Topical and Transdermal Drug Delivery (eBook)

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