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. CONTENTS 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
