title: Chemistry, manufacturing and controls in passive transdermal drug delivery systems.
abstract: Transdermal drug delivery systems (TDDS) are used for the delivery of the drugs through the skin into the systemic circulation by applying them to the intact skin. The development of TDDS is a complex and multidisciplinary affair which involves identification of suitable drug, excipients and various other components. There have been numerous problems reported with respect to TDDS quality and performance. These problems can be reduced by appropriately addressing chemistry, manufacturing and controls requirements, which would thereby result in development of robust TDDS product and processes. This article provides recommendations on the chemistry, manufacturing and controls focusing on the unique technical aspects of TDDS.
authors.affiliation: Amneal Pharmaceuticals, 1 New England Avenue, Piscastaway, NJ 08854, USA.
authors.forename: Tarun
authors.initials: T
authors.lastname: Goswami
authors.affiliation: Amneal Pharmaceuticals, 1 New England Avenue, Piscastaway, NJ 08854, USA.
authors.forename: Jay
authors.initials: J
authors.lastname: Audett
mesh_terms: D000279:Administration, Cutaneous; D000818:Animals; D002626:Chemistry, Pharmaceutical; D016503:Drug Delivery Systems / Q000379:methods*; D004345:Drug Industry; D006801:Humans; D057968:Transdermal Patch