Process For The Preparation Of Anhydrous And Hydrated Active Pharmaceutical Ingredients (Apis); Stable Pharmaceutical Compositions Prepared From The Same And Uses Of Said Compositions

摘要

This invention describes a process for the production of ANHYDROUS active pharmaceutical ingredients (APIs); a process for the preparation of HYDRATED active pharmaceutical ingredients, a process for the preparation of sterile and stable injectable solutions, and their use, more specifically, APIs which are taxane derivatives, especially (2R,3S) 4-acetoxy-2-alpha-benzoyloxy-5beta-20-epoxy-1,7-beta-10-beta-tri-hydroxy-9-oxo-tax-11-en-13alpha-il 3-tert-butoxycarbonylamino-2-hydroxy-3-phenylpropionate (I); 4-acetoxy-2-alpha-benzoyloxy-5-beta-20-epoxy-1, 7beta-10-beta-tri-hidroxy-9-oxo-tax-11-en-13alpha-il (2R,3S) 3-benzoylamino-2-hydroxy-3-phenylpropionate (II), and particularly 4-acetoxy-2-alpha-benzoyloxy-5beta-20-epoxy-1,7-beta-10-beta-tri-hidroxy-9-oxo-tax-11-en-13alpha-il (2R,3S) 3-tert-butoxycarbonylamino-2-hydroxy-3-phenylpropionate tri-hydrate (III).