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This edition first published 2018
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Title of original German edition:
Voigt Pharmazeutische Technologie. By Alfred Fahr
© 12th edition 2014 Deutscher Apotheker Verlag, Birkenwaldstrasse 44, 70191 Stuttgart, Germany
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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

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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. 1.1 General Principles
2. 1.2 Good Manufacturing Practice (GMP)

PART II General and Technological Principles and Unit Operations

2 Unit Operations
1. 2.1 Comminution (Particle Size Reduction)
2. 2.2 Mixing
3. 2.3 Filtration
4. 2.4 Drying
5. Further Reading
3 Physical and Physicochemical Principles of Drug Formulation
1. 3.1 Drug Formulations as Disperse Systems
2. 3.2 Pharmaceutical Solids
3. 3.3 Particle Size
4. 3.4 Particle Size Assay Methods
5. 3.5 Surface Area Assay Methods
6. 3.6 Density
7. 3.7 Relative and Absolute Humidity
8. 3.8 Water Content of Solid Substances
9. 3.9 Solubility
10. 3.10 Dissolution Rate
11. 3.11 Interfacial Phenomena
12. 3.12 Rheology
13. 3.13 Physicochemical Characterization of Biologics
14. Further Reading
4 Sterilization of Drug Formulations: Procedures to Reduce Microbial Count
1. 4.1 General Introduction
2. 4.2 Procedures
3. 4.3 Aseptic Preparation
4. 4.4 Sterility Tests and Microbial Contamination
5 Excipients for Drug Formulation
1. 5.1 General Introduction, Requirements
2. 5.2 Inorganic Excipients
3. 5.3 Organic Excipients
4. 5.4 Surfactants
5. 5.5 Chemically Heterogeneous Groups of Substances with Special Functions
6. 5.6 Antioxidants
7. Further Reading
6 Basic Principles of Probability and Statistics
1. 6.1 Simple Calculations with Probabilities
2. 6.2 Probability Distributions
3. 6.3 Sampling
4. 6.4 Functions of Random Variables
5. 6.5 Statistical Tests
6. 6.6 Linear Regression
7. Further Reading
7 Basic Principles in Biopharmaceutics
1. 7.1 General Considerations on Biopharmaceutics
2. 7.2 Mathematical Formulations and Model Systems
3. 7.3 Bioavailability
4. 7.4 Bioequivalence
5. 7.5 Absorption of Active Ingredients
6. 7.6 Factors Affecting Release and Absorption
7. 7.7 Assay Method
8. Further Reading

PART III Solid Dosage Forms

8 Powders and Granules
1. 8.1 General Considerations and Definitions
2. 8.2 Powders and Granules as Dosage Form
3. 8.3 Production of Powders and Active Substances in Powder Form
4. 8.4 Granulation
5. 8.5 Flow Properties of Bulk Materials
6. 8.6 Test Methods for Powders and Granules
7. Further Reading
9 Tablets
1. 9.1 General Considerations
2. 9.2 Excipients in Tablet Manufacturing
3. 9.3 Direct Compression
4. 9.4 Granulation
5. 9.5 Compaction
6. 9.6 Complications during Compaction
7. 9.7 Special Tablet Types and Chewing Gums Containing Active Ingredients
8. 9.8 Physical Testing of Tablets
9. 9.9 Biopharmaceutical Testing of Tablets
10. 9.10 Concluding Remarks
11. Further Reading
10 Coated Oral Dosage Forms
1. 10.1 General Introduction
2. 10.2 Reasons for Coating Dosage Forms
3. 10.3 Starting Material
4. 10.4 Sugarcoating
5. 10.5 Film Coating of Tablets
6. 10.6 Coating Techniques
7. 10.7 Testing
8. Further Reading
11 Capsules
1. 11.1 General Introduction
2. 11.2 Hard Gelatin Capsules
3. 11.3 Soft Gelatin Capsules
4. 11.4 Modification of Capsules
5. 11.5 Tests
6. Further Reading
12 Peroral Modified Release (MR) Formulations
1. 12.1 General Considerations
2. 12.2 Options to Achieve Prolonged Drug Activity
3. 12.3 Definitions
4. 12.4 Manufacturing Procedures
5. 12.5 Special Products
6. 12.6 Principles of Controlled Release
7. 12.7 Testing
8. Further Reading
13 Rectal Preparations
1. 13.1 General Considerations
2. 13.2 Requirements of Suppositories and Their Components
3. 13.3 Suppository Bases
4. 13.4 Formulation and Manufacturing
5. 13.5 The Suppository as a Disperse System
6. 13.6 Dosing Methods
7. 13.7 Manufacturing and Packaging Procedures
8. 13.8 Further Rectal Drug Formulations
9. 13.9 Biopharmaceutical Aspects
10. 13.10 Testing
11. Further Reading
14 Vaginal Dosage Forms and Dosage Forms to be Introduced in Body Cavities
1. 14.1 Vaginal Dosage Forms
2. 14.2 Medicated Sticks (styli)
3. Further Reading

PART IV Semi-Solid Dosage Forms

15 Semi-Solid Preparations for Cutaneous Application
1. 15.1 General Considerations
2. 15.2 Requirements of Dermal Preparations with Semi-Solid Properties
3. 15.3 Classification and Structure of Semi-Solid Preparations
4. 15.4 Production Technology
5. 15.5 Packaging, Stability, Storage
6. 15.6 Biopharmaceutical Aspects
7. 15.7 Testing of Semi-Solid Preparations
8. 15.8 Special Semi-Solid Preparations for Cutaneous Application
9. 15.9 Requirements of Semi-Solid Preparations Not for Dermal Application
10. Further Reading
16 Patches/Plasters
1. 16.1 General Considerations
2. 16.2 Structure
3. 16.3 Medicated Plasters and Cutaneous Patches
4. 16.4 Transdermal Patches
5. 16.5 Storage Stability and Storage Conditions
6. 16.6 Testing
7. Further Reading

PART V Liquid Dosage Forms

17 Solutions
1. 17.1 Formulations
2. 17.2 Preparation
3. 17.3 Delivery Containers and Dosage
4. 17.4 Biopharmaceutical Aspects
5. 17.5 Testing
6. 17.6 Liquid Preparations for Nasal Administration
7. 17.7 Liquid Preparations for Application in the Ear
8. Further Reading
18 Emulsions
1. 18.1 General Introduction
2. 18.2 Emulsion Types
3. 18.3 Instability Phenomena and Stabilizing Principles
4. 18.4 Surfactants and Emulsifiers
5. 18.5 Emulsion Type
6. 18.6 Chemical and Microbiological Stability
7. 18.7 Preparation Technology
8. 18.8 Testing
9. Further Reading
19 Suspensions
1. 19.1 General Introduction
2. 19.2 Manufacturing Technology
3. 19.3 Physicochemical Aspects
4. 19.4 Stabilization by Macromolecular and Viscosity-Enhancing Additives
5. 19.5 Caking
6. 19.6 Ostwald Ripening
7. 19.7 Testing of Pharmaceutical Suspensions
8. Further Reading
20 Micro- and Nanodispersed Systems
1. 20.1 General Introduction
2. 20.2 Tissue-Specific Drug Administration (Drug Targeting)
3. 20.3 Liposomes
4. 20.4 Colloidal Fat Emulsions
5. 20.5 Microemulsions
6. 20.6 Nanoparticles as Drug Carriers
7. 20.7 Drug Nanoparticles (Drug Nanocrystals)
8. 20.8 Microparticulate Systems
9. Further Reading
21 Parenteral Formulations
1. 21.1 General Introduction
2. 21.2 Requirements of Solutions for Injection and Infusion
3. 21.3 Container Closure Systems and Devices for Parenteral Applications
4. 21.4 Preparation of Solutions
5. 21.5 Suspensions for Injection
6. 21.6 Parenteral Depot Drug Formulations
7. 21.7 Implantable Therapeutic Systems
8. 21.8 Therapeutic Systems (TS) for Infusion Therapy
9. 21.9 Biopharmaceutical Aspects
10. 21.10 Special Infusion and Injection Solutions
11. 21.11 Solutions for Electrolyte Therapy
12. 21.12 Blood Preparations
13. 21.13 Plasma Substitutes and Plasma Expanders
14. 21.14 Preparations for Parenteral Nutrition
15. 21.15 Radiopharmaceuticals
16. 21.16 Solutions for Hemodialysis and Peritoneal Dialysis
17. 21.17 Immune Sera and Vaccines
18. 21.18 Formulation of Biologics
19. 21.19 Cytostatic Drugs
20. 21.20 Testing
21. Further Reading
22 Ophthalmic Preparations
1. 22.1 General Introduction
2. 22.2 Eye Drops
3. 22.3 Eye Lotions
4. 22.4 Ocular Therapeutic Systems
5. 22.5 Maintenance Solutions for Contact Lenses
6. 22.6 Biopharmaceutical Aspects
7. 22.7 Testing
8. Further Reading

PART VI Gaseous Dosage Forms

23 Inhalation Dosage Forms
1. 23.1 Inhalants
2. 23.2 Pressurized Metered Dose Inhalers (pMDI, MDI)
3. 23.3 Nebulizers
4. 23.4 Powder Inhalers (Dry Powder Inhalers DPI)
5. 23.5 Microbiological Requirements
6. 23.6 (In)competence of Using an Inhaler
7. 23.7 Biopharmaceutical Considerations
8. 23.8 Tests and Legal Provisions
9. Further Reading

PART VII General Aspects of Dosage Forms

24 Herbal Drug Preparations (Extracts, Tinctures, and Aqueous Preparations)
1. 24.1 General Introduction
2. 24.2 Crude Herbal Material as a Starting Substance for Dosage Forms
3. 24.3 Pretreatment of the Material
4. 24.4 Principles for Enzyme Elimination
5. 24.5 Herbal Preparations as Multiple Component Systems
6. 24.6 Directions for the Conversion of Plant Components into a Drug Formulation
7. 24.7 Principles of Plant Extraction
8. 24.8 Dosage Forms
9. Further Reading
25 Stability and Stabilization
1. 25.1 General Introduction
2. 25.2 Methods to Determine Stability
3. 25.3 Physical Changes
4. 25.4 Chemical Changes
5. 25.5 Microbial Changes
6. Further Reading
26 Incompatibilities
1. 26.1 General Introduction
2. 26.2 Ionic Interactions
3. 26.3 Phenol–Ether Interactions
4. 26.4 Interactions between Surfactants
5. 26.5 Solubility Changes
6. 26.6 Redistribution Processes
7. 26.7 Changes in the State of Phase
8. 26.8 Incompatibilities with Primary Packaging Material
9. 26.9 Avoidance and Elimination of Incompatibilities
10. Further Reading
27 Packaging Materials and Technology
1. 27.1 General Introduction
2. 27.2 Container Materials
3. 27.3 Containers
28 Recent and Future Developments in Pharmaceutical Technology
1. 28.1 Nano-Systems
2. 28.2 Carrier Systems in Gene Therapy
3. 28.3 Polymers as Carrier Systems
4. 28.4 Inhalation Systems
5. 28.5 Carrier Systems for Peptide/ Protein Drugs
6. 28.6 Individualized Therapeutic Systems
7. 28.7 Carrier Systems and Biotechnology
8. 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

Voigt's Pharmaceutical Technology