Process for manufacturing a resulting multi-layer pharmaceutical film
AssigneeMonosol Rx, LLC
InventorsRobert K. Yang, Richard C. Fuisz, Garry L. Myers, Joseph M. Fuisz
Life of this patent
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Abstract
The invention relates to the film products and methods of their preparation that demonstrate a non-self-aggregating uniform heterogeneity. Desirably, the films disintegrate in water and may be formed by a controlled drying process, or other process that maintains the required uniformity of the film. The films contain a polymer component, which includes polyethylene oxide optionally blended with hydrophilic cellulosic polymers. Desirably, the films also contain a pharmaceutical and/or cosmetic active agent with no more than a 10% variance of the active agent pharmaceutical and/or cosmetic active agent per unit area of the film.
Claims28
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 10-105 sec−1;
- (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%.
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 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 10-105 sec−1;
- (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 visco-elastic film within about the first 4 minutes, wherein the temperature of the polymer matrix is 100° C. or less;
- (d) depositing a layer comprising an pharmaceutical active onto said 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 multi-layer pharmaceutical active in substantially equal sized individual dosage units of said sampled resulting pharmaceutical film, said tests indicating that the uniformity of content in the amount of the pharmaceutical active varies by no more than 10%.
Dependencies are inferred from the claim text.