Navigating sticky areas in transdermal product development

The benefits of transdermal delivery over the oral route to combat such issues of low bioavailability and limited controlled release opportunities are well known and have been previously discussed by many in the field (Prausnitz et al. (2004) [1]; Hadgraft and Lane (2006) [2]). However, significant...

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Bibliographic Details
Published in:Journal of controlled release 2016-07, Vol.233, p.1-9
Main Authors: Strasinger, Caroline, Raney, Sam G., Tran, Doanh C., Ghosh, Priyanka, Newman, Bryan, Bashaw, Edward D., Ghosh, Tapash, Shukla, Chinmay G.
Format: Article
Language:English
Subjects:
Adhesives
Administration, Cutaneous
Animals
Biowaiver
Drug Delivery Systems
Humans
In-vitro permeation
In-vitro release
Pharmaceutical Preparations - administration & dosage
Quality and performance
Quality by design
Residual drug analysis
Skin - metabolism
Skin irritation and sensitization
Transdermal
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Summary:The benefits of transdermal delivery over the oral route to combat such issues of low bioavailability and limited controlled release opportunities are well known and have been previously discussed by many in the field (Prausnitz et al. (2004) [1]; Hadgraft and Lane (2006) [2]). However, significant challenges faced by developers as a product moves from the purely theoretical to commercial production have hampered full capitalization of the dosage forms vast benefits. While different technical aspects of transdermal system development have been discussed at various industry meetings and scientific workshops, uncertainties have persisted regarding the pharmaceutical industry's conventionally accepted approach for the development and manufacturing of transdermal systems. This review provides an overview of the challenges frequently faced and the industry's best practices for assuring the quality and performance of transdermal delivery systems and topical patches (collectively, TDS). The topics discussed are broadly divided into the evaluation of product quality and the evaluation of product performance; with the overall goal of the discussion to improve, advance and accelerate commercial development in the area of this complex controlled release dosage form. [Display omitted]
ISSN:0168-3659
1873-4995
DOI:10.1016/j.jconrel.2016.04.032