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 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.
Office of Pharmaceutical Quality, Center for Drug Evaluations and Research (CDER), United States Food and Drug Administration (US FDA), 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
Caroline
C
Strasinger
Office of Research and Standards, Office of Generic Drugs, CDER, US FDA, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
Sam G
SG
Raney
Office of Clinical Pharmacology, Office of Translational Sciences, CDER, US FDA, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
Doanh C
DC
Tran
Office of Research and Standards, Office of Generic Drugs, CDER, US FDA, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
Priyanka
P
Ghosh
Office of Research and Standards, Office of Generic Drugs, CDER, US FDA, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
Bryan
B
Newman
Office of Clinical Pharmacology, Office of Translational Sciences, CDER, US FDA, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
Edward D
ED
Bashaw
Office of Pharmaceutical Quality, Center for Drug Evaluations and Research (CDER), United States Food and Drug Administration (US FDA), 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
Tapash
T
Ghosh
Office of Clinical Pharmacology, Office of Translational Sciences, CDER, US FDA, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA. Electronic address: Chinmay.Shukla@fda.hhs.gov.
Chinmay G
CG
Shukla
D000279:Administration, Cutaneous; D000818:Animals; D016503:Drug Delivery Systems; D006801:Humans; D004364:Pharmaceutical Preparations / Q000008:administration & dosage*; D012867:Skin / Q000378:metabolism
D004364:Pharmaceutical Preparations
Adhesives; Biowaiver; In-vitro permeation; In-vitro release; Quality and performance; Quality by design; Residual drug analysis; Skin irritation and sensitization; Transdermal