A SOLID LYOPHILIZED TAXANE COMPOSITION, A METHOD FOR PREPARING SAID SOLID COMPOSITION, A PHARMACEUTICAL FORMULATION AND A KIT FOR SAID FORMULATION.

摘要

A solid lyophilized taxane (preferably docetaxel and paclitaxel) composition, suitable for preparing pharmaceutical formulations for mammals, particularly humans, which comprises said taxane, a surface-active agent, a lyophilization excipient and an acid. Also, in addition, it is essentially free of organic solvent. Said solid composition is free of polysorbate 80 and of polyoxyethylated castor oil. It is sterile. It is soluble in aqueous solutions in the absence of organic solvent. Also, it has an apparent density of between 0.05 g/ml and 0.45 g/ml. A double lyophilization method for obtaining said solid taxane composition. A pharmaceutical formulation of a taxane that comprises said solid lyophilized taxane composition and a solubilizing composition. A kit that comprises said compositions and a syringe.