PY6702 - BIOPHARMACEUTICS AND PHARMACOKINETICS (Syllabus) 2013-regulation Anna University

PY6702 - BIOPHARMACEUTICS AND PHARMACOKINETICS (Syllabus) 2013-regulation Anna University

PY6702	BIOPHARMACEUTICS AND PHARMACOKINETICS	LPTC

3003

OBJECTIVES:

• To teach important parameters involved in drug disposition and its principles in living systems.
• To make the students to understand how the drug disposition takes place in the invitro and invivo conditions.

UNIT I	INTRODUCTION TO BIOPHARMACEUTICS	7

Definition and Role in Product Development, Explanation of the Terms: Bioavailability, and Bioequivalence, Equivalence Types: Chemical, Clinical, Therapeutic, Generic, and Pharmaceutical Alternatives. Bio-equivalency testing studies

UNIT II	PRINCIPLES OF DRUGS DISSOLUTION	11

Dissolution of solids: Mechanisms and Models of Dissolution, Factors influencing Dissolution Rate (in vitro Release), Quantitative Study of Dissolution – Methods – Dissolution of Tablets & Capsules. In vitro – In vivo correlations.

UNIT III	PRINCIPLES OF DRUG ABSORPTION AND BIO-AVAILABILITY	11

Physico – Chemical Factors: Lipid Solubility, Dissociation & pH, Complexation & Surface – active agents. Pharmaceutical Factors: Dosage Form Types and Formulation Variables Biological Factors: Passage of Drugs through Natural Membranes, Gastric Emptying & Intestinal Transition. Blood Flow, G.I. – Metabolism & Degradation, Interactions with Food & Co-administered Drugs, Disease State and Route of Administration.

UNIT IV	PHARMACOKINETICS	11

Principles of Pharmacokinetics, Concepts of Compartmental Model, Characteristics of One Compartment Model – based Pharmacokinetic Derivations (involving the concepts of (a.) Experimentally Determined Rates, (b.) Methods of Residuals and (c.) Trapezoidal Rule for the following modes of Drug Administration: Intra-Venous Administration (Plasma Level & Urinary Excretion Data)-Single Dose, Absorption Based Administration (Single Dose) - Absorption Rate Constant (ka), Elimination Rate Constant (K) & Elimination Half life (t½), AUC, Cmax, and tmax. Apparent Volume of Distribution (Vd) & Renal Clearance (Q).

UNIT V	MULTIPLE DOSAGE REGIMENS	5

Concept, Accumulation, Persistent and elimination factors. Calculation of dosage regimen following repetitive IV and oral administration

TOTAL : 45 PERIODS

OUTCOMES: The student will be able to

• Narrate the various factors influencing the drug disposition, various pharmacokinetic parameters.
• Design and interpret the dissolution studies for various dosage forms.

TEXT BOOKS:

1. Brahmankar, D.H. and Sunil B.Jaiswal “Biopharmaceutics and Pharmacokinetics:aTreatise” Vallabh Prakashan, 1995.
2. Kulkarni, J.S. et al. “Biopharmaceutics and Pharmacokinetics”, CBS Publishers, 2006.

REFERENCES:

1. Chatwal, G.R. “Biopharmaceutics and Pharmacokinetics” Himalaya Publishing House, 2003.
2. Jambhekar, Sunil S. and Philip J. Breen “Basic Pharmacokinetics” Pharmaceutical Press, 2009.
3. Milo Gibaldi “Biopharmaceutics & Clinical Pharmacokinetics” Pharma Book Syndicate, 4th Edition, 2011.