JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD

Course Objectives

This subject is designed to impart knowledge and skills necessary for dose

calculations, dose adjustments and to apply Biopharmaceutics theories in practical problem solving. Basic theoretical discussions of the principles of Biopharmaceutics and pharmacokinetics are provided to help the students’ to clarify the concepts.

Course Outcomes

Upon completion of the course student shall be able to:

• Understand the basic concepts in biopharmaceutics and pharmacokinetics.
• Use plasma data and derive the pharmacokinetic parameters to describe the process of drug absorption, distribution, metabolism and elimination.
• Critically evaluate biopharmaceutic studies involving drug product equivalency
• Design and evaluate dosage regimens of the drugs using pharmacokinetic and biopharmaceutic parameters.
• Detect potential clinical pharmacokinetic problems and apply basic pharmacokinetic principles to solve them

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: Distribution of drugs Tissue permeability of drugs, binding of drugs, apparent, volume of drug distribution, protein binding of drugs, factors affecting protein-drug binding. Kinetics of protein binding, Clinical significance of protein binding of drugs

UNIT - II

Metabolism & Excretion: 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: Objectives of bioavailability studies, absolute and relative bioavailability, measurement of bioavailability, in-vitro drug dissolution models, in-vitro, in-vivo correlations, bioequivalence studies, methods to enhance the bioavailability.

UNIT - III

Pharmacokinetics: Introduction to Pharmacokinetics models, Compartment models, Non-compartment models, physiological models, One compartment open model. a. Intravenous Injection (Bolus) b. Intravenous infusion, extra vascular administrations, calculations of Ka, KE. From plasma and urinary excretion data

UNIT - IV

Multicompartment models: Two compartment open model. IV bolus Multiple – Dosage Regimens: a). Repititive Intravenous injections – One Compartment Open Model b). Repititive Extravascular dosing – One Compartment Open model

UNIT - V

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

R17 B. PHARMACY III YEAR

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. Bio pharmaceutics and Pharmacokinetics-A Treatise, By D. M. Brahmankar and Sunil B. Jaiswal, Vallabh Prakashan Pitampura, Delhi
• 5. Fundamentals of Biopharmaceutics and pharmacokinetics by Dr. V. Venkateshwarlu
• 6. Pharmacokinetics: By Milo Glbaldi Donald, R. Mercel Dekker Inc.
• 7. Hand Book of Clinical Pharmacokinetics, By Milo Gibaldi and Laurie Prescott by ADIS Health Science Press.
• 8. Biopharmaceutics; By Swarbrick
• 9. Clinical Pharmacokinetics, Concepts and Applications: By Malcolm Rowland and
• 10. Thomas, N. Tozen, Lea and Febrger, Philadelphia, 1995.
• 11. Dissolution, Bioavailability and Bioequivalence, By Abdou H.M, Mack, Publishing Company, Pennsylvania 1989.
• 12. Biopharmaceutics and Clinical Pharmacokinetics-An introduction 4th edition Revised and expanded by Rebort F Notari Marcel Dekker Inn, New York and Basel, 1987.
• 13. Remington’s Pharmaceutical Sciences, By Mack Publishing Company, Pennsylvania. R17 B. PHARMACY III YEAR