专利名称 | STABLE DOSAGE FORM OF ETIDRONATE-CYTARABINE CONJUGATE, AND USE THEREOF | ||
申请号 | US15780384 | 申请日 | |
公开(公告)号 | US20190038559A1 | 公开(公告)日 | 2016-11-28 |
申请(专利权)人 | 发明人 | Ekaterina Alekseevna IVANOVA; Alexander KARPEISKY; Shawn P ZINNEN; Lisa Lynn CARALLI; Rina Diana SALURIALAM | |
专利来源 | 国家知识产权局 | 转化方式 | |
摘要 |
The invention relates to the field of medicine and pharmaceuticals and particularly to a novel dosage form of an antitumor preparation, which ensures the hydrolytic and physical stability of said preparation, as well as to a method for producing a dosage form of this type. The stable dosage form is a lyophilizate comprising an etidronate-cytarabine conjugate or a pharmaceutically acceptable salt thereof, and a stabilizer, which is a divalent metal salt, in a molar ratio of stabilizer to conjugate of 1 : 1 to 20 : 1. A dosage form of this type ensures the hydrolytic and physical stability of the conjugate during long-term storage, and the stability of solutions of the conjugate for parenteral administration during clinical use. |
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