BIOPHARMACEUTICS AND PHARMACOKINETICS

Course Objectives

This subject is designed to impart knowledge and skills of Biopharmaceutics and pharmacokinetics and their applications in pharmaceutical development, design of dose and dosage regimen, and in solving the problems arisen therein.

Course Outcomes

CO	Statement	Mapping with POs
1	To understand the basic concepts in biopharmaceutics and pharmacokinetics and their significance	PO1, PO2.PO10
2	To use of plasma drug concentration-time data to calculate the pharmacokinetic parameters to describe the kinetics of drug absorption, distribution, metabolism, excretion, elimination	PO1, PO2, PO10, PO11
3	To understand the concepts of bioavailability and bioequivalence of drug products and their significance.	PO1, PO2,PO10
4	To understand various pharmacokinetic parameters, their significance & applications	PO1, PO2, PO06 PO10
5	Employable skills and high technical competence for Pharmaceutical Industry	PO1, PO2.PO11

Course Syllabus

UNIT-I

Introduction to Biopharmaceutics

Absorption; Mechanisms of drug absorption through GIT, factors influencing drug absorption though GIT, absorption of drug from Non per oral extra-vascular routes, Distribution 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: Drug metabolism and basic understanding metabolic pathways renal excretion of drugs, factors affecting renal excretion of drugs, renal clearance, Nonrenal routes of drug excretion of drugs

Bioavailability and Bioequivalence: 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- III

Pharmacokinetics: Definition and introduction to Pharmacokinetics, Compartment models, Noncompartment models, physiological models, One compartment open model. (a). Intravenous Injection (Bolus) (b). Intravenous infusion and (c) Extravascular administrations. Pharmacokinetics parameters - K_E ,t1/2,Vd,AUC,Ka, Clt and CL_R- definitions methods of eliminations, understanding of their significance and application

UNIT- IV

Multicompartment models: Two compartment open model. IV bolus

Kinetics of multiple dosing, steady state drug levels, calculation of loading and mainetnance doses and their significance in clinical settins.

UNIT-V

Nonlinear Pharmacokinetics: a. Introduction, b. Factors causing Non-linearity. Michaelis-menton method of estimating parameters, Explanation with example of drugs.

Recommended Books: (Latest Editions)

Biopharmaceutics and Clinical Pharmacokinetics by, Milo
Biopharmaceutics and Pharmacokinetics; By Robert F Notari
Applied biopharmaceutics and pharmacokinetics, Leon Shargel and Andrew B.C.YU 4th edition,Prentice-Hall Inernational USA
Bio pharmaceutics and Pharmacokinetics-A Treatise, By M. Brahmankar and Sunil B.Jaiswal,Vallabh Prakashan Pitampura, Delhi
Pharmacokinetics: By Milo Glbaldi Donald, R. Mercel Dekker
Hand Book of Clinical Pharmacokinetics, By Milo Gibaldi and Laurie Prescott by ADIS Health Science
Biopharmaceutics; By Swarbrick
Clinical Pharmacokinetics, Concepts and Applications: By Malcolm Rowland and
Thomas, N. Tozen, Lea and Febrger, Philadelphia,
Dissolution, Bioavailability and Bioequivalence, By Abdou H.M, Mack, Publishing Company,Pennsylvania
Biopharmaceutics and Clinical Pharmacokinetics-An introduction 4th edition Revised and expanded by Rebort F Notari Marcel Dekker Inn, New York and Basel,
Remington’s Pharmaceutical Sciences, By Mack Publishing Company, Pennsylvnia