US 12,138,350 B2
Method of producing a extruded composition
Dennis Douroumis, Kent (GB); Mohammed Maniruzzaman, Kent (GB); Saumil Kiritkumar Bhatt, Kent (GB); Anwar Ali, Kent (GB); and Arun Jangra, Kent (GB)
Assigned to Cubic Pharmaceuticals Ltd., Kent (GB); and Delta Pharmaceuticals Ltd., Kent (GB)
Appl. No. 15/549,900
Filed by Cubic Pharmaceuticals Ltd., Kent (GB); and Delta Pharmaceuticals Ltd., Kent (GB)
PCT Filed Feb. 9, 2016, PCT No. PCT/GB2016/050294
§ 371(c)(1), (2) Date Aug. 9, 2017,
PCT Pub. No. WO2016/128727, PCT Pub. Date Aug. 18, 2016.
Claims priority of application No. 1502077.9 (GB), filed on Feb. 9, 2015; and application No. 1517833.8 (GB), filed on Oct. 8, 2015.
Prior Publication US 2018/0021263 A1, Jan. 25, 2018
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 9/20 (2006.01); A61J 3/10 (2006.01); A61K 9/14 (2006.01); A61K 31/00 (2006.01); A61K 31/192 (2006.01); A61K 33/12 (2006.01); A61K 47/32 (2006.01); B29B 9/00 (2006.01); B29C 48/00 (2019.01); B29C 48/05 (2019.01); B29B 9/06 (2006.01)
CPC A61K 9/2095 (2013.01) [A61J 3/10 (2013.01); A61K 9/143 (2013.01); A61K 9/20 (2013.01); A61K 31/00 (2013.01); A61K 31/192 (2013.01); A61K 33/12 (2013.01); A61K 47/32 (2013.01); B29B 9/00 (2013.01); B29C 48/0011 (2019.02); B29C 48/05 (2019.02); B29B 9/06 (2013.01)] 17 Claims
 
1. 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.