Pharmaceutical formulation comprising omeprazole

Details Pharmaceutical formulation comprising omeprazole Pharmaceutical formulation comprising omeprazole

A - Human Necessities

61

K

A61K 31/4439 (2006.01) A61K 9/24 (2006.01) A61K 47/38 (2006.01) A61P 1/00 (2006.01)

Patent

CA 2346988

An enteric coated oral pharmaceutical formulation comprising as active ingredient a compound selected from the group of omeprazole, an alkaline salt of omeprazole, one of the single enantiomers of omeprazole and an alkaline salt of one of the single enantiomers of omeprazole, wherein the formulation comprises a core material that comprises the active ingredient and optionally an alkaline reacting compound, the active ingredient is in admixture with a pharmaceutically acceptable excipient, such as for instance a binding agent, and on said core material a separating layer and an enteric coating layer. A hydroxypropyl cellulose (HPC) with a specific cloud point is used in the manufacture of the claimed pharmaceutical formulations. Furthermore, the application describes the processes for their preparation and the use of the claimed formulations in medicine.

Formulation pharmaceutique entéro-soluble pour une administration orale qui contient comme principe actif un composé sélectionné parmi le groupe oméprazole, un sel alcalin d'oméprazole, un des énantiomères uniques de l'oméprazole et un sel alcalin de l'un des énantiomères uniques de l'oméprazole. La formulation contient une matière noyau comprenant le principe actif et, éventuellement, un composé réactionnel alcalin, le principe actif étant mélangé avec un excipient pharmaceutiquement acceptable, comme par exemple un agent liant. Cette matière noyau est recouverte d'une couche de séparation et d'une couche entéro-soluble. Une hydroxypropyl cellulose (HPC) possédant un point de trouble spécifique est utilisée dans la préparation des formulations pharmaceutiques revendiquées. L'invention a également trait aux procédés de préparation des formulations revendiquées, et leur utilisation en médecine.

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