Practical drug development approaches presented by leading
experts
Designed to support the development of new, effective
therapeutics, Topical and Transdermal Drug Delivery: Principles
and Practice explains the principles underlying the field and
then demonstrates how these principles are put into practice in the
design and development of new drug products. Drawing together and
reviewing the latest research findings, the book focuses on
practical, tested, and proven approaches that are backed by
industry case studies and the authors’ firsthand experience.
Moreover, the book emphasizes the mechanistic information that is
essential for successful drug product development.
Topical and Transdermal Drug Delivery: Principles and
Practice is divided into two parts:
* Part One, Current Science, Skin Permeation, and
Enhancement Approaches, offers readers a fundamental understanding
of the underlying science in the field. It describes the principles
and techniques needed to successfully perform experimental
approaches, covering such issues as skin permeation, enhancement,
and assessment.
* Part Two, Topical and Transdermal Product Development,
guides readers through the complete product development process
from concept to approval, offering practical tips and cautions from
experts in the field. This part also discusses regulations that are
specific to the development of dermal drug products. The final
chapter explores current and future trends, forecasting new
development techniques and therapeutics.
Throughout the book, the authors clearly set forth the basic
science and experimental procedures, making it possible for
researchers to design their own experimental approaches and
accurately interpret their results.
With contributions from experienced drug researchers, this text
is highly recommended for all researchers involved in topical and
transdermal product development who need to know both the state of
the science and the standards of practice.
Tabella dei contenuti
Preface ix
About the Editors xi
Contributors xiii
Part One Current Science, Skin Permeation, and Enhancement
Approaches
1. Skin Structure, Function, and Permeation 3
Heather A.E. Benson
2. Passive Skin Permeation Enhancement 23
Majella E. Lane, Paulo Santos, Adam C. Watkinson, and Jonathan
Hadgraft
3. Electrical and Physical Methods of Skin Penetration
Enhancement 43
Jeffrey E. Grice, Tarl W. Prow, Mark A.F. Kendall, and Michael
S. Roberts
4. Clinical Applications of Transdermal Iontophoresis 67
Dhaval R. Kalaria, Sachin Dubey, and Yogeshvar N. Kalia
5. In Vitro Skin Permeation Methodology 85
Barrie Finnin, Kenneth A. Walters, and Thomas J. Franz
6. Skin Permeation Assessment: Tape Stripping 109
Sandra Wiedersberg and Sara Nicoli
7. Skin Permeation Assessment: Microdialysis 131
Rikke Holmgaard, Jesper B. Nielsen, and Eva Benfeldt
8. Skin Permeation: Spectroscopic Methods 155
Jonathan Hadgraft and Majella E. Lane
9. Skin Permeation Assessment in Man: In Vitro-In Vivo
Correlation 167
Paul A. Lehman, Sam G. Raney, and Thomas J. Franz
10. Risk Assessment 183
Jon R. Heylings
Part Two Topical and Transdermal Product Development
11. An Overview of Product Development from Concept to Approval
203
Adam C. Watkinson
12. Regulatory Aspects of Drug Development for Dermal Products
217
William K. Sietsema
13. Toxicological and Pre-clinical Considerations for Novel
Excipients and New Chemical Entities 233
Andrew Makin and Jens Thing Mortensen
14. Topical Product Formulation Development 255
Marc B. Brown, Robert Turner, and Sian T. Lim
15. Transdermal Product Formulation Development 287
Kenneth J. Miller
16. Sensitivity and Irritation Testing 309
Belum Viswanath Reddy, Geetanjali Sethi, and Howard I.
Maibach
17. New Product Development for Transdermal Drug Delivery:
Understanding the Market Opportunity 345
Hugh Alsop
18. Transdermal and Topical Drug Delivery Today 357
Adam C. Watkinson
19. Current and Future Trends: Skin Diseases and Treatment
367
Simon G. Danby, Gordon W. Duff, and Michael J. Cork
Index 409
Circa l’autore
Heather A. E. Benson, Ph D, is an Associate Professor in the
School of Pharmacy at Curtin University, Australia, where she leads
the Skin Delivery Research Group. Internationally recognized for
her research in skin biology and drug/peptide delivery, Dr. Benson
has published more than 100 peer-reviewed publications on the topic
of drug delivery.
Adam C. Watkinson, MBA, Ph D, has worked in topical and
transdermal drug delivery for twenty-three years and played key
roles in the development of Axiron (transdermal testosterone) and
Sancuso (transdermal granisetron) while at Acrux and Pro Strakan,
respectively. He has published extensively on his research, is the
author of several patents, and holds an Honorary Chair at the
School of Pharmacy at the University of London. He runs Storith
Consulting, a firm offering advice in the areas of drug development
and topical and transdermal drug delivery.
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