公开(公告)号：US20150182629A1

公开(公告)日：2015-07-02

申请号：US14412339

申请日：2013-06-27

Applicant: HETERO RESEARCH FOUNDATION

Inventor： Bandi Parthasaradhi Reddy ,  Podili Khadgapathi ,  Borra Syamprasad

IPC: A61K47/36 ,  A61K9/20 ,  A61K47/14 ,  A61K47/38 ,  A61K47/12 ,  A61K31/195

CPC classification number: A61K47/36 ,  A61K9/2013 ,  A61K9/2054 ,  A61K9/2059 ,  A61K31/195 ,  A61K31/222 ,  A61K47/12 ,  A61K47/14 ,  A61K47/38

Abstract: Stable pharmaceutical compositions of fesoterodine or its pharmaceutically acceptable salt thereof and process for preparing the same. In a first embodiment, a stable pharmaceutical composition is provided comprising fesoterodine fumarate, glyceryl behenate and a stabilizer. The stable pharmaceutical tablet composition may further comprise i) fesoterodine fumarate in an 5 amount of 1% to 5% by weight, ii) glyceryl behenate in an amount of 1% to 8% by weight, iii) pregelatinized starch in an amount of 30% to 50% by weight and iv) a stabilizer in an amount of 0.1% to 10% by weight based on total weight of the composition.

Abstract translation: 非索罗定或其药学上可接受的盐的稳定的药物组合物及其制备方法。 在第一个实施方案中，提供了稳定的药物组合物，其包含富马酸菲索特罗，山特酸甘油酯和稳定剂。 稳定的药物片剂组合物可以进一步包含i）5重量％的1重量％至5重量％的富马酸非索罗定，ii）1重量％至8重量％的山嵛酸甘油酯，iii）预胶化淀粉的量为30 ％至50重量％，和iv）基于组合物总重量的0.1重量％至10重量％的稳定剂。