TAXANE PHARMACEUTICAL FORMULATION, SOLID TAXANE COMPOSITION, METHOD FOR PREPARING THE SOLID TAXANE COMPOSITION, COMPOSITION FOR SOLUBILISING SAID SOLID TAXANE COMPOSITION AND SET OF ELEMENTS (KIT) FOR THE INJECTABLE TAXANE FORMULATION
申请人:Eriochem, S.A.
公开号:EP1994925A1
公开(公告)日:2008-11-26
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。