Oral pharmaceutical compositions containing taxanes and...

A - Human Necessities – 61 – K

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A61K 31/335 (2006.01) A61F 2/02 (2006.01) A61K 9/20 (2006.01) A61K 9/48 (2006.01) A61K 9/64 (2006.01) A61K 9/107 (2006.01)

Patent

CA 2371924

Pharmaceutical compositions for oral administration to mammalian subjects comprise a taxane or taxane derivative (e.g., paclitaxel or docetaxel) as active ingredient and a vehicle comprising at least 30 % by weight of a carrier for the taxane, said carrier having an HLB value of at least about 10. The compositions may also comprise 0 - 70 % of a viscosity-reducing co- solubilizer. The compositions may be incorporated into conventional oral pharmaceutical dosage forms, or can be in the form of a two-part medicament wherein the first part includes the taxane in a solubilizing vehicle and the second part comprises a carrier for the taxane to promote oral absorption. Methods of treatment of taxane- responsive disease conditions employing the novel compositions are also disclosed, whereby the compositions can be administered alone or in association with an oral bioavailability enhancing agent.

Des compositions pharmaceutiques à administrer par voie orale à des sujets mammifères, comprennent un taxane ou un dérivé de taxane (ex. paclitaxel ou docétaxel), en tant que principe actif, et un véhicule comprenant au moins 30 % en poids de support pour le taxane, support présentant une valeur HLB d'au moins environ 10. Lesdites compositions peuvent également comprendre 0 à 70 % d'un co-solubilisant réduisant la viscosité. Lesdites compositions peuvent être incorporées à des formes galéniques pharmaceutiques orales classiques, ou peuvent se présenter sous la forme d'un médicament à deux parties dont la première contient le taxane dans un véhicule solubilisant et la deuxième comporte un support pour le taxane, favorisant l'absorption orale. Des méthodes de traitement d'états pathologiques sensibles au taxane, dans lesquelles lesdites compositions sont utilisées, sont également décrites, les compositions pouvant être administrées seules ou conjointement avec un agent augmentant la biodisponibilité orale.

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