A pharmaceutical formulation of taxane intended to be administered to mammals, preferably humans, comprising two compositions combined prior to being administered, forming a transparent solution free from precipitates, in which said compositions comprise a solid composition of lyophilised taxane, free from tensoactives, oils, polymers, solubility enhancers, preservatives and excipients and a solubilising composition of said lyophilised taxane solid composition that comprises at least one tensoactive. Said formulation is free from polysorbate 80 and polyoxyethylated castor oil. A procedure for the preparation of said solid composition by means of the lyophilisation of taxane in a lyophilising organic solvent. A kit for said injectable formulation of taxane comprising a prefilled syringe. Also a pharmaceutical taxane solution for perfusion, free from organic solvent.
一种拟用于哺乳动物(最好是人类)的
紫杉烷药物制剂,由两种组合物组成,在给药前组合在一起,形成无沉淀的透明溶液,其中所述组合物包括冻干
紫杉烷固体组合物,不含天蚕素、油、聚合物、
增溶剂、
防腐剂和赋形剂,以及所述冻干
紫杉烷固体组合物的增溶组合物,该增溶组合物包含至少一种天蚕素。所述制剂不含聚山
梨醇酯 80 和聚氧
乙烯蓖麻油。一种通过在冻干有机溶剂中冻干
紫杉烷来制备所述固体组合物的方法。一种用于上述可注射的
紫杉烷制剂的试剂盒,包括一个预灌封注射器。不含有机溶剂的用于灌注的药用
紫杉烷溶液。