SUBSTANTIALLY PURE AMORPHOUS FLUVASTATIN, PROCESSES FOR ITS PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING SAME

摘要

A process for producing fluvastatin or a pharmaceutically acceptable salt thereof in a substantially pure amorphous form is provided comprising (a) providing a solvent solution comprising substantially non-amorphous fluvastatin or a pharmaceutically acceptable salt thereof in a solvent capable of dissolving the fluvastatin; and (b) recovering fluvastatin or a pharmaceutically acceptable salt thereof in a substantially pure amorphous form. Also provided is an alternative process for producing fluvastatin or a pharmaceutically acceptable salt thereof in a substantially pure amorphous form comprising (a) providing a solvent solution comprising a straight or branched C₁-C₄ alkyl ester of substantially non-amorphous fluvastatin in a lower alcoholic solvent or cyclic ether solvent capable of dissolving the fluvastatin; (b) hydrolyzing the fluvastatin ester solution with an aqueous solution comprising an alkali metal hydroxide; and (c) recovering fluvastatin or a pharmaceutically acceptable salt thereof in a substantially pure amorphous form.