PERCUTANEOUS ABSORPTION PREPARATION WITH IMPROVED STABILITY, INCLUDING DONEPEZIL Russian patent published in 2024 - IPC A61K9/70 A61K31/445 A61K47/02 A61K47/10 A61K47/20 A61K47/22 A61P25/28 

FIELD: pharmaceutics.

SUBSTANCE: group of inventions can be used to treat dementia. Proposed is a donepezil preparation for percutaneous absorption for the treatment of dementia, comprising a support layer, a drug-containing layer and a release substrate, wherein the drug-containing layer includes donepezil or a pharmaceutically acceptable salt thereof as an active ingredient; pressure sensitive adhesive and a combination of stabilizers. Combination of stabilizers is either (i) a mixture of potassium thiocyanate and a stabilizer, selected from the group comprising tea catechin, (+)-catechin, epigallocatechin gallate, ascorbic acid and isoascorbic acid, or (ii) a mixture of monothioglycerol and a stabilizer, selected from a group comprising tea catechin, (+)-catechin and epigallocatechin gallate. Also disclosed is a method of producing said preparation of donepezil. In the disclosed percutaneous absorption preparation containing donepezil, the formation of impurities is reduced by inhibiting the decomposition of donepezil, which provides improved stability of donepezil during long-term storage.

EFFECT: obtained preparation meets the criteria for acceptability of the content of decomposition products of donepezil presented in the US Pharmacopoeia, under conditions of short-term stress and long-term accelerated test.

10 cl, 13 tbl, 4 ex