PHARMACEUTICAL COMPOSITION CONTAINING TAXANE DERIVATIVE DESTINED FOR THE PREPARATION OF AN INFUSION SOLUTION, METHOD OF PREPARATION THEREOF AND USE THEREOF

摘要

A pharmaceutical composition containing a taxane derivative, destined for the preparation of an infusion solution for administration to patients, containing a concentrate consisting of a pharmaceutically effective amount of docetaxel, a suitable solvent, which is preferably ethanol, a surfactant, which is polysorbate 80 and a pharmaceutically effective amount of an appropriate buffer; and optionally a co-solvent, consisting of an aqueous solution of a pharmaceutically effective amount of polysorbate 80 and optionally suitable organic solvent and/or a pharmaceutically effective amount of an appropriate buffer. This composition shows an excellent chemical and physical stability. The invention includes also a method of preparation of the pharmaceutical composition and the use thereof.