Patent ID: 8900498
Filing Date: 2014-12-02
Classification: A61J,A61K,B29C,F26B

Abstract:
1. A process for manufacturing a resulting multi-layer pharmaceutical film suitable for commercialization and regulatory approval, said resulting multi-layer pharmaceutical film having a substantially uniform distribution of a pharmaceutical active, comprising the steps of: (a) forming a Non-Newtonian visco-elastic polymer matrix by mixing said matrix comprising a polymer selected from the group consisting of water-soluble polymers, water-swellable polymers and combinations thereof, a solvent selected from the group consisting of water, a polar organic solvent and combinations thereof, which polymer matrix is a shear-thinning pseudoplastic fluid when exposed to shear rates of 10-10 (b) casting said polymer matrix; (c) conveying said polymer matrix through a drying apparatus and evaporating at least a portion of said solvent to rapidly form a first visco-elastic film within about the first 4 minutes while maintaining a temperature differential between the polymer matrix and the drying apparatus environment of at least 5° C., wherein the temperature of the polymer matrix is 100° C. or less; (d) depositing a layer comprising a pharmaceutical active onto said first visco-elastic film to form the resulting multi-layer pharmaceutical film; (e) sampling said resulting multi-layer pharmaceutical film at different locations of said resulting multi-layer pharmaceutical film, wherein said sampled resulting multi-layer pharmaceutical film has a water content of 10% or less; and (f) performing analytical chemical tests for content uniformity of said pharmaceutical active in substantially equal sized individual dosage units of said sampled resulting multi-layer pharmaceutical film, said tests indicating that the uniformity of content in the amount of the pharmaceutical active varies by no more than 10%.