Pharmaceutical formulation comprising a...

A - Human Necessities – 61 – K

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Details

A61K 31/4439 (2006.01) A61K 9/48 (2006.01) A61P 1/04 (2006.01)

Patent

CA 2323536

Oral pharmaceutical formulation comprising granules having an inert core coated with a layer, comprising a 2-[[(2-pyridinyl)methyl]sulfinyl]benzimidazole having anti-ulcer activity, a disintegrant and a surfactant in a matrix of a melt coating substance essentially consisting of one or more esters of glycerol and fatty acids, a separating layer and an enteric coating layer, and a process for the preparation of such formulation using a melt coating technique for the preparation of the benzimidazole containing layer.

L'invention se rapporte à une formulation pharmaceutique orale comportant des granules constitués d'un noyau inerte recouvert d'une couche comportant un 2-[[(2-pyridinyl)méthyl]sulfinyl]benzimidazole doté d'une activité anti-ulcéreuse, un désintégrant et un tensioactif dans une matrice d'une substance d'enrobage à l'état fondu constituée essentiellement d'un ou de plusieurs esters de glycérol et d'acides gras, une couche de séparation et une couche de revêtement gastro-résistant. L'invention se rapporte également à un procédé de préparation de ladite formulation mettant en oeuvre une technique d'enrobage avec un produit fondu pour la préparation de la couche contenant le benzimidazole.

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