A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
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).
Guimaraes Eneida
Machado Antonio
Machado Livia
Maranduba Aurelio
Santiago Junior Marcio
Biorganica Ltda.
G. Ronald Bell & Associates
Quiral Quimica Do Brasil S.a.
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