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

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 topic...

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Bibliographic Details
Published in:AAPS PharmSciTech 2012-03, Vol.13 (1), p.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: Article
Language:English
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
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Summary: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.
ISSN:1530-9932
1530-9932
DOI:10.1208/s12249-011-9740-9