PY8701 - BIOPHARMACEUTICS AND PHARMACOKINETICS (Syllabus) 2017-regulation Anna University

PY8701 - BIOPHARMACEUTICS AND PHARMACOKINETICS (Syllabus) 2017-regulation Anna University

PY8701	BIOPHARMACEUTICS AND PHARMACOKINETICS	LPTC

3003

OBJECTIVES:

• To learn 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 in vitro and in vivo conditions.
• To understand the concepts of bioavailability and bioequivalence of drug products and their significance

UNIT I	DRUG ABSORPTION AND DISTRIBUTION	9

Mechanisms of drug absorption through GIT, factors influencing drug absorption though GIT, absorption of drug from Non-per oral extra-vascular routes, Distribution of drugs, Tissue permeability of drugs, binding of drugs, apparent volume of drug distribution, plasma and tissue protein binding of drugs, factors affecting protein-drug binding. Kinetics of protein binding, Clinical significance of protein binding of drugs.

UNIT II	ELIMINATION	9

Drug metabolism, metabolic pathways, factors affecting metabolism, renal excretion of drugs, factors affecting renal excretion of drugs, renal clearance, Non- renal routes of drug excretion of drugs

UNIT III	BIOAVAILABILITY AND BIOEQUIVALENCE	9

Definition and Objectives of bioavailability, absolute and relative bioavailability, measurement of bioavailability, in-vitro drug dissolution models, in-vitro-in-vivo correlations, bioequivalence studies, methods to enhance the dissolution rates and bioavailability of poorly soluble drugs.

UNIT IV	PHARMACOKINETICS	9

Introduction to Pharmacokinetics, Pharmacokinetic models, One compartment open model- Intravenous Bolus Injection – Intravenous infusion - Extra vascular administrations. Determination of pharmacokinetics parameters and their significance - Absorption Rate Constant (ka), Elimination Rate Constant (K) & Elimination Hal- life (t½), AUC, Cmax, and tmax. Apparent Volume of Distribution (Vd) & Renal Clearance (Q).

UNIT V	MULTIPLE DOSAGE REGIMENS AND NONLINEAR PHARMACOKINETICS	9

Concept, Accumulation, Persistent and elimination factors. Calculation of dosage regimen following repetitive IV and oral administration.Nonlinear Pharmacokinetics - Introduction, factors causing Non-linearity, Michaelis-menton method of estimating pharmacokinetic parameters.

TOTAL : 45 PERIODS

OUTCOMES: The student will be able to

• Explain the various factors influencing the drug disposition, various pharmacokinetic parameters.
• Design and interpret the bioavailability and bioequivalence of dosage forms.
• Identify the factors affecting the rate of drug absorption.

TEXT BOOKS:

1. Rosenbaum, S. E. “Basic Pharmacokinetics and Pharmacodynamics: An Integrated Textbook and Computer Simulations”, 2nd Edition, John Wiley & Sons, 2016.
2. Brahmankar, D.M. and Jaiswal, S.B. “Biopharmaceutics and Pharmacokinetics: a Treatise” ,3rd Edition, Vallabh Prakashan, 2015.
3. Chatwal, G.R. “Biopharmaceutics and Pharmacokinetics”, 2nd Edition, Himalaya Publishing House, 2014.

REFERENCES:

1. Shargel,L and Andrew, B.C. Yu. “Applied Biopharmaceutics & Pharmacokinetics”,7th Edition, The McGraw-Hill Companies, Inc, 2016.
2. Gibaldi, M. “Biopharmaceutics & Clinical Pharmacokinetics”, 4th Edition, Pharma Book Syndicate, 2016.
3. Jambhekar, S.S. and Philip, J. B. “Basic Pharmacokinetics” 2nd Edition, Pharmaceutical Press,2012.