申请人:DR. REDDY'S LABORATORIES LIMITED
公开号:US10849916B2
公开(公告)日:2020-12-01
The present invention relates to novel impurities of cyclophosphamide having structure V, VI or VII, stabilized form of these novel impurities, a process of preparing a stabilized form and isolating thereof. The invention also relates cyclophosphamide formulations which include cyclophosphamide, at least one pharmaceutically acceptable excipient, and a certain level of these impurities having structure V, VI or VII. The invention further relate to method of using such stable liquid formulations of cyclophosphamide for parenteral administration in treating various cancer disorders.
本发明涉及具有 V、VI 或 VII 结构的新型环磷酰胺杂质、这些新型杂质的稳定形式、制备稳定形式的工艺及其分离。本发明还涉及环磷酰胺制剂,其中包括环磷酰胺、至少一种药学上可接受的赋形剂和一定含量的具有 V、VI 或 VII 结构的这些杂质。本发明还涉及使用这种稳定的环磷酰胺液体制剂进行肠外给药治疗各种癌症疾病的方法。