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 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:
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
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