US 11,938,222 B2
Pregabalin sustained release composition and method for preparing the same
Zhaolu Zhu, Beijing (CN); Yun Wu, Beijing (CN); Di Lu, Beijing (CN); Yanping Zhao, Beijing (CN); Liying Zhou, Beijing (CN); and Yanan Liu, Beijing (CN)
Assigned to BEIJING TIDE PHARMACEUTICAL CO., LTD., Beijing (CN)
Appl. No. 16/618,756
Filed by Beijing Tide Pharmaceutical Co., Ltd., Beijing (CN)
PCT Filed Jun. 12, 2019, PCT No. PCT/CN2019/090933
§ 371(c)(1), (2) Date Dec. 2, 2019,
PCT Pub. No. WO2019/238068, PCT Pub. Date Dec. 19, 2019.
Claims priority of application No. 201810608326.0 (CN), filed on Jun. 13, 2018; and application No. 201811202248.0 (CN), filed on Oct. 16, 2018.
Prior Publication US 2021/0369621 A1, Dec. 2, 2021
Int. Cl. A61K 9/20 (2006.01); A61K 31/197 (2006.01)
CPC A61K 9/2054 (2013.01) [A61K 9/2009 (2013.01); A61K 9/2018 (2013.01); A61K 9/2027 (2013.01); A61K 9/2031 (2013.01); A61K 9/2059 (2013.01); A61K 31/197 (2013.01)] 11 Claims
 
1. A pregabalin sustained release tablet comprising a pregabalin sustained release composition, wherein, based on the total weight of the pregabalin sustained release composition, the pregabalin sustained release composition comprises:
(a) 25%-35% by weight of an active ingredient;
(b) 15%-30% by weight of a matrix-forming agent;
(c) 9%-29% by weight of a swelling agent;
(d) 4%-14% by weight of a gelling agent; and
(e) 15%-30% by weight of a filler;
wherein, the active ingredient is pregabalin or a pharmaceutically acceptable salt or hydrate thereof,
the swelling agent is polyoxyethylene,
the filler is microcrystalline cellulose, or pregelatinized starch, or a combination thereof,
the matrix-forming agent is a mixture of polyvinyl acetate and polyvinylpyrrolidone, and
the gelling agent is carbomer, and
the pregabalin sustained release tablet has a rigidity of 1909 gram force per millimeter or more at 6 hour after being subjected to a dissolution.