Pharmaceutical compositions containing docetaxel and a...

A - Human Necessities – 61 – K

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A61K 31/337 (2006.01)

Patent

CA 2640950

Pharmaceutical compositions containing polysorbate 80 , anhydrous docetaxel ( I ) or its trihydrate and an organic acid with a pKa between 2.5-4.5 employed as a degradation inhibitor. The compositions thus obtained are sterile and stable up to 30 months when stored at room temperature, corresponding to a range between 15 and 30~C, ~ 1~ C, and present low levels of 7-epi-docetaxel ( II ).

Compositions pharmaceutiques contenant du polysorbate 80, du docétaxel anhydre (I) ou trihydraté et un acide organique ayant un pKa dans la plage de 2,5 à 4,5, employées comme inhibiteur de dégradation. Les compositions ainsi obtenues sont stériles et stables jusqu'à 30 mois lorsqu'elles sont stockées à la température ambiante, soit une plage de 15 à 30°C, ± 1°C, et elles présentent de faibles taux de 7-épidocétaxel (II).

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