A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 31/337 (2006.01) A61K 47/40 (2006.01)
Patent
CA 2309326
A process for the preparation of rapidly soluble products for pharmaceutical use is provided. The process comprises the following steps: dissolving in ethanol a taxoid or a salt, or a hydrate, or a solvate thereof; adding to the solution a lyophilized solid cyclodextrin derivative; and evaporating the solvent and drying to obtain a solid, which comprises the taxoid as the active ingredient and the cyclodextrin derivative. The weight ratio of taxoid:cyclodextrin derivative ranges between 1:25 and 1:400. The taxoid is selected from the group consisting of paclitaxel and docetaxel, and the cyclodextrin derivative is selected from the group consisting of acetyl-y-cyclodextrin and hydroxy-propyl-.beta.-cyclodextrin. When hydroxy-propyl-p-cyclodextrin is used, the taxoid can be only docetaxel in a 1:25 to 1:100 taxoid:cyclodextrin weight ratio.
La présente invention concerne des compositions pharmaceutiques à l'état solide solubles dans l'eau et leurs solutions dans des solvants aqueux, lesdites compositions contenant a) en tant que principe actif un taxoïde finement dispersé, de grande aire de surface, amorphe et de préférence lyophilisé tel que le paclitaxel ou le docétaxel, leurs sels ou leurs hydrates ou solvates polymorphes tels que des solvates formés d'éthanol, b) de l'acétyl-.gamma.-cyclodextrine ou hydroxy-propyl-.beta.-cyclodextrine (cyclodextrine) finement dispersée, à grande aire de surface, amorphe et de préférence lyophilisée, le rapport pondéral entre ledit taxoïde et ladite cyclodextrine s'établissant entre 1:25 et 1:400, et c) facultativement d'autres matières auxiliaires hydrosolubles usuelles dans les produits pharmaceutiques à des fins parentérales.
Geczy Joseph M.
G. Ronald Bell & Associates
Hexal Ag
Thissen Laboratoires S.a.
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