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Composition based on ziprasidone, method of treating psychoses and process for preparing big crystals of ziprasidone
Composition based on ziprasidone, method of treating psychoses and process for preparing big crystals of ziprasidone
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机译:基于齐拉西酮的组合物,治疗精神病的方法和齐拉西酮大晶体的制备方法
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摘要
In the present invention, there is disclosed a pharmaceutical composition comprising crystalline ziprasidone free base or crystalline ziprasidone hydrochloride particles having a mean particle size equal to or less than about 85 microns and a pharmaceutically acceptable diluent or carrier. There is also disclosed a process for preparing large crystals of ziprasidone hydrochloride monohydrate, comprising the steps of: 1) dissolving ziprasidone free base in a solvent comprising tetrahydrofuran and water, in a volume ratio of about 22 to 35 unit volumes of tetrahydrofuran to about 1.5 to 8 volumes of water; 2) heating the solution resulting from step (1); 3) adding hydrogen chloride to the solution resulting from step (2); and 4) cooling the solution resulting from step (3).
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