Handwritten Notes
Semester 6
BP 604 T. BIOPHARMACEUTICS AND PHARMACOKINETICS (Theory)
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 regimens, 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, and 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:
UNIT-I
Introduction Biopharmaceutics to Absorption; Mechanisms of drug absorption through GIT, factors influencing drug absorption through GIT, absorption of the drug from Non per oral extravascular routes, Distribution Tissue permeability of drugs, binding of drugs, apparent, the 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 of 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) Extravascular 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 maintenance doses, and their significance in clinical settings.
UNIT- V
Nonlinear Pharmacokinetics:
b. Factors causing Non-linearity.
c. Michaelis-mention method of estimating parameters,
Explanation with an 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 International Edition.USA
4. Biopharmaceutics 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, Pennsylvania
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