Oral pharmaceutical dosage forms comprising a proton pump...

A - Human Necessities – 61 – K

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A61K 33/06 (2006.01) A61K 9/20 (2006.01) A61K 9/24 (2006.01) A61K 9/28 (2006.01) A61K 9/50 (2006.01) A61K 31/4439 (2006.01) A61K 45/06 (2006.01) A61P 1/04 (2006.01)

Patent

CA 2213996

An oral pharmaceutical dosage form comprising an acid susceptible proton pump inhibitor and one or more antacid agents or an alginate in a fixed formulation, wherein the proton pump inhibitor is protected by an enteric coating layer and an optional separating layer in between the proton pump inhibitor and the enteric coating. The fixed formulation is in the form of multilayered tablets, sachets or multiple unit tableted dosage forms. The multiple unit dosage form is most preferred. The new fixed formulation is especially useful in the treatment of disorders associated with dyspepsia such as heartburn.

Forme galénique par voie orale comprenant un inhibiteur de la pompe à protons sensible à l'acide et un ou plusieurs agents antiacide ou un alginate dans une formulation fixe, l'inhibiteur de la pompe à protons étant protégé par une couche de revêtement gastro-résistant et par une éventuelle couche de séparation entre l'inhibiteur de la pompe à protons et ladite couche de revêtement gastro-résistant. La formulation fixe se présente sous la forme de comprimés à plusieurs couches, de sachets ou de formes galéniques en comprimés à unités multiples. La forme galénique à unités multiples est la formule idéale. La nouvelle formulation fixe est particulièrement utile dans le traitement de troubles associés à la dyspepsie telle que les aigreurs d'estomac.

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