A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 9/16 (2006.01) A61K 9/10 (2006.01) A61K 9/14 (2006.01) A61K 31/4439 (2006.01) A61K 47/12 (2006.01) A61K 47/26 (2006.01) A61K 47/36 (2006.01)
Patent
CA 2592030
A solid rapidly gelling oral pharmaceutical dosage form, as well as aqueous suspensions prepared thereof, comprising an acid sensitive proton pump inhibitor as active ingredient distributed in a multitude of enteric coated pellets and a suspension modifying granulate comprising a rapidly dissolving diluent granulated together with a gelling agent chosen among xanthan gums, and an acidic pH-regulating agent and a binder. The suspension modifying granulate is rapidly disintegrating and gelling when suspended in an aquoeous medium and thus forming a homogenous stable and robust suspension having a reproducible and stable viscosity. Furthermore the invention relates to an improved process for its manufacture and the use of such formulation in medical treatment including prevention of gastrointestinal disorders in humans.
La présente invention décrit une forme galénique solide et gélifiant instantanément pour administration orale, ainsi que des suspensions aqueuses préparées à partir de ladite forme galénique. Ladite forme galénique comprend un inhibiteur de la pompe à protons sensible aux acides au titre de principe actif, réparti dans une multitude de gélules entériques, ainsi qu'un granulé modifiant les suspensions et comprenant un diluant à dissolution rapide, préférentiellement le glucose ou le sucrose, un agent gélifiant choisi parmi les gommes de xanthane, un agent promoteur de pH acide et un agent liant. Ledit granulé ne contient ni sels de type bicarbonate, ni sels de type carbonate, et, préférentiellement, ne contient pas de lactose. En outre, l'invention concerne un procédé amélioré de fabrication de ladite forme galénique et l'emploi d'une telle formule dans un traitement médical incluant la prévention de troubles gastro-intestinaux chez l'humain.
Persson Eva
Trofast Eva
Astrazeneca Ab
Fetherstonhaugh & Co.
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