Patent ID: 7838551

Claim:
A process for the preparation of a concentrated pharmaceutical composition of docetaxel comprising the following steps: a) obtaining an anhydrous form of docetaxel in which the water content is from 0.08 to 0.12% w/w, by the substeps: a)(i) the hydrated docetaxel, in a solvent or in a chemically inert solvent mixture that forms an azeotrope with water and is of sufficient polarity to effect complete solubilization of the docetaxel, said solvent being selected from the group consisting of linear or branched alcohols, organic acids, halogenated solvents, and an aromatic solvent; a)(ii) removing the water of hydration contained in the mixture (i) by azeotropic distillation at a temperature between −20 and 40° C. and at a pressure between <0.001 and 800 mm Hg, until the water content is from 0.08 to 0.12% w/w; b) adding an acid, selected from the group consisting of tartaric acid, ascorbic acid, citric acid and acetic acid to polysorbate 80, under an atmosphere of nitrogen, in a sufficient quantity to adjust the pH in the range of 3.0 to 6.5; c) slowly adding anhydrous solid docetaxel, obtained by the process comprising a)(i) and a)(ii) and from which alcoholic solvents have been removed, to the resulting solution of the step (B), under agitation and a nitrogen atmosphere, until the docetaxel is completely solubilized and a transparent solution is formed, in which the concentration of the docetaxel in its anhydrous form in the polysorbate 80, is in the range from 1 to 100 mg/ml; and d) filtering the concentrated solution obtained in c) by passage through a sterilizing membrane having a porosity from 0.22 to 0.45 μm, to obtain a concentrated pharmaceutical composition of docetaxel.