Gastric reflux resistant dosage forms

A - Human Necessities – 61 – K

Patent

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A61K 9/48 (2006.01)

Patent

CA 2633924

Gastric resistant film-forming compositions are described herein. The composition contains a gastric resistant natural polymer, a film-forming natural polymer, and optionally a gelling agent. Suitable gastric resistant natural polymers include polysaccharides such as pectin and pectin-like polymers. The film-forming composition can be used to prepare soft or hard shell gelatin capsules which can encapsulate a liquid or semi-solid fill material or a solid tablet (SOFTLET®) containing an active agent and one or more pharmaceutically acceptable excipients. Alternatively, the composition can be administered as a liquid with an active agent dissolved or dispersed in the composition. The compositions are not only gastric resistant but may also prevent gastric reflux associated with odor causing liquids, such as fish oil or garlic oil, encapsulated in a unit dosage form and esophageal irritation due to the reflux of irritant drugs delivered orally.

La présente invention concerne des compositions filmogènes résistantes au suc gastrique. La composition contient un polymère naturel résistant au suc gastrique, un polymère naturel filmogène, et facultativement un agent gélifiant. Les polymères naturels résistants au suc gastrique adaptés comprennent des polysaccharides tels que la pectine et des polymères de type pectine. La composition filmogène peut être utilisée pour préparer des capsules de gélatine à coque molle ou dure qui peuvent encapsuler un matériau de remplissage liquide ou semi-solide, ou un comprimé solide (SOFTLET®) contenant un agent actif et un ou plusieurs excipients pharmaceutiquement acceptables. En variante, la composition peut être administrée sous forme liquide avec un agent actif dissous ou dispersé dans la composition. Les compositions ne sont pas seulement résistantes au suc gastrique mais peuvent également prévenir le reflux gastrique associé à des liquides causant une odeur, tels que l'huile de poisson ou l'huile d'ail, encapsulés dans une forme pharmaceutique unitaire, et une irritation oeophagienne due au reflux de médicaments irritants administrés par voie orale.

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