Controlled release solid oral dosage formulations comprising...

A - Human Necessities – 61 – K

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A61K 9/32 (2006.01) A61K 9/16 (2006.01) A61K 9/24 (2006.01) A61K 9/26 (2006.01) A61K 9/36 (2006.01) A61K 31/4422 (2006.01)

Patent

CA 2662122

Controlled release oral dosage formulations containing calcium channel blockers, and methods of use thereof, are provided for the once-a-day treatment of cardiovascular disorders, such as hypertension, angina, and cardiac arrhythmia. The active agent is preferably a dihydropyridine calcium channel blocker, such as nisoldipine. The formulation provides an increase in the bioavailability of the calcium channel blocker as compared to the bioavailability of the calcium channel blocker in other drug delivery formulations known in the art. In one embodiment, the formulation provides an increase in the bioavailability of the calcium channel blocker, nisoldipine, as compared to the same dose of nisoldipine in the coat-core version of the drug (SULAR®). The formulation can be in the form of a trilayer tablet containing a core or central layer and one or more barrier layers.

La présente invention concerne des formulations posologiques à libération contrôlée administrées par voie orale contenant des inhibiteurs calciques et concerne également des méthodes d'utilisation de ces formulations, lesquelles sont conçues pour être administrées une fois par jour pour le traitement de troubles cardio-vasculaires tels que l'hypertension, l'angine de poitrine et l'arythmie cardiaque. L'agent actif est de préférence un inhibiteur calcique de dihydropyridine tel que la nisoldipine. La formulation de cette invention permet d'accroître la biodisponibilité de l'inhibiteur calcique comparée à celle observée dans d'autres formulations d'administration de médicaments connues. Selon un mode de réalisation, la formulation permet d'accroître la biodisponibilité de l'inhibiteur calcique, la nisoldipine, comparée à celle observée pour la même dose de nisoldipine dans la version enveloppe-noyau du médicament (SULAR®). Cette formulation peut se présenter sous la forme d'un comprimé à trois couches contenant un noyau ou couche centrale et une ou plusieurs couches barrières.

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