Biopharmaceutics and Pharmacokinetics - B. Pharma 6th Semester Notes Pdf


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.

Course Content:


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


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 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.


Pharmacokinetics: Definition and introduction to Pharmacokinetics, Compartment models, Non compartment 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


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.


Nonlinear Pharmacokinetics: a. Introduction, b. Factors causing Non-linearity.

c. Michaelis-menton method of estimating parameters, Explanation with example of drugs.

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,Vallabh Prakashan Pitampura, Delhi

5. Pharmacokinetics: By Milo Glbaldi Donald, R. Mercel Dekker Inc.

6. Hand Book of Clinical Pharmacokinetics, By Milo Gibaldi and Laurie Prescott by ADIS Health Science Press.

7. Biopharmaceutics; By Swarbrick

8. Clinical Pharmacokinetics, Concepts and Applications: By Malcolm Rowland and

9. Thomas, N. Tozen, Lea and Febrger, Philadelphia, 1995.

10.  Dissolution, Bioavailability and Bioequivalence, By Abdou H.M, Mack, Publishing Company,Pennsylvania 1989.

11.  Biopharmaceutics and Clinical Pharmacokinetics-An introduction 4th edition Revised and expanded by Rebort F Notari Marcel Dekker Inn, New York and Basel, 1987.

12.  Remington’s Pharmaceutical Sciences, By Mack Publishing Company, Pennsylvnia

Post a Comment