摘要 |
A lyophilized solid composition of taxane (preferably docetaxel and paclitaxel), is suitable to prepare a pharmaceutical formulation to be administered to mammals, particularly humans, comprising a taxane, a tensoactive, a lyophilizing excipient, and acid; also essentially free from organic solvents. The 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 0.05 g/ml to 0.45 g/ml. A procedure of double lyophilization obtains a solid composition of taxane. A pharmaceutical formulation of a taxane comprises a solid composition of lyophilized taxane and a solubilizing composition. A kit comprises the compositions and a syringe.
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