Voigt's Pharmaceutical Technology E-Book

Alfred Fahr

• Herausgeber: John Wiley & Sons
• Kategorie: Wissenschaft und neue Technologien
• Sprache: Englisch

Seitenzahl: 2061

Veröffentlichungsjahr: 2018

Beschreibung

A textbook which is both comprehensive and comprehensible and that offers easy but scientifically sound reading to both students and professionals

Now in its 12th edition in its native German, Voigt's Pharmaceutical Technology is an interdisciplinary textbook covering the fundamental principles of pharmaceutical technology. Available for the first time in English, this edition is produced in full colour throughout, with a concise, clear structure developed after consultation with students, instructors and researchers.  This book:

• Features clear chapter layouts and easily digestible content
• Presents novel trends, devices and processes
• Discusses classical and modern manufacturing processes
• Covers all formulation principles including tablets, ointments, capsules, nanosystems and biopharmaceutics
• Takes account of legal requirements for both qualitative and quantitative composition
• Addresses quality assurance considerations
• Uniquely relates contrasting international pharmacopeia from EU, US and Japan to formulation principles
• Includes examples and text boxes for quicker data assimilation

Written for both students studying pharmacy and industry professionals in the field as well as toxicologists, biochemists, medical lab technicians, Voigt’s Pharmaceutical Technology is the essential resource for understanding the various aspects of pharmaceutical technology.

Leseprobe

Voigt's Pharmaceutical Technology

Prof. Dr. Alfred Fahr

Institute of Pharmaceutical Technology Friedrich - Schiller University of Jena, Germany

Translated by Prof. Dr. Gerrit Scherphof

This edition first published 2018 © 2018 John Wiley & Sons Ltd.

All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, except as permitted by law. Advice on how to obtain permission to reuse material from this title is available at http://www.wiley.com/go/permissions.

The right of Alfred Fahr to be identified as the author of this work has been asserted in accordance with law.

Title of original German edition:Voigt Pharmazeutische Technologie. By Alfred Fahr © 12th edition 2014 Deutscher Apotheker Verlag, Birkenwaldstrasse 44, 70191 Stuttgart, Germany All rights reserved.

No part of this book may be translated, reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopying, microfilming, recording, or otherwise, without written permission from the original copyright holder.

The use of general descriptive names, trade names, trademarks, etc. in a publication, even if not specifically identified, does not imply that these names are not protected by the relevant laws and regulations.

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Limit of Liability/Disclaimer of Warranty

In view of ongoing research, equipment modifications, changes in governmental regulations, and the constant flow of information relating to the use of experimental reagents, equipment, and devices, the reader is urged to review and evaluate the information provided in the package insert or instructions for each chemical, piece of equipment, reagent, or device for, among other things, any changes in the instructions or indication of usage and for added warnings and precautions. While the publisher and author have used their best efforts in preparing this work, they make no representations or warranties with respect to the accuracy or completeness of the contents of this work and specifically disclaim all warranties, including without limitation any implied warranties of merchantability or fitness for a particular purpose. No warranty may be created or extended by sales representatives, written sales materials or promotional statements for this work. The fact that an organization, website, or product is referred to in this work as a citation and/or potential source of further information does not mean that the publisher and author endorse the information or services the organization, website, or product may provide or recommendations it may make. This work is sold with the understanding that the publisher is not engaged in rendering professional services. The advice and strategies contained herein may not be suitable for your situation. You should consult with a specialist where appropriate. Further, readers should be aware that websites listed in this work may have changed or disappeared between when this work was written and when it is read. Neither the publisher nor the author shall be liable for any loss of profit or any other commercial damages, including but not limited to special, incidental, consequential, or other damages.

Library of Congress Cataloging-in-Publication Data

Names: Fahr, Alfred, author. Title: Voigt's pharmaceutical technology / by Alfred Fahr; translated by Gerrit Scherphof. Other titles: Voigt Pharmazeutische Technologie. English | Pharmaceutical technology Description: Hoboken, NJ: Wiley, 2018. | Includes bibliographical references and index. | Identifiers: LCCN 2017031789 (print) | LCCN 2017033911 (ebook) | ISBN 9781118972434 (pdf) |  ISBN 9781118972441 (epub) | ISBN 9781118972625 (cloth) Subjects: | MESH: Technology, Pharmaceutical Classification: LCC RS380 (ebook) | LCC RS380 (print) | NLM QV 778 | DDC 615.1/9–dc23 LC record available at https://lccn.loc.gov/2017031789

Cover image: © Lightspring/Shutterstock

Cover design by Wiley

Contents

Contributors

Foreword

Acknowledgements

List of Abbreviations

Index of Pharmacopeia Boxes

PART I Dosage Forms

1 Drug Formulations as Application System—Science and Legal Provisions

1.1 General Principles

1.2 Good Manufacturing Practice (GMP)

PART II General and Technological Principles and Unit Operations

2 Unit Operations

2.1 Comminution (Particle Size Reduction)

2.2 Mixing

2.3 Filtration

2.4 Drying

Further Reading

3 Physical and Physicochemical Principles of Drug Formulation

3.1 Drug Formulations as Disperse Systems

3.2 Pharmaceutical Solids

3.3 Particle Size

3.4 Particle Size Assay Methods

3.5 Surface Area Assay Methods

3.6 Density

3.7 Relative and Absolute Humidity

3.8 Water Content of Solid Substances

3.9 Solubility

3.10 Dissolution Rate

3.11 Interfacial Phenomena

3.12 Rheology

3.13 Physicochemical Characterization of Biologics

Further Reading

4 Sterilization of Drug Formulations: Procedures to Reduce Microbial Count

4.1 General Introduction

4.2 Procedures

4.3 Aseptic Preparation

4.4 Sterility Tests and Microbial Contamination

5 Excipients for Drug Formulation

5.1 General Introduction, Requirements

5.2 Inorganic Excipients

5.3 Organic Excipients

5.4 Surfactants

5.5 Chemically Heterogeneous Groups of Substances with Special Functions

5.6 Antioxidants

Further Reading

6 Basic Principles of Probability and Statistics

6.1 Simple Calculations with Probabilities

6.2 Probability Distributions

6.3 Sampling

6.4 Functions of Random Variables

6.5 Statistical Tests

6.6 Linear Regression

Further Reading

7 Basic Principles in Biopharmaceutics

7.1 General Considerations on Biopharmaceutics

7.2 Mathematical Formulations and Model Systems

7.3 Bioavailability

7.4 Bioequivalence

7.5 Absorption of Active Ingredients

7.6 Factors Affecting Release and Absorption

7.7 Assay Method

Further Reading

PART III Solid Dosage Forms

8 Powders and Granules

8.1 General Considerations and Definitions

8.2 Powders and Granules as Dosage Form

8.3 Production of Powders and Active Substances in Powder Form

8.4 Granulation

8.5 Flow Properties of Bulk Materials

8.6 Test Methods for Powders and Granules

Further Reading

9 Tablets

9.1 General Considerations

9.2 Excipients in Tablet Manufacturing

9.3 Direct Compression

9.4 Granulation

9.5 Compaction

9.6 Complications during Compaction

9.7 Special Tablet Types and Chewing Gums Containing Active Ingredients

9.8 Physical Testing of Tablets

9.9 Biopharmaceutical Testing of Tablets

9.10 Concluding Remarks

Further Reading

10 Coated Oral Dosage Forms

10.1 General Introduction

10.2 Reasons for Coating Dosage Forms

10.3 Starting Material

10.4 Sugarcoating

10.5 Film Coating of Tablets

10.6 Coating Techniques

10.7 Testing

Further Reading

11 Capsules

11.1 General Introduction

11.2 Hard Gelatin Capsules

11.3 Soft Gelatin Capsules

11.4 Modification of Capsules

11.5 Tests

Further Reading

12 Peroral Modified Release (MR) Formulations

12.1 General Considerations

12.2 Options to Achieve Prolonged Drug Activity

12.3 Definitions

12.4 Manufacturing Procedures

12.5 Special Products

12.6 Principles of Controlled Release

12.7 Testing

Further Reading

13 Rectal Preparations

13.1 General Considerations

13.2 Requirements of Suppositories and Their Components

13.3 Suppository Bases

13.4 Formulation and Manufacturing

13.5 The Suppository as a Disperse System

13.6 Dosing Methods

13.7 Manufacturing and Packaging Procedures

13.8 Further Rectal Drug Formulations

13.9 Biopharmaceutical Aspects

13.10 Testing

Further Reading

14 Vaginal Dosage Forms and Dosage Forms to be Introduced in Body Cavities

14.1 Vaginal Dosage Forms

14.2 Medicated Sticks (styli)

Further Reading

PART IV Semi-Solid Dosage Forms

15 Semi-Solid Preparations for Cutaneous Application

15.1 General Considerations

15.2 Requirements of Dermal Preparations with Semi-Solid Properties

15.3 Classification and Structure of Semi-Solid Preparations

15.4 Production Technology

15.5 Packaging, Stability, Storage

15.6 Biopharmaceutical Aspects

15.7 Testing of Semi-Solid Preparations

15.8 Special Semi-Solid Preparations for Cutaneous Application

15.9 Requirements of Semi-Solid Preparations Not for Dermal Application

Further Reading

16 Patches/Plasters

16.1 General Considerations

16.2 Structure

16.3 Medicated Plasters and Cutaneous Patches

16.4 Transdermal Patches

16.5 Storage Stability and Storage Conditions

16.6 Testing

Further Reading

PART V Liquid Dosage Forms

17 Solutions

17.1 Formulations

17.2 Preparation

17.3 Delivery Containers and Dosage

17.4 Biopharmaceutical Aspects

17.5 Testing

17.6 Liquid Preparations for Nasal Administration

17.7 Liquid Preparations for Application in the Ear

Further Reading

18 Emulsions

18.1 General Introduction

18.2 Emulsion Types

18.3 Instability Phenomena and Stabilizing Principles

18.4 Surfactants and Emulsifiers

18.5 Emulsion Type

18.6 Chemical and Microbiological Stability

18.7 Preparation Technology

18.8 Testing

Further Reading

19 Suspensions

19.1 General Introduction

19.2 Manufacturing Technology

19.3 Physicochemical Aspects

19.4 Stabilization by Macromolecular and Viscosity-Enhancing Additives

19.5 Caking

19.6 Ostwald Ripening

19.7 Testing of Pharmaceutical Suspensions

Further Reading

20 Micro- and Nanodispersed Systems

20.1 General Introduction

20.2 Tissue-Specific Drug Administration (Drug Targeting)

20.3 Liposomes

20.4 Colloidal Fat Emulsions

20.5 Microemulsions

20.6 Nanoparticles as Drug Carriers

20.7 Drug Nanoparticles (Drug Nanocrystals)

20.8 Microparticulate Systems

Further Reading

21 Parenteral Formulations

21.1 General Introduction

21.2 Requirements of Solutions for Injection and Infusion

21.3 Container Closure Systems and Devices for Parenteral Applications

21.4 Preparation of Solutions

21.5 Suspensions for Injection

21.6 Parenteral Depot Drug Formulations

21.7 Implantable Therapeutic Systems

21.8 Therapeutic Systems (TS) for Infusion Therapy

21.9 Biopharmaceutical Aspects

21.10 Special Infusion and Injection Solutions

21.11 Solutions for Electrolyte Therapy

21.12 Blood Preparations

21.13 Plasma Substitutes and Plasma Expanders

21.14 Preparations for Parenteral Nutrition

21.15 Radiopharmaceuticals

21.16 Solutions for Hemodialysis and Peritoneal Dialysis

21.17 Immune Sera and Vaccines

21.18 Formulation of Biologics

21.19 Cytostatic Drugs

21.20 Testing

Further Reading

22 Ophthalmic Preparations

22.1 General Introduction

22.2 Eye Drops

22.3 Eye Lotions

22.4 Ocular Therapeutic Systems

22.5 Maintenance Solutions for Contact Lenses

22.6 Biopharmaceutical Aspects

22.7 Testing

Further Reading

PART VI Gaseous Dosage Forms

23 Inhalation Dosage Forms

23.1 Inhalants

23.2 Pressurized Metered Dose Inhalers (pMDI, MDI)

23.3 Nebulizers

23.4 Powder Inhalers (Dry Powder Inhalers DPI)

23.5 Microbiological Requirements

23.6 (In)competence of Using an Inhaler

23.7 Biopharmaceutical Considerations

23.8 Tests and Legal Provisions

Further Reading

PART VII General Aspects of Dosage Forms

24 Herbal Drug Preparations (Extracts, Tinctures, and Aqueous Preparations)

24.1 General Introduction

24.2 Crude Herbal Material as a Starting Substance for Dosage Forms

24.3 Pretreatment of the Material

24.4 Principles for Enzyme Elimination

24.5 Herbal Preparations as Multiple Component Systems

24.6 Directions for the Conversion of Plant Components into a Drug Formulation

24.7 Principles of Plant Extraction

24.8 Dosage Forms

Further Reading

25 Stability and Stabilization

25.1 General Introduction

25.2 Methods to Determine Stability

25.3 Physical Changes

25.4 Chemical Changes

25.5 Microbial Changes

Further Reading

26 Incompatibilities

26.1 General Introduction

26.2 Ionic Interactions

26.3 Phenol–Ether Interactions

26.4 Interactions between Surfactants

26.5 Solubility Changes

26.6 Redistribution Processes

26.7 Changes in the State of Phase

26.8 Incompatibilities with Primary Packaging Material

26.9 Avoidance and Elimination of Incompatibilities

Further Reading

27 Packaging Materials and Technology

27.1 General Introduction

27.2 Container Materials

27.3 Containers

28 Recent and Future Developments in Pharmaceutical Technology

28.1 Nano-Systems

28.2 Carrier Systems in Gene Therapy

28.3 Polymers as Carrier Systems

28.4 Inhalation Systems

28.5 Carrier Systems for Peptide/ Protein Drugs

28.6 Individualized Therapeutic Systems

28.7 Carrier Systems and Biotechnology

Further Reading

A Selected Dosage Forms (Compared between Ph. Eur., USP, and JP)

Index

Online supplementary material

EULA

List of Table

Chapter 2

Table 2.1

Table 2.2

Table 2.3

Table 2.4

Table 2.5

Chapter 3

Table 3.1

Table 3.2

Table 3.3

Table 3.4

Table 3.5

Table 3.6

Table 3.7

Table 3.8

Table 3.9

Table 3.10

Table 3.11

Table 3.12

Table 3.13

Table 3.14

Table 3.15

Chapter 4

Table 4.1

Table 4.2

Table 4.3

Table 4.4

Table 4.5

Table 4.6

Table 4.7

Table 4.8

Table 4.9

Chapter 5

Table 5.1

Table 5.2

Table 5.3

Table 5.4

Table 5.5

Table 5.6

Table 5.7

Table 5.8

Table 5.9

Table 5.10

Table 5.11

Table 5.12

Table 5.13

Table 5.14

Table 5.15

Table 5.16

Table 5.17

Table 5.18

Table 5.19

Table 5.20

Table 5.21

Table 5.22

Table 5.23

Table 5.24

Table 5.25

Chapter 7

Table 7.1

Table 7.2

Table 7.3

Table 7.4

Table 7.5

Chapter 8

Table 8.1

Table 8.2

Table 8.3

Chapter 9

Table 9.1

Chapter 10

Table 10.1

Table 10.2

Chapter 12

Table 12.1

Table 12.2

Table 12.3

Chapter 13

Table 13.1

Table 13.2

Chapter 15

Table 15.1

Table 15.2

Table 15.3

Table 15.4

Table 15.5

Table 15.6

Table 15.7

Chapter 17

Table 17.1

Table 17.2

Chapter 18

Table 18.1

Table 18.2

Table 18.3

Chapter 20

Table 20.1

Table 20.2

Chapter 21

Table 21.1

Table 21.2

Table 21.3

Table 21.4

Table 21.5

Table 21.6

Chapter 25

Table 25.1

Table 25.2

Table 25.3

Table 25.4

Table 25.5

Table 25.6

Table 25.7

Table 25.8

Chapter 26

Table 26.1

Table 26.2

Table 26.3

Table 26.4

Table 26.5

Table 26.6

Table 26.7

Table 26.8

Table 26.9

Chapter 27

Table 27.1

Table 27.2

Table 27.3

Chapter 1

Table A.1

Guide

Cover

Table of Contents

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Contributors

Prof. Dr. Heike Bunjes

Institut für Pharmazeutische Technologie

Technische Universität Braunschweig

Braunschweig, Germany

Prof. Dr. Rolf Daniels

Institute for Pharmacy

Pharmaceutical Technology

Eberhard Karls University Tübingen

Tübingen, Germany

Prof. Dr. Dagmar Fischer

Institute for Pharmacy

Department of Pharmaceutical Technology

Friedrich-Schiller University of Jena

Jena, Germany

Prof. Dr. Judith Kuntsche

Department of Physics, Chemistry and Pharmacy

University of Southern Denmark

Odense, Denmark

Prof. Dr. Sylvio May

Department of Physics

North Dakota State University

Fargo ND, USA

PD Dr. habil. Stefan Scheler

Novartis Technical Operations

Biologics Technical Development & Manufacturing

Sandoz GmbH

Langkampfen, Austria

Foreword