A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 9/19 (2006.01) A61K 31/337 (2006.01)
Patent
CA 2638034
A solid lyophilized taxane (preferably docetaxel and paclitaxel) composition, suitable for preparing pharmaceutical formulations for mammals, particularly humans, which comprises said taxane, a surface-active agent, a lyophilization excipient and an acid. Also, in addition, it is essentially free of organic solvent. Said solid composition is free of polysorbate 80 and of polyoxyethylated castor oil. It is sterile. It is soluble in aqueous solutions in the absence of organic solvent. Also, it has an apparent density of between 0.05 g/ml and 0.45 g/ml. A double lyophilization method for obtaining said solid taxane composition. A pharmaceutical formulation of a taxane that comprises said solid lyophilized taxane composition and a solubilizing composition. A kit that comprises said compositions and a syringe.
L'invention concerne une composition solide de taxane (de préférence de docétaxel y paclitaxel) lyophilisée, adaptée pour la préparation de formulations pharmaceutiques pour mammifères, en particulier les humains, contenant ledit taxane, un agent tensio-actif, un excipient de lyophilisation et un acide, et ne contenant essentiellement pas de solvant organique. Ladite composition solide ne contient pas de polysorbate 80 ni d'huile de castor polyoxyéthylée, elle est stérile et soluble dans des solutions aqueuses en l'absence d'un solvant organique, et présente une densité apparente variant entre 0,05 g/ml et 0,45 g/ml. L'invention concerne également un procédé de double lyophilisation permettant d'obtenir ladite composition solide de taxane. L'invention concerne en outre une formulation pharmaceutique de taxane contenant ladite composition solide de taxane lyophilisée et une composition de solubilisation. L'invention concerne enfin un ensemble comprenant lesdites compositions et une seringue.
Bouzada Antonio Osvaldo
Iturraspe Jose Bernardo
Moyano de Iturraspe Nora Adriana
Nunez Jose Lucio
Eriochem S.a.
Mcmillan Llp
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