Inhalation Drug Delivery E-Book

• Herausgeber: John Wiley & Sons
• Kategorie: Wissenschaft und neue Technologien
• Serie: Postgraduate Pharmacy Series
• Sprache: Englisch

Seitenzahl: 330

Veröffentlichungsjahr: 2012

Beschreibung

There has been a rapid evolution in the field of inhalation drug therapy, including new drugs, increased regulation and quality control, and strong pressure from generics. Inhalation Drug Therapy brings together the most current inhalation drug research, as well as practical developments and processes, into one essential guide. Focusing on inhalation products and specific equipment and techniques used in manufacturing and quality control, the book balances research with the industrial aspects of creating the drugs, and features a highly regarded author team with both academic and industry experience.

Leseprobe

Contents

Cover

Title Page

Copyright

List of Contributors

Series Foreword

Preface

Chapter 1: Inhalation Drug Delivery

1.1 Introduction

1.2 Brief Review of the Respiratory System and its Physiology

1.3 Deposition and the Fate of Particles in the Respiratory Tract

1.4 Deposition Mechanisms

1.5 Parameters Influencing Particle Deposition

1.6 The Clearance of Deposited Particles

1.7 Airways Geometry and Humidity

1.8 Lung Clearance Mechanisms

1.9 Local and Systemic Drug Delivery

1.10 Conclusion

References

Chapter 2: Inhalation and Nasal Products

2.1 Introduction

2.2 Dry Powder Inhalers (DPIs)

2.3 Liquid and Propellant-Based Inhalers

2.4 Nasal Formulations

2.5 Conclusion

References

Chapter 3: Formulation of Inhalation Medicines

3.1 Introduction

3.2 Pressurized Metered-Dose Inhaler (pMDI) Formulation

3.3 Dry Powder Inhaler (DPI) Formulation

3.4 Conclusion

References

Chapter 4: Novel Particle Production Technologies for Inhalation Products

4.1 Introduction

4.2 Conventional Crystallization and Milling

4.3 Specialized Milling

4.4 Solvent Precipitation

4.5 Spray-Drying and Related Droplet Evaporation Methods

4.6 Supercritical Fluid (SCF) Technology

4.7 Conclusion

Acknowledgments

References

Chapter 5: Methods for Understanding, Controlling, Predicting, and Improving Drug Product Performance

5.1 Introduction

5.2 Particle Sizing

5.3 Powder and Particulate Characterization Systems

5.4 Practical Issues in Process Control

5.5 Biopharmaceutical Powder Stability

5.6 Liquids: Solutions and Suspensions

5.7 Conclusion

References

Chapter 6: Aerodynamic Assessment for Inhalation Products: Fundamentals and Current Pharmacopoeial Methods

6.1 Introduction

6.2 Impactor/Impinger Design

6.3 Aerodynamic Assessment

6.4 Inertial Impaction and Cut-Off Diameter

6.5 Pharmacopoeial Procedure

6.6 Cascade Impactor: General Set-Up and Operation

6.7 Impactor/Impinger Characteristics

6.8 Data Analysis

6.9 Cleaning Instructions for Impactors

6.10 Test Limitations

6.11 Future Considerations

References

Chapter 7: Proteins, Peptides, and Controlled-release Formulations for Inhalation

7.1 Proteins and Peptides for Inhalation

7.2 Controlled-Release Formulations for Inhalation

References

Chapter 8: Pharmaceutical Development Studies for Inhalation Products

8.1 Introduction

8.2 Pharmaceutical Development Studies for Inhalation Products

8.3 Conclusion

Acknowledgements

References

Chapter 9: Quality of Inhalation Products: Specifications

9.1 Introduction

9.2 Inhalation-Product Specifications

9.3 Additional Quality Aspects

References

Index

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Library of Congress Cataloging-in-Publication Data

Colombo, Paolo, 1944-

Inhalation drug delivery : techniques and products / Paolo Colombo, Daniela Traini, and Francesca Buttini.

p. ; cm.

Includes bibliographical references and index.

Summary: “Provides students and those in industry with concise clear guide to the essential fundamentals in inhalation drug delivery”–Provided by publisher.

ISBN 978-1-118-35412-4 (hardback)

I. Traini, Daniela. II. Buttini, Francesca. III. Title.

[DNLM: 1. Administration, Inhalation. 2. Drug Delivery Systems–methods. WB 342]

615′.6–dc23

2012028075

A catalogue record for this book is available from the British Library.

Wiley also publishes its books in a variety of electronic formats. Some content that appears in print may not be available in electronic books.

List of Contributors

Francesca Buttini

Department of Pharmacy, The University of Parma, Parma, Italy

Hak-Kim Chan

Advanced Drug Delivery Group, Faculty of Pharmacy, The University of Sydney, Sydney, Australia

Gaia Colombo

Department of Pharmaceutical Sciences, The University of Ferrara, Ferrara, Italy

Paolo Colombo

Department of Pharmacy, The University of Parma, Parma, Italy

Philip Chi Lip Kwok

Department of Pharmacology and Pharmacy, LKS Faculty of Medicine, The University of Hong Kong, Hong Kong, China

David A.V. Morton

Monash Institute of Pharmaceutical Sciences, Monash University, Melbourne, Australia

Chiara Parlati

Department of Pharmacy, The University of Parma, Parma, Italy; Novartis V&D, Technology Development, Siena, Italy

Paola Russo

Department of Pharmaceutical and Biomedical Sciences, The University of Salerno, Fisciano, Italy

Rania Osama Salama

Advanced Drug Delivery Group, Faculty of Pharmacy, The University of Sydney, Sydney, Australia; Faculty of Pharmacy, Alexandria University, Egypt

Daniela Traini

Respiratory Technology, The Woolcock Institute of Medical Research & The Discipline of Pharmacology, The University of Sydney, Sydney, Australia

Wong Tin Wui

Faculty of Pharmacy, Universiti Teknologi MARA, Puncak Alam, Selangor, Malaysia

Paul M. Young

Respiratory Technology, The Woolcock Institute of Medical Research & The Discipline of Pharmacology, The University of Sydney, Sydney, Australia

Series Foreword

ULLA Postgraduate Pharmacy Series

The ULLA series is an innovative series of introductory text-books for postgraduate students in the pharmaceutical sciences.

This series is produced by the ULLA Consortium (European University Consortium for Advanced Pharmaceutical Education and Research). The Consortium is a European academic collaboration in research and teaching of the pharmaceutical sciences that is constantly growing and expanding. The Consortium was founded in 1990 and consists of pharmacy department from leading universities throughout Europe including:

Faculty of Pharmacy, Uppsala University, SwedenSchool of Pharmacy, University of London, UKLeiden/Amsterdam Center for Drug Research, University of Leiden, The NetherlandsVrije Universiteit Amsterdam, The NetherlandsSchool of Pharmaceutical Sciences, University of Copenhagen DenmarkFaculty of Pharmacy, Universities of Paris Sud, FranceFaculty of Pharmacy, University of Parma, ItalyFaculty of Pharmaceutical Sciences, Katholieke Universiteit, Belgium

The editorial board for the ULLA series consists of several academics from these European Institutions who are all experts in their individual field of pharmaceutical science.

Previous titles include:

Pharmaceutical Toxicology

Paediatric Drug Handling

Molecular Biopharmaceutics

International Research in Healthcare

Facilitating Learning in Healthcare

Biomedical and Pharmaceutical Polymers

The titles in this ground breaking series are primarily aimed at PhD students and will also have global appeal to postgraduate students undertaking masters of diploma courses, undergraduates for specific courses, and practising pharmaceutical scientists.

Further information on the Consortium can be found at www.u-l-l-a.org

Preface

This book aims to provide a comprehensive and up-to-date understanding of the processes and mechanisms involved in inhalation drug delivery, with a strong focus on inhalation products and specific equipment and techniques used in laboratories today. It will accurately reflect the current state of our knowledge in the field of inhalation and will provide a good basis for the development of this knowledge. Theory will be covered, providing balanced new perspectives by drawing on research from a variety of fields and from industrial experience.

This book is intended as an aid to those studying pharmacy, pharmaceutical science and technology, or related subjects, at both undergraduate and postgraduate levels. Students will benefit from the concise presentation of a great deal of relevant information, and will find this book an invaluable tool for understanding the field of inhaled pharmaceutical aerosols.

1

Inhalation Drug Delivery

Daniela Traini

Respiratory Technology, The Woolcock Institute of Medical Research & The Discipline of Pharmacology, The University of Sydney, Sydney, Australia

1.1 Introduction

The lung offers a unique and challenging route for drug delivery for the treatment of local respiratory and systemic diseases. Advances in drug formulation and inhalation device design are creating new opportunities for inhaled drug delivery as an alternative to oral and parenteral delivery methods. Nebulizers, pressurized metered-dose inhalers (pMDIs), and dry powder inhalers (DPIs) have each found a niche in the quest for optimal treatment and convenient use. While nebulizers have evolved relatively independently of the drug formulations they deliver, the current generation of pMDIs and DPIs have been developed or tailored for the specific pharmaceutical being delivered, resulting in improved performance. However, the process of delivering drugs to the lung is not simple and is related to many factors associated with the inhaled product and the patient. This chapter will briefly review the anatomy and physiology of the lungs and the various parameters that influence drug deposition.

1.2 Brief Review of the Respiratory System and its Physiology

The respiratory tract comprises the conducting and the respiratory regions. The conducting region essentially consists of the nasal cavity, nasopharynx, bronchi, and bronchioles. Airways distal to the bronchioles and the alveoli constitute the respiratory region, where rapid solute exchange takes place. According to Wiebel's tracheobronchial classification [1], the conducting airways comprise the first 16 generations, and generations 17–23 include the respiratory bronchioles, the alveolar ducts, and the alveolar sacs.