Stable transdermal amphetamine compositions and methods of manufacture
AssigneeNoven Pharmaceuticals, Inc.
InventorsViet Nguyen, Jun Liao, Prashant Patel
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Abstract
Described are transdermal drug delivery compositions comprising amphetamine, methods of making transdermal drug delivery compositions comprising amphetamine, and therapeutic methods of using them. In specific embodiments, the compositions are free of components with moieties that are reactive with amphetamine. In specific embodiments, the compositions are manufactured using solvents free of components with moieties that are reactive with amphetamine. Therapeutic methods using the compositions also are described.
Claims14
A composition for the transdermal delivery of amphetamine through skin in the form of a monolithic, flexible, finite transdermal drug delivery system for topical application to skin, consisting of a drug-impermeable backing layer, a single polymer layer, and, optionally, a release liner,
- wherein the single polymer layer comprises amphetamine or a pharmaceutically acceptable salt or prodrug thereof in a polymer matrix that comprises an antioxidant and a polymer that is free of vinyl acetate moieties and is selected from:
- acrylic polymers made from one or more monomers selected from butyl acrylate, methyl acrylate, methyl methacrylate, acrylic acid, ethyl hexyl acrylate, hydroxy ethyl acrylate, and octyl acrylamide, and
- rubber-based polymers selected from polyisobutylene polymers and styrene-isoprene-styrene block copolymers,
- and mixtures thereof.
Dependencies are inferred from the claim text.