Inhalation Drug Delivery Techniques and Products

by Colombo, Paolo; Traini, Daniela; Buttini, Francesca

• ISBN13: 9781118354124
• ISBN10: 1118354125
• Edition: 1st
• Format: Hardcover
• Copyright: 2013-02-11
• Publisher: Wiley-Blackwell

Summary

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 for manufacturing and quality control. It will accurately reflect the current state of the knowledge in the field of inhalation and will give a good background for the development and manufacturing of inhalation products; attention has been dedicated to the assessment of aerodynamic properties of inhalation products as performed during the studies for the pharmaceutical development of the combination of formulation and device for the delivery. The authors will be bringing new perspectives by drawing on research from a variety of fields and adding balance with industrial aspects. In conclusion the book wants to stress to the reader the importance of the connection between the invention and quality controlled requirements in order to provide the safety and the efficacy of the drug. The book is organized into 9 chapters dedicated to inhalation product description - noting that these kind of products are a combination between the formulation and a device. The first four chapters are focused on formulations of inhalation medicine with a particular attention on production of novel respirable particles. The complexity and challenge of aerosol performance are described in Chapter 5 in order to understand control, and predict and improve the drug product performance. The following chapter is dedicated to the aerodynamic assessment dealing in the Pharmacopoeia to give a practical guidance to assess the most important characteristic of the quality of the product: the respirability. Chapter 7 is dedicated to the formulation of protein and peptides for inhalation together, with a treatment on the applicability of the controlled release concept to inhalation formulation. The last two chapters are devoted to the description of the guidance for the pharmaceutical development studies for inhalation products together with the specifications applied to quality of finished inhalation product. ULLA Consortium http://www.ullapharmsci.org/ is made up of representatives from the following Universities: The Faculty of Pharmacy, University of Uppsala (Sweden) The School of Pharmacy, University of London (United Kingdom) The Leiden/Amsterdam Center for Drug Research, University of Leiden and the Vrije Universiteit Amsterdam (The Netherlands) The Faculty of Pharmaceutical Sciences, University of Copenhagen (Denmark) The Faculty of Pharmacy, University of Paris Sud (France) The Faculty of Pharmacy, University of Parma (Italy) The Faculty of Pharmaceutical Sciences, Katholieke Universiteit Leuven (Belgium) ULLA Series - Originally the idea was to publish a series of textbooks with Pharmaceutical Press, they published four with two more due late 2010. PP had new director who decided to concentrate on their big earners so agreed that they no longer wanted to publish this series. An agreement was signed in 2010, £200 payment on signature of contract and 2% net receipts royalty on all published titles. Published with Pharmaceutical Press Information at June 2010 1. Pharmaceutical Toxicology Gerard J Mulder and Lennart Dencker Pharmaceutical Press, London, 2006, pp 280, £ 29.95 Sales 1958 (16/4/10) 2. Paediatric Drug Handling Ian Costello, Paul F Long, Ian Wong, Catherine Tuleu and Vincent Yeung Pharmaceutical Press, London, 2007, pp 144, £ 24.95 Sales - 708 (16/4/10) 3. International Research in Healthcare Felicity Smith, Sally-Anne Francis and Ellen Schafheutle Pharmaceutical Press, London, 2008, pp192, £ 29.95 Sales 171 (16/4/10) 4. Molecular Biopharmaceutics Bente Steffansen, Birger Brodin and Carsten Uhd Nielsen Pharmaceutical Press, London, 2009, pp 371, £ 125 Sales - 185 (16/4/10) 5. Most recently: Biomedical and Pharmaceutical Polymers, Denis Labarre, Gilles Ponchel and Christine Vauthier (Paris), 256 pages Publisher: Pharmaceutical Press; 1 edition (11 Oct 2010), £34.99

Author Biography

Paolo Colombo, Department of Pharmacy, University of Parma, Parma, Italy.

Daniela Traini, Faculty of Pharmacy, The University of Sydney, Australia.

Francesca Buttini, Department of Pharmacy, University of Parma, Parma, Italy.

Table of Contents

List of contributors xi

Series foreword xiii

Preface xv

1 Inhalation drug delivery 1
Daniela Traini

2 Inhalation and nasal products 15
Daniela Traini and Paul M. Young

3 Formulation of inhalation medicines 31
Daniela Traini and Paul M. Young

4 Novel particle production technologies for inhalation products 47
Hak-Kim Chan and Philip Chi Lip Kwok

5 Methods for understanding, controlling, predicting, and improving drug product performance 63
David A. V. Morton

6 Aerodynamic assessment for inhalation products: fundamentals and current pharmacopoeial methods 91
Francesca Buttini, Gaia Colombo, Philip Chi Lip Kwok and Wong Tin Wui

7 Proteins, peptides, and controlled-release formulations for inhalation 121
Philip Chi Lip Kwok, Rania Osama Salama and Hak-Kim Chan

8 Pharmaceutical development studies for inhalation products 145
Gaia Colombo, Chiara Parlati and Paola Russo

9 Quality of inhalation products: specifications 169
Paolo Colombo, Francesca Buttini and Wong Tin Wui

Index.