1st Edition

Dermal Drug Delivery From Innovation to Production

Edited By Tapash K. Ghosh Copyright 2020
    464 Pages 60 B/W Illustrations
    by CRC Press

    464 Pages 60 B/W Illustrations
    by CRC Press

    With the continued advancement of better-quality control and patient outcome reporting systems, changes in the development, control, and regulation of all pharmaceutical delivery systems including transdermal and topical products have been happening on a continuous basis. In light of various quality issues that have been reported by patients and practitioners resulting in the recall or removal of products from the market, both the pharmaceutical industries and regulatory agencies have been adopting new measures to address these issues. With chapters written by experts in this field, this book takes a 21st century multidisciplinary and cross-functional look at these dosage forms to improve the development, design, manufacturing, quality, clinical performance, safety, and regulation of these products.

    This book offers a wealth of up-to-date information organized in a logical sequence corresponding to various stages of research, development, and commercialization of dermal drug delivery products. The authors have been carefully selected from different sectors of pharmaceutical science for their expertise in their selected areas to present objectively a balanced view of the current state of these products development and commercialization via regulatory approval. Their insights will provide useful information to others to ensure the successful development of the next generation dermal drug products.

    Key Features:

    • Presents current advancements including new technologies of transdermal and topical dosage forms.

    • Presents challenges in the development of the new generation of transdermal and topical dosage forms.
    • Introduces new technologies and QbD (quality by design) aspects of manufacturing and control strategies.
    • Includes new perspectives on pre-clinical and clinical development, regulatory considerations, safety and quality.
    • Discusses regulatory challenges, gaps, and future considerations for dermal drug delivery systems.

    Chapter 1 Dermal and Transdermal Drug Delivery Systems: An Overview and Recent Advancements

    Kenneth A Walters & Majella E Lane

    Chapter 2 Preclinical and Clinical Safety and Assessment of Transdermal and Topical Dermatological Products

    Lindsey C. Yeh & Howard I. Maibach

    Chapter 3 Selection considerations for membranes and models for in-vitro/ex-vivo permeation studies

    Pei-Chin Tsai, Tannaz Ramezanli, Dina Wadie, Sonia Trehan, Nathaly Martos, Zheng Zhang, Bozena Michniak-Kohn

    Chapter 4 Design, Development, Manufacturing and Testing of Transdermal Drug Delivery Systems

    Timothy A. Peterson, Steven M. Wick & Chan Ko

    Chapter 5 Quality by Design (QbD) principles in the development of Transdermal Drug Delivery Products

    Muralikrishnan Angamuthu, H.N. Shivakumar & S. Narasimha Murthy

    Chapter 6 Microneedles for Drug Delivery: Industrial and Regulatory Perspectives

    Lisa A. Dick, Dan M. Dohmeier, Ann M. Purrington & Scott A. Burton

    Chapter 7 Biopharmaceutics Aspects of Dermally Applied Drug Delivery Systems

    Tapash Ghosh

    Chapter 8 Quality and Performance Tests for Dermal Drug Delivery Systems

    Margareth R.C. Marques, Tony Bennett & Gregory Fieldson

    Chapter 9 Perspective on Clinical Trials for Dermal Drug Delivery Systems

    John T. Farrar & Shamir Kalaria

    Chapter 10 Regulatory Standards for Approval of Topical Dermatological Drug Products

    April C. Braddy & Dale P. Conner

    Chapter 11 Gaps and Future Considerations for Development of Dermal Transdermal and Topical Delivery Systems

    Caroline Stransinger

    Chapter 12 Regulatory Challenges in Chemistry, Manufacturing and Controls: Gaps and Future Consideration for Locally Acting Topical Dermal Systems

    Shulin Ding

    Chapter 13 Development of Topical and Transdermal Dosage Forms: Regulatory Perspective

    Amit Mitra & Sarah A. Ibrahim

    Chapter 14 Innovations and Future Prospects of Dermal Delivery Systems

    Rashmi Upasani, Anushree Herwadkar, Neha Singh and Ajay K. Banga


    Tapash K. Ghosh is employed by the Office of Clinical Pharmacology and Biopharmaceutics at CDER, FDA. Before joining the FDA, he held faculty positions in the division of pharmaceutical sciences at the Massachusetts College of Pharmacy in Boston and Howard University in Washington, DC. He is the author of numerous scientific publications and the principle editor of other scientific books.