Fenofibrate tablets

A - Human Necessities – 61 – K

Patent

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Details

A61K 31/216 (2006.01) A61K 9/14 (2006.01) A61K 9/20 (2006.01) A61K 9/28 (2006.01) A61K 31/215 (2006.01)

Patent

CA 2435714

The present invention relates to a galenic formulation of fenofibrate for oral administration and to the process for its preparation. According to the invention, the formulation is a tablet obtained by compressing a mixture comprising: a) granules containing: - 1 to 5% of a surfactant; - micronized fenofibrate; and - at least one solid excipient selected from starch, cellulose and derivatives thereof, with the exception of C12 disaccharides, said granules being obtained by granulating the mixture with the aid of an aqueous solution of polyvinylpyrrolidone; b) crosslinked polyvinylpyrrolidone; and c) optionally flow aids or lubricants, the amount of fenofibrate being greater than 50% by weight, expressed relative to the weight of the tablet. The formulation in accordance with the invention is useful in the treatment of hypercholesterolemia and hypertriglyceridemia.

La présente invention a pour objet une nouvelle formulation galénique du fénofibrate administrable par voie orale ainsi que son procédé de préparation. Selon l'invention, il s'agit d'un comprimé obtenu par compression d'un mélange comprenant: a) un granulat contenant: 1 à 5 % d'un agent tensioactif; du fénofibrate micronisé; au moins un excipient solide choisi parmi l'amidon, la cellulose ou leurs dérivés, à l'exception des disaccharides en C¿12?; ledit granulat étant obtenu par granulation du mélange à l'aide d'une solution aqueuse de polyvinylpyrrolidone b) de la polyvinylpyrrolidone réticulée; c) éventuellement des agents d'écoulement ou de lubrification, la quantité de fénofibrate étant supérieure à 50 % en poids, exprimé par rapport au du poids du comprimé. Application: traitement des hypercholestérolémies et des hypertriglycéridémies.

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