Passive Transdermal Systems Whitepaper Incorporating Current Chemistry, Manufacturing and Controls (CMC) Development Principles

• Published in: AAPS PharmSciTech Vol. 13; no. 1; pp. 218 - 230
• Main Authors: Van Buskirk, Glenn A., Arsulowicz, Daniel, Basu, Prabir, Block, Lawrence, Cai, Bing, Cleary, Gary W., Ghosh, Tapash, González, Mario A., Kanios, David, Marques, Margareth, Noonan, Patrick K., Ocheltree, Terrance, Schwarz, Peter, Shah, Vinod, Spencer, Thomas S., Tavares, Lino, Ulman, Katherine, Uppoor, Rajendra, Yeoh, Thean
• Format: Journal Article
• Language: English
• Published: Boston Springer US 01-03-2012
• Subjects: Administration, Cutaneous; Animals; Biochemistry; Biomedical and Life Sciences; Biomedicine; Biotechnology; Chemistry, Pharmaceutical - methods; Conferences; Development; Drug delivery; Drug Delivery Systems - methods; Drug Delivery Systems - trends; Drug development; Drug Discovery - methods; Drug Industry - methods; Education; Food quality; Humans; Pharmaceutical Preparations - administration & dosage; Pharmaceutical Preparations - chemistry; Pharmaceutical Preparations - metabolism; Pharmacology/Toxicology; Pharmacy; Reviews; White Paper; CMC; residual drug; TDS; quality by design (QbD); ICH
• ISSN: 1530-9932; 1530-9932
• DOI: 10.1208/s12249-011-9740-9

In this whitepaper, the Manufacturing Technical Committee (MTC) of the Product Quality Research Institute has updated the 1997 Transdermal Drug Delivery Systems Scale-Up and Post Approval Change workshop report findings to add important new product development and control principles. Important topics reviewed include ICH harmonization, quality by design, process analytical technologies, product and process validation, improvements to control of critical excipients, and discussion of Food and Drug Administration’s Guidance on Residual Drug in Transdermal and Related Drug Delivery Systems as well as current thinking and trends on
in vitro
–
in vivo
correlation considerations for transdermal systems.