C - Chemistry – Metallurgy – 07 – D
Patent
C - Chemistry, Metallurgy
07
D
C07D 403/10 (2006.01) A61K 31/4184 (2006.01) A61P 9/12 (2006.01)
Patent
CA 2670207
A process for preparing a crystalline form of candesartan cilexetil referred to as Form I, which has a content of Form II lower than 1% (w/w), is described. The process comprises a seeding stage with a crystalline product, which mainly comprises Form I, and a digestion stage. The invention also relates to said crystalline form, the pharmaceutical compositions containing it and its use for the preparation of a medicament for the treatment of hypertension. Candesartan cilexetil Form I has shown good stability under accelerated stability conditions, when the content of Form II is lower than 1% w/w.
L'invention porte sur un procédé de préparation d'une forme cristalline de candesartan cilexetil désignée comme Forme I, qui a une teneur en Forme II inférieure à 1 % (p/p). Le procédé comprend un stade d'ensemencement par un produit cristallin, lequel comprend principalement la Forme I, et un stade de digestion. L'invention porte également sur ladite forme cristalline, sur les compositions pharmaceutiques la contenant et son utilisation pour la préparation d'un médicament pour le traitement de l'hypertension. La Forme I de candesartan cilexetil a présenté une bonne stabilité dans des conditions de stabilité accélérée, lorsque la teneur de la Forme II est inférieure à 1 % p/p.
Cosme Gomez Antonio
Gonzalez Hernandez Pedro
Palomo Nicolau Francisco Eugenio
Rodriguez Salgado Natividad
Vicioso Sanchez Mercedes
Chemo Iberica S.a.
Robic
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