PROCESS FOR PREPARING A CRYSTALLINE FORM OF CANDESARTAN CILEXETIL

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 includes a seeding stage with a crystalline product, which mainly includes Form I, and a digestion stage. The invention also relate...

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Hauptverfasser: GONZALEZ HERNANDEZ, PEDRO, VICIOSO SANCHEZ, MERCEDES, RODRIGUEZ SALGADO, NATIVIDAD, PALOMO NICOLAU, FRANCISCO EUGENIO, COSME GOMEZ, ANTONIO
Format: Patent
Sprache:eng ; fre ; ger
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Zusammenfassung: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 includes a seeding stage with a crystalline product, which mainly includes Form I, and a digestion stage. The invention also relates to the 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.