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

摘要

A lyophilised solid composition of taxane (preferably docetaxel and paclitaxel), suitable to prepare pharmaceutical formulation to be administered to mammals, particularly humans, comprising said taxane, a tensoactive, lyophilizing excipient and acid; also essentially free from organic solvents. Said solid composition is free from polysorbate 80 and polyoxyethylated castor oil; it is sterile; it is soluble in aqueous solutions in the absence of organic solvent and it has an apparent density from 0.05g/ml and 0.45g/ml. A procedure of double lyophilisation to obtain said solid composition of taxane. A pharmaceutical formulation of a taxane which comprises said solid composition of lyophilized taxane and a solubilizing composition. A kit comprising said compositions, and a syringe.