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Title:
安定性が向上したドネペジル含有経皮吸収製剤
Document Type and Number:
Japanese Patent JP7419565
Kind Code:
B2
Abstract:
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.

Inventors:
Jean, Sun-Woo
Shin, Chang-Yel
Kim, Hae-sung
Cha, Kwan-ho
Kim, Hyun-Jun
hyun, sang-min
Masaoki Goto
Application Number:
JP2022568614A
Publication Date:
January 22, 2024
Filing Date:
May 12, 2021
Export Citation:
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Assignee:
Don-Aesti Company Limited
KM-Trans Transderm Co., Ltd.
International Classes:
A61K31/445; A61K9/70; A61K47/20; A61K47/22; A61P25/28
Domestic Patent References:
JP2022514037A
Foreign References:
WO2008066180A1
WO2008066185A1
Attorney, Agent or Firm:
Yamazaki International Patent Office
Park Shinon
Toshiaki Akamatsu
Tadao Naito
Chihiro Imai