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, plas- ma and tissue protein binding of drugs, factors affecting protein-drug binding. Kinetics of protein binding, Clinical significance of protein binding of drugs

(10 Hours)

Unit II

Elimination: Drug metabolism and basic understanding metabolic pathways renal excretion of drugs, factors affecting renal excretion of drugs, renal clearance, Non renal routes of drug excretion of drugs

Bioavailability and Bioequivalence:Definition and Objectives of bioavailability, absolute and relative bio- availability, 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.

(10 Hours)

Unit III

Pharmacokinetics: Definition and introduction to Pharmacokinetics, Compartment models, Non com- partment models, physiological models, One compartment open model. (a). Intravenous Injection (Bolus) (b). Intravenous infusion and (c) Extra vascular administrations. Pharmacokinetics parameters – KE ,t1/2,- Vd,AUC,Ka, Clt and CLR- definitions methods of eliminations, understanding of their significance and application

(10 Hours)

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.

(08 Hours)

Unit V

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

(07 Hours)

‘Biopharmaceutics and Pharmacokinetics – Theory’ is a course offered in the sixth semester of B. Pharm program at School of Pharmacy, Health Sciences campus, Amrita Vishwa Vidyapeetham.

Course Duration: 45 Hours

Scope:

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 arised therein.

Objectives:

Upon completion of the course student shall be able to:

1. Understand the basic concepts in biopharmaceutics and pharmacokinetics and their significance.
2. Use of plasma drug concentration-time data to calculate the pharmacokinetic parameters to describe the kinetics of drug absorption, distribution, metabolism, excretion, elimination.
3. To understand the concepts of bioavailability and bioequivalence of drug products and their significance.
4. Understand various pharmacokinetic parameters, their significance & applications.

Recommended Books (Latest Editions)

1. Biopharmaceutics and Clinical Pharmacokinetics by, Milo Gibaldi.
2. Biopharmaceutics and Pharmacokinetics; By Robert F Notari
3. Applied biopharmaceutics and pharmacokinetics, Leon Shargel and Andrew B.C.YU 4th edition,- Prentice-Hall Inernational edition.USA
4. Bio pharmaceutics and Pharmacokinetics-A Treatise, By D. M. Brahmankar and Sunil B.Jaiswal,Val- labh Prakashan Pitampura, Delhi
5. Pharmacokinetics: ByMilo Glbaldi Donald, R. Mercel Dekker Inc.
6. Hand Book of Clinical Pharmacokinetics, ByMilo Gibaldi and Laurie Prescott by ADIS Health Sci- ence Press.
7. Biopharmaceutics; By Swarbrick
8. Clinical Pharmacokinetics, Concepts and Applications: ByMalcolm Rowland and
9. Thomas, N. Tozen, Lea and Febrger, Philadelphia, 1995.
10. Dissolution, Bioavailability and Bioequivalence, By Abdou H.M, Mack, Publishing Company,Penn- sylvania 1989.
11. Biopharmaceutics and Clinical Pharmacokinetics-An introduction 4th edition Revised and expand- ed by Rebort F Notari Marcel Dekker Inn, New York and Basel, 1987.
12. Remington’s Pharmaceutical Sciences, ByMack Publishing Company, Pennsylvnia