BIOPHARMACEUTICS AND PHARMACOKINETICS

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Dinesh Kumar Sharma

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Course Name: Biopharmaceutics and Pharmacokinetics

Code(Credit) : BPHT3204(4-0-0)

Course Objectives

  • 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 arisen therein.

Course Outcomes

CO                                                       Statement Mapping with POs
1 To understand the basic concepts in biopharmaceutics and pharmacokinetics and their significance PO1, PO2.PO10
2 To use of plasma drug concentration-time data to calculate the pharmacokinetic parameters to describe the kinetics of drug absorption, distribution, metabolism, excretion, elimination PO1, PO2, PO10, PO11
3 To understand the concepts of bioavailability and bioequivalence of drug products and their significance. PO1, PO2,PO10
4 To understand various pharmacokinetic parameters, their significance & applications PO1, PO2, PO06 PO10
5 Employable skills and high technical competence for Pharmaceutical Industry PO1, PO2.PO11

Course Syllabus

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, Nonrenal 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, Noncompartment 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 mainetnance doses and their significance in clinical settins.

UNIT-V   

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

 

 

Recommended Books: (Latest Editions)

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

Session Plan

Session 1

Introduction to Biopharmaceutics: Absorption; Mechanisms of drug absorption through GIT

Mechanisms of drug absorption through GIT

Session 2

Factors influencing drug absorption through GIT

Factors influencing drug absorption

Session 3

Absorption  of  drug  from  Non  per  oral  extra-vascular  routes

Non per oral extra-vascular routes

Session 4

Distribution Tissue permeability of drugs

Distribution Tissue permeability of drugs

Session 5

Binding of drugs, apparent, volume  of drug distribution

volume of drug distribution

Session 6

Plasma and tissue protein binding of drugs

protein binding of drug

Session 7

Factors affecting protein-drug binding

Factors affecting protein-drug binding)

Session 8

Kinetics of protein binding

Kinetics of protein binding

Session 9

Clinical significance of protein binding of drugs

Clinical significance of protein binding of drugs

Session 10

Elimination: Drug metabolism and basic understanding metabolic pathways renal excretion of drugs

excretion of drug-

Session 11

Factors affecting renal excretion of drugs, renal clearance

factors affecting excretion of drug-

Session 12

Non renal routes of drug excretion of drugs

non renal excretion of drug-

Session 13

Bioavailability and Bioequivalence: Definition and Objectives of bioavailability

Definition and Objectives of bioavailability

Session 14

Absolute and relative bioavailability

Absolute and relative bioavailability

Session 15

Measurement of bioavailability

MEASUREMENT OF bioavailability

Session 16

In-vitro drug dissolution models

in vitro dissolution testing models

Session 17

In-vitro-in-vivo correlations

IVIVC

Session 18

Bioequivalence studies  

bioequivalence studies

Session 19

Methods to enhance the dissolution rates and bioavailability of poorly soluble drugs

BIOAVAILABILITY ENHANCEMENT APPROACH_

Session 20

Pharmacokinetics: Definition and introduction to Pharmacokinetics

pharmacokinetics

Session 21

Compartment models

pharmacokineticmodels

Session 22

Non compartment models

Non compartment models

Session 23

Physiological models

Physiological models

Session 24

One compartment open model (a) Intravenous Injection (Bolus) (b) Intravenous infusion and (c) Extra vascular administrations

pharmacokineticmodels

Session 25

Extra vascular administrations

Extra vascular administrations

Session 26

Pharmacokinetics parameters - KE ,t1/2, Vd, UC, Ka

Pharmacokinetics parameters

Session 27

Clt and CLR- definitions methods of eliminations

pharmacokinetis

Session 28

Understanding of their significance and application

pharmacokineticmodels

Session 29

Multicompartment models

pharmacokineticmodels

Session 30

Two-compartment open model

Two-compartment open model

Session 31

IV bolus Kinetics of multiple dosing

IV

Session 32

Steady-state drug levels

steady state

Session 33

Calculation of loading and maintenance doses

pharmacokinetics of multiple dosing

Session 34

Significance in clinical settings

significance

Session 35

Nonlinear Pharmacokinetics: Introduction

nonlinearkinetics

Session 36

Factors causing Non-linearity

factors causing nonlinearity

Session 37

Michaelis-menton method of estimating parameters

michalish mentan nonlinearkinetics

Session 38

Michaelis-menton method of estimating parameters, Explanation with example of drugs

michaelis nonlinearkinetics

Case Studies

Case Studies

Our Main Teachers

M. Pharm (Pharmaceutics)