Stable particulate pharmaceutical composition of solifenacin...

A - Human Necessities – 61 – K

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A61K 31/4725 (2006.01) A61K 9/14 (2006.01) A61K 47/26 (2006.01) A61K 47/32 (2006.01) A61K 47/34 (2006.01) A61K 47/36 (2006.01) A61K 47/38 (2006.01)

Patent

CA 2591761

A granular pharmaceutical composition of solifenacin or its salt that in the application of preparations of solifenacin or its salt in clinical fields, has spherical form suitable for coating, being capable of inhibiting aging decomposition so as to be stable. In particular, there is provided a granular pharmaceutical composition produced by in the formulation of granular composition of solifenacin, employing a binding agent of < 174~C Tg or mp. Further, there is provided a granular composition of solifenacin or its salt further stabilized by addition of crystallization promoting treatment after production of the granular pharmaceutical composition.

La présente invention décrit une préparation pharmaceutique granulaire de solifénacine ou de son sel qui présente une forme sphérique adaptée à l'élaboration d'enrobages, dans le cas de formules à application thérapeutique de solifénacine ou de son sel. La décomposition due au vieillissement de ladite préparation pharmaceutique est retardée, ce qui permet de garantir sa stabilité. La présente invention décrit en particulier une préparation pharmaceutique granulaire élaborée lors de la formulation d'une préparation granulaire de solifénacine et employant un agent de liaison de point de fusion ou de Tg <174 °C. La présente invention décrit en outre une préparation granulaire de solifénacine ou de son sel stabilisée en pratiquant un traitement favorisant la cristallisation après fabrication de la préparation pharmaceutique granulaire.

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