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

摘要

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.