Formulation comprising fenofibric acid, a physiologically...

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Details

A61K 31/192 (2006.01) A61K 9/20 (2006.01) A61K 9/28 (2006.01) A61K 9/48 (2006.01)

Patent

CA 2510261

A formulation comprising i) fenofibric acid, a physiologically acceptable salt or derivative thereof and optionally other active substances, ii) a binder component comprising at least one enteric binder, and optionally iii) other physiologically acceptable excipients is described. Fenofibric acid, the physiologically acceptable salt or derivative thereof is preferably in the form of a molecular dispersion in these formulations. An advantageous process for their preparation, in particular by melt extrusion, and the use of this formulation for oral administration of fenofibric acid, a physiologically acceptable salt or derivative thereof are likewise described.

La présente invention concerne une formulation comportant i) de l'acide fénofibrique, un sel ou un dérivé pharmaceutiquement acceptable de celui-ci et éventuellement d'autres substances actives, ii) un composant agglutinant comportant au moins un agglutinant entérique et, éventuellement iii) d'autres excipients physiologiquement acceptables. L'acide fénofibrique, le sel ou le dérivé physiologiquement acceptable de celui-ci, se présente de préférence comme une dispersion moléculaire dans lesdites formulations. L'invention se rapporte également à un procédé avantageux de préparation de ces formulations, notamment par extrusion à l'état fondu, et à l'utilisation de cette formulation pour une administration orale d'acide fénofibrique, d'un sel ou d'un dérivé physiologiquement acceptable de cet acide.

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