental Methods of Analysis 20 10 5 5 60 100 PPRPH1003 Biological Methods of Screening 20 10 5 5 60 100


20 10 5 5 60 100

Total 400


Subject Code Name of the Subject Day to day Assessment

Mid sem exam

End sem

Grand total

PPRPH1011 Dosage Form Design 40 20 40 100 PPRPH1012 Instrumental Methods of Analysis 40 20 40 100 PPRPH1013 Biological Methods of Screening 40 20 40 100 PPRPH1014 Seminar/ Assignment 100 100 PPRPH1015 Comprehensive Viva-Voce 100 100 Total 500 Grand Total (Theory + Practical) 900

II Semester Theory

Subject Code Name of the Subject Mid

sem Quiz/ MCQ

Assign -ment

Atten-dance

End Sem

Grand total

PPRPH2101 Novel Drug Delivery Systems 20 10 5 5 60 100 PPRPH2102 Advanced Physical Pharmaceutics 20 10 5 5 60 100 PPRPH2103 Biopharmaceutics and Clinical Pharmacokinetics 20 10 5 5 60 100 PPRPH2104 Industrial Pharmacy 20 10 5 5 60 100 Total 400


Subject Code Name of the Subject Day to day

Assessment Mid sem

exam End sem Grand

total PPRPH2111 Novel Drug Delivery System 40 20 40 100 PPRPH2112 Advanced Physical Pharmaceutics 40 20 40 100 PPRPH2113 Biopharmaceutics and Pharmacokinetics 40 20 40 100 PPRPH2114 Seminar Presentation 100 100 PPRPH2115 Assignments on Research Paper 100 100 PPRPH2116 Comprehensive Viva-Voce 100 100 Total 600 Grand Total (Theory + Practical) 1000

III Semester


Assessment Mid sem seminar

End sem

Grand total


100 100


100 100

Total 200

18

IV Semester


Mid sem exam

End sem

Grand total

PPRPH4001


100 100

PPRPH4002 Seminar and Viva – Voce 100 100 Total 200

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Scheme of Examination for Master of Pharmacy (M. Pharmacy) Pharmaceutical Analysis and Quality Assurance

I Semester Theory

Subject Code Name of the Subject Mid sem

Quiz/ MCQ

Assign -ment

Atten-dance

End Sem

Grand total

PPRPH1001 Dosage Form Design 20 10 5 5 60 100 PPRPH1002 Instrumental Methods of Analysis 20 10 5 5 60 100 PPRPH1003 Biological Methods of Screening 20 10 5 5 60 100 PPRPH1004 Research Methodology and statistical Methods 20 10 5 5 60 100 Total 400



Mid sem exam

End sem

Grand total


II Semester Theory


Quiz/ MCQ

Assign -ment

Atten-dance

End Sem

Grand total

PPRPH2201 Stability of Drugs and Drug Products 20 10 5 5 60 100 PPRPH2202 Advanced Instrumental Methods of Analysis 20 10 5 5 60 100 PPRPH2203 Chromatographic Methods of Analysis 20 10 5 5 60 100 PPRPH2204 Quality Assurance, GMP & Validation 20 10 5 5 60 100 Total 400



Assessment Mid sem

exam End sem

Grand total

PPRPH2211 Stability of Drugs and Drug Products 40 20 40 100 PPRPH2212 Advanced Instrumental Methods of Analysis 40 20 40 100 PPRPH2213 Chromatographic Methods of Analysis 40 20 40 100 PPRPH2214 Seminar Presentation 100 100 PPRPH2215 Assignments on Research Paper 100 100 PPRPH2216 Comprehensive Viva-Voce 100 100 Total 600 Grand Total (Theory + Practical) 1000

III Semester



End sem

Grand total


100 100


100 100

Total 200

20

IV Semester


Mid sem exam

End sem

Grand total

PPRPH4001


100 100


21

Scheme of Examination for Master of Pharmacy (M. Pharmacy) Pharmaceutical Chemistry

I Semester -Theory


Quiz/ MCQ

Assign -ment

Atten-dance

End Sem

Grand total


I Semester Practical Subject Code Name of the Subject Day to day

Assessment Mid sem

exam End sem

Grand total


II Semester Theory


Quiz/ MCQ

Assign -ment

Atten-dance

End Sem

Grand total

PPRPH2301 Chemistry of Bulk Drugs 20 10 5 5 60 100 PPRPH2302 Advanced Medicinal Chemistry 20 10 5 5 60 100 PPRPH2303 Chemistry of Natural Products 20 10 5 5 60 100 PPRPH2304 Stereochemistry and Reaction Mechanism 20 10 5 5 60 100 Total 400

II Semester Practical Subject Code Name of the Subject Day to day

Assessment Mid sem

exam End sem

Grand total

PPRPH2311 Chemistry of Bulk Drugs 40 20 40 100 PPRPH2312 Advanced Medicinal Chemistry 40 20 40 100 PPRPH2313 Chemistry of Natural Products 40 20 40 100 PPRPH2314 Seminar Presentation 100 100 PPRPH2315 Assignments on Research Paper 100 100 PPRPH2316 Comprehensive Viva-Voce 100 100 Total 600 Grand Total (Theory + Practical) 1000

III Semester Subject Code Name of the Subject Day to day


End sem

Grand total


100 100


100 100

Total 200

IV Semester Subject Code Name of the Subject Day to day

Assessment Mid sem

exam End sem

Grand total

PPRPH4001


100 100


22

Scheme of Examination for Master of Pharmacy (M. Pharmacy) Pharmacology

I Semester Theory


Quiz/ MCQ

Assign -ment

Atten-dance

End Sem

Grand total


I Semester Practical Subject Code Name of the Subject Day to day

Assessment Mid sem

exam End sem

Grand total


II Semester Theory Subject Code Name of the Subject Mid

sem Quiz/ MCQ

Assign -ment

Atten-dance

End Sem

Grand total

PPRPH2401 Pharmacokinetics and Drug Metabolism 20 10 5 5 60 100 PPRPH2402 Advanced Systemic Pharmacology 20 10 5 5 60 100 PPRPH2403 Cellular and Molecular Pharmacology 20 10 5 5 60 100 PPRPH2404 Clinical Pharmacology and Toxicology 20 10 5 5 60 100 Total 400

II Semester Practical Subject Code Name of the Subject Day to day

Assessment Mid sem

exam End sem

Grand total

PPRPH2411 Pharmacokinetics and Drug Metabolism 40 20 40 100 PPRPH2412 Advanced Systemic Pharmacology 40 20 40 100 PPRPH2413 Bioassays and Screening Methods 40 20 40 100 PPRPH2414 Seminar Presentation 100 100 PPRPH2415 Assignments on Research Paper 100 100 PPRPH2416 Comprehensive Viva-Voce 100 100 Total 600 Grand Total (Theory + Practical) 1000

III Semester Subject Code Name of the Subject Day to day


End sem

Grand total


100 100


100 100

Total 200

IV Semester Subject Code Name of the Subject Day to day

Assessment Mid sem

exam End sem

Grand total

PPRPH4001


100 100


23

PHARMACEUTICS SEMESTER – I

PPRPH 1001: DOSAGE FORM DESIGN

(THEORY)

UNIT – I 1. Preformulation Studies in Pharmaceutical Product Development: Introduction, organoleptic properties, purity, particle size, shape, and surface area. Solubilisation, surfactants and its importance, temperature, pH, pKa, partition coefficient, co-solvency; Techniques for the study of crystal properties and polymorphism. Physicochemical characteristics of new drug molecules with respect to different dosage forms. 2. Drug Stability : Introductory overview: Importance of stability attributes for drug products, potential adverse effects of instability in pharmaceutical products, the gamut of stability concerns, reasons for stability testing, modes of degradation, the essential elements of high quality cost effective stability programme, conformance periods, shelf life and expiration dates, some possible strategies to improve shelf life. Solution stability, solid state stability, parameters for physical stability, protocol for physical stability testing, determination of shelf life by accelerated stability testing studies. UNIT – II Product Development: a) Formulation of pharmaceutical dosage forms (solid dosage forms). b) Formulation of pharmaceutical dosage forms (liquid dosage forms). c) Formulation of pharmaceutical dosage forms (semi-solid dosage forms). d) Formulation of pharmaceutical dosage forms (parenterals). UNIT – III Evaluation of pharmaceutical products: a) Evaluation of pharmaceutical dosage forms (solid dosage forms). b) Evaluation of pharmaceutical dosage forms (liquid dosage forms). c) Evaluation of pharmaceutical dosage forms (semi-solid dosage forms). d) Evaluation of pharmaceutical dosage forms (parenterals). UNIT – IV Cosmetic Formulations: Formulation and evaluation of various cosmetic preparations like Hair care products, Skin care products, Colour cosmetics, Dental Products, Personal hygiene products. Safety consideration and safety testing of cosmetic products. UNIT – V Pharmaceutical additives, drug excipient interactions and incompatibility, method to detect drug excipient interactions. Packaging Technology: Introduction, packaging protection functions, ICH guidelines, material and pack selection, testing the finished products in its pack- leakage detection method, evaluating rubber stopper assembly, legislations and guidelines relating to packaging, modern packaging technology including blister packing, product labeling consideration on packaging materials. Books Recommended: 1. L. Lachman, Lieberman and Kanig: “The Theory and Practice of Industrial Pharmacy”, Varghese

Publishing House, Mumbai. 2. Herbert A. Lieberman, Leon Lachman and Joseph B. Schwartz ed., “Pharmaceutical Dosage

Forms – Tablets”, Volumes 1 to 3, Marcel Dekker, NY. 3. Kenneth E. Avis, Leon Lachman and Herbert A. Lieberman ed.: “Pharmaceutical Dosage Forms-

Parenteral Medications”, Volume 1 and 2, Marcel Dekker, NY. 4. Herbert A. Lieberman, Martin M. Rieger and Gilbert ed.: “Pharmaceutical Dosage Forms-

Disperse Systems”, Volume 1 and 2, Marcel Dekker, NY.

24

5. G.S Banker and C.T. Rhodes ed. “Modern Pharmaceutics” Marcel Dekker, NY. 6. Salvatore Turco and Robert E. King: “Sterile Dosage Forms” Lea and Febiger, Philadelphia. 7. L. V. Allen, N. G. & Popovich H. C. Ansel: “Ansel’s Parmaceutical Dosage Forms and Drug

Delivery Systems”, 8th edition, Lipincott William & Wilkins, USA, 2005. 8. M. E. Aulton: “Pharmaceutics – The Science of Dosage Form Design”, 2nd edition, Churchill

Livingstone, 2002 9. Patrick J. Sinko Ed.: “Martin’s Physical Pharmacy and Pharmaceutical Sciences”, 5th edition,

Lippincott Williams & Wilkins, 2009. 10. Walter Lund Ed.: “The Pharmaceutical Codex – Principle and Practice of Pharmaceutics”, 12th

edition, CBS Publishers (India) & The Pharmaceutical Press (London), 2009. 11. E. A. Rawlins ed.: “Bentley's Text Book of Pharmaceutics” EL. Publications. 12. H. Butler Ed.: “Paucher’s Perfumes, Cosmetics & Soaps”, 10th edition (1st Indian edition), Springer

(India) Pvt. Ltd. 13. B.M. Mithal, R.N. Saha: “A Handbook of Cosmetics”, 1st edition (Reprint), Vallabh Prakashan,

Delhi, 2010. 14. P.S. Kohli: “Drug Formulation Manual”, Eastern Publishers, New Delhi. 15. J.I. Wells: “Pharmaceutical Preformulation”, Ellis Horwood Ltd., NY, 1988. 16. Harry’s text book of Cosmeticology 17. Cosmeceuticals, marcel Dekker Inc. NY 18. T. Carstensen & C T Rhodes: “Drug Stability Principles and Practices”, Marcel Dekker Inc. NY

PPRPH 1002: INSTRUMENTAL METHODS OF ANALYSIS

(THEORY)

UNIT – I UV-Visible spectroscopy: Brief review of electromagnetic spectrum, UV-Visible range, energy-wavelength-colour relationships. Interaction of electro - magnetic radiation (UV-Vis) and matter and its effects, Chromophores and their interaction with EMR, Woodward-Fieser rule, Absorption spectra of organic compounds and complexes illustrating the phenomenon and its utilization in qualitative and quantitative studies of drugs, Beer-Lambert’s law, Shifts and their interpretation (including solvent effects). Multicomponent analysis, derivative spectroscopy, Instrumentation Spectrofluorimerty: Fluorescence, Phosphorescence, Chemiluminescence - Theory, instrumentation and applications Infrared Spectrophotometry:Nature of Infra-red radiation, Interaction of IR radiation with organic molecules and effects on bonds, Molecular or infra-red spectra, Brief outline of classical IR instrumentation and interpretation of spectra, including sample preparation for spectroscopy, Qualitative interpretation of IR Spectra, Influence of substituent’s, ring size, hydrogen bonding vibrational coupling and field effect on frequency, Quantitative methods, FT-IR and applications. Recent advances in IR Spectroscopy (FT-NIR) UNIT – II Nuclear Magnetic Resonance Spectroscopy: Fundamental principles of NMR (Magnetic Properties of nuclei, applied field and precession, absorption and transition frequency). Chemical shift concept, Isotopic nuclei, Reference standards, proton magnetic spectra, their characteristics, presentation, terms used in describing spectra and their interpretation (signal no., position, intensity), Brief outline of instrumental arrangements and some practical details, Signal multiplicity phenomena in high resolution NMR, Spin-spin coupling, Application of Signal Splitting and coupling constant data to interpretation of spectra, Decoupling and shift reagent methods. Quantitative NMR. Brief outline of principles of 13C NMR. Introduction to 2-D NMR Techniques. Applications of NMR technique in Pharmaceutical science and biotechnology. Mass Spectrometry: Theory instrumentation, practical consideration, structure elucidation, detection of impurities, quantitative analysis, application to determination of structure, the gas chromatograph mass spectrometer combination. Atomic spectroscopy and plasma emission spectroscopy, Electron microscopy Optical Rotatory Dispersion: Terminology ,Plain Curves, Rotatory dispersion of ketones, The Axial Haloketone Rule, Octant Rule.

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UNIT – III Recent trends in chromatography with reference to analysis of drugs and related substances: a) High performance TLC –Principle, adsorbents, retention and separation parameters, detection methods, qualitative and quantitative HPTLC. b) Gas Chromatography: Introduction, principles, Instrumentation, carrier gas, types of columns, column selection- liquid stationary phases, column efficiency parameters, the Van Deemter equation, Resolution, Derivatisation methods, Detectors. A critical comparison of sensitivity, selectivity and field of applications of these detectors. Applications of GC in Pharmaceutical science. Hyphenated techniques: Brief introduction and applications. c) Hyphenated techniques-Brief introduction and applications Liquid Chromatography: Instrumentation, columns, packing materials, column selection, mobile phase selection, efficiency parameters, resolution and optimization of chromatographic parameters. Detectors in HPLC: Comparison of sensitivity , selectivity and field of applications of these detectors. Modes of HPLC-Ion-pair, Ion-exchange, Size exclusion, Supercritical, Chiral, Gel-permeation, Flash chromatography. Applications of liquid chromatography. Electrophoresis: Principle, techniques, instrumentation including detection strategies and applications in paper and gel electrophoresis. UNIT – IV Liquid Chromatography: Instrumentation, columns, packing materials, column selection, mobile phase selection, efficiency parameters, resolution and optimization of chromatographic parameters. Detectors in HPLC: Comparison of sensitivity selectivity and field of applications of these detectors. Modes of HPLC-Ion-pair, Ion-exchange, Size exclusion, Supercritical, Chiral, Gel-permeation, Flash chromatography. Applications of liquid chromatography.

Electrophoresis: Principle, techniques, instrumentation including detection strategies and applications. UNIT-V Thermo gravimetric Analysis (TGA), Differential thermal analysis (DTA), Differential

Scanning Calorimetry (DSC), X ray Diffraction(XRD). Radio assaying, Radio immuno assaying and auto radiography. Computer aids in Pharmaceutical Analysis. Statistical treatment of data, test for significance, analysis of variance, multivariant statistics. All topics will include instrumentation methodologies, techniques and applications to structural and quantitative analysis of drug and their methodologies. Books Recommended: 1. H. Beckett & J. B. Stenlake: “Practical Pharmaceutical Chemistry”, 4th edition, Part-1, CBS

Publishers, New Delhi, 2005 2. C. D. Jerassi: ”Optical Rotatory Dispersion “(For ORD). 3. Robert. D. Brown: “Introduction to Instrumental Analysis”, Pharma Book Syndicate, 2006. 4. Chatwal & Anand: “Instrumental Methods of Analysis”, 5th edition, Himalaya Publishing House,

2008. 5. B. K. Sharma,” Instrumental and Chemical Analysis”, 25th edition, Goel Publishers. 6. C. N.R. Rao: ” UV and Visible Spectroscopy – Chemical Application” 7. Silverstein: ”Spectrometric Identification of Organic Compound”, John Wiley & sons. 8. C. N. R. Rao: “Chemical Application of IR Spectroscopy “ 9. Weissberger: ”Physical Methods of Organic Chemistry-“ 10. B.Kienicz & C. Djerassi: ”Interpretation of Mass Spectra of Organic Compounds” 11. Jackmann: ”Application of NMR Spectra to Organic Chemistry” 12. Willard, Meritt, Dean, Settle, Wadworth: “Instrumental method of Analysis”, 7th edition, CBS

Publishers, New Delhi. 13. John R. Dyer: ”Applications of Absorption spectroscopy of organic compounds “ Prentice Hall of

India, New Delhi.

26

14. “Indian Pharmacopoeia” Government of India, Ministry of Health & Family Welfare, the Indian Pharmacopoeia Commision, Ghaziabad, 2007.

15. “British Pharmacopoeia”, British Pharmacopoeia Commision, The Stationary Office,6th edition, 2009.

16. “United States Pharmacopoeia”, USP 32 – NF 27, Vol 1 & 2, Asian Edition, 2008. 17. D. A. R Williams: ”Nuclear Magnetic Resonance Spectroscopy”, John Wiley & Sons, 2008. 18. Clive Whiston: ”X-Ray Methods”, John Wiley & Sons, 2008. 19. Stuart, George, Peter: ”Modern Infra Red Spectroscopy”, John Wiley & Sons, 2008. 20. W. Geary: ”Radio Chemical Methods”, John Wiley &Sons, 2008. 21. Michael Thomas: ”Ultra Violet and Visible Spectroscopy”, John Wiley & Sons,2008. 22. James Barker: ”Mass Spectrometry”, 2nd edition, John Wiley & Sons, 2008. 23. James W. Dodd & Kenneth: ”Thermal methods” John Wiley & Sons, 2008. 24. Maureen Melvin: ”Electrophoresis”, John Wiley & Sons, 2008. 25. William Kemp: ”Organic spectroscopy” ELBS, London. 26. Kalsi: ”Spectroscopy of Organic compounds” New age International.

PPRPH1003: BIOLOGICAL METHODS OF SCREENING

(THEORY) 4 Hrs/ Week

UNIT- I Drug Discovery Process: Principles, techniques and strategies used in new drug discovery. High throughput screening: Human genomics; Regulations for laboratory animal care and ethical requirements: Organization of screening.

UNIT- II Preclinical and clinical models employed in the screening of new drugs belonging to following categories: Antipsychotic agents, Anti anxiety Agents; Nootropic Drugs; Antidepressant Drugs; Anticonvulsants; Anti Parkinsonism Agents; Opioid Analgesics; Anti-Inflammatory Drugs. UNIT- III Preclinical and clinical models employed in the screening of new drugs belonging to following categories: Infarction; Antihypertensive; Anti Atherosclerotic Drugs; Anti Malarial; Anthelmintics; Anti Diabetics; Models For Local Anesthetics; Activity on the GI Tract, Transgenic Animals And Other Genetically Prone Animal Models. UNIT- IV Principles of Biological Standardization: Methods of biological assay, Principles of biological assays with certain examples as per IP and BP. Development of new bioassay methods. Alternatives to animal screening procedures: Cell-Line, Patch-Clamp Techniques, In-Vitro Models, molecular biology techniques. Principles of toxicity evaluations, ED50, LD50 and TD values. International guidelines (ICH recommendations). UNIT- V Receptor-Radioligand Binding Assays: General principles and techniques of radio ligand binding assays. Specific assay design for adrenoreceptors, dopamine receptors, histamine receptors, GABA and benzodiazepine receptors. Immunoassay: General principles of immunoassay, Theoretical basis, Optimization of immunoassay, Heterogenous immunoassay system, Homogenous immunoassay system. Production of immunoassay reagent: Introduction, receptors or binders, unlabeled ligands Calibrators, Labeled ligands and receptor, Separation technique, buffers. Immunoassay Methods Evaluation: Protocol outline, objective &preparation, evaluation of precision, standard tracer, sensitivity, evaluation of accuracy, antibody characteristics, monitoring, reaction conditions, clinical evaluation.

27

Books Recommended: 1. H. G. Vogel: “Drug Discovery and Evaluation-Pharmacological Assays”, 2nd edition, Springer

Verlag, Berlin, Germany, 2002. 2. Robert A.Turner: “Screening Methods in Pharmacology” 3. M. N. Ghosh: “Fundamentals of Experimental Pharmacology”, 2nd edition, Scientific Book Agency,

Calcutta, India, 1984. 4. D. R. Laurence and A.L. Bacharach: “Evaluation of Drug Activities: Pharmacometerics”, Vol. 1,

Academic Press, London, U.K., 1964. 5. David R. Gross: “Animal Models in Cardiovascular Research”, 2nd edition, Kluwer Academic

Publishers, London, U.K., 1994.

PPRPH 1004: RESEARCH METHODOLOGY AND STATISTICAL METHODS (THEORY)

UNIT – I Research Process: Introduction to research methodology, objectives, classification of research methods: Historical method, case study method, survey method, experimental method, and other methods( field investigation research, evaluation research, auction research, ex-post facto research, laboratory research, business game) – Definition, significance, sources, advantages, limitations, steps involved in research. Research Problem: sources, criteria of a good research problem, formulating and stating the problem, common errors in selecting and formulating a research problem. Research Design: Definitions, need for a research design, characteristics of good research design, components of a research design, types of research design: descriptive, diagnostic, exploratory and experimental. UNIT – II Sampling Methods: Introduction of sampling, probability and non probability sampling, sampling procedures – simple random, stratified, systematic, cluster and multistage sampling, concept of sampling distribution. Collection and Processing of Data: Sources of data, methods of collection of primary and secondary data, editing, coding, classification and tabulation of data, graphical and representation of data, diagrammatic representation of data. UNIT – III Inferential Statistics: Basics of Statistical Inference, Sampling distribution, Estimation – Point estimation, Interval estimation, Parameter, Statistic, Concept of a hypothesis, Research Hypothesis, Null Hypothesis, Level of Significance, Comparison of means of two samples, Comparison of sample proportion with population proportion, Comparison of two sample proportions, Degrees of Freedom, Critical Value, Table value, Type I and Type II errors, Rules for rejection & acceptance of Null Hypothesis, Standard Error. UNIT – IV Inferential Statistics – Parametric and Non-Parametric Test: ‘t’ test – Comparison of sample mean with the population mean, Comparison of means of two independent samples, Comparison of two correlated samples ‘Z’ test – different applications ANOVA – one way ANOVA: ‘F’ test, Chi square test. UNIT – V Correlation and Linear Regression: Introduction of correlation & regression concepts, estimation of correlation coefficient, regression coefficients, variance of sample estimates of the parameters, non linear regressions, weighted and transformations in regression analysis, application of linear regressions - standard curves in drug analysis and drug stability studies, analysis of covariance.

28

Books Recommended: 1. Santosh Gupta: “Research Methodology and Statistical Techniques”, Deep & Deep Publication,

2001 2. C. R. Kothari: “Research Methodology – Methods & Techniques”, 2nd edition, Wishwa Prakashan,

2000. 3. K. P. C. Swain: “A Text book of Research Methodology”, 1st edition, Kalyani Publishers, 2007. 4. “Research Methodology and Statistical Techniques” Indira Gandhi National Open University.

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PPRPH 1011: DOSAGE FORM DESIGN (PRACTICAL)

1. Accelerated stability studies of various formulations or drugs with respect to (a) Temperature (b)

Effect of buffers / pH dependent (2 – 4 Expts.) 2. Formulations and evaluation of some liquid orals such as Analgesic-antipyretics, Antihistamines,

Co-trimoxazole, suspensions etc. (2 – 3 Expts.) 3. Formulation and evaluation of stability of reconstituted dry syrups of Amoxicillin, Ampicillin etc. ( 2

Expts.) 4. Preparation and evaluation of diclofenac sodium gels containing two different bases. (2 Expts.) 5. Formulation and evaluation of semisolid dosage forms using different – bases and drugs

(cetrimide, salicylic acid) of current interest. 6. To study the effect of particle size, moisture content and lubricants on flowability and

compressibility of powders. 7. Study of effect of various binding agents on the properties of tables (2 Expts.) 8. Preparation and evaluation of Skin care and Hair care products (4-5 Expts)

PPRPH 1012: INSTRUMENTAL METHODS OF ANALYSIS (PRACTICAL)

1. Use of spectrophotometer for analysis of pharmacopoeial compounds and their formulations. 2. Use of fluorimeter for analysis of pharmacopoeial compounds. 3. Use of Flame Photometer for analysis of Na+, K+ & Ca++ etc. in Biological fluids and formulations. 4. Use of Potentiometer and Conductometer for the analysis of Pharmacopoeial compounds. 5. Use of Nephelo-Turbidimetric analysis for dispersions and limit tests. 6. Experiments on electrophoresis. 7. Experiments on chromatography.

a. Adsorption chromatography - thin layer chromatography. b. Paper chromatography: Ascending technique,Descending technique,Circular technique. c. HPLC

8. Assays involving following procedures : Non-Aqueous, Diazotisation, Complexation and Redox titrations.


(PRACTICAL) 6 Hrs/Week

1. Introduction to Pharmacological evaluation methods and CPCSEA and OECD guidelines, GLP

norms 2. Standard techniques for injection of drugs, collection of blood samples and feeding of animals 3. Study of various techniques of anesthesia and euthanasia 4. To study the effect of pentobarbital on righting reflex (hypnosis) in mice 5. To study the effect of chlorpromazine on the locomotor activity of mice using actophotometer 6. To study the apomorphine induced compulsive behaviour (stereotype) in mice 7. To study the muscle relaxant property of diazepam in mice using rotarod apparatus 8. To study the analgesic effect of morphine in mice using the tail-flick method and hot plate method 9. To study the analgesic effect of morphine against acetic acid-induced writhing in mice 10. To study the anti-inflammatory property of indomethacin against carrageenan-induced paw

edema 11. General methods for evaluating the antimicrobial activities of chemotherapeutic agents. 12. Estimation of biochemical and free radical scavengers. 13. General screening methods for the anti ulcer activity, intestinal motility, and anti-diarrheal.. 14. General screening procedure of anti-hypertensive’s. 15. General screening methods for evaluating the diuretic activity

30

Books Recommended: 1. R. A Turner: “Screening Methods in Pharmacology”, Academic Press, London1965 2. H.G. Vogel (ed), Drug Discovery and Evaluation-Pharmacological Assays, 2nd edition, Springer

Verlag, Berlin, Germany, 2002. 3. S .K. Kulkarni: “Hand Book of Experimental Pharmacology”, 3rd edition, Vallabh Prakashan

Publisher, Delhi,1999. 4. J. H. Burn: ”Practical Pharmacology”, Blackwell Scientific, Oxford, London. 5. M. N. Ghosh: “Fundamental of Experimental Pharmacology”, Scientific Book Agency, Calcutta. 6. P. Jaju: ”Pharmacology: A Practice Exercise Book”. Jaypee Brothers, New Delhi. 7. D. R. Lawrence and A. L. Bacharch: ”Evaluation of Drug Activities–Pharmacometrics ”Academic

Press. 8. W. L. M. Perry: ”Pharmacological Experiments on Isolated Preparations”, E & S, Livingston,

London. 9. U. K. Sheth, N K. Dadkar and U. G. KamaT: “Selected Topics in Experimental Pharmacology”,

Kothari Book Depot, Mumbai. 10. E. B. Thomson: “Drug Bioscreening” VCH, New York.

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Semester - II PPRPH 2101: NOVEL DRUG DELIVERY SYSTEMS

(THEORY)

UNIT - I Fundamentals of controlled drug delivery systems, terminology, potential advantages, drug properties relevant to formulation, pharmacokinetic and pharmacodynamic basis of controlled drug delivery.

UNIT - II Design, fabrication, evaluation and applications of the following controlled release systems: Controlled release oral drug delivery systems. Modulated GI retentive drug delivery systems. UNIT - III Parenteral controlled drug delivery systems Implantable therapeutic systems: Osmotic – Pump Delivery Transdermal therapeutic systems. Ocular and Intravaginal – Intrauterine- and Intraurethral- Drug Delivery Devices. UNIT – IV Bioadhesive drug delivery systems. Proteins and peptide drug delivery Resealed erythrocytes Colloidal drug delivery systems: Liposomes, microspheres, nanoparticles and polymeric micelles UNIT - V Drug targeting: Concepts and drug carrier systems. Approaches to active drug targeting: Monoclonal antibodies, Targeting to particluar organs such as brain, lungs, liver and targeting to neoplastic diseases. Books Recommended: 1. Banker and Rhodes, Eds.: “Modern Pharmaceutics,” 3rd ed.(Revised & Expanded), Marcel

Dekker series in Drugs and Pharmaceutical Sciences –Vol. 72), 1996. 2. L. V. Allen, N. G. Popovich & H. C. Ansel: “Ansel’s Parmaceutical Dosage Forms and Drug

Delivery Systems”, 8th edition, Lipincott William & Wilkins, USA, 2005. 3. Gebelein & Carraher, Jr., Eds.: “Polymeric Materials in Medication,” Plenum Press (Polymer Sci.

& Biotechnology- Vol. 32), 1985. 4. McGinity, Ed.: “Aqueous Polymoric Coating for Pharmaceutical Dosage Forms”, Marcel Dekker

(series in Drugs and Pharmaceutical Sciences –Vol.36), 1989. 5. Y. W. Chien: “Novel Drug Delivery System”, 2nd edition (Revised and Expanded), vol. 50, Drugs

& the Pharmaceutical Sciences, Marcel Dekker, New York, 2007. 6. J. R. Robinson and V. H. Lee Ed.: “Controlled Drug Delivery – Fundamentals and Applications”

2nd edition (Revised and Expanded), vol. 29, Drugs & The Pharmaceutical Sciences, Marcel Dekker, New York, 2005.

7. Jain, Ed.: “Advances in Controlled & Novel Drug Delivery,” CBS Publishers & Distributors, 2000. 8. Potts and Guy, Eds.: “Mechanisms of Transdermal Drug Delivery,” Marcel Dekker (series in

Drugs and Pharmaceutical Sciences -Vol. 83), 1997. 9. “Remington: The Science and Practice of Pharmacy”, 21st edition, Lippincott William & Wilkins,

USA, 2006. 10. Rawlins ed.: “Bentley’s Text Book of Pharmaceutics”, EL. Publications. 11. Simon Benita: “Microencapsulation”, Marcel Dekker Inc. 12. Drug Targeting and Delivery edited by H.E.Junginger 13. Specialized Drug Delivery Systems edited by Praveen Tyle, Pub. By Marcel Dekker Inc. 14. Colloidal Drug Delivery System by Jorg Kreuter.

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PPRPH 2102: ADVANCED PHYSICAL PHARMACEUTICS (THEORY)

UNIT – I Solubility in systems containing Surface-Active agents: Theory of micelles formation, physical methods of investigation of Micellar solution, factors influencing critical Micelle concentration.Theory of Mechanism of solubilization. Phase equilibria in systems containing surface-active agents, factors involved in the formation of solubilized pharmaceutical products, formulation of solubilized products, containing vitamins and Hormones. Complexation: Metal complex, organic molecular complex, inclusion compounds, crystalline structure of complexs, hydrophobic interactions, analysis of complex. Protein binding and complexation influencing the drug action. Thermodynamic treatment of stability constants. UNIT – II Kinetics and Drug stability: Rate equation, kinetics of decomposition, stability testing protocol, drug degradation and methods of stabilization, methods of accelerated stability testing in dosage forms, freeze-thaw methods, centrifugal methods, temperature and humidity control. Solid state properties: Crystal properties and polymorphism, techniques for study of crystal properties; solid state stability, flow properties of powders.

UNIT – III Polymer Science: Types of polymers, properties of polymers, thermodynamics of polymer solution and polymers in solid state. Applications of polymers in pharmaceutical formulations. Rheology of Powders: Basic properties of powders, fundamental properties of powder relation to flow properties. Evaluation, flow properties of powder systems. Rheology Application and Practice: Factors affecting rheological properties, Rheology and product design, Rheology and Pharmaceutical Processing, Biological application UNIT – IV Physics of Tablet Compression: Solid behavior under compression: Transmission of forces through power, distribution of forces within the power mass, Dye wall pressure, Effect of pressure on relative volume, lubrication of dye-wall. Adhesion and cohesion of particles during granulation of granules. Bonding during compression and strength of tablet, factors affecting strength of tablet. Theories of Dispersion: Solid liquid dispersion: absorption, wetting, crystal growth mechanisms and prevention of crystal growth. Solid Dispersion: Introduction and classification, Mechanism of formation, methods of analysis, pharmaceutical applications. UNIT – V Diffusion and Dissolution: Steady state diffusion, measurement of diffusion coefficient, Dissolution: Dissolution rate, dissolution of tablets and granules, Hixon-Crowell Cube root law in dissolution of powder. Drug release from polymer and granular matrices. Diffusion principles in Biological systems: Gastro-intestinal absorption of drugs, pH partition hypothesis. Modification of the pH partition principles, percutaneous absorption, Buccal absorption, uterine diffusion. Books recommended: 1. Bean, Backett & Carless: “Advances in Pharmaceutical Sciences” Vol. I-IV 2. Patrick J. Sinko Ed.: “Martin’s Physical Pharmacy and Pharmaceutical Sciences”, 5th edition,

Lippincott Williams & Wilkins, 2009. 3. Leon Lachman, H. A. Lieberman & J. L. Kanig : “The Theory and Practice of Indusrtrial

Pharmacy”, 3rd edition, Varghese Publishing House, Bombay, 1991. 4. E. Shotton: “Physical Pharmaceutics”, 1st Indian edition, Oxford University press, London, 2008.

33

PPRPH 2103: BIOPHARMACEUTICS AND CLINICAL PHARMACOKINETICS (THEORY)

UNIT – I Bioavailability and bioequivalence: Bioequivalence and its determination, study design for the assessment of bioavailability and bioequivalence, factors influencing bioavailability and bioequivalence. Correlation of in vitro dissolution & in vivo bioavailability. Statistical concepts in estimation of bioavailability and bioequivalence. Factors affecting bioavilability: Physico-chemical factors and formulation factors UNIT – II Transport of drugs through membranes and barriers other than GI Tract: Buccal absorption , salivary excretion of drugs , excretion of drugs via sweat, excretion of drugs into milk, penetration of drugs into eye, transfer across placenta, passage of drugs into and out of cerebrospinal and brain. Measurment and Interpretation of in vitro Rates of Dissolution. Intrinsic rates of dissolution, dissolution of drugs from solid dosage forms, various modern methods and models for testing dissolution rate, factors and kinetics of dissolution. UNIT – III Pharmacokinetics: Consideration of one, two and multiple compartment models on intravenous administration, intravenous infusion and first order absorption of single dose. Kinetic of multiple dosing: Dosage regimens, loading and maintenance doses, one and two compartment models on intervenous administration, and first order absorption of single dosing. Kinetics of reversible pharmacological effects - direct and indirect effects. Clinical Pharmacokinetics Concept, absorption, distribution and renal clearance and elimination, Disposition and absorption kinetics, intravenous dose, constant i.v. infusion, single dose oral administration, multiple dose injections, multiple dosage oral administration, metabolite kinetics. Curve Fitting, Wagner-Nelson, Loo Riegelman methods and Deconvolution methods for estimation of absorption rate constants. Therapeutic regimens: Therapeutic response and toxicity, Clinical trial studies. UNIT – IV Physiologic Pharmacokinetic Models: Concepts, physiologic pharmacokinetic models with binding blood flow - limited versus diffusion – limited model, applications and limitation of physiologic pharmacokinetic models, Mean Residence Time (MRT), Statistical Moments Theory, Mean Absorption Time (MAT), Mean Dissolution Time (MDT). Non-Linear Pharmacokinetics: Recognition of non-linearity, one and two compartment open model with Michaelis- Menton kinetics, determination of Km and Vm, non-linear tissue binding constants. UNIT – V Clinical Pharmacokinetics: Altered kinetics in pregnancy, child birth, infants and geriatrics, kinetics in G.I. disease, malabsorption syndrome, liver, renal, cardiac and pulmonary disease state. Drug Interaction : Kinetics of drug interaction, study of drug-drug interactions mediated through absorption, metabolism and elimination, Mechanism of interaction and consequence. Influence of alcohol, smoking, food and beverages on drug action. Drub Metabolism: Site of metabolism, factors effecting drug metabolism, types of biotransformation of drugs in the body Books Recommended: 1. Gibaldi M., Pharmacokinetics, Marcel Dekker Inc. New York. 2. Milo Gibaldi: “Biopharmaceutics and Clinical Pharmacokinetics”, 4th edition (Indian Reprint),

PharmaMed Press, 2008. 3. H.M. Abdou, Dissolution, Bioavailbility and Bioequivalence, Mack Publishing Co. Easton , PA 4. R. V. Smith & J. T. Stewart: “Text Book of Biopharmaceutical Analysis”, Lea and Febiger,

Philadelphia. 5. J. G. Wagner: “Fundamentals of Clinical Pharmacokinetics”, Drug Intelligence Pub. Hamilton.

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6. P. G. Welling, F.I.S. Tse, & S. V. Dighe, ed.: “Pharmaceutical Bioequivalance”, Marcel Dekker Inc., New York

7. Gibalidi and D.Perrier: “Pharmacokinetics”, Marcel Dekker Inc., New York. 8. M. Rowland & T. N.Tozer: “Clinical Pharmacokinetics – Concept and Applications”, Lea and

Febiger, USA. 9. L. Shargel, & ABC.Yu: “Applied Biopharmaceutics & Pharmacokinetics”, Appleton and Lange,

Connecticut, USA. 10. R. E. Hotari: “Biopharamaceutics and Clinical Pharmcokinetics”, Marcel Dekker Inc., New York

and Basel.

PPRPH 2104: INDUSTRAIL PHARMACY

(THEORY)

UNIT - I

Pilot Plant Scale Up Techniques: Significance of pilot plant scale-up phase to effect an orderly set up from laboratory procedures and formulations to routine production procedures. Pilot study of some important dosage forms such as tablets, capsules and liquid orals and discussion on important parameters such as formula and equipment, product uniformity and stability. Raw materials and process, physical layouts, personnel requirements and reporting responsibilities.

Optimization techniques in pharmaceutical and processing: Optimization parameters, statistical design and other applications, design, development and optimization of in-vitro test systems to evaluate and monitor the performance of different types dosage forms, the relevance and importance of in-vitro/in-vivo associations at every stage of product development and manufacture, the regulatory evolution and current thinking on this aspect, application of statistical techniques in product development and evaluation including quality control.

UNIT – II

Drug Regulatory Affairs:

Drugs and Cosmetic Act 1940 and Rules made there under in 1945 with reference to, import and manufacture of drugs (Allopathic drugs), Schedules to the Act and Rules with special reference to schedule M , the current Good Manufacturing Practices (Preparation of Batch manufacturing record, batch packing record, validation protocol, standard operating procedure for equipments, flow charts etc.)

OPPI Guidelines

Drug Price Control Order

UNIT – III

Global Regulatory Requirements Brief introduction to general requirements of health regulatory agencies such as US FDA, MCA, TGA, WHO, ANVISA etc., Decision trees for the various steps in regulatory guide lines like ICH, SUPAC etc., Basics in Drug approval process with special reference to some of the following:

(a) History and Various phases of drug development and drug approval (b) Investigational New drug (IND), (c) New Drug Application (NDA) (Phase I-IV): content and format (d) Abbreviated new drug application (ANDA); (e) Content, development flow sheet and format, exclusivity, concept of paragraph I to IV (f) Clinical study and basic concepts of Good clinical practice

Introduction to orange book, freedom of information (FOI), inactive ingredient guide (IIG), Drug master file (DMF), open part of DMF, codes of therapeutic equivalency, CDER, CBER Validation of process like blending, granulation, cleaning validation, equipments like sterilizers, filters, dissolution apparatus, etc., Computer system validation (21CFR 11), basic concept in analytical method validation.

35

UNIT – IV

Patents and Intellectual Property Rights

Accreditation Agencies: NABL, ISO,

Production planning and control,

UNIT – V

Environment protection Act, Pollution Control, Factories Act.

Industrial Safety: Industrial hazards due to fire accidents, mechanical and electrical equipments, Chemicals and pharmaceuticals; Monitoring and preventive systems (Safety measures). Books Recommended : 1. Lachman Leon & H. A. Liberman, The Theory and Practice of Industrial Pharmacy, Varghese

Publishing Co. 2. Gilber S. Banker and C. T. Rhodes, Modern Pharmaceutics Marcel Dekker Inc. 3. Kenneth Harburn, Quality Control of Packaging materials in the pharmaceutical Industry. 4. Sidney H. Willing, Good Manufacturing Practice for pharmaceuticals, Mercel Decker Inc. 5. Kinam Park, Shalaby. S. W, and Haesun park, Biodegradable Hydrogel for Drug Delivery,

Technomic Basel. 6. Armstrong, N. A. and James K. C. , Pharmaceutical Experimental Design and Interpretation,

Taylor and Francis, London. 7. Brody, A. L. and Marsh , K.S. , Encyclopedia of Packaging Technology, John wiley and sons,

New York. 8. Remingtons “Pharmaceutical Sciences” 9. Bentley’s Pharmaceutics. 10. Pilot plants model and scale-up methods, by Johnstone and Thring. 11. GMP practices for pharmaceutical –James Swarbrick. 12. How to practice GMPs by P.P.Sharma. 13. Chemical Engineering Plant Design by Vibrant. 14. Pharmaceutical Process Validation by Loftus and Nash. 15. Drug and Cosmetic Act 1940.

PPRPH 2111: NOVEL DRUG DELIVERY SYSTEMS (PRACTICAL)

1. Study on diffusion of drugs through various polymer members (2 expts.) 2. Preparation and study on invitro dissolution of various sustained action products and comparison

with marketed products (3 expts.) 3. Preparation of matrix tablets using various polymers like PVP etc and studying their release

patterns (2 expts.) 4. Preparation and evaluation of microcapsules by different microencapsulation techniques like:

(a) Simple coacervation techniques: Gelatin-water-ethanol. (b) Coacervation by temperature changes: Ethylcellulose in cyclohexane for phenobarbitone. (c) Coacervation by non-solvent-addition: cellulose acetate butyrate in methyl ethyl ketone using

isopropylether as non-solvent ( 1 expt. in each). 5. Preparation and evaluation of wax embedded micro-spheres of diclofenac sodium and

theophylline ( 2 expts.) 6. Preparation of various polymer films containing different drugs and studying the film

characteristics and release patters ( 3 expts.). 7. To perform sugar coating and nonenteric and enteric film coating on tablet and their evaluation (3

expts.) PPRPH 2112: ADVANCED PHYSICAL PHARMACEUTICS

(PRACTICAL) 1. Study of drug degradation kinetics for drugs like Aspirin 2. Determination of the aqueous solubility of given drug samples . 3. To study the apparent partition coefficient of a drug in n-octanol- water system. 4. To characterize polymers rheology

36

5. Physical stability testing of disperse systems 6. 7. Study of dissolution kinetics for commercial dosage forms 8. Study of drug diffusion through polymeric membranes 9. Analysis of binary complexes of drug and beta cyclodextrins 10. XRD, DSC studies of drug samples

PPRPH 2113: BIOPHARMACEUTICS AND PHARMACOKINETICS (PRACTICAL)

1. To perform bioequivalence testing on marketed analgesic / sulphonamide tablets. 2. Comparison of dissolution of different marketed products of co-trimoxazole and other

suspensions. 3. To determine Ka, biological half-life, AUC and other pharmacokinetic parameters of rifampicin /

nitrofurantoin by urinary excretion method. 4. To determine protein-binding of drugs by equilibrium dialysis method (2 expts.) 5. Bioavailability studies of paracetamol or any other drug by salivary data (2 expts.) 6. To study the influence of urinary pH on salicylate excretion. 7. Calculation of Ka, Ke, t ½, Cmax and Tmax from the given data (2 expts.) 8. Calculation of AUC and bioequivalence from the given data (2 expts.)

SEMESTER – III PPRPH3001 Seminar – I (Mid Semester Seminar on Selected Topics of respective

specialization)


SEMESTER – IV

PPRPH4001 Project dissertation (Preface, Objectives General introduction, Drug

profile, Review of Literature, Plan of work, Methodology/ Experimental work and Investigations, , Interpretation and analysis of data, Results and Discussion, Publications/ Abstracts of the author, mode of Presentation)

PPRPH4002 Seminar and Viva – Voce

37

PHARMACEUTICAL ANALYSIS AND QUALITY ASSURANCE SEMESTER – I


(THEORY)

UNIT – I 1. Preformulation Studies in Pharmaceutical Product Development: Introduction, organoleptic properties, purity, particle size, shape, and surface area. Solubilisation, surfactants and its importance, temperature, pH, pKa, partition coefficient, co-solvency; Techniques for the study of crystal properties and polymorphism. Physicochemical characteristics of new drug molecules with respect to different dosage forms. 2. Drug Stability : Introductory overview: Importance of stability attributes for drug products, potential adverse effects of instability in pharmaceutical ,products, the gamut of stability concerns, reasons for stability testing, modes of degradation, the essential elements of high quality cost effective stability programme, conformance periods, shelf life and expiration dates, some possible strategies to improve shelf life. Solution stability, solid state stability, parameters for physical stability, protocol for physical stability testing, determination of shelf life by accelerated stability testing studies. UNIT – II Product Development: a) Formulation of pharmaceutical dosage forms (solid dosage forms). b) Formulation of pharmaceutical dosage forms (liquid dosage forms). c) Formulation of pharmaceutical dosage forms (semi-solid dosage forms). d) Formulation of pharmaceutical dosage forms (parenterals). UNIT – III Evaluation of pharmaceutical products: a) Evaluation of pharmaceutical dosage forms (solid dosage forms). b) Evaluation of pharmaceutical dosage forms (liquid dosage forms). c) Evaluation of pharmaceutical dosage forms (semi-solid dosage forms). d) Evaluation of pharmaceutical dosage forms (parenterals). UNIT – IV Cosmetic Formulations: Formulation and evaluation of various cosmrtic preparations like Hair care products, Skin care products, Colour cosmetics, Dental Products, Personal hygiene products. Safety consideration and safety testing of cosmetic products. UNIT – V Pharmaceutical additives, drug excipient interactions and incompatibility, method to detect drug excipient interactions. Packaging Technology: Introduction, packaging protection functions, ICH guidelines, material and pack selection, testing the finished products in its pack- leakage detection method, evaluating rubber stopper assembly, legislations and guidelines relating to packaging, modern packaging technology including blister packing, product labeling consideration on packaging materials. Books Recommended: 1. L. Lachman, Lieberman and Kanig: “The Theory and Practice of Industrial Pharmacy”, Varghese


Forms – Tablets”, Volumes 1 to 3, Marcel Dekker, NY. 3. Kenneth E. Avis, Leon Lachman and Herbert A. Lieberman ed.: “Pharmaceutical Dosage Forms-

Parenteral Medications”, Volume 1 and 2, Marcel Dekker, NY. 4. Herbert A. Lieberman, Martin M. Rieger and Gilbert ed.: “Pharmaceutical Dosage Forms-

Disperse Systems”, Volume 1 and 2, Marcel Dekker, NY. 5. G.S Banker and C.T. Rhodes ed. “Modern Pharmaceutics” Marcel Dekker, NY. 6. Salvatore Turco and Robert E. King: “Sterile Dosage Forms” Lea and Febiger, Philadelphia.

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7. L. V. Allen, N. G. & Popovich H. C. Ansel: “Ansel’s Parmaceutical Dosage Forms and Drug Delivery Systems”, 8th edition, Lipincott William & Wilkins, USA, 2005.

8. M. E. Aulton: “Pharmaceutics – The Science of Dosage Form Design”, 2nd edition, Churchill Livingstone, 2002

9. Patrick J. Sinko Ed.: “Martin’s Physical Pharmacy and Pharmaceutical Sciences”, 5th edition, Lippincott Williams & Wilkins, 2009.

10. Walter Lund Ed.: “The Pharmaceutical Codex – Principle and Practice of Pharmaceutics”, 12th edition, CBS Publishers (India) & The Pharmaceutical Press (London), 2009.

11. E. A. Rawlins ed.: “Bentley's Text Book of Pharmaceutics” EL. Publications. 12. H. Butler Ed.: “Paucher’s Perfumes, Cosmetics & Soaps”, 10th edition (1st Indian edition), Springer




(THEORY)

UNIT – I UV-Visible spectroscopy: Brief review of electromagnetic spectrum, UV-Visible range, energy-wavelength-colour relationships. Interaction of electro - magnetic radiation (UV-Vis) and matter and its effects, Chromophores and their interaction with EMR, Woodward-Fieser rule, Absorption spectra of organic compounds and complexes illustrating the phenomenon and its utilization in qualitative and quantitative studies of drugs, Beer-Lambert’s law, Shifts and their interpretation (including solvent effects). Multicomponent analysis, derivative spectroscopy, Instrumentation Spectrofluorimerty: Fluorescence, Phosphorescence, Chemiluminescence - Theory, instrumentation and applications Infrared Spectrophotometry:Nature of Infra-red radiation, Interaction of IR radiation with organic molecules and effects on bonds, Molecular or infra-red spectra, Brief outline of classical IR instrumentation and interpretation of spectra, including sample preparation for spectroscopy, Qualitative interpretation of IR Spectra, Influence of substituents, ring size, hydrogen bonding vibrational coupling and field effect on frequency, Quantitative methods, FT-IR and applications. Recent advances in IR Spectroscopy (FT-NIR) UNIT – II Nuclear Magnetic Resonance Spectroscopy: Fundamental principles of NMR (Magnetic Properties of nuclei, applied field and precession, absorption and transition frequency). Chemical shift concept, Isotopic nuclei, Reference standards, proton magnetic spectra, their characteristics, presentation, terms used in describing spectra and their interpretation (signal no., position, intensity), Brief outline of instrumental arrangements and some practical details, Signal multiplicity phenomena in high resolution NMR, Spin-spin coupling, Application of Signal Splitting and coupling constant data to interpretation of spectra, Decoupling and shift reagent methods. Quantitative NMR. Brief outline of principles of 13C NMR. Introduction to 2-D NMR Techniques. Applications of NMR technique in Pharmaceutical science and biotechnology. Mass Spectrometry: Theory instrumentation, practical consideration, structure elucidation, detection of impurities, quantitative analysis, application to determination of structure, the gas chromatograph mass spectrometer combination. Atomic spectroscopy and plasma emission spectroscopy, Electron microscopy Optical Rotatory Dispersion: Terminology ,Plain Curves, Rotatory dispersion of ketones, The Axial Haloketone Rule, Octant Rule. UNIT – III Recent trends in chromatography with reference to analysis of drugs and related substances: a) High performance TLC –Principle, adsorbents, retention and separation parameters, detection methods, qualitative and quantitative HPTLC.

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b) Gas Chromatography: Introduction, principles, Instrumentation, carrier gas, types of columns, column selection- liquid stationary phases, column efficiency parameters, the Van Deemter equation, Resolution, Derivatisation methods, Detectors. A critical comparison of sensitivity, selectivity and field of applications of these detectors. Applications of GC in Pharmaceutical science. Hyphenated techniques: Brief introduction and applications. c) Hyphenated techniques-Brief introduction and applications Liquid Chromatography: Instrumentation, columns, packing materials, column selection, mobile phase selection, efficiency parameters, resolution and optimization of chromatographic parameters. Detectors in HPLC: Comparison of sensitivity , selectivity and field of applications of these detectors. Modes of HPLC-Ion-pair, Ion-exchange, Size exclusion, Supercritical, Chiral, Gel-permeation, Flash chromatography. Applications of liquid chromatography. Electrophoresis: Principle, techniques, instrumentation including detection strategies and applications in paper and gel electrophoresis. UNIT - IV Liquid Chromatography: Instrumentation, columns, packing materials, column selection, mobile phase selection, efficiency parameters, resolution and optimization of chromatographic parameters. Detectors in HPLC: Comparison of sensitivity selectivity and field of applications of these detectors. Modes of HPLC-Ion-pair, Ion-exchange, Size exclusion, Supercritical, Chiral, Gel-permeation, Flash chromatography. Applications of liquid chromatography.





Publishers, New Delhi. 13. John R. Dyer: ”Applications of Absorption spectroscopy of organic compounds “ Prentice Hall of

India, New Delhi. 14. “Indian Pharmacopoeia” Government of India, Ministry of Health & Family Welfare, the Indian

Pharmacopoeia Commision, Ghaziabad, 2007. 15. “British Pharmacopoeia”, British Pharmacopoeia Commision, The Stationary Office,6th edition,

2009. 16. “United States Pharmacopoeia”, USP 32 – NF 27, Vol 1 & 2, Asian Edition, 2008. 17. D. A. R Williams: ”Nuclear Magnetic Resonance Spectroscopy”, John Wiley & Sons, 2008. 18. Clive Whiston: ”X-Ray Methods”, John Wiley & Sons, 2008.

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19. Stuart, George, Peter: ”Modern Infra Red Spectroscopy”, John Wiley & Sons, 2008. 20. W. Geary: ”Radio Chemical Methods”, John Wiley &Sons, 2008. 21. Michael Thomas: ”Ultra Violet and Visible Spectroscopy”, John Wiley & Sons,2008. 22. James Barker: ”Mass Spectrometry”, 2nd edition, John Wiley & Sons, 2008. 23. James W. Dodd & Kenneth: ”Thermal methods” John Wiley & Sons, 2008. 24. Maureen Melvin: ”Electrophoresis”, John Wiley & Sons, 2008. 25. William Kemp: ”Organic spectroscopy” ELBS, London. 26. Kalsi: ”Spectroscopy of Organic compounds” New age International.

PPRPH 1003: BIOLOGICAL METHODS OF SCREENING



UNIT- II Preclinical and clinical models employed in the screening of new drugs belonging to following categories: Antipsychotic agents, Anti anxiety Agents; Nootropic Drugs; Antidepressant Drugs; Anticonvulsants; Anti Parkinsonism Agents; Opioid Analgesics; Anti-Inflammatory Drugs. UNIT- III Preclinical and clinical models employed in the screening of new drugs belonging to following categories: Infarction; Antihypertensive; Anti Atherosclerotic Drugs; Anti Malarial; Anthelmintics; Anti Diabetics; Models For Local Anesthetics; Activity on the GI Tract, Transgenic Animals And Other Genetically Prone Animal Models. UNIT- IV Principles of Biological Standardization: Methods of biological assay, Principles of biological assays with certain examples as per IP and BP. Development of new bioassay methods. Alternatives to animal screening procedures: Cell-Line, Patch-Clamp Techniques, In-Vitro Models, molecular biology techniques. Principles of toxicity evaluations, ED50, LD50 and TD values. International guidelines (ICH recommendations). UNIT- V Receptor-Radioligand Binding Assays: General principles and techniques of radio ligand binding assays. Specific assay design for adrenoreceptors, dopamine receptors, histamine receptors, GABA and benzodiazepine receptors. Immunoassay: General principles of immunoassay, Theoretical basis, Optimization of immunoassay, Heterogenous immunoassay system, Homogenous immunoassay system. Production of immunoassay reagent: Introduction, receptors or binders, unlabeled ligands Calibrators, Labeled ligands and receptor, Separation technique, buffers. Immunoassay Methods Evaluation: Protocol outline, objective &preparation, evaluation of precision, standard tracer, sensitivity, evaluation of accuracy, antibody characteristics, monitoring, reaction conditions, clinical evaluation.

Books Recommended:

6. H. G. Vogel: “Drug Discovery and Evaluation-Pharmacological Assays”, 2nd edition, Springer Verlag, Berlin, Germany, 2002.

7. Robert A.Turner: “Screening Methods in Pharmacology” 8. M. N. Ghosh: “Fundamentals of Experimental Pharmacology”, 2nd edition, Scientific Book Agency,




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UNIT – I Research Process: Introduction to research methodology, objectives, classification of research methods: Historical method, case study method, survey method, experimental method, and other methods( field investigation research, evaluation research, auction research, ex-post facto research, laboratory research, business game) – Definition, significance, sources, advantages, limitations, steps involved in research. Research Problem: sources, criteria of a good research problem, formulating and stating the problem, common errors in selecting and formulating a research problem. Research Design: Definitions, need for a research design, characteristics of good research design, components of a research design, types of research design: descriptive, diagnostic, exploratory and experimental. UNIT – II Sampling Methods: Introduction of sampling, probability and non probability sampling, sampling procedures – simple random, stratified, systematic, cluster and multistage sampling, concept of sampling distribution. Collection and Processing of Data: Sources of data, methods of collection of primary and secondary data, editing, coding, classification and tabulation of data, graphical and representation of data, diagrammatic representation of data. UNIT – III Inferential Statistics: Basics of Statistical Inference, Sampling distribution, Estimation – Point estimation, Interval estimation, Parameter, Statistic, Concept of a hypothesis, Research Hypothesis, Null Hypothesis, Level of Significance, Comparison of means of two samples, Comparison of sample proportion with population proportion, Comparison of two sample proportions, Degrees of Freedom, Critical Value, Table value, Type I and Type II errors, Rules for rejection & acceptance of Null Hypothesis, Standard Error. UNIT – IV Inferential Statistics – Parametric and Non-Parametric Test: ‘t’ test – Comparison of sample mean with the population mean, Comparison of means of two independent samples, Comparison of two correlated samples ‘Z’ test – different applications ANOVA – one way ANOVA: ‘F’ test, Chi square test. UNIT – V Correlation and Linear Regression: Introduction of correlation & regression concepts, estimation of correlation coefficient, regression coefficients, variance of sample estimates of the parameters, non linear regressions, weighted and transformations in regression analysis, application of linear regressions - standard curves in drug analysis and drug stability studies, analysis of covariance. Books Recommended: 1. Santosh Gupta: “Research Methodology and Statistical Techniques”, Deep & Deep Publication,



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1. Accelerated stability studies of various formulations or drugs with respect to (a) Temperature (b) Effect of buffers / pH dependent (2 – 4 Expts.) 2. Formulations and evaluation of some liquid orals such as Analgesic-antipyretics, Antihistamines,

Co-trimoxazole, suspensions etc. (2 – 3 Expts.) 3. Formulation and evaluation of stability of reconstituted dry syrups of Amoxicillin, Ampicillin etc. ( 2

Expts.) 4. Preparation and evaluation of diclofenac sodium gels containing two different bases. (2 Expts.) 5. Formulation and evaluation of semisolid dosage forms using different – bases and drugs

(cetrimide, salicylic acid) of current interest. 6. To study the effect of particle size, moisture content and lubricants on flowability and

compressibility of powders. 7. Study of effect of various binding agents on the properties of tables (2 Expts.) 8. Preparation and evaluation of Skin care and Hair care products (4-5 Expts)




8. Assays involving following procedures : Non-Aqueous, Diazotisation, Complexation and Redox

titrations.

PPRPH 1013: BIOLOGICAL METHODS OF SCREENING (PRACTICAL)

6 Hrs/Week 1. Introduction to Pharmacological evaluation methods and CPCSEA and OECD guidelines, GLP norms 2. Standard techniques for injection of drugs, collection of blood samples and feeding of animals 3. Study of various techniques of anesthesia and euthanasia 4. To study the effect of pentobarbital on righting reflex (hypnosis) in mice 5. To study the effect of chlorpromazine on the locomotor activity of mice using actophotometer 6. To study the apomorphine induced compulsive behaviour (stereotype) in mice 7. To study the muscle relaxant property of diazepam in mice using rotarod apparatus 8. To study the analgesic effect of morphine in mice using the tail-flick method and hot plate method 9. To study the analgesic effect of morphine against acetic acid-induced writhing in mice 10. To study the anti-inflammatory property of indomethacin against carrageenan-induced paw edema 11. General methods for evaluating the antimicrobial activities of chemotherapeutic agents. 12. Estimation of biochemical and free radical scavengers. 13. General screening methods for the anti ulcer activity, intestinal motility, and anti-diarrheal.. 14. General screening procedure of anti-hypertensive’s. 15. General screening methods for evaluating the diuretic activity

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Books Recommended: 1. R. A. Turner: “Screening Methods in Pharmacology”, Academic Press, London1965 2. H. G. Vogel (ed), Drug Discovery and Evaluation-Pharmacological Assays, 2nd edition, Springer






II SEMESTER PPRPH 2201: STABILITY OF DRUGS AND DRUG PRODUCTS

(THEORY) 4 Hrs/Week

UNIT – I 1. Overview of kinetic concepts – First, second and pseudo orders. 2. Complex order kinetics – concepts; equations and their application, series, consecutive and

reversible reaction, steady state approximation. 3. Stability prediction by pharmacist and calculation protocols. UNIT – II 1. Temperature as a stress: Arrhenius theory, activation energy calculations, Q10 value

Calculations. 2. Interpretation of kinetic data: Transition state theory, media effects, catalysis, pH effects. Some

practical applications. UNIT – III 1. Drug decomposition mechanisms:

a) Hydrolysis and acyltransfers: Nature of reaction, structure and utility, stabilization of Pharmaceuticals with examples.

b) Oxidation: Nature of oxidation, kinetics of oxidation, oxidation pathways of pharmaceutical Interest, Inhibition of oxidation

c) Photolysis: Energetics of photolysis, kinetics of photolysis, photolytic reactions of pharmaceutical interest, prevention of photolytic reactions.

2. Solid state chemical decomposition- Kinetics of solid state decomposition, Pharmaceutical examples of solid state decomposition, pure drugs, drug excipient and drug-drug interaction in solid state methods of stabilization. UNIT – IV 1. Physical stability testing of dosage forms:

a. Solids – tablets, capsules, powder and granules b. Disperse systems c. Microbial decomposition d. Over-view, physical stability of novel drug carriers, liposomes, niosomes, nano-particles.

UNIT - V 1. Strategy and tactics of stability testing: a. Regulatory requirements b. Stability protocols

c. Experimental Design d. Interpretation of data

44

Books Recommended: 1. Jens T. Carstensen “Drug stability: Principles and practices “ 2. H. A. Lieberman, Leon Lachman, J. B. Schwartz Ed.: “Parmaceutical Dosage Forms: Tablets”, 2nd edition

(Revised and Expanded), Vol. 1, 2 & 3, Marcel Dekker Inc.,Vol – 1, 2 & 3, New York, 2008. 3. Leon Lachman, H. A. Lieberman & J. L. Kanig : “The Theory and Practice of Indusrtrial Pharmacy”, 3rd

edition, Varghese Publishing House, Bombay, 1991. 4. W.Grimm “Stability Testing of Drug Products”. 5. Patrick J. Sinko Ed.: “Martin’s Physical Pharmacy and Pharmaceutical Sciences”, 5th edition,

Lippincott Williams & Wilkins, 2009.Manavalan and Ramaswamy “Physical Pharmaceutics “ 6. Yoshioka and Stella ,”Stability of Drugs and Dosage Forms” 7. Remington:” The Science and Practice of Pharmacy “ 21st edition, Wolter’s Kluwer Health (India)

Pvt .Ltd. 8. Satinder Ahuja: ”Hand book of Modern Pharmaceutical Analysis”, Elsevier, 2005

PPRPH 2202: ADVANCED INSTRUMENTAL METHODS OF ANALYSIS (THEORY)

4 Hrs/Week UNIT – I Preparation of drug samples for analysis: Pharmaceutical samples, fundamental theories controlling preparation techniques, specific sample preparation techniques ; Special Techniques like Immunological methods (RIA – ELISA) and electrophoresis (gel and capillary) UNIT – II A detailed study of the principles, instrumentation and applications of the following Instrumental analysis:

X-ray fluorescence spectrometry X-ray diffraction Scintillation counter Electron spin resonance spectroscopy (ESR) ORD & CD

UNIT – III

Brief study of the theory, instrumentation and application of the following analytical techniques: Atomic force microscopy, Plasma atomic emission spectroscopy, Photon correlation spectroscopy, Chemiluminiscence

UNIT – IV A detailed study of the various principles and procedure involved in the quantitative analysis of pharmaceutical preparations and dosage forms containing the following groups of drugs included in I.P. (Biological and microbiological methods excluded) (a) Analgesics and Antipyretics (b) Sedatives & Tranquillizers (c) Antihypertensives (d) Antibiotics & Antibacterials (e) Vitamins (f) Steroids (g) Antidiabetics

UNIT – V A detailed study of the principles and procedures involved in the qualitative and quantitative analysis of pharmaceutical preparations and dosage forms using the following reagents and reactions.

(i) Oxidative coupling reactions using MBTH (3-methyl-2-benzothiazolinone hydrazine hydrochloride)

(ii) Diazotization followed by coupling (iii) Oxidation followed by complexation. (iv) Oxidation followed by charge transfer reaction.

45

(v) Condensation reactions using the reagents Para Dimethyl Amino Benzaldehyde (PDAB), Para Dimethyl Amino Cinnamaldehyde (PDAC), Folin’s reagent and Gibb’s reagent.

(vi) Folinciocalteu reagent (FC reagent) (vii) Ninhydrin reagent

PPRPH 2203: CHROMATOGRAPHIC METHODS OF ANALYSIS

(THEORY) 4Hrs/Week

UNIT – I Introduction to chromatographic techniques- History, classification , separation techniques, choice of methods Ion Exchange chromatography-introduction ,principles, types of ion exchange synthetic resins, physical properties , factors affecting ion exchange, methodology and applications

UNIT – II Paper chromatography- introduction ,principles, types of paper chromatography – ascending paper chromatography, descending paper chromatography, radial paper chromatography, development techniques, operational techniques , applications

TLC- introduction, principles, techniques, Rf values, applications

HPTLC- introduction, theory ,instrumentation, applications

UNIT III HPLC- introduction ,theory, instrumentation, solvent treatment systems, pumps- reciprocating and displacement pumps, columns, detectors - UV detectors, fluorimetric detectors, refractive index detectors ,applications, recent advancements

Gas chromatography- introduction ,theory ,instrumentation, carrier gases, stationary phases in GLC and GSC, detectors -flame ionization detectors , electron capture detectors, thermal conductivity detectors, typical gas chromatogram, derivitisation techniques, programmed temperature gas chromatography, applications

UNIT – IV

Gel filtration and Affinity chromatography- introduction, techniques, applications

Evaluation of impurities in pharmaceuticals by chromatographic methods-Preliminary evaluation of impurities and degradation studies.case studies of some drugs like Metoprolol tartrate, chlorthalidone, Terbutaline sulphate, Levastatin, Zidovudine and Imipramine

UNIT - V

A detailed study of the principles, instrumentations and applications in drug analysis of: GC-MS, LC-MS, GC-FTIR with reference to drug metabolism, toxicological and forensic studies, diagnosis of disease state, quantification of drugs in biological samples,. Super critical fluid chromatography size exclusion chromatography Books Recommended: 1. Robert. D. Brown: “Introduction to Instrumental Analysis”, Pharma Book Syndicate, 2006. 2. Gary. D. Christian: “Analytical Chemistry”, 6th edition, John Wiley & Sons, 2007. 3. D. A. Skoog, F. J. Holler & T. A. Nieman: “Principles of Instrumental Analysis”, 5th edition

Thomson, Brooks/Cole, 2005. 4. Willard, Meritt & Dean et al.: “Instrumental Method of Analysis”, 7th edition, CBS Publishers. 5. “Indian Pharmacopoeia” Government of India, Ministry of Health & Family Welfare, the Indian

Pharmacopoeial Commision, Ghaziabad, 2007. 6. British Pharmacopoeia, 2009. 7. United States Pharmacopoeia, 2009.

46

8. H. Beckett and J. B. Stenlake: “Practical Pharmaceutical Chemistry”, Vol- II, 1st edition, CBS Publishers, 2005.

9. B. K. Sharma: “Instrumental and Chemical Analysis”, Goel Publishers. 10. Chatwal & Anand: “Instrumental Methods of Analysis”, 5th edition, Himalaya Publishing House,

2008. 11. Mendham et al.: “Vogel’s Text book of Quantitative Analysis”, 6th edition, Pearsons Education

Ltd., 2008. 12. K. A. Connors: “A Text Book of Pharmaceutical Analysis”, 3rd edition, John Wiley & Sons, 2007. 13. P. D. Sethi: “High Performance Liquid Chromatography”, CBS Publishers. 14. P .D. Sethi: “High Performance Thin Layer Chromatography”, CBS Publishers. 15. Satinder Ahuja and Karen Mills Asante: ”Hand book of Isolation and Charecterisation of Impurities

in Pharmaceuticals” Elsevier, New Delhi. 16. Snyder ,”Practical HPLC Method Development” John Wiley&Sons, Canada 17. Sandie Lindsay: ”High Performance Liquid Chromatography”, 2nd edition, John Wiley & Sons,

2008. 18. Ian A. Fowlis: ”Gas Chromatography”,2nd edition, John Wiley &Sons,2008 19. Egon Stahl: ”Thin Layer chromatography”,2nd edition, Springer publications 20. Richard & Shiela: ”Thin Layer Chromatography” John Wiley & Sons, 2008.

PPRPH2204: QUALITY ASSURANCE, GMP & VALIDATION

(THEORY) 4 Hrs/week

UNIT – I Concept of Total quality management (TQM) philosophy and GMPs and GLPs, Introduction to ICH process, US-FDA guidelines for GMP, Evaluation and accreditation, Organization and Functioning of ISO 9000, ISO 14000, WHO, NABL, OSHB (ISO18000) UNIT – II Recent amendments to drugs and cosmetics Acts and other relevant rules. Consumer protection. Environmental protection, Factory Act, Certificate and licensing procedures. WHO Certification, Globalization of drug industry, Introduction to export and import policy of drugs, Raw Materials, Finished Products & Analytical Procedures UNIT – III Intellectual property rights, Patents, Trade marks, Copy rights, Indian patent act Data generation and storage. Quality control documentation. Retention samples, Records, Audits of quality control facilities, Finished products release, Quality review, Quality audits, Batch release documents Warehousing, Good Warehousing practices, Materials management. Distribution and distribution records, Handling of returned goods. Recovered materials and processing. Complaints and recalls-evaluation of complaints, Recall procedures, Related records and documents, Waste disposal, Scrap disposal procedures and records UNIT – IV Equipment, Selection, Purchase specifications, Maintenance, Clean in place and Sterilize in place methods (TP and STP), Raw materials, Purchase specifications, Stores, Selection of venders, Control of Raw materials. UNIT – V Validation of Analytical Methods, Calibration of Instruments and equipment. Protocol for process validation, Cleaning validation, Validation of Air handling system, Sterile and non sterile areas.

Books Recommended: 1. Monica Girmaldi and Janet Gough Davis: ”The Internal Quality Audits”, Harwood International

Publishing. 2. Terveeks & Deeks: ”Validation Master Plan “, Davis Harwood International Publishing.

47

3. Carleton & Agalloco: ”Validation of Asceptic Pharmaceutical Processes”, 2nd edition, Marcel Dekker.

4. Chow: ”Statistical Design and Analysis in Pharmaceutical Science”, Marcel Dekker. 5. de Spautz: ”Automation & Validation of Information in Pharmaceutical Processing”, Marcel

Dekker. 6. Singer: ”Guidelines for Laboratory Quality Auditing “, Marcel Dekker. 7. Lewis: ”Pharmaceutical Experimental Design”, Marcel Dekker. 8. Guarino: ”New Drug approval process”, 2nd edition, Vol. 56, Marcel Dekker., New York. 9. Janet Gough Davis: ”Hosting A Compliance Audit” Harwood International Publishing. 10. Quality Assurance Guide by Organisation of Pharmaceutical Products of India 11. Sidney Willig and James R. Stoker: ”Good Manufacturing Practices for Phramaceuticals”, 3rd

edition, Vol. 52, Dekker series. 12. Jurg P. Seiler: ”Good Laboratory Practice”, 2nd edition, Springer, 2007. 13. P. P. Sharma: ”How to Practice GMP’s”, Vaudana Publications. 14. Sadhan K. Ghosh: “ISO 9000 & TQM 15. Quality Assurance of Pharmaceuticals- A compendium Of Guidelines- WHO publication.

PPRPH2211: STABILITY OF DRUGS AND DRUG PRODUCTS


1. Stability studies of marketed formulations as per ICH guidelines 2. Quality control process involved in the evaluation of various non sterile formulations such as

capsules, tablets, oral liquids, etc., Books Recommended:

1. ICH Guidelines 2. Pharmacopoeia’s

PPRPH2212: ADVANCED INSTRUMENTAL MATHODS OF ANALYSIS


1. Quantitative analysis of pharmaceutical preparations and dosage forms containing the following

groups of drugs included in I.P. (a) Analgesics and Antipyretics (b) Sedatives & Tranquillizers (c) Antihypertensives (d) Antibiotics & Antibacterials (e) Vitamins (f) Steroids (g) Antidiabetics 2. Analysis of drugs using various reagents Books Recommended: 1. T. Higuchi & E. B. Hanssen: “Text Book of Pharmaceutical Analysis”, 1st edition, A Wiley Inter

Science Publications, 2005. 2. P. D. Sethi: ”Quantitative Analysis of Drugs in Pharmaceutical Formulation” , CBS publishers 3. D. C. Garatt: “Quantitative Analysis of Drugs”, 3rd edition, CBS Publishers, 2005. 4. Jenkins ,”Quantitative Analysis “Mc.Grew Hill company. 5. Gearien and Garbosh: ”Methods of Drug Analysis “, Lea & Fibeger 6. John Dyer: ”Applications of Absorption Spectroscopy of Organic Compounds “ Prentice Hall of

India, New Delhi. 7. Y. R. Sharma: ”Elementary Organic Spectroscopy “ S. Chand & Company, New Delhi. 8. Willard, Meritt, Dean, et al.: “Instrumental Method of Analysis”, 7th edition, CBS Publishers.

PPRPH2213: CHROMATOGRAPHIC METHODS OF ANALYSIS


1. Separation and identification of plant pigments by Column chromatography 2. Separation and identification of amino acids by Paper chromatography 3. Preparation of Silica gel TLC plates 4. Separation and identification of amino acids by Thin layer chromatography 5. Separation and identification of sulphonamides by Paper chromatography

48

6. Separation and identification of sulphonamides by Thin layer chromatography 7. Separation of a mixture of amino acids by Thin layer chromatography 8. Assay of drugs official in Pharmacopoeia’s using HPLC Books Recommended: 1. Robert.D.Brown: “Introduction to Instrumental Analysis”, Pharma Book Syndicate, 2006. 2. Gary. D. Christian: “Analytical Chemistry”, 6th edition, John Wiley & Sons, 2007. 3. D. A. Skoog, F. J. Holler, T. A. Nieman “Principles of Instrumental Analysis”, 5th edition, Thomson

Brooks/Cole, 2005, 4. Willard, Meritt, Dean et al.: “Instrumental Method of Analysis”, 7th edition, CBS Publishers. 5. Indian Pharmacopoeia” Government of India, Ministry of Health & Family Welfare, the Indian

Pharmacopoeia Commision, Ghaziabad, 2007. 6. British Pharmacopoeia, 2009. 7. United States Pharmacopoeia, 2009. 8. H. Beckett and J. B. Stenlake: “Practical Pharmaceutical Chemistry”, Vol- II, 1st edition, CBS

Publishers, 2005. 9. B. K. Sharma: “Instrumental and Chemical Analysis”, Goel Publishers. 10. Chatwal & Anand: “Instrumental Methods of Analysis”, 5th edition, Himalaya Publishing House,

2008. 11. Mendham et al.: “Vogel’s Text Book of Quantitative Analysis”, 6th edition, Pearsons Education

Ltd., 2008. 12. K. A. Connors: “A Text Book of Pharmaceutical Analysis”, 3rd edition, John Wiley & Sons, 2007. 13. P. D. Sethi: “High Performance Liquid Chromatography” CBS publishers 14. P. D. Sethi: “High Performance Thin Layer Chromatography” CBS publishers 15. Satinder Ahuja and Karen Mills Asante: ”Hand Book of Isolation and Characterization of

Impurities in Pharmaceuticals”,Elsevier series, New Delhi 16. Snyder ,”Practical HPLC Method Development” John Wiley&Sons, Canada


specialization)


SEMESTER – IV




49

PHARMACEUTICAL CHEMISTRY SEMESTER – I


(THEORY) UNIT – I Preformulation Studies in Pharmaceutical Product Development: Introduction, organoleptic properties, purity, particle size, shape, and surface area. Solubilisation, surfactants and its importance, temperature, pH, pKa, partition coefficient, co-solvency; Techniques for the study of crystal properties and polymorphism. Physicochemical characteristics of new drug molecules with respect to different dosage forms. Drug Stability : Introductory overview: Importance of stability attributes for drug products, potential adverse effects of instability in pharmaceutical products, the gamut of stability concerns, reasons for stability testing, modes of degradation, the essential elements of high quality cost effective stability programme, conformance periods, shelf life and expiration dates, some possible strategies to improve shelf life. Solution stability, solid state stability, parameters for physical stability, protocol for physical stability testing, determination of shelf life by accelerated stability testing studies. UNIT – II Product Development: a) Formulation of pharmaceutical dosage forms (solid dosage forms). b) Formulation of pharmaceutical dosage forms (liquid dosage forms). c) Formulation of pharmaceutical dosage forms (semi-solid dosage forms). d) Formulation of pharmaceutical dosage forms (parenterals). UNIT – III Evaluation of pharmaceutical products: a) Evaluation of pharmaceutical dosage forms (solid dosage forms). b) Evaluation of pharmaceutical dosage forms (liquid dosage forms). c) Evaluation of pharmaceutical dosage forms (semi-solid dosage forms). d) Evaluation of pharmaceutical dosage forms (parenterals). UNIT – IV Cosmetic Formulations: Formulation and evaluation of various cosmrtic preparations like Hair care products, Skin care products, Colour cosmetics, Dental Products, Personal hygiene products. Safety consideration and safety testing of cosmetic products. UNIT – V Pharmaceutical additives, drug excipient interactions and incompatibility, method to detect drug excipient interactions. Packaging Technology: Introduction, packaging protection functions, ICH guidelines, material and pack selection, testing the finished products in its pack- leakage detection method, evaluating rubber stopper assembly, legislations and guidelines relating to packaging, modern packaging technology including blister packing, product labeling consideration on packaging materials. Books Recommended: 1. L. Lachman, Lieberman and Kanig: “The Theory and Practice of Industrial Pharmacy”, Varghese


Forms – Tablets”, Volumes 1 to 3, Marcel Dekker, NY.

50

3. Kenneth E. Avis, Leon Lachman and Herbert A. Lieberman ed.: “Pharmaceutical Dosage Forms-Parenteral Medications”, Volume 1 and 2, Marcel Dekker, NY.

4. Herbert A. Lieberman, Martin M. Rieger and Gilbert ed.: “Pharmaceutical Dosage Forms-Disperse Systems”, Volume 1 and 2, Marcel Dekker, NY.








PURPH 1002: INSTRUMENTAL METHODS OF ANALYSIS

(THEORY) UNIT – I UV-Visible spectroscopy: Brief review of electromagnetic spectrum, UV-Visible range, energy-wavelength-colour relationships. Interaction of electro - magnetic radiation (UV-Vis) and matter and its effects, Chromophores and their interaction with EMR, Woodward-Fieser rule, Absorption spectra of organic compounds and complexes illustrating the phenomenon and its utilization in qualitative and quantitative studies of drugs, Beer-Lambert’s law, Shifts and their interpretation (including solvent effects). Multicomponent analysis, derivative spectroscopy, Instrumentation Spectrofluorimerty: Fluorescence, Phosphorescence, Chemiluminescence - Theory, instrumentation and applications Infrared Spectrophotometry:Nature of Infra-red radiation, Interaction of IR radiation with organic molecules and effects on bonds, Molecular or infra-red spectra, Brief outline of classical IR instrumentation and interpretation of spectra, including sample preparation for spectroscopy, Qualitative interpretation of IR Spectra, Influence of substituents, ring size, hydrogen bonding vibrational coupling and field effect on frequency, Quantitative methods, FT-IR and applications. Recent advances in IR Spectroscopy (FT-NIR) UNIT – II Nuclear Magnetic Resonance Spectroscopy: Fundamental principles of NMR (Magnetic Properties of nuclei, applied field and precession, absorption and transition frequency). Chemical shift concept, Isotopic nuclei, Reference standards, proton magnetic spectra, their characteristics, presentation, terms used in describing spectra and their interpretation (signal no., position, intensity), Brief outline of instrumental arrangements and some practical details, Signal multiplicity phenomena in high resolution NMR, Spin-spin coupling, Application of Signal Splitting and coupling constant data to interpretation of spectra, Decoupling and shift reagent methods. Quantitative NMR. Brief outline of principles of 13C NMR. Introduction to 2-D NMR Techniques. Applications of NMR technique in Pharmaceutical science and biotechnology. Mass Spectrometry: Theory instrumentation, practical consideration, structure elucidation, detection of impurities, quantitative analysis, application to determination of structure, the gas chromatograph mass spectrometer combination. Atomic spectroscopy and plasma emission spectroscopy, Electron microscopy

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Optical Rotatory Dispersion: Terminology ,Plain Curves, Rotatory dispersion of ketones, The Axial Haloketone Rule, Octant Rule. UNIT – III Recent trends in chromatography with reference to analysis of drugs and related substances: a) High performance TLC –Principle, adsorbents, retention and separation parameters, detection methods, qualitative and quantitative HPTLC. b) Gas Chromatography: Introduction, principles, Instrumentation, carrier gas, types of columns, column selection- liquid stationary phases, column efficiency parameters, the Van Deemter equation, Resolution, Derivatisation methods, Detectors. A critical comparison of sensitivity, selectivity and field of applications of these detectors. Applications of GC in Pharmaceutical science. Hyphenated techniques: Brief introduction and applications. c) Hyphenated techniques-Brief introduction and applications Liquid Chromatography: Instrumentation, columns, packing materials, column selection, mobile phase selection, efficiency parameters, resolution and optimization of chromatographic parameters. Detectors in HPLC: Comparison of sensitivity , selectivity and field of applications of these detectors. Modes of HPLC-Ion-pair, Ion-exchange, Size exclusion, Supercritical, Chiral, Gel-permeation, Flash chromatography. Applications of liquid chromatography. Electrophoresis: Principle, techniques, instrumentation including detection strategies and applications in paper and gel electrophoresis. UNIT - IV Liquid Chromatography: Instrumentation, columns, packing materials, column selection, mobile phase selection, efficiency parameters, resolution and optimization of chromatographic parameters. Detectors in HPLC: Comparison of sensitivity selectivity and field of applications of these detectors. Modes of HPLC-Ion-pair, Ion-exchange, Size exclusion, Supercritical, Chiral, Gel-permeation, Flash chromatography. Applications of liquid chromatography.

Electrophoresis: Principle, techniques, instrumentation including detection strategies and applications. UNIT- V Thermo gravimetric Analysis (TGA), Differential thermal analysis (DTA), Differential




Publishers, New Delhi.

52

13. John R. Dyer: ”Applications of Absorption spectroscopy of organic compounds “ Prentice Hall of India, New Delhi.



16. “United States Pharmacopoeia”, USP 32 – NF 27, Vol 1 & 2, Asian Edition, 2008. 17. D. A. R Williams: ”Nuclear Magnetic Resonance Spectroscopy”, John Wiley & Sons, 2008. 18. Clive Whiston: ”X-Ray Methods”, John Wiley & Sons, 2008. 19. Stuart, George, Peter: ”Modern Infra Red Spectroscopy”, John Wiley & Sons, 2008. 20. W. Geary: ”Radio Chemical Methods”, John Wiley &Sons, 2008. 21. Michael Thomas: ”Ultra Violet and Visible Spectroscopy”, John Wiley & Sons,2008. 22. James Barker: ”Mass Spectrometry”, 2nd edition, John Wiley & Sons, 2008. 23. James W. Dodd & Kenneth: ”Thermal methods” John Wiley & Sons, 2008. 24. Maureen Melvin: ”Electrophoresis”, John Wiley & Sons, 2008. 25. William Kemp: ”Organic spectroscopy” ELBS, London. 26. Kalsi: ”Spectroscopy of Organic compounds” New age International.




UNIT- II Preclinical and clinical models employed in the screening of new drugs belonging to following categories: Antipsychotic agents, Anti anxiety Agents; Nootropic Drugs; Antidepressant Drugs; Anticonvulsants; Anti Parkinsonism Agents; Opioid Analgesics; Anti-Inflammatory Drugs. UNIT- III Preclinical and clinical models employed in the screening of new drugs belonging to following categories: Infarction; Antihypertensive; Anti Atherosclerotic Drugs; Anti Malarial; Anthelmintics; Anti Diabetics; Models For Local Anesthetics; Activity on the GI Tract, Transgenic Animals And Other Genetically Prone Animal Models. UNIT- IV Principles of Biological Standardization: Methods of biological assay, Principles of biological assays with certain examples as per IP and BP. Development of new bioassay methods. Alternatives to animal screening procedures: Cell-Line, Patch-Clamp Techniques, In-Vitro Models, molecular biology techniques. Principles of toxicity evaluations, ED50, LD50 and TD values. International guidelines (ICH recommendations). UNIT- V Receptor-Radioligand Binding Assays: General principles and techniques of radio ligand binding assays. Specific assay design for adrenoreceptors, dopamine receptors, histamine receptors, GABA and benzodiazepine receptors. Immunoassay: General principles of immunoassay, Theoretical basis, Optimization of immunoassay, Heterogenous immunoassay system, Homogenous immunoassay system. Production of immunoassay reagent: Introduction, receptors or binders, unlabeled ligands Calibrators, Labeled ligands and receptor, Separation technique, buffers.

53

Immunoassay Methods Evaluation: Protocol outline, objective &preparation, evaluation of precision, standard tracer, sensitivity, evaluation of accuracy, antibody characteristics, monitoring, reaction conditions, clinical evaluation. Books Recommended: 11. H. G. Vogel: “Drug Discovery and Evaluation-Pharmacological Assays”, 2nd edition, Springer






UNIT – I Research Process: Introduction to research methodology, objectives, classification of research methods: Historical method, case study method, survey method, experimental method, and other methods( field investigation research, evaluation research, auction research, ex-post facto research, laboratory research, business game) – Definition, significance, sources, advantages, limitations, steps involved in research. Research Problem: sources, criteria of a good research problem, formulating and stating the problem, common errors in selecting and formulating a research problem. Research Design: Definitions, need for a research design, characteristics of good research design, components of a research design, types of research design: descriptive, diagnostic, exploratory and experimental. UNIT – II Sampling Methods: Introduction of sampling, probability and non probability sampling, sampling procedures – simple random, stratified, systematic, cluster and multistage sampling, concept of sampling distribution. Collection and Processing of Data: Sources of data, methods of collection of primary and secondary data, editing, coding, classification and tabulation of data, graphical and representation of data, diagrammatic representation of data. UNIT – III Inferential Statistics: Basics of Statistical Inference, Sampling distribution, Estimation – Point estimation, Interval estimation, Parameter, Statistic, Concept of a hypothesis, Research Hypothesis, Null Hypothesis, Level of Significance, Comparison of means of two samples, Comparison of sample proportion with population proportion, Comparison of two sample proportions, Degrees of Freedom, Critical Value, Table value, Type I and Type II errors, Rules for rejection & acceptance of Null Hypothesis, Standard Error. UNIT – IV Inferential Statistics – Parametric and Non-Parametric Test: ‘t’ test – Comparison of sample mean with the population mean, Comparison of means of two independent samples, Comparison of two correlated samples ‘Z’ test – different applications ANOVA – one way ANOVA: ‘F’ test, Chi square test.

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UNIT – V Correlation and Linear Regression: Introduction of correlation & regression concepts, estimation of correlation coefficient, regression coefficients, variance of sample estimates of the parameters, non linear regressions, weighted and transformations in regression analysis, application of linear regressions - standard curves in drug analysis and drug stability studies, analysis of covariance. Books Recommended: 1. Santosh Gupta: “Research Methodology and Statistical Techniques”, Deep & Deep Publication,




(PRACTICAL) Accelerated stability studies of various formulations or drugs with respect to (a) Temperature (b) Effect of buffers / pH dependent (2 – 4 Expts.) Formulations and evaluation of some liquid orals such as Analgesic-antipyretics, Antihistamines, Co-trimoxazole, suspensions etc. (2 – 3 Expts.) Formulation and evaluation of stability of reconstituted dry syrups of Amoxicillin, Ampicillin etc. ( 2 Expts.) Preparation and evaluation of diclofenac sodium gels containing two different bases. (2 Expts.) Formulation and evaluation of semisolid dosage forms using different – bases and drugs (cetrimide, salicylic acid) of current interest. To study the effect of particle size, moisture content and lubricants on flowability and compressibility of powders. Study of effect of various binding agents on the properties of tables (2 Expts.) Preparation and evaluation of Skin care and Hair care products (4-5 Expts)


(PRACTICAL) 1. Use of spectrophotometer for analysis of pharmacopoeial compounds and their formulations. 2. Use of fluorimeter for analysis of pharmacopoeial compounds. 3. Use of Flame Photometer for analysis of Na+, K+ & Ca++ etc. in Biological fluids and formulations. 4. Use of Potentiometer and Conductometer for the analysis of Pharmacopoeial compounds. 5. Use of Nephelo-Turbidimetric analysis for dispersions and limit tests. 6. Experiments on electrophoresis. 7. Experiments on chromatography.


8. Assays involving following procedures : Non-Aqueous, Diazotisation, Complexation and Redox

titrations.


6Hrs/Week

1. Introduction to Pharmacological evaluation methods and CPCSEA and OECD guidelines, GLP norms

2. Standard techniques for injection of drugs, collection of blood samples and feeding of animals 3. Study of various techniques of anesthesia and euthanasia 4. To study the effect of pentobarbital on righting reflex (hypnosis) in mice 5. To study the effect of chlorpromazine on the locomotor activity of mice using actophotometer 6. To study the apomorphine induced compulsive behaviour (stereotype) in mice

55

7. To study the muscle relaxant property of diazepam in mice using rotarod apparatus 8. To study the analgesic effect of morphine in mice using the tail-flick method and hot plate method 9. To study the analgesic effect of morphine against acetic acid-induced writhing in mice 10. To study the anti-inflammatory property of indomethacin against carrageenan-induced paw edema 11. General methods for evaluating the antimicrobial activities of chemotherapeutic agents. 12. Estimation of biochemical and free radical scavengers. 13. General screening methods for the anti ulcer activity, intestinal motility, and anti-diarrheal.. 14. General screening procedure of anti-hypertensive’s. 15. General screening methods for evaluating the diuretic activity

Books Recommended: 1. R. A Turner: “Screening Methods in Pharmacology”, Academic Press, London1965 2. H.G. Vogel (ed), Drug Discovery and Evaluation-Pharmacological Assays, 2nd edition, Springer






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SEMESTER - II PPRPH 2301: CHEMISTRY OF BULK DRUGS


UNIT- I Process Chemistry in the Pharmaceutical Industry Basic principles of chemical development; techniques for the minimization of by-product impurities; criteria for cost-effective synthesis of enantiopure compounds by resolutions; asymmetric synthesis, and "chiral pool" strategy; synthesis for labeling substances with hydrogen or carbon isotopes UNIT- II Pharmaceutical & Chemical Formulation problems I Physical degradation of pharmaceutical products, loss of volatile constituents, loss of water, absorption of water, crystal growth, polymorphism, color change; factors influencing chemical degradations like hydrolysis, oxidation, isomerisation, polymerisation, decarboxylation etc.; methods of reducing physical and chemical degradations

UNIT- III Pharmaceutical &Chemical Formulation problems II Preparation of water soluble compounds through salt formation, by covalent attachment of solubilizing moieties, Drug solubilization with organic solvents/micellar solutions/colloidal disperse systems, Improvement of drug properties by cyclodextrins, chemical, physicochemical solutions to formulation problems. Designing robust crystallization process for API.

UNIT- IV Excipient Technology Excipients for pharmaceutical use, physical and chemical properties of excipients, physicochemical modification and its role on drug-excipient interaction and formulation enhancement

UNIT- V Generic Drugs and Technology transfer Pilot plant study and scale-up techniques: Details of Pilot Scale-up methods, scope and uses. Regulatory aspects of pharmaceutical and bulk drug manufacture and drug analysis Recommended Books: 1. Peterskyes: “A Guide to Mechanisms in Organic Chemistry”, Orient Longman, New Delhi. 2. Tandom & Gowel: “Reactive Intermediates in Organic chemistry 3. Stevenson & wi ed.: “Recent Advances in Chiral Separations”, Plenum Press, 1990. 4. “Comprehensive Medicinal Chemistry”, series I-IV, Academic Press. 5. R. A. Steldon: “Chiral Technology”, Marcell Dekker Inc. New York, 1993. 6. K. G. Gadamasetti ed. “Process Chemistry in the Pharmaceutical Industry”, Marcel Dekker, Inc.,

New York, 1999. 7. M. Nafissi, J.A. Ragan & K. M. De Vries ed.: “From Bench to Pilot Plant: Process Research in the

Pharmaceutical Industry”, American Chemical Society, Washington DC, 2002. 8. S. Lee & G. Robinson: “Process Development: Fine Chemicals from Grams to Kilograms”, Oxford

University Press, New York, 1995. 9. Oljan Repic, Cljan Repic, Oljan Repic: “Principles Of Process Research And Chemical

Development In The Pharmaceutical Industry”, Wiley-interscience.

57

PPRPH 2302: ADVANCED MEDICINAL CHEMISTRY (THEORY)

UNIT- I Approaches to design enzyme inhibitors a) Introduction i) Enzyme inhibitors in Medicine ii) Enzyme inhibitors in basic Research iii) Drug Design based on Antagonism and Enzyme Inhibition b) Rational design of non covalently & covalently binding enzyme inhibitors Rapid reversible inhibitors, slow & tight binding inhibitors, Transition state analogs, multisubstrate inhibitors. UNIT- II QSAR Historical Perspective, Target Selection and Lead Identification- Natural Product Sources, Fermentation/ microbial sources and Synthetic History and development of QSAR, Drug-Receptor Interactions, Quantitative model parameters: lipophilicity, electronic and steric factors, Hansch Analysis, Free Wilson analysis, relationship between them and their application. Statistical methods-regression analysis, partial-least square analysis (PLS) and other multivariate statistical methods, 2D and 3D QSAR approaches UNIT- III Molecular modeling a. Introduction to Molecular Modeling- concepts and methods b. Molecular mechanics-Force field (potential energy function) c. Quantum Mechanics- Calculation of affinity, unknown receptors, Pharmacophore models d. Known receptor sites e. Searching for similarity, molecular comparison and finding common pattern f. Energy Minimization methods-Steepest,desent, conjugate gradients, Newton methods (Non

mathematical) g. Conformational Analysis

i) Systematic search ii) Monte Carlo Simulations iii) Molecular Dynamics Simulations

h. Ligand design based on 3D structure Introduction to Pharmacogenomics

UNIT- IV Proteins and Peptide Drugs Chemistry, structure and stability, Reactivity of proteins and peptides. Different ways to synthesize these Drugs- Study of insulin, Relaxin, Somatostatin, DNAse interferon. Role of Recombinant DNA technology and Drug Discovery Cloning DNA, expression of clonal DNA, manipulation of DNA sequence information new biological targets for drug developments, novel biotechnology derived pharmaceutical products. Antibody, antisense oligonucleotide therapy and gene therepy.

58

UNIT- V Prodrug Design Introduction, chemical bond, gastrointestinal absorption, parenteral administration, distribution, transdermal absorption, pharmacokinetics and biopharmaceutical aspects, rational of Prodrug design and practical considerations Recommended Books: 1. Comprehensive Medicinal Chemistry series I-IV (Academic Press) 2. Burger: Medicinal Chemistry (John Wiley & Sons N.Y.) 3. Foye: Principals of Medicinal Chemistry (Varghese & Co.) 4. Lednicer: Organic drug Synthesis Vol.1,2,3,4(John Wiley & Sons N.Y) 5. Ariens: Medicinal Chemistry series 6. Elies & West: Progress in Medicinal Chemistry series 7. Wilson & Gisvold: Text book of Medicinal Chemistry (J.B.Lippin) 8. QSAR & Strategies in the design of Bioactive Compound J. K. Seydel Latest after 1984 Deuts

che Bibliofech. 9. Nucleic acid targeted Drug Design Propst & Thomas 1997 Marcel Decker. 10. Structure based Drug Design Pandi veera Pandian 1997 Merck Decker 11. A Guide to chemical Basis of Drug Design Burger Alfred 1997 Wiley interscience. 12. Computer aided Drug Design Perun 1st 1989 / Latest Marcel Decker 13. Computational Medicinal Chemistry for Drug Design Patrick Bultinck 2004 Marcel Decker. 14. Nucleic acid targeted Drug Design Propst & Thomas 1997 Marcel Decker 15. Principles of Drug Design by Smith 16. Strategy of Drug Design by Brucell 17. The organic chemistry of the Drug Design and Drug action by Richard B. Silverman 18. Introduction to Quantitative Drug Design by Y.C.Martin 19. Drug Design volumes by Ariens.

PPRPH 2303: CHEMISTRY OF NATURAL PRODUCTS (THEORY)

4 Hrs/ Week UNIT- I Natural products as leads a) Introduction b) Primary and secondary metabolites in plants, marine natural products c) Study of natural products as leads like cannabinoids, etoposide, teniposide, khellin, artemisin etc. UNIT- II Alkaloids

a) Detailed chemistry and properties of alkaloids b) Isolation, purification and structural elucidation of morphine, vincristine, reserpine, ephedrine and

atropine. UNIT- III Steroids a) General introduction b) Stereochemistry, nomenclature and structural elucidation of sterols (cholesterol), sapogenin

(diosgenin), and solasodine. Flavonoids Detailed chemistry and properties of Flavonoids and chemical account of rutin & quercetin

59

UNIT- IV Antibiotics Bioactive compounds from micro-organism with reference to antibiotics, anti-protozoals and marine natural products Microbial conversions as tools in the preparations of Drugs.

(i) Practical and Theoretical aspects of microbial transformation (ii) Microbial conversions of drugs like steroids, prostaglandins and antibiotics

UNIT- V Pharmacological Screening of Herbal Drugs Introduction and evaluation of herbal drugs for antidiabetic, hepatoprotective, diuretic, anti-diarrhocal, antiulcer, wound healing, cardiovascular, anti-inflammatory,analgesic, antipyretic, antifertility, anti-oxidant, anti-viral & cyto-toxic properties.

Recommended Books: 1) Natural product chemistry by Nakanishi Goggolo 2) Modern methods of plant analysis – Peech and M. V. Tracey 3) Phytochemistry Vol I & II by Miller, Jan, Nostrant, Rein Hid 4) Recent advances in Phytochemistry Vol. I & IV – Scilicet, Runeckles 5) Natural Product Chemistry “A laboratory guide” by Rapheal Ikan. 6) The alkaloid chemistry and physiology by THF Manske 7) Introduction to molecular Phytochemistry – CH Wells, Chapmannstall 8) Organic chemistry of natural products Vol I & II by Gurudeep Chatwal 9) Organic chemistry of natural products Vol I & II by O. P. Agarawal 10) Organic chemistry Vol I & II by I. L. Finar 11) Elements of Biotechnology by P. K. Gupta 12) Pharmaceutical Biotechnology by S. P. Vyas and V. K. Dixit\ 13) Biotechnology by Purohit and Mathoor 14) Phytochemical methods by Harborne

PPRPH 2304: STEREOCHEMISTRY & REACTION MECHANISM


UNIT- I Stereochemistry Molecular dissymmetry, compounds with one, two or more unequal asymmetric carbon atoms and recimic modifications, configuration modifications, configuration absolute and relative, conformations in cyclic compounds, optical isomerism, shape of cyclohexanes and six-membered heterocyclic rings, shape of rings other than six membered ones. role of inductive, resonance and steric effects in structure and relativity, dynamic stereochemistry UNIT- II Chiral Technology Introduction to chirality and Techniques used in asymmetric synthesis. Case study of Diltiasm,Timolol, Vitamin C, Ampicillin, dextra-propoxyphen, thinenamycin, Citrenalol, propanolol, Atenolol and Naproxen Protective Groups for- Hydroxyl, Amino, carbonyl and Carboxilic acid functional groups UNIT- III Reactions and Mechanism Study of reactions of Synthetic importance: Birch reduction, Mannich reaction, Aldol condensation, Diel’s alder reaction, Meerwin Pondroff-Verley reduction, Oppeneaur oxidation, Beckmann

60

rearrangement, Grignard reaction, Hoffmann rearrangement, Catalytic hydrogenation reactions, Ozonolysis, Reformatsky reaction, Micheal reaction, Photochemical Reactions - Basic theory, orbital symmetry rules and their applications, photochemistry of carbonyl, alkene and aromatic compounds Catalysis - Introduction, phase transfer catalysis in anhydride, epoixde, ester, nitryl, sulphide formation, ester formation, ester hydrolysis and reduction reactions Pericyclic Reactions-Mechanism, types of Pericyclic reactions-cycloaddition, Electrocyclic reactions, sigmatrophic rearrangement UNIT- IV Synthon Approach Definition of terms- disconnection, synthon, functional group interconversions, Basic rules in disconnection. Use of synthon approach in synthesis of following compounds: Trimethoprim, Terfenadine, Ibuprofen, Propranolol, Fentanyl, Ciprofloxacin, Cimetidine, Piroxicam, Rosiglitazone, Diclofenac, Captopryl, Nifedipine, Losartan. UNIT- V Combinatorial Chemistry Introduction, Combinatorial approaches, Chemical peptide and small molecule libraries, Applications, methodology, Combinatorial Organic Synthesis, Assays and screening of combinatorial libraries, Introduction to high Throughputs Screening (HTS) Recommended Books: 1) Drug stereochemistry Wainer Stering 1st Edn. 1996 Marcel Decker. 2) “Asymmetrical Synthesis”, R.A Aitkin and S.M. Kilengi, Ed., Blackie Academic and professional

London, 1995 3) “Advanced Organic chemistry, Reaction mechanisms and structure”, J.march, john Wiley and

sons, N.Y. 4) Recent advances in Chiral Separations, Ed. Stevenson & wi, Latest 1990, Plenum Press. 5) “Chiral Technology” R. A. Steldon, Marcell Dekker Inc. NewYork 1993. 6) Combinational Chemistry-synthesis and applications- Stephen R. Wilson 7) Combinatorial Chemistry Ed. Fennirl Hicham 2000 Oxford University 8) Reactive intermediates in Organic chemistry- Tandom and Gowel. 9) Molecular reaction and photochemistry- C.H. Deupuy and O.L. Chapman

PPRPH 2311: CHEMISTRY OF BULK DRUGS (PRACTICAL)

( 6 hr/week) 1. Synthesis and purification of selected drugs 2. To perform the following reaction of synthetic importance • Birch reaction • Clemmensons reduction • Meerwin-Pondroff,s reduction • Grignard reaction • Oppeneaur oxidation • Benzylic acid rearrangement • Beckmann rearrangement • Photochemical reaction

Recommended Books: 1. Organic synthesis: Fieser and William Son (CBA Publisher) 2. Mann and Saunders, ‘Practical Organic chemistry’ (Orient Longman)

61

3. A.I.Vogel, ‘Practical Qualitative and Quantitative Organic Chemistry (Orient Longman) 4. Systematic Identification of Org. Compounds Shriner & Herman 1998 John Wiley & sons 5. Reaction Synthesis in Organic Chemistry Laboratory Tiezel/ Ether 1989, University Science.

PPRPH 2312: ADVANCED MEDICINAL CHEMISTRY

(PRACTICAL) (6 hr/week)

1) Synthesis of drugs using 3/4 steps, and/ OR Synthon approach using basic operations like molecular distillation, fractional crystallization and purification by column chromatography, preparative TLCand structural confirmation by spectroscopic methods.

2) Drug designand molecular modeling Experiments using softwares – a. Conformational analysis, b. QSAR, c. Docking, d. Protein/Enzyme structure analysis

Recommended Books/Softwares: 1. Organic synthesis: Fieser and William Son (CBA Publisher) 2. Mann and Saunders, ‘Practical Organic chemistry’ (Orient Longman) 3. A.I.Vogel, ‘Practical Qualitative and Quantitative Organic Chemistry (Orient Longman) 4. Systematic Identification of Org. Compounds Shriner & Herman 1998 John Wiley & sons 5. Reaction Synthesis in Organic Chemistry Laboratory Tiezel/ Ether 1989, University Science. 6. Hyperchem soft. Hypercube Inc. 7. Autodock soft. The Scripps Research Institute

PPRPH 2313: CHEMISTRY OF NATURAL PRODUCTS (PRACTICAL)

(6 hr/week) 1) Isolation, characterization like melting point, mixed melting point, molecular weight determination,

functional group analysis, chromatographic techniques for identification of isolated compounds and interpretation of UV&IR data of following (Any 10) I. Eugenol from Clove II. Curcumin from Turmeric III. Sennosides from Senna IV. Hesperidine from Orange peel V. Embelin from embela Ribes

VI. Glycyrrhizin from glycyrrhiza glabra VII. Plumbigin from Plumbago Rosea VIII. Solarin from potato IX. Naringen from grape fruit peel X. Trimystin and Myristin from Nutmeg

XI. Azylic acid from Castor oil XII. Pectin from Orange peel XIII. Lycopene from Tomato peel XIV. Epicatechin from Cashew kernel, outer kernel XV. Piperin from Black pepper

Recommended Books: 1. Organic synthesis; Fieser and William Son (CBS publishers) 2. Mann and Saunders. Practical Organic Chemistry (orient Longman) 3. I. Vogel, Practical Qualitative and Quantitative Organic Chemistry (Orient Longman)

62

4. Modern methods of plant analysis – Peech and M. V. Tracey 5. Phytochemistry Vol I & II by Miller, Jan, Nostrant, Rein Hid 6. Recent advances in Phytochemistry Vol. I & IV – Scilicet, Runeckles 7. Natural Product Chemistry “A


specialization)


SEMESTER – IV




63

PHARMACOLOGY SEMESTER - I

PPRPH 1001: DOSAGE FORM DESIGN (THEORY)

4 Hrs/ Week UNIT – I 1. Preformulation Studies in Pharmaceutical Product Development: Introduction, organoleptic properties, purity, particle size, shape, and surface area. Solubilisation, surfactants and its importance, temperature, pH, pKa, partition coefficient, co-solvency; Techniques for the study of crystal properties and polymorphism. Physicochemical characteristics of new drug molecules with respect to different dosage forms. 2. Drug Stability: Introductory overview: Importance of stability attributes for drug products, potential adverse effects of instability in pharmaceutical ,products, the gamut of stability concerns, reasons for stability testing, modes of degradation, the essential elements of high quality cost effective stability programme, conformance periods, shelf life and expiration dates, some possible strategies to improve shelf life. Solution stability, solid state stability, parameters for physical stability, protocol for physical stability testing, determination of shelf life by accelerated stability testing studies. UNIT – II Product Development: a) Formulation of pharmaceutical dosage forms (solid dosage forms). b) Formulation of pharmaceutical dosage forms (liquid dosage forms). c) Formulation of pharmaceutical dosage forms (semi-solid dosage forms). d) Formulation of pharmaceutical dosage forms (parenterals). UNIT – III Evaluation of pharmaceutical products: a) Evaluation of pharmaceutical dosage forms (solid dosage forms). b) Evaluation of pharmaceutical dosage forms (liquid dosage forms). c) Evaluation of pharmaceutical dosage forms (semi-solid dosage forms). d) Evaluation of pharmaceutical dosage forms (parenterals). UNIT – IV Cosmetic Formulations: Formulation and evaluation of various cosmrtic preparations like Hair care products, Skin care products, Colour cosmetics, Dental Products, Personal hygiene products. Safety consideration and safety testing of cosmetic products. UNIT – V Pharmaceutical additives, drug excipient interactions and incompatibility, method to detect drug excipient interactions. Packaging Technology: Introduction, packaging protection functions, ICH guidelines, material and pack selection, testing the finished products in its pack- leakage detection method, evaluating rubber stopper assembly, legislations and guidelines relating to packaging, modern packaging technology including blister packing, product labeling consideration on packaging materials. Books Recommended: 1. L. Lachman, Lieberman and Kanig: “The Theory and Practice of Industrial Pharmacy”, Varghese


Forms – Tablets”, Volumes 1 to 3, Marcel Dekker, NY.

64

3. Kenneth E. Avis, Leon Lachman and Herbert A. Lieberman ed.: “Pharmaceutical Dosage Forms-Parenteral Medications”, Volume 1 and 2, Marcel Dekker, NY.

4. Herbert A. Lieberman, Martin M. Rieger and Gilbert ed.: “Pharmaceutical Dosage Forms-Disperse Systems”, Volume 1 and 2, Marcel Dekker, NY.








PURPH 1002: INSTRUMENTAL METHODS OF ANALYSIS (THEORY)

4 Hrs/ Week UNIT – I UV-Visible spectroscopy: Brief review of electromagnetic spectrum, UV-Visible range, energy-wavelength-colour relationships. Interaction of electro - magnetic radiation (UV-Vis) and matter and its effects, Chromophores and their interaction with EMR, Woodward-Fieser rule, Absorption spectra of organic compounds and complexes illustrating the phenomenon and its utilization in qualitative and quantitative studies of drugs, Beer-Lambert’s law, Shifts and their interpretation (including solvent effects). Multicomponent analysis, derivative spectroscopy, Instrumentation Spectrofluorimerty: Fluorescence, Phosphorescence, Chemiluminescence - Theory, instrumentation and applications Infrared Spectrophotometry:Nature of Infra-red radiation, Interaction of IR radiation with organic molecules and effects on bonds, Molecular or infra-red spectra, Brief outline of classical IR instrumentation and interpretation of spectra, including sample preparation for spectroscopy, Qualitative interpretation of IR Spectra, Influence of substituents, ring size, hydrogen bonding vibrational coupling and field effect on frequency, Quantitative methods, FT-IR and applications. Recent advances in IR Spectroscopy (FT-NIR) UNIT – II Nuclear Magnetic Resonance Spectroscopy: Fundamental principles of NMR (Magnetic Properties of nuclei, applied field and precession, absorption and transition frequency). Chemical shift concept, Isotopic nuclei, Reference standards, proton magnetic spectra, their characteristics, presentation, terms used in describing spectra and their interpretation (signal no., position, intensity), Brief outline of instrumental arrangements and some practical details, Signal multiplicity phenomena in high resolution NMR, Spin-spin coupling, Application of Signal Splitting and coupling constant data to interpretation of spectra, Decoupling and shift reagent methods. Quantitative NMR. Brief outline of principles of 13C NMR. Introduction to 2-D NMR Techniques. Applications of NMR technique in Pharmaceutical science and biotechnology. Mass Spectrometry: Theory instrumentation, practical consideration, structure elucidation, detection of impurities, quantitative analysis, application to determination of structure, the gas chromatograph mass spectrometer combination.

65

Atomic spectroscopy and plasma emission spectroscopy, Electron microscopy Optical Rotatory Dispersion: Terminology ,Plain Curves, Rotatory dispersion of ketones, The Axial Haloketone Rule, Octant Rule. UNIT – III Recent trends in chromatography with reference to analysis of drugs and related substances: a) High performance TLC –Principle, adsorbents, retention and separation parameters, detection methods, qualitative and quantitative HPTLC. b) Gas Chromatography: Introduction, principles, Instrumentation, carrier gas, types of columns, column selection- liquid stationary phases, column efficiency parameters, the Van Deemter equation, Resolution, Derivatisation methods, Detectors. A critical comparison of sensitivity, selectivity and field of applications of these detectors. Applications of GC in Pharmaceutical science. Hyphenated techniques: Brief introduction and applications. c) Hyphenated techniques-Brief introduction and applications Liquid Chromatography: Instrumentation, columns, packing materials, column selection, mobile phase selection, efficiency parameters, resolution and optimization of chromatographic parameters. Detectors in HPLC: Comparison of sensitivity , selectivity and field of applications of these detectors. Modes of HPLC-Ion-pair, Ion-exchange, Size exclusion, Supercritical, Chiral, Gel-permeation, Flash chromatography. Applications of liquid chromatography. Electrophoresis: Principle, techniques, instrumentation including detection strategies and applications in paper and gel electrophoresis. UNIT - IV Liquid Chromatography: Instrumentation, columns, packing materials, column selection, mobile phase selection, efficiency parameters, resolution and optimization of chromatographic parameters. Detectors in HPLC: Comparison of sensitivity selectivity and field of applications of these detectors. Modes of HPLC-Ion-pair, Ion-exchange, Size exclusion, Supercritical, Chiral, Gel-permeation, Flash chromatography. Applications of liquid chromatography.





Publishers, New Delhi.

66

13. John R. Dyer: ”Applications of Absorption spectroscopy of organic compounds “ Prentice Hall of India, New Delhi.



16. “United States Pharmacopoeia”, USP 32 – NF 27, Vol 1 & 2, Asian Edition, 2008. 17. D. A. R Williams: ”Nuclear Magnetic Resonance Spectroscopy”, John Wiley & Sons, 2008. 18. Clive Whiston: ”X-Ray Methods”, John Wiley & Sons, 2008. 19. Stuart, George, Peter: ”Modern Infra Red Spectroscopy”, John Wiley & Sons, 2008. 20. W. Geary: ”Radio Chemical Methods”, John Wiley &Sons, 2008. 21. Michael Thomas: ”Ultra Violet and Visible Spectroscopy”, John Wiley & Sons,2008. 22. James Barker: ”Mass Spectrometry”, 2nd edition, John Wiley & Sons, 2008. 23. James W. Dodd & Kenneth: ”Thermal methods” John Wiley & Sons, 2008. 24. Maureen Melvin: ”Electrophoresis”, John Wiley & Sons, 2008. 25. William Kemp: “Organic spectroscopy” ELBS, London. 26. Kalsi: ”Spectroscopy of Organic compounds” New age International.




UNIT- II Preclinical and clinical models employed in the screening of new drugs belonging to following categories: Antipsychotic agents, Anti anxiety Agents; Nootropic Drugs; Antidepressant Drugs; Anticonvulsants; Anti Parkinsonism Agents; Opioid Analgesics; Anti-Inflammatory Drugs. UNIT- III Preclinical and clinical models employed in the screening of new drugs belonging to following categories: Infarction; Antihypertensive; Anti Atherosclerotic Drugs; Anti Malarial; Anthelmintics; Anti Diabetics; Models For Local Anesthetics; Activity on the GI Tract, Transgenic Animals And Other Genetically Prone Animal Models. UNIT- IV Principles of Biological Standardization: Methods of biological assay, Principles of biological assays with certain examples as per IP and BP. Development of new bioassay methods. Alternatives to animal screening procedures: Cell-Line, Patch-Clamp Techniques, In-Vitro Models, molecular biology techniques. Principles of toxicity evaluations, ED50, LD50 and TD values. International guidelines (ICH recommendations). UNIT- V Receptor-Radioligand Binding Assays: General principles and techniques of radio ligand binding assays. Specific assay design for adrenoreceptors, dopamine receptors, histamine receptors, GABA and benzodiazepine receptors. Immunoassay: General principles of immunoassay, Theoretical basis, Optimization of immunoassay, Heterogenous immunoassay system, Homogenous immunoassay system. Production of immunoassay reagent: Introduction, receptors or binders, unlabeled ligands Calibrators, Labeled ligands and receptor, Separation technique, buffers.

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Immunoassay Methods Evaluation: Protocol outline, objective &preparation, evaluation of precision, standard tracer, sensitivity, evaluation of accuracy, antibody characteristics, monitoring, reaction conditions, clinical evaluation. Books Recommended: 1. H. G. Vogel: “Drug Discovery and Evaluation-Pharmacological Assays”, 2nd edition, Springer






4 Hrs/ Week UNIT – I Research Process: Introduction to research methodology, objectives, classification of research methods: Historical method, case study method, survey method, experimental method, and other methods( field investigation research, evaluation research, auction research, ex-post facto research, laboratory research, business game) – Definition, significance, sources, advantages, limitations, steps involved in research. Research Problem: sources, criteria of a good research problem, formulating and stating the problem, common errors in selecting and formulating a research problem. Research Design: Definitions, need for a research design, characteristics of good research design, components of a research design, types of research design: descriptive, diagnostic, exploratory and experimental. UNIT – II Sampling Methods: Introduction of sampling, probability and non probability sampling, sampling procedures – simple random, stratified, systematic, cluster and multistage sampling, concept of sampling distribution. Collection and Processing of Data: Sources of data, methods of collection of primary and secondary data, editing, coding, classification and tabulation of data, graphical and representation of data, diagrammatic representation of data. UNIT – III Inferential Statistics: Basics of Statistical Inference, Sampling distribution, Estimation – Point estimation, Interval estimation, Parameter, Statistic, Concept of a hypothesis, Research Hypothesis, Null Hypothesis, Level of Significance, Comparison of means of two samples, Comparison of sample proportion with population proportion, Comparison of two sample proportions, Degrees of Freedom, Critical Value, Table value, Type I and Type II errors, Rules for rejection & acceptance of Null Hypothesis, Standard Error. UNIT – IV Inferential Statistics – Parametric and Non-Parametric Test: ‘t’ test – Comparison of sample mean with the population mean, Comparison of means of two independent samples, Comparison of two correlated samples ‘Z’ test – different applications ANOVA – one way ANOVA: ‘F’ test, Chi square test.

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UNIT – V Correlation and Linear Regression: Introduction of correlation & regression concepts, estimation of correlation coefficient, regression coefficients, variance of sample estimates of the parameters, non linear regressions, weighted and transformations in regression analysis, application of linear regressions - standard curves in drug analysis and drug stability studies, analysis of covariance. Books Recommended: 1. Santosh Gupta: “Research Methodology and Statistical Techniques”, Deep & Deep Publication,




Accelerated stability studies of various formulations or drugs with respect to (a) Temperature (b) Effect of buffers / pH dependent (2 – 4 Expts.) Formulations and evaluation of some liquid orals such as Analgesic-antipyretics, Antihistamines, Co-

trimoxazole, suspensions etc. (2 – 3 Expts.) Formulation and evaluation of stability of reconstituted dry syrups of Amoxicillin, Ampicillin etc. ( 2

Expts.) Preparation and evaluation of diclofenac sodium gels containing two different bases. (2 Expts.) Formulation and evaluation of semisolid dosage forms using different – bases and drugs (cetrimide,

salicylic acid) of current interest. To study the effect of particle size, moisture content and lubricants on flowability and compressibility of

powders. Study of effect of various binding agents on the properties of tables (2 Expts.) Preparation and evaluation of Skin care and Hair care products (4-5 Expts)




8. Assays involving following procedures: Non-Aqueous, Diazotisation, Complexation and Redox

titrations.


6 Hrs / Week

1. Introduction to Pharmacological evaluation methods and CPCSEA and OECD guidelines, GLP norms

Standard techniques for injection of drugs, collection of blood samples and feeding of animals 3. Study of various techniques of anesthesia and euthanasia 4. To study the effect of pentobarbital on righting reflex (hypnosis) in mice 5. To study the effect of chlorpromazine on the locomotor activity of mice using actophotometer

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6. To study the apomorphine induced compulsive behaviour (stereotype) in mice 7. To study the muscle relaxant property of diazepam in mice using rotarod apparatus 8. To study the analgesic effect of morphine in mice using the tail-flick method and hot plate method 9. To study the analgesic effect of morphine against acetic acid-induced writhing in mice 10. To study the anti-inflammatory property of indomethacin against carrageenan-induced paw edema 11. General methods for evaluating the antimicrobial activities of chemotherapeutic agents. 12. Estimation of biochemical and free radical scavengers. 13. General screening methods for the anti ulcer activity, intestinal motility, and anti-diarrheal.. 14. General screening procedure of anti-hypertensive’s. 15. General screening methods for evaluating the diuretic activity

Books recommended 1. R. A. Turner: “Screening Methods in Pharmacology”, Academic Press, London1965 2. H. G. Vogel (ed), Drug Discovery and Evaluation-Pharmacological Assays, 2nd edition, Springer






SEMESTER - II

PPRPH 2401: PHARMACOKINETICS & DRUG METABOLISM (THEORY)

4 Hrs / Week UNIT- I Drug absorption: Gastrointestinal, Percutaneous and rectal kinetics and factors affecting drug absorption and bioavailability. Basic concepts of pharmacokinetics: Compartmental models; One, two and Non compartmental approaches to pharmacokinetics. Recent trends, merits and limitations of these approaches. UNIT- II Drug distribution: Plasma protein binding – Factors affecting plasma protein binding, Tissue binding, transfer of drugs through biological barriers and their therapeutic implication in drug action. Elimination of drugs: Concept of renal clearance and excretion of drugs, biological half-life. UNIT- III Reaction of body to foreign substances: Biotransformation of drugs, phase I and phase II metabolic reactions. Microsomal and non microsomal reactions. Drug metabolism in liver, kidney, intestine and placenta. Drug metabolism in fetus and new born. In-vitro and In-vivo studies in drug metabolism UNIT- IV Factors influencing drug metabolism: 1. Stereo chemical, and physico chemical factors, 2. Physiological factors: species difference, stain difference, sex, age and environmental factors.

3. Pathological states, 4. Genetic factors: Pharmacogenetics, heritable factors recognized in man

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by use of drugs. Elimination: Over all apparent elimination rate constant, and half life. Under the following conditions:

a. Intravenous bolus injection b. Intravenous infusion c. Single dose oral administration d. Multiple dose injections e. Multiple dosage oral administration.

Non invasive methods of estimating pharmacokinetic parameters with emphasis on salivary and urinary compartments. Concept of Clearance: Organ clearance, Total Clearance, Hepatic Clearance, Gut Wall, Lung Clearance and Renal Clearance. UNIT- V Pro drug concept Non-liner Pharmacokinetics: Concepts of linear and non linear pharmacokinetics, Michaelis - Menton kinetics characteristics. Basic kinetic parameters, possible causes of non induction, non linear binding, non linearity of pharmacological responses Time dependent pharmacokinetics: Introduction, classification, physiologically induced time dependency: Chronopharmacokinetics, chemically induced time dependency. Drug Metabolism – sites of metabolism, factors affecting drug metabolism (genetics, species and environmental). Books Recommended: 1. M. Gibaldi: “Pharmacokinetics”, Marcel Dekker Inc. New York. 2. H. M. Abdou: “Dissolution, Bioavailbility and Bioequivalence”, Mack Publishing Co. Easton, PA. 3. R. V. Smith & J. T. Stewart: “Text Book of Biopharmaceutical Analysis”, Lea and Febiger,

Philadelphia. 4. J. G. Wagner: Fundamentals of Clinical Pharmacokinetics, Drug Intelligence Pub. Hamilton. 5. P.G. Welling, F.I.S. Tse & S.V. Dighe (eds): “Pharmaceutical Bioequivalance”, Marcel Dekker

Inc., New York. 6. M. Gibalidi, D. Perrier: “Pharmacokinetics”, Marcel Dekker Inc., New York. 7. M. Rowland & T. N. Tozer: “Clinical Pharmacokinetics - Concept and Applications” , Lea and

Febiger, USA. 8. L. Shargel & A. B. C. Yu: “Applied Biopharmaceutics & Pharmacokinetics”, Appleton and Lange,


and Basel.

PPRPH 2402: ADVANCED SYSTEMIC PHARMACOLOGY (THEORY)

4Hrs / Week UNIT- I Basic Principles of Pharmacology: Mechanisms of drug action, membrane transporters and drug response, adverse drug reactions, pharmacokinetics and pharmacogenetics. Pharmacology of the Autonomic Nervous System: Physiology of autonomic nervous system. Muscarinic receptor agonists and antagonists, Anticholinesterase agents,Agents acting at neuromuscular junction and autonomic ganglia, Adrenergic agonists and antagonists, 5-Hydroxytryptamine receptor agonists and antagonists

UNIT – II Drugs Acting on the Central Nervous System: Neurotransmission in central nervous system, General anesthetics, Local anesthetics, Hypnotics and sedatives, analgesics, Pharmacology of ethanol, Drug addiction and drug abuse, Analgesic, Antipyretic, and Anti-inflammatory Agent

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UNIT- III Drugs Affecting Renal and Cardiovascular Function: Diuretics, Vasopressin and other agents affecting the renal conservation of water,Renin, angiotensin, and their modulators, Calcium channel blockers Drugs Acting on the Blood and Blood-Forming Organs: Hemopoietic agents: Growth factors, minerals, and vitamins Blood coagulation and anticoagulant, thrombolytic, and antiplatelet drugs UNIT- IV Pharmacology of Chemotherapeutic and Antimicrobial Agents: General considerations of antimicrobial therapy, Sulfonamides, trimethoprim, quinolones, other related agents, Penicillins, cephalosporins, and other beta-lactam antibiotics, Aminoglycosides Protein synthesis inhibitors and miscellaneous antibacterial agents, Antifungal agents, Antiviral agents (Non-retroviral) Antineoplastic Agents UNIT- V Immunosuppressants, Tolerogens, and Immunostimulants Hormones and Their Antagonists: Pituitary hormones and their hypothalamic releasing factors, Thyroid and antithyroid drugs, Estrogens and progestin’s, Androgens, Adrenocortical steroids and their synthetic analogs, inhibitors of synthesis and actions of adrenocortical hormones, Agents affecting mineral ion homeostasis and bone turnover Pharmacology of Dermatological Agents Ocular Pharmacology Books Recommended: 1. H. P. Rang & M. M. Dale, “Pharmacology”, 6th edition, Churchill Livingstone, 2007. 2. T. W. A. Rall, A.I.S. Nies and P. Taylor “Goodman and Gilman’s The Pharmacological Basis of

Therapeutics”, 11th edition, Mc Graw Hill, Pergamon Press, 2006. 3. B. G. Katzung: “Basic and Clinical Pharmacology” 9th edition, Mc Graw Hill, Singapore, 2004. 4. David E. Golan “Principals of Pharmacology”, Lippincott Williams & Wilkins, USA, 2005. 5. Richard A. Harvey “Pharmacology”, 4th edition, Wolters Kluwer (India) Pvt. Ltd., New Delhi,2006. 6. R. S. Satoskar and S. D. Bhadarkar: “Pharmacology and Pharmacotherapeutics”, 21st edition (single

volume), Popular Prakashan Publication, Dubai, 2009. 7. K. D. Tripathi: “Essentials of Medical Pharmacology”, 6th edition, Jaypee Brothers Medical Publication, Delhi,

2008.

PPRPH 2403: CELLULAR AND MOLECULAR PHARMACOLOGY (THEORY)

4 hrs / week UNIT- I Molecular mechanism of drug action: Receptor occupancy and cellular signaling systems such as G-proteins, cyclic nucleotides, calcium and phosphatidyl inositol. Ionic channels and their modulators: calcium, potassium, sodium and chloride channels UNIT- II Endogenous bioactive molecules such as cytokines, neuropeptides and their modulators, neurosteroids, nitric oxide, phosphodiestrase enzyme and protein kinase C, arachidonic acid metabolites, COX-2 regulators and their role in inflammation, endothelium derived vascular substances (NO, endothelins) and their modulators. Pharmacology of atrial peptides, reactive oxygen intermediates, antioxidants and their therapeutic implications. UNIT- III Recent trends on different classes of receptors and drugs acting on them

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a) Angiotensin receptors b) Excitatory amino acid receptors c) Kinin receptors d) Adrenoceptors e) Low molecular weight heparins, hirudins and GP II/IIIa receptor antagonists f) Imidazole receptors g) Cholinergic receptors h) Dopamine receptors i) Serotonin receptors j) Hormone receptors k) GABA and Benzodiazepine receptors l) Opiod receptors m) Purinergic receptors n) Glutamate receptors

UNIT- IV Apoptosis: pharmacological and clinical implications Adhesion therapy and cardiac and vascular remodeling Molecular Oncology: Causes of cancer, genetic of cancer, oncogenes, tumor suppressor genes. Contrast the use of therapeutic agents for cancer chemotherapy versus immunosuppression in terms of Dosage and degree of elective toxicity.

Ion channel and their modulators: calcium, potassium, sodium and chloride channels Basic Concepts of Chronopharmacology and their implications to Drug Therapy.

UNIT - V Basic concepts of high throughput screening Immunopharmacology: Antibody dependent and cellular cytotoxicity. Concept of gene therapy and recent development in the treatment of various hereditary diseases. Transgenic mouse and its applications. Human genome mapping and its potential in drug research.

Molecular Neurology: Molecular genetics of Alzheimer's disease, Myasthenia gravis and parkinsonism. Molecular mechanism and regulation of behavior.

Books Recommended: 1. B. G. Katzung: “Basic and Clinical Pharmacology, Lange Medical Publisher, USA. 2. F. S. K. Barar: “Essentials of Pharmacotherapeutics”, S. Chand and Company, New Delhi. 3. W. C. Bowman and M. J. Rand: “Textbook of Pharmacology”, Blackwell, Oxford. 4. K. L. Melmon and Morelli: “Clinical Pharmacology: Basic Principle of Therapeutics”, Mc Millan,

New York. 5. C. R. Craig and B. E. Stitzel: “Modern Pharmacology”, Little Brown and Co, Boston. 6. V. A. Drill: “Pharmacology in Medicine”, McGraw Hill, New York. 7. Grollman Pharmacology and Therapeutics, Lea and Tebiger, Philadelphia 8. Z. M. Bacq & Cepek: “Fundamentals of Biochemical Pharmacology” 9. G. S. Avery: “Drug Treatment”, Adis Press, Sydney. 10. T. W. A. Rall, A. I. S. Nies and P. Taylor “Goodman and Gilman’s The Pharmacological Basis of

Therapeutics”, 11th edition, Mc Graw Hill, Pergamon Press, 2006. 11. H. P. Rang & M. N. Dale: “Pharmacology”, Churchill Livingston,UK.

PPRPH 2404: CLINICAL PHARMACOLOGY & TOXICOLOGY

(THEORY) 4 hrs / week UNIT- I Drugs interactions: Mechanism, Pharmacokinetic & Pharmacodynamic drug-drug interaction, Food-drug and drink interaction Adverse drug reactions: Definition and classification, epidemiology, predisposing factors, pharmacovigilance & pharmacoepidemiology, mechanism of ADR & different types of ADR, Therapeutic Drug Monitoring

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UNIT- II General principles of regulatory toxicology. Use of animals in preclinical toxicology studies, role of preclinical toxicology in drug discovery and development process. Experimental considerations for assessing possible human risk. Flow chart for development of preclinical testing. Dose conversion factors, clinical signs toxicity. UNIT- III Single dose and repeat dose toxicity studies; Factors influencing such studies such as species, sex, size, route, dose level; Data evaluation and regulatory requirements. Determination of Maximum Tolerated Dose (MTD) and LD 50 as per revised OECD guidelines. Allergenicity testing, dermal toxicity, immunotoxicology and in vitro methods of toxicology. UNIT- IV Clinical trials: definition, phase I – IV studies, design documentation, presentation and interpretation, statistical analysis of clinical data, factorial design, guidelines as per Indian and other regulatory authorities. Testing of Acute, Sub acute and chronic toxicity .Determination of LD

50 and ED

50

Reproductive toxicology Assessment of male reproductive toxicity, spermatogenesis; Risk assessment in male reproductive toxicity; Female reproductive toxicology; Oocyte toxicity; alterations in reproductive endocrinology; Relationship between maternal and developmental toxicity. UNIT- V

Monoclonal Antibodies: Scope and limitation of monoclonal antibodies, formation and selection of hybrid cells, and identification of specific antibody producing hybrid cell lines. Applications of monoclonal antibodies in clinical, treatment, and biomedical research. Monoclonal antibodies as therapeutic agents, preventing rejection of transplanted organs, treatment of bacterial blood infections. Chemically linked monoclonal antibodies, human monoclonal antibodies, and hybrid human-mouse monoclonal antibodies. Books Recommended: 1. Roger and Walker “Clinical Pharmacy and Therapeutics “4th edition, Churchill Livingstone Publication, 2007. 2. D. R. Laurence, P.N. Bennett and M.J. Brown: “Clinical Pharmacy” 3. Herphendol: “Clinical Pharmacology” 4. Shayne C Gad: “Drug safety Evaluation” Wiley Interscience. 5. Michael J Derelanko:“The Toxicologist’s Pocket Handbook”, 2nd edition, CRC press, 2008. 6. Relevent OECD guidelines (Internet resources) http://www.ingentaconnect.com

/content/oecd/16073/2001/00000001/00000004

PPRPH 2411: PHARMACOKINETICS AND DRUG METABOLISM (PRACTICAL)

6 Hrs/Week

1. Pharmacokinetic study of sulphonamides after oral administration in humans from urine samples. 2. Pharmacokinetic study of sulphonamides after oral administration in rabbits from blood data. 3. Pharmacokinetic study of sulphonamides after I.V. administration in rabbits from blood data. 4. Calculation of bioavailability of sulphonamide from the above blood data in rabbits. 5. To determine Protein binding studies of any three drugs by using equilibrium dialysis method. 6. Bioavailability studies of sulphonamide/paracetamol or any other drug from salivary data of

humans. 7. To study the influence of urinary pH on salicylate excretion. 8. Calculation of different Pharmacokinetic parameters like Ka, Ke, t

½, C

max, T

max and AUC from the

given blood data. 9. Calculation of different Pharmacokinetic parameters like Ka, Ke, t

½, C

max, T

max and AUC from the

given urine data.

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10. To determine protein-binding of drugs by equilibrium dialysis method. Books Recommended: 1. M. Gibaldi: “Pharmacokinetics”, Marcel Dekker Inc. New York. 2. H. M. Abdou: “Dissolution, Bioavailbility and Bioequivalence”, Mack Publishing Co. Easton, PA. 3. R. V. Smith & J. T. Stewart: “Text Book of Biopharmaceutical Analysis”, Lea and Febiger,

Philadelphia. 4. J. G. Wagner: Fundamentals of Clinical Pharmacokinetics, Drug Intelligence Pub. Hamilton. 5. P.G. Welling, F.I.S. Tse & S.V. Dighe (eds): “Pharmaceutical Bioequivalance”, Marcel Dekker

Inc., New York. 6. M. Gibalidi, D. Perrier: “Pharmacokinetics”, Marcel Dekker Inc., New York. 7. M. Rowland & T. N. Tozer: “Clinical Pharmacokinetics - Concept and Applications” , Lea and

Febiger, USA. 8. L. Shargel & A. B. C. Yu: “Applied Biopharmaceutics & Pharmacokinetics”, Appleton and Lange,


and Basel.

PPRPH 2412: ADVANCED SYSTEMIC PHARMACOLOGY (PRACTICAL)

6 Hrs/ Week 1. Experiments for studying the effects of the more important biogenic agents like histamine,

acetylcholine, 5HT, oxytocin and their effect in the presence of antagonist on suitable isolated tissue preparations.

2. Determination of PA2 value of Atropine using acetylcholine as an agonist employing guinea pig preparation

3. Effect of various pharmacological agents on heart rate, and force of contraction on isolated frog heart.

4. To study the effects of drugs on normal and hypodermic heart 5. Effect of various agents on rat blood pressure. 6. To study the effect of hepatic microsomal enzyme induction on the duration of action of

pentobarbital sodium 7. To study the local anesthetic property of procaine hydrochloride using foot withdrawal reflex of

frog 8. To study the local anesthetic property of procaine hydrochloride using conduction block method

and surface anesthesia method 9. Test for pyrogens (Rabbit method) 10. To study the drug activity on esophageal motility. 11. Estimation of PA2 values of various antagonists under suitable isolated tissue preparations. 12. Calculation of pA2, PD2 values using isolated tissue Preparations – rat funds strip, rat uterus,

guinea pig tracheal chain rabbit aortic strip ideal preparation, mammalian heart – etc. 13. To study the effect of drugs on the coronary blood flow and heart rate of isolated rat heart

(Langendorff’s heart preparation) Books Recommended: 1. J. H. Burn: “Practical Pharmacology”, Blackwell Scientific, Oxford, London. 2. M. N. Ghos: “Fundamental of Experimental Pharmacology”, Scientific Book Agency, Calcutta. 3. B. P. Jaju: “Pharmacology: A Practice Exercise Book”, Jaypee Brothers, New Delhi. 4. D. R. Lawrence, and A. L. Bacharch: “Evaluation of Drug Activities – Pharmacometrics”,

Academic Press. 5. S. K. Kulkarni: “Handbook of Experimental Pharmacology”, Vallabh Prakashan, New Delhi. 6. W. L. M. Perry: “Pharmacological Experiments on Isolated Preparations”, E & S Livingston,

London. 7. U. K. Sheth, N. K. Dadkar & U. G. Kamat: “Selected Topics in Experimental Pharmacology”,

Kothari Book Depot, Mumbai. 8. E. B. Thomson: “Drug Bioscreening”, VCH, New York 9. R. A. Turner: “Screening Methods in Pharmacology”, Academic Press, London, 1995.

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10. H. G. Vogel & W. H. Vogel: “Drug Discovery and Evaluation: Pharmacological Assays”, Springer, New York.

PURPH 2413: BIOASSAYS AND PHARMACOLOGICAL SCREENING METHODS PRACTICAL)

6 hrs/week 1. Bio-assay of acetylcholine on the rectus abdominis muscle of frog by interpolation method 2. Bioassay of acetylcholine on the rectus abdominis muscle of frog by three point method. 3. Effect of an agonist on acetylcholine using rectus abdominis muscle of frog 4. Effect of an antagonist on acetylcholine using rectus abdominis muscle of frog 5. Bioassay of histamine in the guinea pig ileum 6. Four-point bioassays of various agonists using rectus abdominus muscle of frog, guinea pig

ileum, rat uterus, rat fundus. Calculate log fiducial limits of error. 7. To study the effect of various agonists on isolated guinea pig tracheal chain, isolated phrenic

nerve diaphragm, isolated rat aorta, isolated rabbit atria and gastrocnemius muscle of rabbit. 8. To study the anti convulsant property of diazepam against pentylenetetrazol-induced convulsions

in rats. 9. To study the amnesic (loss of memory) effect of scopolamine using passive avoidance step-down

task paradigm in mice 10. To study the anti secretory and ulcer protective effect of cimetidine in pylorus ligated rats 11. Insulin hypoglycemic action in rabbits or rats 12. To determine the acute toxicity of the given drugs (to calculate LD50 value) 13. General screening methods for evaluating the diuretic activity.

Books Recommended 1. J. H. Burn: “Practical Pharmacology”, Blackwell Scientific, Oxford, London. 2. M. N. Ghos: “Fundamental of Experimental Pharmacology”, Scientific Book Agency, Calcutta. 3. B. P. Jaju: “Pharmacology: A Practice Exercise Book”, Jaypee Brothers, New Delhi. 4. D. R. Lawrence, and A. L. Bacharch: “Evaluation of Drug Activities – Pharmacometrics”,

Academic Press. 5. S. K. Kulkarni: “Handbook of Experimental Pharmacology”, Vallabh Prakashan, New Delhi. 6. W. L. M. Perry: “Pharmacological Experiments on Isolated Preparations”, E & S Livingston,

London. 7. U. K. Sheth, N. K. Dadkar & U. G. Kamat: “Selected Topics in Experimental Pharmacology”,

Kothari Book Depot, Mumbai. 8. E. B. Thomson: “Drug Bioscreening”, VCH, New York 9. R. A. Turner: “Screening Methods in Pharmacology”, Academic Press, London, 1995. 10. H. G. Vogel & W. H. Vogel: “Drug Discovery and Evaluation: Pharmacological Assays”, Springer,

New York.


specialization)


SEMESTER – IV




m. pharm syllabus & regulations revised

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