|Title:||Method for stabilizing anti-dementia drug|
|Abstract:|| The present invention provides a method for stabilizing an anti-dementia drug in a pharmaceutical composition containing the anti-dementia drug and a high molecular weight basic substance by adding a high molecular weight acidic substance to said pharmaceutical composition. Further, the present invention provides a pharmaceutical composition containing an anti-dementia drug and a high molecular basic substance in which a high molecular weight acidic substance is contained for stabilizing the anti-dementia drug. Furthermore, the present invention provides a method for manufacturing a pharmaceutical composition which comprises steps wherein a solution or suspension containing a high molecular weight acidic substance is added to a mixture of an anti-dementia drug and a high molecular weight basic substance for the sake of stabilizing the anti-dementia drug.|
|Inventor(s):|| Ueki; Yosuke (Gifu, JP), Suzuki; Yasuyuki (Gifu, JP), Fujioka; Satoshi (Gifu, JP) |
|Assignee:|| EISAI R & D Management Co., Ltd. (Tokyo, JP) |
|Filing Date:||Feb 25, 2010|
|Claims:||1. A method for stabilizing donepezil or a pharmaceutically acceptable salt thereof that is in contact with ethylcellulose, comprising adding a methacrylic acid-ethyl acrylate copolymer in a mixture comprising the donepezil or a pharmaceutically acceptable salt thereof, the ethylcellulose, and a water-soluble sugar or sugar alcohol during a mixing or granulation step and preparing a sustained-release matrix-type pharmaceutical composition comprising the donepezil uniformly distributed with the ethylcellulose and the methacrylic acid-ethyl acrylate copolymer, wherein the sustained-release matrix-type pharmaceutical composition comprises the ethylcellulose in an amount of 12% to 32% by weight, and the methacrylic acid-ethyl acrylate copolymer in an amount of 15.8% to 37% by weight. |
2. The Method of claim 1 wherein the water-soluble sugar or sugar alcohol is lactose.