C - Chemistry – Metallurgy – 07 – D
Patent
C - Chemistry, Metallurgy
07
D
C07D 453/02 (2006.01) A61K 9/20 (2006.01) A61K 31/439 (2006.01) A61K 47/34 (2006.01) A61P 1/12 (2006.01) A61P 13/02 (2006.01) A61P 27/08 (2006.01)
Patent
CA 2561167
A solid pharmaceutical preparation of solifenacin or a salt thereof, the preparation being stable and inhibited from decomposing with time when supplied to clinical fields. In a pharmaceutical preparation containing solifenacin or a salt thereof, the compound in an amorphous form was revealed to be causative of cardinal-drug decomposition with time. The composition for a solid pharmaceutical preparation of solifenacin or a salt thereof contains solifenacin or its salt each in a crystalline form, and the content of the compound in an amorphous form in the composition is within the range which exerts no influence on product stability. Also provided are: a process for producing the composition; and a medicinal composition for solid pharmaceutical preparations which contains solifenacin and an amorphization inhibitor.
Préparation pharmaceutique solide de solifénacine ou un sel de cette dernière, la préparation étant stable et inhibant de décomposition différée en cas d'alimentation á des domaines cliniques. Dans une préparation pharmaceutique contenant de la solifénacine ou un sel, le composé sous forme amorphe s'est avéré provoquer la décomposition de médicament cardinal différé. La composition d'une préparation solide pharmaceutique de solifénacine et un sel contient de la solifénacine ou un sel sous forme cristalline, et le contenu du composé sous forme amorphe dans la composition est dans la plage qui n'exerce aucune influence sur la stabilité du produit. Il est également prévu un processus pour la production de la composition et une composition médicale pour des préparations solides pharmaceutiques qui contient la solifénacine et un inhibiteur d'amorphisation.
Masaki Katsuhiro
Murayama Daisuke
Sugihara Akio
Yasuji Takehiko
Astellas Pharma Inc.
Norton Rose Or S.e.n.c.r.l. S.r.l./llp
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