Presented ByDileep Singh BaghelAsst. Professor, LSPS, LFAMS

Lovely Professional University, Punjab1

Pharmaceutical Industry Main Customers

Medicines

Return

Documents

Patient

Regulatory Agencies

Pharmaceutical Industry

From Molecule to PatientDiscovery/ Literature

serve Research and Development Approval

ManufactureDistribution

Therapeutic Target

Final Dosage formPatient

By which drug molecules are delivered to sites of action within the body is c/a Dosage form.

Mechanism for safe and convenient delivery of accurate dosage.

Protection of drug from atmosphere or increasing self life of drugs.

Masking taste and odour.Delivering the drugs within body

tissues.Sustained release medication.Controlled release medication.Optimal drug action or Improving

ADME of the drugs.

They are classified according to:

Route of administration Physical form

Oral Solid Topical

Semisolid Rectal Liquid Parenteral Gaseous Vaginal Inhaled Opthalmic

Classification of dosage forms :

PharmaceuticsActive Ph. IngredientsPharmacokineticsPharmacodynamicAdverse EffectsBusiness & EconomicsGovernmental RegulationTherapeutic usage/ EquivalencePharmaceutical EquivalenceBioequivalence

7

Pharmaceutics is the science of dosage form design.

There are many chemicals with known pharmacological properties but in a raw form it is worth less for patient.

Pharmaceutics deals with the formulation of a pure drug substance into a dosage form.

8

ACTIVEPHARMACEUTICA

LINGREDIENT

Drugs or Active Ph. Ingredient

PROVIDES THE THERAPEUTIC EFFECT

ACTIVE PHARMACEUTICAL INGREDIENTS = DRUG SUBSTANCES

+API

DOSAGE FORM

EXCIPIENTS

INERTACTIVE

EffectivenessSafetyReliabilityStability

PhysicalChemicalMicrobiological

Pharmaceutical eleganceAppearanceOrganoleptic properties

ConvenienceEase of useDosing frequencyConsumer acceptance

Excipients may be added to protect the drugAntioxidantsPreservativesChelating agentsBuffering agents

Therapeutic usage -Determining which diseases are

approved to be treated by a drugDiscovering how a drug works to

achieve its therapeutic activityFinding the recommended dosage

and route administration of a drugLearning how a drug is absorbed,

distributed, metabolized, and excreted

List of possible unpleasant or dangerous secondary effects other than the desired effects

Causes of ADRs - Interactions

Drug/DrugDrug/FoodDrug/Herb

Toxic potential

Business & EconomicsDrug pricesDrug salesDrug companies

Drug ManufacturersDrug Stores

Most commonly prescribed drugs

Government regulationDrug approval process.Identifying which countries have

approved the usage of a specific drug.

The restriction or prohibition of the usage of specific drugs (controlled substances)

Policies and codes regulating the manufacture, distribution, and sales of pharmaceutical agents

Pharmaceutical Equivalence Same active ingredient. Same strength. Same dosage form and route of administration. Comparable labeling Meet compendial or other standards of

identity, strength, quality, purity and potency Bioequivalence

In vivo measurement of active moiety (moieties) in biologic fluid (blood/urine)

In vivo pharmacodynamic comparison In vivo clinical comparison In vitro comparison

Therapeutic Equivalence

QUALITY EVALUATION QUALITY EVALUATION OF HERBAL DRUGSOF HERBAL DRUGS

CHEMICALCHEMICAL

BIOLOGICAL

BIOLOGICAL

ORGANOLEPTIC

ORGANOLEPTIC BOTANICALBOTANICAL

PHYSIC

AL

PHYSIC

AL

• Moist. Cont.• Extrac. Values• Ash Values• Fluores. Analy.

Macroscopic Microscopic

• Qualitative • Quantitative• SEM Studies • Powder Studies

•Shape•External•Marking

• Colour • Odour• Taste• Texture • Fracture

Antagonistic

Microbial Contamination

• Toxicological• Pharmacological • Other specific activities

• Bacterial• Fungal

•Qualitative• Quantitative • Chromatography• Heavy metal • Pesticide residue• Mycotoxin

HPTLC GLC HPLC

HPTLC Finger printing Sec. Metabolites DNA Finger printing

Standardization & Quality Evaluation

Thank You