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.
Claims16
A composition for the transdermal delivery of amphetamine in the form of a monolithic, flexible, finite 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 a polymer matrix that comprises:
- amphetamine, or a pharmaceutically acceptable salt or prodrug thereof, or a pharmaceutically acceptable salt of a prodrug thereof, in an amount from about 15% to about 20% by weight, based on the total dry weight of the polymer matrix;
- and
- one or more polymers free of vinyl acetate moieties and selected from:
- acrylic polymers made from monomers consisting of one or more monomers selected from butyl acrylate, methyl acrylate, methyl methacrylate, ethyl hexyl acrylate, and octyl acrylamide,
- rubber-based polymers selected from polyisobutylene polymers and styrene-isoprene-styrene block copolymers,
- and mixtures thereof.
Dependencies are inferred from the claim text.