Barrier film lined backing layer composition and method for topical administration of active agents
AssigneeNoven Pharmaceuticals, Inc.
InventorsDavid Kanios, Juan A. Mantelle, David Houze
Life of this patent
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Abstract
A transdermal drug delivery device for topical application of active agents is disclosed. The invention comprises the use of a flexible and soft backing layer, in particular a cellular foam, having an inner surface and an outer surface, wherein an impermeable polymeric barrier film is affixed to its inner surface. The barrier film functions to anchor and support an active agent carrier composition disposed thereon, and to prevent passage of such composition into the backing layer. The system provides excellent flexibility and conformability for topical application to sites subject to frequent movement or which are greatly contoured. Methods of use are also disclosed.
Claims16
A flexible transdermal drug delivery system that substantially maintains contact with movement at the topical site of application, comprising
- (a) a carrier composition layer comprising a therapeutically effective amount of one or more drugs;
- (b) a flexible, soft backing layer consisting essentially of a cellular foam which is substantially permeable to the carrier composition;
- (c) a barrier layer substantially compatible with and impermeable to the drug and carrier composition and consisting essentially of a film of thermoplastic polymers and rubbers having an average thickness of about 0.1 mils to about 4.0 mils and an inner and outer surface, the outer surface of which is joined to the backing layer by means of a low molecular weight adhesive or by co-extrusion, and the inner surface of which is in contact with the carrier composition.
A flexible transdermal drug delivery system that substantially maintains contact with movement at the topical site of application comprising:
- (a) a carrier composition layer comprising a therapeutically effective amount of one or more drugs;
- (b) a flexible, soft backing layer consisting essentially of a cellular foam selected from the group consisting of polyethylene, vinyl acetates, ethylene/vinyl acetate copolymers, wherein the carrier composition is excluded from the backing layer;
- (c) a barrier layer substantially compatible with and impermeable to the one or more drugs and carrier composition consisting essentially of a film of a thermoplastic polymer selected from the group consisting of polyester, ethylene vinyl alcohol and acrylonitrile-methyl acrylate copolymers having thickness of up to 2.5 mils and an inner and outer surface of which of joined to the backing layer by means of a low molecular weight adhesive, and the inner surface of which is in contact with carrier composition.
A method for topical administration of a therapeutically effective amount of one or more drugs to a mammal in need of relief from pain or inflammation comprising the steps of topically applying a flexible transdermal delivery system for administration of one or more drugs to an area of the mammal which is contoured or generally subject to frequent movement, bending or flexing, and maintaining said system in substantially intimate contact with the area of topical application for the internet duration of use, wherein said flexible transdermal delivery system comprises:
- (a) a carrier composition layer comprising a therapeutically effective amount of one or more drugs selected from the group consisting of analgesics, non-steroidal anti-inflammatory agents, anesthetics, corticosteroids and anti-inflammatory agents;
- (b) a flexible, soft backing layer consisting essentially of a cellular foam, wherein the carrier composition is excluded from the backing layer;
- (c) a barrier layer substantially compatible with and impermeable to said one or more drugs and carrier composition consisting essentially of a film of a thermoplastic polymer selected from the group consisting of polyester, ethylene vinyl alcohol and acrylonitrile-methyl acrylate copolymers having an average thickness of up to 2.5 mils and an inner and outer surface, the outer surface of which is joined to the backing layer by means of a low molecular weight adhesive or by co-extrusion and the inner surface of which is in contact with the carrier composition.
Dependencies are inferred from the claim text.