Pharmaceutically acceptable composition comprising an...

A - Human Necessities – 61 – K

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A61K 31/337 (2006.01) A61K 47/42 (2006.01) A61K 47/48 (2006.01)

Patent

CA 2362338

An optically clear, pharmaceutically acceptable aqueous composition comprising paclitaxel or a derivative thereof, serum albumin and a pharmaceutically acceptable vehicle, wherein the composition comprises no more than 10 % organic solvent and has a pH of about 3.0 to about 4.8, is described. The serum albumin can be fatted or defatted, and the composition can optionally be lyophilized or optionally lyophilized and reconstituted. At least 70 % of the paclitaxel is bound to serum albumin, the ratio of paclitaxel to albumin is at least about 1:5, and the concentration of paclitaxel is at least about 25 µg/ml. Methods of making and using this composition are also provided.

L'invention concerne une composition aqueuse pharmaceutiquement acceptable, optiquement claire, comprenant du paclitaxel ou un dérivé de celui-ci, une albumine sérique et un excipient pharmaceutiquement acceptable, cette composition comprenant au maximum 10 % de solvant organique, et présentant un pH d'environ 3,0 à 4,8. L'albumine sérique peut être grasse ou dégraissée, et la composition peut, éventuellement, être lyophilisée ou lyophilisée et reconstituée. Au moins 10 % du paclitaxel est lié à une albumine sérique, le rapport paclitaxel-albumine étant d'au moins 1/5, et la concentration du paclitaxel étant d'au moins 25µg/ml. L'invention concerne également des procédés permettant de préparer et d'utiliser cette composition.

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