Topical and Transdermal Drug Delivery – Principles and Practice

Heather A. E. Benson , PhD, 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, PhD, 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 ProStrakan, 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.

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