BP604T - Biopharmaceutics and Pharmacokinetics

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.

UNIT-1

Chapter-1

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,

Chapter-2

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-2

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-3

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-4

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 settins.

UNIT-5

Nonlinear Pharmacokinetics: a. Introduction, b. Factors causing Non-linearity. c. Michaelis-menton method of estimating parameters, Explanation with example ofdrugs.