| abstract |
The present invention relates to a percutaneous absorption preparation for the treatment of dementia wherein the drug-containing layer comprises donepezil or a pharmaceutically acceptable salt thereof as an active ingredient and a stabilizer which 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. The present invention provides a percutaneous absorption preparation comprising donepezil that meet the criteria of Procedure 1 and Procedure 2 presented in the U.S. Pharmacopoeia in short-term stress test (70℃ 48 hours storage), long-term accelerated test 1 (40℃ relative humidity 75% 1 month storage), and long-term accelerated test 2 (40℃ relative humidity 75% 3 months storage). The donepezil-containing percutaneous absorption preparation reduces the production of impurities by inhibiting decomposition of donepezil, thereby making it possible to make a percutaneous absorption preparation comprising donepezil with improved stability for long-term preservation. |