New modified release tablet formulations for proton pump...

A - Human Necessities – 61 – K

Patent

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Details

A61K 9/54 (2006.01) A61K 9/24 (2006.01) A61K 9/26 (2006.01) A61K 9/52 (2006.01) A61K 31/4439 (2006.01) A61P 1/04 (2006.01)

Patent

CA 2584419

An oral solid pharmaceutical dosage form comprising an acid sensitive proton pump inhibitor (PPI) as single active drug, relasing the PPI in two separate pulses, one immediate and one delayed. The PPI is formulated into a core material in the form of tablets, which are coated i.a. with a combination of a delay release modifying layer and a lag time controlling layer that together achieves beneficial release properties. The tablets are further provided with an enteric coating layer. The application also relates to processes for preparing the dosage forms as well as their use in the treatment of gastrointestinal diseases.

L'invention concerne une forme de dosage pharmaceutique solide oral comprenant un inhibiteur de la pompe à protons (PPI) sensible à un acide comme médicament actif unique qui libère la PPI en deux impulsions séparées, l'une immédiate et l'autre retardée. La PPI est formulée dans un matériau de noyau sous forme de comprimés enrobés au moyen d'une combinaison de couche de modification de libération différée et de couche de commande de temps de latence qui ensemble fournissent des propriétés de libération bénéfiques. Les comprimés sont ensuite enrobés dans une couche de revêtement entérique. L'invention concerne également des procédés permettant de préparer les formes de dosage ainsi que des procédés d'utilisation permettant de traiter les maladies gastro-intestinales.

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