Method of producing a extruded composition
AssigneesCubic Pharmaceuticals Ltd., Delta Pharmaceuticals, Inc.
InventorsDennis Douroumis, Mohammed Maniruzzaman, Saumil Kiritkumar Bhatt, Anwar Ali, Arun Jangra
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Abstract
The present invention relates to a method of producing a direct compression tablet composition comprising the step of processing ibuprofen, a hydrophilic polymer, and an inorganic excipient by an extrusion process to produce an extruded composition in which the ibuprofen forms a solid dispersion/solution within the hydrophilic polymer. The invention is particularly useful in preparing oral dissolvable tablets. Also provided are composition comprising an inorganic excipient and ibuprofen within a hydrophilic polymer.
Claims17
A method of producing a direct compression tablet comprising ibuprofen, said method comprising the steps of:
- (a) providing ibuprofen;
- (b) providing a hydrophilic polymer selected from the group consisting of i) copolymers based on dimethylaminoethyl methacrylate, butyl methacrylate and methyl methacrylate;
- and ii) N-vinyl-2-pyrrolidone and vinyl acetate copolymers;
- (c) providing an inorganic excipient, wherein the inorganic excipient is a metal aluminosilicate;
- (d) processing (a) to (c) by a hot melt extrusion process to produce an extruded composition wherein the hydrophilic polymer is provided in an amount sufficient for at least 90 wt %, 95 wt %, or 98 wt % of the ibuprofen to form a solid amorphous dispersion/solution within the hydrophilic polymer, and wherein the metal aluminosilicate is provided in an amount greater than or equal to 10 wt % based on the weight of the extruded composition;
- e) blending the extruded composition with one or more pharmaceutically acceptable excipients to produce a composition blend;
- and
- (f) directly compressing the composition blend into an orally-disintegrating tablet.
A method of producing a direct compression tablet comprising ibuprofen, said method comprising the steps of:
- (a) providing ibuprofen;
- (b) providing a hydrophilic polymer selected from the group consisting of:
- i) copolymers based on dimethylaminoethyl methacrylate, butyl methacrylate and methyl methacrylate in an amount of 15 wt % to 40 wt %;
- and ii) N-vinyl-2-pyrrolidone and vinyl acetate copolymers in an amount of 30 wt % to 35 wt;
- (c) providing an inorganic excipient, wherein the inorganic excipient is a metal aluminosilicate;
- (d) processing (a) to (c) by a hot melt extrusion process to produce an extruded composition wherein the ibuprofen forms a solid amorphous dispersion/solution within the hydrophilic polymer, and wherein the metal aluminosilicate is provided in an amount greater than or equal to 10 wt % based on the weight of the extruded composition;
- (e) blending the extruded composition with one or more pharmaceutically acceptable excipients to produce a composition blend;
- and
- (f) directly compressing the composition blend into an orally-disintegrating tablet.
Dependencies are inferred from the claim text.