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

The invention relates to a taxane pharmaceutical formulation to be administered to mammals, preferably humans, comprising two compositions which are combined prior to administration such as to form a transparent solution free of precipitates, whereby said compositions comprise a lyophilised solid taxane composition free of surfactants, oils, polymers, solubility enhancers, preservatives and excipients, and a composition for solubilising said lyophilised solid taxane composition, containing at least one surfactant. Said formulation is free of polysorbate 80 and polyoxyethylated castor oil. The invention also relates to a method for preparing the solid composition, comprising the lyophilisation of taxane in an organic lyophilisation solvent. The invention further relates to a kit for the injectable taxane formulation, containing a pre-filled syringe, and a pharmaceutical taxane perfusion solution that is free of organic solvent.