Essentials of Biopharmaceutics and Pharmacokinetics - E-Book

Ashutosh Kar

Description

Essentials of Biopharmaceutics and Pharmacokinetics

Kar’s Essentials of Biopharmaceutics and Pharmacokinetics deals with how a drug exerts its action in the human body through the fundamentals of absorption, distribution, metabolism and excretion. The book adopts a growth-oriented format and design that is developed systematically and methodically.

The book interrelates five different sections:

Section 1 Biopharmaceutics and Pharmacokinetics: What Do They Mean?

Section 2 Biopharmaceutics

Section 3 Pharmacokinetics

Section 4 Clinical Pharmacokinetics

Section 5 Bioavailability and Bioequivalence

Each section starts with a basic theory and fields of application, focuses on model-independent pharmacokinetic analyses, expatiates various biopharmaceutical aspects of dosage form and evaluation, provides an altogether new approach in understanding both dosage regimen design and individualization, and explains modification in drug molecules related to the pharmacokinetics.

Undoubtedly, the unique blend of fundamental principles and latest breakthroughs in the field will certainly provide sufficient subject matter to the students of pharmacy, pharmacology, medicinal chemistry scientists, who need a simple as well as detailed introduction in theory and application.

Sujets

• Medical
• Médecine
• Pharmacy

Informations

• Publié par: Elsevier
• Date de parution: 15 septembre 2010
• Nombre de lectures: 1
• EAN13: 9788131232620
• Langue: English
• Poids de l'ouvrage: 7 Mo

Extrait

Essentials of Biopharmaceutics and Pharmacokinetics
First Edition

Ashutosh Kar
Formerly Professor , School of Pharmacy, Addis Ababa University, Addis Ababa, Ethiopia
Dean, Chairman and Professor, Faculty of Pharmaceutical Sciences, Guru Jambheshwar University, Hisar, India
Professor, School of Pharmacy, Al Arab Medical University, Benghazi, Libya
Professor, College of Pharmacy, University of Delhi, Delhi, India
Professor and Head, Department of Pharmaceutical Chemistry, Faculty of Pharmaceutical Sciences, University of Nigeria, Nsukka, Nigeria
Elsevier
Copyright
Essentials of Biopharmaceutics and Pharmacokinetics
KAR
ELSEVIER
A division of Reed Elsevier India Private Limited.
Mosby, Saunders, Churchill Livingstone, Butterworth Heinemann and Hanley Belfus are the Health Science imprints of Elsevier
2011 Elsevier
All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means - electronic or mechanical, including photocopy, recording, or any information storage and retrieval system - without permission in writing from the publisher.
ISBN: 978-81-312-2639-1

Notice

Knowledge and best practice in this field are constantly changing. As new research and experience broaden our knowledge, changes in practice, treatment and drug therapy may become necessary or appropriate. Readers are advised to check the most current information provided (1) on procedures featured or (2) by the manufacturer of each product to be administered, to verify the recommended dose or formula, the method and the duration of administration, and the contraindications. It is the responsibility of the practitioner, relying on their own experience and knowledge of the patient, and to take diagnoses, to determine dosages and the best treatment for each individual patient, and to take all appropriate safety precautions. To the fullest extent of the law, neither the Publisher nor the Authors assume any liability for any injury and/or damage to persons or property arising out or related to any use of the material contained in this book.
The Publisher
Registered Office: 622, Indraprakash Building, 21 Barakhamba Road, New Delhi-110 001.
Corporate Office: 14th Floor, Building No. 10B, DLF Cyber City, Phase II, Gurgaon-122002, Haryana, India.
Commissioning Editor : Nilabh Ranjan
Development Editor : Subodh K. Chauhan
Manager - Publishing Operations : Sunil Kumar
Manager - Production : N.C. Pant
Laser typeset by ACE PRO India P. Ltd.
Printed and bound at Rajkamal Electric Press, Kundli, Haryana, India.
Dedication
Leena
For the infinite joy and for her amazing grandmothering
Aditi and Aryan
For the eternal sunshine they fill in our lives with
Table of Contents
Instructions for online access
Cover Image
Title Page
Copyright
Dedication
Preface
Section 1 Biopharmaceutics and Pharmacokinetics: What Do They Mean?
Introduction to Biopharmaceutics and Pharmacokinetics
Section 2 Biopharmaceutics
Biopharmaceutics
Section 3 Pharmacokinetics
Pharmacokinetics
Section 4 Clinical Pharmacokinetics
Clinical Pharmacokinetics
Section 5 Bioavailability and Bioequivalence
Bioavailability and Bioequivalence
Index
Preface
Essentials of Biopharmaceutics and Pharmacokinetics correlates the intricacies involved in the interdisciplinary interaction of two qualitative subjects. The text has been designed in a manner so as to help its readers comprehend the subjects with the insight of a researcher. The primary objective of this textbook is to provide the reader an in-depth knowledge of the principles of Biopharmaceutics and Pharmacokinetics, which could be extended wisely to the product development as well as the drug therapies. The teachers indeed would find the subject matter quite user friendly and the students shall be able to grasp the basic concepts of complex topics like critical drug-delivery modalities and effective safe drug therapy.
The pharmacy degree (B. Pharm.) students in all Indian universities shall be duly benefitted from this textbook because the course content in it has been carefully developed as per the latest prescribed syllabi for B. Pharm. This book shall further enrich the knowledge of R D scientists in the pharmaceutical industry in general and those associated with Pharmaceutics, Biopharmaceutics and Pharmacokinetics in particular.
The entire course content has been categorized into five sections, namely

Section 1 Biopharmaceutics and Pharmacokinetics: What Do They Mean?
Section 2 Biopharmaceutics
Section 3 Pharmacokinetics
Section 4 Clinical Pharmacokinetics
Section 5 Bioavailability and Bioequivalence
Each section in the book deals with a brief introduction, definition, classification, exemplification, laws, graphics, diagrammatic representations, illustrations and highlights, and concludes with Selected Biography and Review Questions.
Besides maintaining a logical chain of continuity in all the five sections in a lucid manner, an attempt has been made to include very interesting examples that will create enough interest in the fields of Biopharmaceutics and Pharmacokinetics.
The author solemnly believes that this book will provide a positive help and an urgent need to all aspirant UG/PG pharmacy students across the various Indian universities. Any suggestions for improvement of the book are invited.
The author would like to place on record the excellent help and cooperation by the entire publishing team of Elsevier in bringing out this book in a record time frame.

Ashutosh Kar
Section 1 Biopharmaceutics and Pharmacokinetics: What Do They Mean?
1
Introduction to Biopharmaceutics and Pharmacokinetics

Chapter Outline

1. Introduction

2. Historical Perspective of Biopharmaceutics

3. Extravascular Administration of a Drug

4. Scope of Biopharmaceutics

5. Variants in Biopharmaceutics

6. Pharmacokinetics

7. Clinical Pharmacokinetics

8. Pharmacodynamics

9. Toxicokinetics and Clinical Toxicology

10. Bioavailability

11. Bioequivalence

1 Introduction
This chapter deals specifically with two extremely important aspects, namely biopharmaceutics and pharmacokinetics . These would be treated individually and briefly in the sections that follow.
Definition and Scope: Biopharmaceutics refers to the study of relationship existing among physical, chemical and biological characteristic features of matter in relation to drugs, drug products, drug availability and actions .

2 Historical Perspective of Biopharmaceutics
Historically, the pharmaceutical scientists made a genuine effort towards the systematic evaluation of the relative availability of drug to the human animal body in vivo after due administration of the respective dosage form (or drug product) and ultimately comparing critically the following aspects:

Particular pharmacologic activity profile
Clinical responses
Possible toxic activity feature

Examples

Isoproterenol-a -adrenergic agonist used as a bronchodilator represents a typical example that shows different pharmacologic activity with different routes of administration, such as
Intravenous (IV) administration causes an enhancement in the heart rate. Oral administration shows practically little effect on heart rate.
Interestingly, the degree of bioavailability also varies appreciably from one particular drug product (manufactured by A ) to another product (manufactured by B ) containing the same drug , even though the route of administration remains the same. Nevertheless, the actual observed difference in the bioavailability of the drug substance may be shown by carefully examining the difference in the specific therapeutic effectiveness of the drug products or the dosage forms .
It may, however, be concluded that the following three important aspects, namely:

precise nature of the drug molecule,
actual route of administration of the dosage form and
critical formulation of the drug product may accurately establish and determine whether the administered secondary pharmaceutical product is deemed to be

(a) effective therapeutically,
(b) toxic in nature and
(c) devoid of any apparent pharmacologic effect.
As to date, biopharmaceutics has virtually emerged as the most versatile and well-developed scientific discipline that actually looks at closely the prevailing interrelationship among the following three critical aspects, such as:

drug's physicochemical features,
drug product (dosage form) in which medicament is administered and
route of drug administration [ i.e., intramuscular (IM), IV, subcutaneous (SC)] exerting its effect upon the ensuing rate as well as degree of systemic drug absorption.
In other words, biopharmaceutics predominantly gets influenced by four cardinal circumstances, which essentially contributes towards:

actual stability of the drug within the dosage form,
actual release pattern of the drug from the dosage form,
actual rate of dissolution or release profile of the drug at the site of absorption ( in vivo ) and
actual absorption of the drug systematically.
Figure 1.1 represents the diagram of a general scheme , elaborating explicitly the ensuing dynamic relationships as stated above.

Figure 1.1 Diagrammatic representation of a general scheme demonstrating evidently the dynamic relationship existing among: drug, dosage form,