公开(公告)号：US20230201131A1

公开(公告)日：2023-06-29

申请号：US17924781

申请日：2021-05-12

申请人： DONG-A ST CO., LTD. ,  KM TRANSDERM LTD.

发明人： Sun-Woo JANG ,  Chang-Yell SHIN ,  Hae-Sun KIM ,  Kwang-Ho CHA ,  Hyun-jung KIM ,  Sang-Min HYUN ,  Masaoki GOTO

IPC分类号： A61K9/70 ,  A61K31/445 ,  A61K47/16 ,  A61K47/20 ,  A61K47/22

CPC分类号： A61K9/7038 ,  A61K31/445 ,  A61K47/16 ,  A61K47/20 ,  A61K47/22

摘要： A percutaneous absorption preparation for the treatment of dementia wherein the drug-containing layer contains donepezil or a pharmaceutically acceptable salt thereof as an active ingredient and a stabilizer that is either (i) a mixture of a thiocyanate salt and a compound selected from the group consisting of tea catechin, (+)-catechin, epigallocatechin gallate, ascorbic acid, and isoascorbic acid, or (ii) a mixture of monothioglycerol and a compound selected from the group consisting of tea catechin, (+)-catechin, epigallocatechin gallate, and ascorbic acid is disclosed. The percutaneous absorption preparation meets the criteria of Procedure 1 and Procedure 2 of the U.S. Pharmacopoeia in short-term stress test (70° C. 48 hours storage), long-term accelerated test 1 (40° C. relative humidity 75% 1 month storage), and long-term accelerated test 2 (40° C. relative humidity 75% 3 months storage), and exhibits improved stability for long-term preservation.