A lyophilised Solid Taxane composition, a method for preparing the solid composition, a Pharmaceutical Formulation and a Set (Kit) for the preparation of an injectable formulation of Taxane

摘要

A Solid Taxane composition (preferably docetaxel and paclitaxel Lyophilized), suitable to prepare Pharmaceutical formulations for Mammals, including humans, comprising Said Taxane, Surfactant, excipient lyophilization and acid, and is essentially free of solvent Organic.Where The Solid composition is free of Polysorbate 80 and polyoxyethylated castor oil; sterile; it is Soluble in aqueous solutions in the absence of Organic Solvent; and has an apparent density of between 0.05 g / mi and 0.45 g / mi. A procedure of double freeze drying to obtain Solid Taxane composition.A Pharmaceutical formulation comprising Said Composition of Taxane lyophilised Solid Taxane Composition and a solubilizer. An Assembly comprising Said compositions and a syringe.