BIOPHARMACEUTICS AND PHARMACOKINETICS

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, 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. 

UNIT- III

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

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. 

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