pharmacy syllabus need breaking - pharmainfo.net...... underlying the mechanism action of...

M.PHARM. (PHARMACOLOGY) COURSES OF STUDY

FIRST SEMESTER MPOC 101: Instrumental methods of Analysis - (Common to all Branches)

MPOC 102: Modern Analytical Techniques - (Common to all Branches)

MPOC 103: Molecular And Biochemical Pharmacology (Common with M.Pharm., Pharmaceutical Chemistry)

MPOC 104: Systemic Pharmacology And Toxicology

MPOC 105: Pharmacological Screening methods (common with M.Pharm Pharmaceutical chemistry and M.Pharm Industrial Pharmacognosy)

MPOP 106: Pharmaceutical Analysis Practical (Common to all Branches)

MPOP 107:Advanced pharmacology Practical I (Common with M.Pharm Industrial Pharmacognosy)

SECOND SEMESTER MPOC 201: Biopharmaceutics - (Common with M.Pharm Inustrial Pharmacy and M. Pharm. Pharmacy

Practice)

MPOC 202: Clinical Pharmacokinetics - (Common with M.Pharm Inustrial Pharmacy and M. Pharm. Pharmacy Practice)

MPOC 203: Biological and Biochemical Analysis (Common with M.Pharm. Quality

Assurance)

MPOC 204: Advances in Drug Design(Common with M.Pharm Industrial Pharmacy)

MPOC 205: Advances in Pharmacology

MPOP 206: Biopharmaceutics Practical (Common with M. Pharm. Pharmacy Practice)

MPOP 207: Advanced Pharmacology Practical -II

THIRD SEMESTER MPOC 301: Research methodology and Pharmaceutical Statistics

MPOE 302: Elective:

1. MPOE 302(1) Advances in Industrial Pharmacy

2. MPOE 302(2) Pharmaceutical Healthcare

3. MPOE 302(3) Analytical method development

4. MPOE 302(4) Clinical pharmacology

5. MPOE 302(5) Strategy in Drug Synthesis

6. MPOE 302(6) Pharmacobiotechnology - Theory MPOT 303: Thesis Phase I

www.Pharmainfo.Net

www.Pharmainfo.Net

FOURTH SEMESTER MPOT 401: Thesis Phase II

SCHEME OF EXAMINATIONS

Code Subject Hrs/Week

Creditpoints

Evaluation (Marks)

L T P Univ.Exam

Sessional Total

I-Semester MPOC 101 Instrumental methods of

Analysis 2 1 -- 3 75 25 100

MPOC 102 Modern Analytical Techniques 2 1 -- 3 75 25 100

MPOC 103 Molecular And Biochemical Pharmacology 2 1 -- 3 75 25 100

MPOC 104 Systemic Pharmacolgy And Toxicology 2 1 -- 3 75 25 100

MPOC 105 Pharmacological Screening methods 2 1 -- 3 75 25 100

MPOP 106 Pharmaceutical Analysis Practical -- -- 4 2 60 40 100

MPOP 107 Advanced Pharmacology Practical I -- -- 6 3 60 40 100

II-Semester

MPOC 201 Biopharmaceutics 2 1 -- 3 75 25 100

MPOC 202 Clinical Pharmacokinetics 2 1 -- 3 75 25 100

MPOC 203 Biological and Biochemical Analysis 2 1 -- 3 75 25 100

MPOC 204 Advances in Drug Design 2 1 -- 3 75 25 100

MPOC 205 Recent Advances in Pharmacology 2 1 -- 3 75 25 100

MPOP 206 Biopharmaceutics Practical -- -- 4 2 60 40 100

MPOP 207 Advanced Pharmacology Practical II -- -- 6 3 60 40 100

III Semester

MPOC 301

Research Methodology & Pharmaceutical Statistics 2 1 -- 3

75

25 100

www.Pharmainfo.Net

www.Pharmainfo.Net

MPOC 302 Elective 2 1 -- 3 75 25 100

MPOT 303 Thesis Phase I 15 6 60 40 100

MPOT 401 IV- Semester Thesis Phase II

13 60 40 100

Syllabus

FIRST SEMESTER

MPOC 101: INSTRUMENTAL METHODS OF ANALYSIS (Theory) 35 Hrs.

1. UV-Visible Spectrophotometry: Theory Beer and Lambert - Limitations of the law, Design and working of single beam and double beam spectrophotometers. Applications of UV absorptions spectrophotometry in qualitative analysis and quantitative analysis.

2. Fluorimetry: Theory - Photoluminescence Fluorescence and Phosphorescence. Chemical structure and fluorescence - factors affecting fluorescence intensity. Instrumentation and Pharmaceutical applications of fluorimetry.

3. Flame Photometry and Atomic Absorption Spectrophotometry: Theory, Instrumentation Types of interference and elimination of interference - Pharmaceutical applications

4. Chromatography: Principle, technique and applications of HPTLC, Gel filtration, Ion exchange chromatography and super critical fluid chromatography.

5. Chromatography: HPLC, GC, Plate theory, Van Deempter equation - Principle, Instruments and application. Chromatographic attributes: Capacity factor, resolution, theoretical plates and symmetry factor

6. Preliminary studies on X-Ray Diffraction and Inductively coupled plasma mass spectrometry

7. Introduction to Radio Immuno Assay

Books for Reference:

1. GN. Jeffery, Jbassett, J. Mendham and R.C. Denney, (ed), Vogels textbooks of quantitative inorganic analysis, ELBS, London.

2. A.H. Beckett and J.B. Stenlake, Practical pharmaceutical chemistry, part I and II, the Athlone Press London.

3. D.A. Skoog, D.M., West and F.J. Holler Fundamentals of Analytical Chemistry, Saunders College publishing, New York.

4. D.A. Skoog and J.J Leary Principles of Instrumental Analysis, Saunders college publishing, New York.

5. H.H Willard, L.L. Meritt, J.A. Dean and F.A. Settle, Instrumental methods of Analysis, Wadsworth, New York.

6. V.K. Srivastava and K.K. Srivastav, Introduction to Chromatography, S. Chand & Company, New Delhi.

7. H. Strobel and W.R. Heinemann Chemical Instrumentation, Addition-Wisely, Boston.

www.Pharmainfo.Net

www.Pharmainfo.Net

8. John R. Dyer, Applications of absorption Spectroscopy of Organic Compounds, Prentice Hall London.

9. Robert M. Silverstein, Clayton Bassler and Terence C. Morril, Spectrophotometric Identification of organic Compounds, John Wiley & Sons, New York.

10. Y.H. Sharma, Elementary Organic Absorption Spectroscopy, S. Chand & Co., New Delhi.

11. Undenfriend S., Florescence in biology and Medicine, Academic Press , New York.

12.

13. Pharmacopoeia of India, Govt. of India, Ministry of Health.

14. British Pharmacopoeia, ministry of Health and Social Welfare, UK.

15. United States Pharmacopoeia, US Pharmacopoeia Convention Inc. Rockville, USA.

16. A.K. Srivastava, P.C. Jain Chemical Analysis, S. Chand & Company Ltd., New Delhi.

17. Robet V. Smith, James T. Stewart, text books of Biopharmaceutical Analysis, Lea & Febiger, Philadelphia.

MPOC 102: MODERN ANALYTICAL TECHNIQUES (Theory) 35 Hrs.

1. IR-Spectrophotometry: Theory, molecular vibration, instrumentation sample preparation - application of IR spectrophotometry in pharmacy. Introduction to FTIR

2. NMR-Spectrometry: Theory and instrumentation spin-spin coupling, chemical shift, magnetic equivalence spin-spin decoupling shift reagents, applications of NMR spectrometry in pharmacy and interpretation of NMR spectra (using spectra of simple organic compound as example)

3. Mass Spectrometry: Theory, fragmentation pattern, ionization techniques: electron bombardment, chemical ionization, field desorption, fast atom bombardment. Different analysers. Interpretation of mass spectra, determination of molecular weight and molecular formula and applications of mass spectrometry

4. Theory, instrumentation and applications of Differential Thermal Analysis and Differential Scanning Calorimetry.

5. A preliminary study of principle, Instrument and applications of 13C NMR

6. Introduction to Bio Assay- bio assay of Insulin Microbiological assay of Vitamins & antibiotics

Books for reference:

1. A.H. Beckett and J.B. Stenlake, Practical pharmaceutical chemistry, part I and II, the Athlone Press London.

2. D.A. Skoog and Leary J.J., Principles of Instrumental Analysis, Saunders college publishing, New York.

3. H.H Willard, L.L. Meritt, J.A. Dean and F.A. Settle, Instrumental methods of Analysis, Wadsworth, New York.

4. H. Strobel and W.R. Heinemann Chemical Instrumentation, Addition-Wisely, Boston.

5. John R. Dyer, Applications of absorption Spectroscopy of Organic Compounds, Prentice Hall London.

6. Robert M. Silverstein, Clayton Bassler and Terence C. Morril, Spectrophotometric Identification of organic Compounds, John Wiley & Sons, New York.

www.Pharmainfo.Net

www.Pharmainfo.Net

7. Y.H. Sharma, Elementary Organic Absorption Spectroscopy, S. Chand & Co., New Delhi.

8. Barrow, G.M., Introduction to molecular spectroscopy, McGraw-Hill. London.

9. Haris, R.K. Nuclear Magnetic Resonance Spectroscopy, Pitman, London.

10. A.K. Srivastava, P.C. Jain Chemical Analysis, S. Chand & Company Ltd., New Delhi.

MPOC 103 . MOLECULAR AND BIOCHEMICAL PHARMACOLOGY (35 Hrs)

1. Receptor pharmacology

Receptor different types, Theories of receptor, G-protein coupled receptor, enzyme inhibitor, Enzymes ligand gated, ion channel attached to receptor, (Sodium, Potassium, Calcium, and Chloride channels) second messengers, NMDA channels, cAMP, cGMP, InsP3, AA.

Neurohumoral transmission in central nervous systems, autonomic and somatic nervous system- molecular basis, underlying the mechanism action of cholinergic, adrenergic agonist and antagonist and neuromuscular blocking agents,

2. Chemotherapy

(a) Molecular & biochemical mechanism involved in the anti microbial effects of various Chemotherapeutic agents (Anti bacterial, Anti fungal, Anti viral, and Anti cancer)

b) Gene therapy, recent advances made in the gene therapy of cancer diseases and other chronic diseases.

3. a) Immuno pharmacology: Cellular mediators and their interactions during immune response and Eicosanoids.

b) Autocoids, histamine, angiotensin, 5HT, and their antagonists.

c) Drugs inhibiting the transport of carrier systems.


1. th Ed.)

2. Pharmacology by H.P.Rang and M.M.Dale (3rd end)

3. Basic and Clinical Pharmacology by BB.G.Katzung (7th Ed.)

4.

5. Clinical Pharmacology by D.R.Lawrence and P.N.Bennett

6.

MPOC 104 SYSTEMIC PHARMACOLGY AND TOXICOLOGY (35hrs)

1. Various CNS disorders and drugs acting on CNS,

2. a) Renal pharmacology Diuretics & Anti diuretics

www.Pharmainfo.Net

www.Pharmainfo.Net

b) Drugs used in the treatment of bronchial asthma (Patho physiological approach)

c) Drugs acting on G.I.T

d) Drugs used in peptic ulcer, patho physiology of peptic ulcer, anti diarrhoeal, emetics & anti emetics

3 a) Drugs affecting uterine motility:

Oxytocine and other drugs

b) Endocrine pharmacology :

Drugs acting on pituitary, thyroids, antithyroids, insulin and oral antidiabetics, Corticosteroids, and androgens, oestrogens and progesterone.

4 a) Cardiovascular Pharmacology, Cardiotonics, Antiarrhythmic, Anti anginals, Anti hypertensives And Hypolipedemic Agents.

b) Toxicology :

Acute poisoning, chronic poisoning, general principles of management of heavy metal poisoning and chelating agents).

Reference Books: 1. The pharmacological Basis of therapeutics (9th Ed.)


3. Pharmacology by H.P.Rang and M.M.Dale (3rdEd.)

4. AMA Drug Evaluation 6th Ed.,

5.

6. Annual review of Pharmacology and toxicology

7.

8.

MPOC 105: PHARMACOLOGICAL SCREENING METHODS - 35Hrs 1. (a)Basic principles of screening of drugs for pharmacological activities.

(b)Pre-clinical screening General screening procedure for CNS activities, General CNS profile- Study using pole climbing pattern, Rota rod, Actophotometer and Jiggle cage experiments.

2. (a)Specific screening procedure for local anesthetics Rabbit cornea, lumbar plexus of frog and Infiltration anesthesia on guinea pigs

(b) Screening for anti hypertensive agents:

www.Pharmainfo.Net

www.Pharmainfo.Net

How to do experimentally induced hypertension in albino rats, and using these animals for screening of anti hypertensive, anaesthetized dog method etc.

(c) Screening for anti arrhythmic activity:

A study of aconitine or digoxin or isoprenaline induced arrhythmias in animals and use of these animals to screen anti arrhythmic drugs. Studying various types of arrhythmiasis based on ECG pattern recorded - and isolated frog heart.

(d) Screening for analgesic and anti-convulsent activities using, hot plate, tail flick and tail clip methods (analgesic activity) MES seizures produced in albino rats and to study the effects of anti convulsant (phenytoin), protection of electrically induced convulsion in albino rats. Protection of cardiazol induced convulsion in rat by sodium valproate.

3. (a) Screening for anti depressant, anti psychiatric, anti parkinsonism and anti ulcer effect

(b) Screening for anti fertility activity and anti pyretic & anti inflammatory.

(c) Screening for skeletal muscle relaxants effect of drugs using nerve muscle preparations, phrenic nerve diaphragm and frog rectus preparation.

4 (a) Toxicological studies:

Acute, sub acute, and chronic toxicological studies and calculation of median lethal dosage for drugs


1. th Ed.

2. Pharmacology, by H.P.Rang

3. th Ed.

4. Evaluation of drug activities pharmacometrics by D.R.Laurence and A.L.Bacharah Vol 1. and 2.

5. Modern Drug Research Paths to better and safe drugs by Y.C.Martin, E.Kutter and V.Austel.

6. Practical approach in toxicity studies by pooley and leslie.

7. Screeining methods in Pharmacology by R.A.Tuner.

8. Clinical Pharmacology by D.R.Laurence and P.N.Bennett.

9. Methods of clinical drug trails by Aln Sperit and Smith.

10. Alternatives to animal experiments: Developing in-vitro methods and changing legislation. TIPS., 11:1990 104-107

11. Alternatives to animals in toxicity testing. Scientific American., 261(1989), 16-22.

12. Clinical drug trial and tribulations by Allan E.cato (1980)

13. The Oxford text book of clinical Pharmacology and drug therapy by D.G.Grehame-Smith and J.K.Aronson

14. International aspects of drug evaluation and usage by Jouhar and Grayson.

www.Pharmainfo.Net

www.Pharmainfo.Net

MPOP 106: PHARMACEUTICAL ANALYSIS (Practical) 45 Hrs.

1. Experiments based on theory subjects Instrumental methods of analysis and Modern Analytical techniques

2. Experiments would be selected illustrating the principles involved in estimation of raw materials and finished products representing major categories of drug formulations from pharmacopoeias.

MPOP 107: ADVANCED PHARMACOLOGY PRACTICAL - 1 70 Hrs.

1. Laboratory animals : Breeding, maintanance and handling preparation of Physiological solution and drug solution

2. Screening procedure for the following drugs:

Local anesthetics, antiepileptics, antidepressants, anti-inflammatory, antidiabetics, antiulcer, analgesics and antimicrobial agents.

3.

4 a. Effect of drugs on blood pressure, splenic volume, intestinal movements and respiration in anesthetized dog (with software model)

b. Acute and sub acute toxicity studies and calculation of LD50

SECOND SEMESTER

MPOC 201: BIOPHARMACEUTICS (Theory) 35 Hrs.

1. Drug absorption and disposition: Mechanism of drug transport, factors affecting absorption, distribution, biotransformation and elimination.

2. First order process, rate constants, half-life; Zero order process

3. Open one compartment model: Description, volume of distribution, drug concentration in plasma, kinetics of I.V. administration, short term constant rate I .V. infusion, absorption rate and drug effects , continuous constant rate infusion, repetitive dosing- average concentration of drug at steady state , loading dose , dosing interval.

4. Open two-compartment model; Kinetics of absorption, distribution and elimination. Multiple dose administration. Limitation of multi- compartmental analysis.

5. Non-compartmental model; Area under first moment curve (AUMC), Apparent volume of distribution, mean residence time (MRT), Drug absorption predicting steady state concentration.


1. Gennaro A R, Remington: The Science and Practice of Pharmacy, 20th Edn.,Vol I & II, Lippincott Williams & Willkins, Philadelphia, PA, 2000.

www.Pharmainfo.Net

www.Pharmainfo.Net

2. Gibaldi M, Bio-Pharmaceutics and Clinical Pharmacokinetics, 4th edn., Lea and Febiger, Philadelphia, 1991.

3. Notari R E, Bio-Pharmaceutics and Clinical Pharmacokinetics, 4th Edn., Marcel Dekker, Inc., New York, 1987.

4. Brahmankar and Jaiswal, Bio- Pharmaceutics and Pharmacokinetics A Treatise, 2nd Edn., Vallabh Prakashan, New Delhi, 1998.

5. Swarbrick J, Current Concept in Phramaceutical Science: Bio Pharmaceutics, Lea & Febiger, Philadelphia, 1970.

MPOC 202: CLINICAL PHARMACOKINETICS (Theory) 35 Hrs.

1. Clearance concepts- organ clearance, total clearance, renal clearance and excretion.

2. Hepatic clearance and elimination, other non renal clearance. Extraction ratio

3. Bio-availability and bio equivalency testing; Estimation methods, dissolution testing, in vitro & in vivo correlation study , bio equivalency testing of dosage forms.

4. Pharmacokinetic variability; Body weight & size, obesity, age. Drug metabolism, Plasma protein binding and renal excretion in newborn & children. Sex, pregnancy and genetic factors. Poly morphic acetylation and oxidation.

5. Pharmcokinetic variability: Drug interactions

6. Effect of disease states on drug disposition, therapeutic drug monitoring and dosage prediction of digoxin, gentamycin and anticonvulsants. Hypothesis of individualisation & optimisation of drug therapy.


1. Gennaro A R, Remington: The Science and Practice of Pharmacy, 20th Edn.,Vol I & II, Lippincott Williams & Willkins, Philadelphia, PA, 2000.

2. Gibaldi M, Bio-Pharmaceutics and Clinical Pharmacokinetics, 4th edn., Lea and Febiger, Philadelphia, 1991.

3. Notari R E, Bio-Pharmaceutics and Clinical Pharmacokinetics, 4th Edn., Marcel Dekker, Inc., New York, 1987.

4. Brahmankar and Jaiswal, Bio- Pharmaceutics and Pharmacokinetics, 2nd Edn., Vallabh Prakashan, New Delhi, 1998.

5. Wagner J G, Bio- Pharmaceutics and relevant Pharmacokinetics, Drug Intelligence Publications, Washington DC, 1971.

6. Rowland M and Tozer TN, Clinical Pharmacokinetics concepts and applications, 3rd Edn., Lea & Febiger, Philadelphia, 1995.

7. Shargel L and Yu AB, Applied Bio-Pharmaceutics and Pharmacokinetics, Appleton & Lange, Norwalk, CT, 1993.

MPOC 203 Biological and Biochemical Analysis Theory 35 Hrs.

www.Pharmainfo.Net

www.Pharmainfo.Net

1. Design and analysis of biological assay-precision, estimation of error, assay depending on individual effective dose and measured effect on individual biological system. Assay depending on quantal responses and combination of potency estimates. Bioassay of heparin, oxytocin, vaopressin, insulin, digoxin and amylase.

2. Bio assay of the following products: Vaccines : Diphtheria, Tetanus, Pertusis, Plague, Rabies, Smallpox and Typhoid - Antitoxins : Diphtheria, Rabies anti serum and Tetanus antitoxin

3. Pyrogen test including Lal test Test for Histamine like substance, Freedom from undue toxicity and living contaminants in vaccines.

4. Microbiological Assays of Vitamins and Antibiotics. 5. Immuno Assays including Radio Immuno Assays. 6. Affinity Chromatography 7. Sterility tests

Reference:

1. Pharmacopoeia of India, 4th Edition 1996. 2. British Pharmacopeia, 1993 3. Biological standardization Burn, Fininey and Godwin 4. Microbial Assays Barton J.Wright 5. Gennaro A R, Remington: The Science and Practice of Pharmacy, 20th Edn.,Vol I & II, Lippincott

Williams & Willkins, Philadelphia, PA, 2000.

MPOC 204: ADVANCES IN DRUG DESIGNS 35 Hrs.

1. General approach to discovery of New Drugs: Lead discovery; Lead modification; Structural modification-homologation-chain branching; Ring-chain transformation; Bio isosterism; Quantitative structure activity relationship. Physicochemical Principles of Drug Action: Partition coefficient & Drug Action; Chemical bonding & Drug Action; Electronic Structure & Drug Action.

2. Receptor; Background; Forces of drug receptor interaction Theories of drug-receptor interaction; Structure of Receptor and Drug-receptor interactions Ligand gated ion channel, G-Protein coupled receptors, Tyrosine kinase/ enzyme coupled receptors, steroid receptors. Receptor pharmacology and drug action.

3. Enzymes: Background;Theories of enzyme inhibition; Groups of drugs that work by enzyme inhibition; Enzyme inhibition as a tool for drug development

4. Drug stereochemistry: basic concepts; Chirality & Drug action ;Influence of geometric isomerism on drug action; Conformational flexibility and multiple mode of action; current regulatory affairs on racemic drugs

5. Drug metabolism & Drug design: Drug metabolism; Introduction; Basic concepts; Importance of biotransformation. Metabolites as independent drugs; necessity of prodrugs; Bio transformation as a source of drug design; concept of hard drugs and soft drugs

www.Pharmainfo.Net

www.Pharmainfo.Net

6. Design of new chemical entities (physicochemical approaches); Case Studies-Design of H2Receptors: histamine agonist; Design of Bronchodilators (salbutamol analogues); Design of Antibiotics (Clavulanic acid); Design of anticancer drugs (alkylating agents)


1. William O Foye, Principles of Medicinal Chemistry, 4th Ed., B I Waverly Pvt. Ltd., New Delhi, 1995.

2. -3, 5th Ed., Wily Interscience, New York, 1995.

3. Martin Y.C, Quantitative Drug Design: A Critical Introduction, Marcel Dekker, Inc., New York, 1978.

4. Ariens(Ed), Drug Design, Vols 1-10, Academic Press, New York, 1971- 1980.

5. th Ed., Medical Economics Company, Montvale, NJ, 2001

6. nd Ed., Wright, London, 1988.

7. Ganellin, Medicinal Chemistry.

MPOC 205: ADVANCES IN PHARMACOLOGY - 35 Hours 1.Recent advances in Pharmacotherapy of the following: -

(a) Neurological and psychiatric disorders, pain pathways and its management, parkinsonism, Alzheimer disease, Schizophrenia.

(b) CNS disorders, Hypertension, angina pectoris, CCF, Arteriosclerosis and myocardial infarction,

(c) GIT disorders, peptic ulcer and Diarrhoea

2. Recent advances in Pharmacotherapy of the following:-

(a)Respiratory disorders: Bronchial asthma and chronic obstructive pulmonary disorders

(b) Rheumatoid arthritis, gout and osteoporosis.

(c) Metabolic disorders: Diabetes mellitus

3. Recent advances in Pharmacotherapy of the following:-

(a) Infectious diseases: Upper and lower respiratory infection, UTI, STD, Tuberculosis & Leprosy & HIV infections, mycotic infections

(b) Neoplastic disorders: Acute Leukemia, malignant lymphomas, breast cancer, GIT cancer, lung cancers and prostate cancer

(c) Ocular disorders


1. pharmacological Basis of therapeutics (9th Ed.)

www.Pharmainfo.Net

www.Pharmainfo.Net

2. Pharmacology by H.P.Rang and M.M.Dale (3rd Ed.)


4.

5. Clinical Pharmacology by D.R.Lawrence and P.N.Bennett

6.

MPOP 206: BIOPHARMACEUTICS- PRACTICAL 45 Hrs.

1. Experiments based on Bio pharmaceutics theory would be selected for the practical.

MPOP 207: ADVANCED PHARMACOLOGY- PRACTICAL- II 70 Hrs.

1. Recording of dose response curve for receptor agonist

2. Calculation of PA 2 value for antagonist using a suitable tissue

3. Bioassay of actlycholine using a suitable tissue by interpolation, matching, 3 point and 4 point methods

4. Bioassay of histamine, oxytocin and d-tubacurarine

THIRD SEMESTER MPOC 301: RESEACH METHODOLOGY AND PHARMACEUTICAL STATISTICS (Theory) 35 Hrs.

[Student should be familiar with pharmaceutical/chemical applications and use statistical tools, by way of calculations, but not expected to derive and find proof.]

1. Writing of articles, thesis scientific writing, preparing title, abstracts; organization of thesis and conventions adopted in writing; citing references; preparation of oral, poster presentation. Accessing required information in a systematic manner from abstracts, books journals, conference proceedings, thesis and dissertations, internet, CDROM etc. Ethics, rights, permissions

2. The Population - The sample; measures describing the center of data distributions; measurement of spread of data. Introduction to Probability - The Binomial and Normal distributions - their significance.

3. Statistical inference: -Statistical estimation (confidence intervals) - Hypothesis testing - t tests, F tests, ANOVA [one way], Chi square test.

4. Linear regression and correlation. 5. Control charts Constructing control charts, between batch variation as a measure of variability,

quality control charts in research and development, quality control charts for proportions. 6. Non parametric methods

www.Pharmainfo.Net

www.Pharmainfo.Net

7. Data characteristics suitable to non parametric procedures; Sign test, Wilcoxon signed rank test; Wilcoxon rank sum test; kruskal Wallis test[one way ANOVA]; Runs test for randomness; Contingency tables.

References:

4. Pharmaceutical Statistics, 2nd Ed., Sanford Bolton, Dekker series. 5. How to write and publish a scientific paper, 4th Ed., Robert A Day Cambridge University

presses. 6. Fundamentals of Analytical Chemistry 7th Ed., Skoog, West, Holler Saunders

College Publishing.

MPOE 302(1) ADVANCES IN INDUSTRIAL PHARMACY (Theory) 35 Hrs

1. Pre formulation studies and new formulation development.

2. New drug development and approval process: Investigational New Drugs (IND), New Drug Application ( NDA ), Supplemental New Drug Application ( SNDA ) , ICH requirements for registration of pharmaceuticals.

3. Validation techniques.

4. Methods of enhancing bioavailability, solubilisation, pro drugs, enhancement of dissolution characteristics, bioavailability enhancers.

5. Pharmaceutical product stability testing- ICH guidelines.

6. Polymers: Pharmaceutical applications, molecular weight, conformation, polymer solution, gel formation, coacervation, phase separation, microencapsulation, mechanical properties, biomedical uses of polymers.


1. Gennaro A R, Remington, The Science and Practice of Pharmacy, 20th Ed.,Vol I & II, Lippincott Williams & Willkins, Philadelphia, PA, 2000.

2. Lachman L & Liberman H A, The theory and Practice of Industrial Pharmacy, 3rd Ed., Vergese Publishing House, Mumbai, 1991.

3. Banker G S and Rhodes C T, Modern Pharmaceutics, 3rd Ed., Marcel Dekker, Inc., New York, 1995.

4. Aulton M E., Pharmaceutics The Science of Dosage Form Design, 1st (International Student) Ed., Churchill Livingstone, New York, 1996.

5. Ansel H C, Allen, Jr., L V et al, Pharmaceutical Dosage Forms and Drug Delivery Systems, 7th

Ed., Lippincott Williams & Wilkins, Philadelphia, PA, 2000.

6. FDA Code of Federal Regulations, Title 21, Part 300 314.

7. Guarino, R A, New Drug Approval Process, Marcel Dekker, Inc., New York, 1987.

8. Martin A et al, Physical Pharmacy, Indian Ed., New Delhi, 1998.

MPOE 302(2) PHARMACEUTICAL HEALTH CARE - THEORY 35 Hrs.

www.Pharmainfo.Net

www.Pharmainfo.Net

1. Concept and necessity of Pharmaceutical Health care. 2. A rational approach in paediatrics and geriatric care. 3. Therapeutic consideration with rational approach during pregnancy and lactation. 4. Evaluation of Immune system and its fuctions. 5. Rational use of antimicrobials. 6. Assessment and clinical significance of malnutrition, enteral and parentral nutrition, Nutritional

consideration in major organ failure. 7. Standard treatment protocols of the following diseases Hypertention, Diabetes mellitus, Peptic

Ulcer, Diarrhoea, Urinary tract infection, Bronchitis, Asthma. 8. Self care: Constipation, Common cold, cough, pain, and sun light protection.

REFERENCES :

1. Drug Treatment Protocols, Edited by Damil H.Albert, 2nd Ed., American Pharmaceutical Association, Washington.

2. Role of Pharmacist in the health care system , WHO / PHARM / 94. 569

3. Handbook of Nonprescription Drugs, American Pharmaceutical Association, 12th Ed., 1996.

4. Standard Treatment Guidelines

j) by WHO k) by Government of India l) by Various state governments

MPOE 302(3) ANALYTICAL METHOD DEVELOPMENT THEORY 35 HRS.

1. Errors in Analysis: Accuracy (absolute method, comparative method); Precision; classification of errors, estimation of errors, sources of errors, minimization of errors, normal distribution of errors. Significant figures in analytical chemistry rules and computations.

2. Calibrations, Standardisations: Calibrating signals, apparatuses; calibration curves external standard methods, internal standard method, standard addition method [applications in HPLC and GLC with calculations], linear regression of straight line calibration curves using the regression equation [applications and calculations].

3. Obtaining and Preparing Samples For Analysis: Importance of sampling techniques sampling techniques random, stratified, systematic, cluster, for quality control. Sample preparation reducing particle size, making solutions, separating analyte from interferants extraction, automated extraction, solid phase extraction, solid phase micro extraction, super critical fluid extraction and micro wave assisted extraction.

www.Pharmainfo.Net

www.Pharmainfo.Net

4. Validating the analytical method including bio-analytical method: Need for validation; historical background; validation of analytical procedures-- methodology guidelines of ICH; FDA; USP. Understanding of the following concepts in validation accuracy, precision, specificity, limit of detection, limit of quantification, blind analysis of standard sample, ruggedness testing, robustness testing, equivalency testing. Validating the method as standard method collaborative test two sample collaborative testing, control charts.

5. Development of HPLC method: Selection of tools: Choice of HPLC mode, Column, Mobile phase, Special additives. Method Development guiding tools: Separation factor, Selectivity factor, Resolution, Tailing factor. Controlling selectivity: Solvent: Organic phase, Aqueous phase, Additional Variables: pH, Stationary Phase, Temperature. Column Conditions: Flow, Column dimension, Particle diameter. Derivatisation.

6. System suitability tests as per Pharmacoepoeial specification.

7. Development of stability indicating analytical method

Books for References:

1. HPLC method development, Lunn. G(1996),John wiley & Interscience.

2. Pharmacopoeia of India, 4th Ed. (1996), Govt.of India, Ministry of Health and Family Welfare.

3. British Pharmacopeia (1993) London, 4. ICH guide lines: validation of analytical procedures, methodology, November 1996.

5. th Ed.

6. Pharmaceutical process validation II Ed., Ira R berry, Robert a Nash; Marcel Decker series, 1993.

7. Pharmaceutical statistics II Ed., Sanford Bolton, Decker series, Newyork and Basel.

8. Fundamentals of analytical chemistry 7th Ed.; Skoog, West, Holler, Saunders college publishing.

MPOE 302(4): CLINICAL PHARMACOLOGY -THEORY (35 Hrs)

1. (a) Definition and scope of clinical pharmacology, measurement of drug response in man.

(b) Clinical trails- Phase I, Phase II , Phase III and post marketing surveillance data analysis & presentation skills

(c) Pharmaco- epidemiology.

2 (a) Drug Drug interaction, Drug food interaction, and Drug disease interaction in clinical pharmacology.

(b) Adverse drug reactions and ADR monitoring.

3 (a) Essential drug list, national drug policy

(b) Orphans drugs

www.Pharmainfo.Net

www.Pharmainfo.Net

vension in Therapeutic drug monitoring in special situations such as pediatrics, geriatric and pregnant cases.


1. Goodman and Gil Pharmacological Basis of Therapeutic 9th Ed.

2. Pharmacology, by H.P.Rang and M.M. Dale 3rd Ed.

3. th Ed.

4. Evaluation of drug activities pharmacometrics by D.R.Laurence and A.L.Bachanarach Vol 1. and 2

5. Modern Drug Research Paths to better and safe drugs by Y.C.Martin, E.Kutter and V.Austel

6. Practical approach in toxicity studies by pooley and leslie

7. Screeining methods in Pharmacology by R.A.Tuner

8. Clinical Pharmacology by D.R.Laurence and P.N.Bennett

9. Methods of clinical drug trials by Aln Sperit and Smion

10. Alternatives to animal experiments: Developing in-vitro methods and changing legislation. TIPS., 11:1990 104-107

11. Alternatives to animals in toxicity testing. Scientific American., 261(1989): 16-22

12. Clinical drug trial and tribulations by Allan E.Cato (1980).

13. The Oxford text book of Clinical Pharmacology and drug therapy by D.G.Grehame-Smith and J.K.Aronson.

14. International aspects of drug evaluation and usage by Jouhar and Grayson.

MPOE 302(5): STRATEGY IN DRUG SYNTHESIS Theory 35 Hrs.

1. Organic Name Reaction :

Aldol Condensation, Arndt-Eistert Synthesis, Bayer-Villiger rearrangement, Beckmann rearrangement, Cannizaro reaction, Claisen condensation, Claisen rearrangement, Curtius rearrangement, Diels-Alder reaction, Favoriskii rearrangement, Fries rearrangement, Hoffman rearrangement, Pinacol rearrangement, Mannich reaction, Perkin reaction, Reformatsky reaction, Scmidt rearrangement.

2. Introduction: Basic rules in disconnection. 3. Application of Synthon approach to drug synthesis: Case Studies.

o. Antihistaminic agents: Promethazine, Cyclizine, Diphenhydramine. p. Adrenergic agents: Stimulants, Epinephrine, Ephedrine. q. Adrenergic blocking agents: Propranolol, Guanethidine. r. Psychotropic agents: Chlorpromazine, Chloprothixene.

www.Pharmainfo.Net

www.Pharmainfo.Net

s. Antidepresants: Imipiramine. t. CNS Stimulants: Amphetamine. u. Narcotic analgesics: Meperidine, Methadone, Propoxyphene.


1. Organic Chemistry, Morrison and Boyd, Prentice Hall Pvt. Ltd., New Delhi.

2. Advanced Organic Chemistry, Jerry March, Mc-Graw-Hill.

3. Solomons Organic chemistry 5th Ed.

4. Organic Chemistry, I.L. Finar Vol. I, ELBS.

5. Modern Synthetic reaction, H.O.House.

6. Some Modern Method of Organic Synthesis, W. Carruthers.

7. Designing organic synthesis with work book a programmed introduction to the synthon approach, Stuart Warren.

MPOE-302(6): PHARMACOBIOTECHNOLOGY (Theory) 35 Hrs.

1. Fermentation (Microbial biotechnology): Introduction and scope, Fermentation process. Types of Fermentation processes: Batch culture, Continous culture, Fed-batch culture, Cascade fermentation. Upstream processes, Fermentation process, Monitoring microbial growth, Down stream processing, Microbial products, Improvements in microbial strains. Production of Riboflavine, Ascorbic acid, Fungal amylases, Citric acid, L-Glutamic acid and Penicillin.

2. Enzyme Biotechnology: Introduction, Properties and charateristics of enzymes. Basic nomenclature of enzymes. Factors influencing enzyme action. Sources of enzymes. Methods of enzyme production. Profile of some important enzymes: Hyaluronidase, Penicillinase, Streptokinase, Amylases, Protease. Enzyme Immobilization: Carrier matrices, Materials and Methods of immobilization (Adsorption method, Covalent bonding, Entrapment, Encapsulation). Advantages and disadvantages of immobilization. Application of Enzymes and Immobilized enzymes.

3. Plant Tissue Culture Technology: Introduction and scope. Princple underlying plant culture (totipotency). Nutrient media composition and preparation. Role of plant growth regulators in Cell culture. Laboratory requirements for plant tissue culture. Aseptic techniques and Maintenance of Aseptic environment. Basic steps in plant tissue/cell/organ culture. Selection and preparation of explants. Surface sterilization of explants.

4. Types of Plant culture: Callus culture, Suspension cell culture, Meristem culture, Organ culture, Protoplast culture. Subculture techniques. Precautions in Plant Tissue/Cell culture. Applications of plant tissue/cell culture: Micropropagation & Cloning, Genetically modified plants, Medicinal plant improvement, Production of secondary metabolites. Survey of phytochemicals produced through plant cell cultures.

www.Pharmainfo.Net

www.Pharmainfo.Net

5. Bio-Transformation: Introduction, Types of biotransformation reactions. Design and Methodologies for biotransformation. Cell immobilization, Advantages of cell immobilization. Illustrations of biotransformations with special reference to steroids. Examples of biotransformations using plant cells (Steviol, Codeine, Scopalamine, Hydroxylation of beta methyl digitoxin, Arbutin).

6. Genetic Engineering: Introduction, Properties of DNA. Replication of DNA, and enzymes involved. Steps in engineering the Genes and the enzymes involved. Cloning vectors. Introduction of rDNA into a host cell. Screening and selection of recombinants. Typical examples of Recombinant DNA technology products (human insulin, human growth hormone, Alteplase, Interferons, Vaccines, Coagulation factors etc).


1. Duby R. C., Textbook of Biotechnology, 2006, S. Chand & Company, New Delhi. 2. Nagori B.P. and Roshan Issarani, Foundations in Pharmaceutical Biotechnology, 2007, Pharma

Book Syndicate, Hyderabad. 3. Sambamurthy K. And Ashutosh Kar, Pharmaceutical Biotechnology, 2006, New Age International

Publishers, New Delhi. 4. Ashutosh Kar, Pharmacognosy and Pharmacobiotechnology, 2nd Ed., 2006, New Age

International Publishers Ltd., New Delhi. 5. NIIR Board of Consultants and Engineers, Enzymes Biotechnology Handbook, 2004, NIIR, New

Delhi. 6. NIIR Board, Plant Biotechnology Handbook, 2004, NIIR, New Delhi. 7. NIIR Board, Biotechnology Handbook, 2003, NIIR, New Delhi.

MPOT 303: Thesis Phase I

Field training for a period of one month in the institute, CRO or R&D of Pharma industries is to be completed at the beginning of Third Semester. The candidate has to prepare an Orientation Report.

FOURTH SEMESTER

MPOT 401: Thesis Phase II

THESIS III and IV SEMESTERS

Phase-I In the third semester, students will be placed to Pharmaceutical Industries / Hospitals / other allied organizations to provide orientation & exposure. Simultaneously the student will carry out a small project leading to a report at the end of that period. The faculty member of the department and an expert from the respective organization jointly evaluate the report for 10 marks. The students are expected to identify a project towards their thesis and start working on it and submit Phase I thesis during this stay. The students will come back to the Department to appear for third semester examination. On completion of third semester examination the students will return back to the industry/ Hospitals / other allied organizations where he was placed and would continue the thesis work under the collective guidance of a faculty member and a guide drawn from the collaborating organization.

www.Pharmainfo.Net

www.Pharmainfo.Net

Phase-II The students would continue the thesis work in the fourth semester, in collaborating organizations, under the supervision of two guides one from the Department and another from collaborating organization allotted by the Head of the Department of Pharmacy.

www.Pharmainfo.Net

www.Pharmainfo.Net

pharmacy syllabus need breaking - pharmainfo.net...... underlying the mechanism action of...

Documents