公开(公告)号：EP4371559A1

公开(公告)日：2024-05-22

申请号：EP22854852.5

申请日：2022-01-18

申请人： Beijing Wehand-Bio Pharmaceutical Co., Ltd

发明人： LIU, Yuling ,  WANG, Hongliang ,  LIU, Zhihua ,  SHENG, Wei ,  CHEN, Luxiao ,  XU, Xueqing ,  CHEN, Yankun ,  MA, Rui

IPC分类号： A61K9/22 ,  A61K9/30 ,  A61K31/4422 ,  A61K47/12 ,  A61P9/12

摘要： The present invention relates to an osmotic pump controlled-release tablet of an insoluble drug and a preparation method therefor. The osmotic pump controlled-release tablet comprises a tablet core, a semi-permeable membrane coating and a drug-release hole, wherein the tablet core comprises a solid dispersion of the insoluble drug and a penetration enhancer, the solid dispersion of the insoluble drug comprises the insoluble drug and a carrier, the insoluble drug is selected from nicardipine, nifedipine and felodipine and pharmaceutically acceptable salts thereof, and the carrier is selected from organic acids. Compared with the prior art, the drug solubility of the osmotic pump controlled-release tablet of the insoluble drug of the present invention is greatly improved, a large amount of penetration enhancers or other excipients do not need to be used in the tablet core, the drug-loading capacity is improved, and the tablet core is not too large; the degree of release in vivo is greatly improved; and the preparation process is simple, has low requirements for equipment and a low cost, and facilitates industrialized production.