Method for preparing novel fenofibrate galenic formulations,...

A - Human Necessities – 61 – K

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A61K 9/16 (2006.01) A61K 9/48 (2006.01) A61K 31/215 (2006.01)

Patent

CA 2342742

The invention concerns a method for preparing novel galenic formulations for providing fenofibrate with enhanced bioavailability when it is orally absorbed, and consisting in: (a) micronizing fenofibrate; (b) granulating the fenofibrate in the presence of a liquid medium comprising a surfactant, water and water-miscible alcohol; and (c) drying the resulting granular material. The invention also concerns the galenic formulations obtained by said method. Said formulations are used for preparing a medicine for oral administration and comprising fenofibrate as active principle, in particular for treating hypercholesterolemia and hypertriglyceridemia.

La présente invention se rapporte à un procédé de préparation de nouvelles formulations galéniques permettant de conférer au fénofibrate une biodisponibilité améliorée lorsqu'il est absorbé par voie orale, et qui comprend (a) la micronisation du fénofibrate, (b) la granulation du fénofibrate en présence d'un milieu liquide comprenant un agent tensioactif, de l'eau et un alcool hydromiscible, et (c) le séchage du granulat ainsi obtenu. L'invention se rapporte également aux formulations galéniques obtenues par ledit procédé. Applications: préparation d'un médicament destiné à une administration par voie orale et comprenant du fénofibrate en tant que principe actif, notamment pour le traitement des hypercholestérolémies et hypertriglycéridémies.

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