申请人:——
公开号:US20040024052A1
公开(公告)日:2004-02-05
Processes are provided for preparing mupirocin calcium dihydrate from pseudomonic acid in a two phase system by using an organic carboxylate.
A highly pure composition of amorphous mupirocin calcium is provided, and processes for its prepration by solvent removal, lyophilization and precipitation with use of an anti-solvent. Pharmaceutical compositions of amorphous form, and methods of using them to treat infections are also provided.
Also provided are combined processes for preparing mupirocin calcium dihydrate and amorphous, by producing amorphous form first, followed by conversion of amorphous form into the dihydrate through crystallization from an aqueous solution. Also provided are processes for removing the water of crystallization of the dihydrate to obtain muprirocin calcium anhydrate.
提供了一种使用有机羧酸盐在两相体系中从假单胞菌酸制备盐酸倍氯米松二水合物的工艺。提供了高纯度无定形盐酸倍氯米松钙的组合,并通过溶剂去除、冻干和使用抗溶剂沉淀的工艺来制备它。还提供了无定形形式的制药组合物以及使用它们来治疗感染的方法。还提供了联合工艺,通过首先生产无定形形式,然后通过从水溶液中结晶将无定形形式转化为二水合物。还提供了去除二水合物结晶水以获得盐酸倍氯米松无水物的工艺。