Pharmaceutical use of a composition containing fenofibrate

A - Human Necessities – 61 – K

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A61K 9/50 (2006.01) A61K 31/216 (2006.01)

Patent

CA 2540235

The invention is related to the use of a composition of fenofibrate containing micronized fenofibrate, a surfactant and a binding cellulose derivative as a solubilization adjuvant, said composition containing an amount of fenofibrate greater than or equal to 60% by weight, for the preparation of a medicament for treating hypertriglyceridemias, hypercholesterolemias or hyperlipidemias while reducing the food effect on the bioävailability of fenofibrate. The invention is also related to an immediate release composition in the form of granules comprising : (a) a neutral core; (b) an active layer, wich surrounds the core; and (c)an outer layer; wherein said active layer comprises micronized fenofibrate, a surfactant and a binding cellulose derivative; and wherein said composition has a dissolution profile of less than 10% at 5 minutes and more than 80% at 20 minutes according to the European Pharmacopoeia in a dissolution medium constituted by water with 0.025 M sodium lauryl sulfate.

L'invention concerne l'utilisation d'une composition de fénofibrate contenant du fénofibrate micronisé, un tensioactif et un dérivé cellulosique de liaison comme adjuvant de solubilisation, ladite composition renfermant une quantité de fénofibrate supérieure ou égale à 60 % en poids, pour la préparation d'un médicament destiné à traiter l'hypertriglycéridémie, l'hypercholestérolémie ou l'hyperlipidémie tout en réduisant l'effet des aliments sur la biodisponibilité du fénofibrate. L'invention concerne également une composition à libération immédiate se présentant sous la forme de granulés comportant: (a) un noyau neutre; (b) une couche active entourant le noyau; et (c) une couche externe; ladite couche active renfermant du fénofibrate micronisé, un tensioactif et un dérivé cellulosique de liaison; et ladite composition présentant un profil de dissolution inférieur à 10 % après 5 minutes et supérieur à 80 % après 20 minutes, selon la pharmacopée européenne, dans un milieu de dissolution constitué d'eau avec 0,025 M de laurylsulfate de sodium.

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