Self emulsifying lipid matrix (selm)

A - Human Necessities – 61 – K

Patent

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Details

A61K 9/14 (2006.01) A61K 9/68 (2006.01) A61K 31/5375 (2006.01) A61K 47/14 (2006.01) A61K 47/44 (2006.01)

Patent

CA 2431397

The present invention relates to a pharmaceutical composition for oral administration of an active compound showing a bioavailability of 20 % or less. The composition comprises, based on its total weight, from 0.01 % to about 15 % (w/w) of said active compound molecularly dissolved in the composition, from 30 to 80 % (w/w) of an edible lipid matrix and from 1 to 20 % (w/w) of an edible emulsifier, the ratio between the dose weight of the active compound and its solubility in the composition being equal to or greater then 0.6 ml. The high percentage of fat (30-80 %) enables to considerably increase the amount of the drug molecularly dispersed in the dosage form, thus allowing to significantly reduce the number of unit doses which must be taken daily be patients.

L'invention concerne une composition pharmaceutique orale d'un composé actif présentant une biodisponibilité <= 20 %. La composition comprend, sur la base de son poids total, de 0,01 % à environ 15 % (M/M) dudit composé actif moléculairement dissout dans la composition, de 30 à 80 % (M/M) d'une matrice lipide comestible et de 1 à 20 % (M/M) d'un émulsifiant comestible, le rapport entre la dose pondérale du composé actif et sa solubilité dans la composition étant supérieur ou égal à 0,6 ml. Le pourcentage élevé de gras (30-80%) permet d'augmenter considérablement la quantité de médicament moléculairement dispersée dans la forme posologique, ce qui permet de réduire de façon importante le nombre d'unités de doses devant être ingéré quotidiennement par les patients.

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