COMPOSITION PHARMACEUTIQUE POUR LA PRÉVENTION OU LE TRAITEMENT D'UNE DÉMENCE ET D'UN DYSFONCTIONNEMENT COGNITIF, CONTENANT DU DONÉPÉZIL OU UN SEL DE QUALITÉ PHARMACEUTIQUE DE CELUI-CI ET DE LA MÉMANTINE OU UN SEL DE QUALITÉ PHARMACEUTIQUE DE CELLE-CI, ET SON PROCÉDÉ DE PRÉPARATION

摘要

An immediate-release type pharmaceutical composition for preventing or treating dementia and cognitive dysfunction, including donepezil or a pharmaceutically acceptable salt thereof and memantine or a pharmaceutically acceptable salt thereof, and a method of preparing the pharmaceutical composition are disclosed. The method includes: granulating donepezil or a pharmaceutically acceptable salt thereof by a wet process; and adding memantine or a pharmaceutically acceptable salt thereof to the granulated donepezil or a pharmaceutically acceptable salt thereof and directly compressing and homogenizing the resulting mixture, thereby addressing problems such as reduced efficacy due to a decrease in elution of a donepezil active ingredient upon co-administration of Aricept® (donepezil hydrochloride) and Ebixa® (memantine hydrochloride), which are commercially available, and content uniformity is secured by selecting an excipient having a particle size similar to that of particles of the active ingredients. In addition, the pharmaceutical composition of the present invention is very stable without related substances.