| abstract |
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. |