发明名称 LYOPHILIZED SOLID TAXANE COMPOSITION, A PROCESS FOR PREPARING SAID SOLID COMPOSITION, A PHARMACEUTICAL FORMULATION AND A KIT FOR SAID FORMULATION
摘要 A lyophilized solid composition of taxane (preferably docetaxel and paclitaxel), is suitable to prepare a pharmaceutical formulation to be administered to mammals, particularly humans, comprising a taxane, a tensoactive, a lyophilizing excipient, and acid; also essentially free from organic solvents. The solid composition is free from polysorbate 80 and polyoxyethylated castor oil; it is sterile; it is soluble in aqueous solutions in the absence of organic solvent and it has an apparent density from 0.05 g/ml to 0.45 g/ml. A procedure of double lyophilization obtains a solid composition of taxane. A pharmaceutical formulation of a taxane comprises a solid composition of lyophilized taxane and a solubilizing composition. A kit comprises the compositions and a syringe.
申请公布号 US2009215882(A1) 申请公布日期 2009.08.27
申请号 US20070161609 申请日期 2007.01.19
申请人 ERIOCHEM, S.A. 发明人 BOUZADA ANTONIO OSVALDO;NUNEZ JOSE LUCIO;ITURRASPE JOSE BERNARDO;MOYANO DE ITURRASPE NORA ADRIANA
分类号 A61K31/337 主分类号 A61K31/337
代理机构 代理人
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