A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 9/28 (2006.01) A61K 9/20 (2006.01) A61K 9/48 (2006.01) A61K 31/445 (2006.01)
Patent
CA 2658493
The present invention relates to a pharmaceutical composition comprising 2,3- dihydro-5,6-dimethoxy-2-[[1 -(phenylmethyl)-4-piperidinyl]methyl]-1 H-inden-1 -one, herein after referred to as Donepezil, or a pharmaceutically acceptable salt thereof, for treating of Alzheimer's disease and senile dementia. The present invention also relates to a manufacturing process for the preparation of Donepezil tablets containing and retaining polymorphic Form I of Donepezil hydrochloride. This composition also discloses the use of the excipients that ensure adequate flowability of a dry blend as well as required content uniformity and drug release rate of the final product.
La présente invention concerne une composition pharmaceutique comprenant du (2RS)-2-[(1-benzylpipéridin-4-yl)méthyl]-5,6-diméthoxy-2,3-dihydro-1H-indén-1-one, ci-après dénommé donépézil, ou un sel pharmaceutiquement acceptable de celui-ci, pour le traitement de la maladie d'Alzheimer et de la démence sénile. La présente invention concerne également un procédé de fabrication pour la préparation de comprimés de donépézil contenant et conservant une forme polymorphe I de chlorhydrate de donépézil. Cette composition décrit également l'utilisation d'excipients qui assurent une coulabilité adéquate d'un mélange sec, ainsi que l'uniformité de teneur et la vitesse de libération du médicament requis du produit final.
Cindric Violeta
Devcic Maja
Grebenar Ivica
Miric Snjezana
Borden Ladner Gervais Llp
Pliva Hrvatska D.o.o.
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