Composition and dosage form for delayed gastric release of...

A - Human Necessities – 61 – K

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A61K 9/22 (2006.01) A61K 9/20 (2006.01) A61K 9/28 (2006.01) A61K 9/34 (2006.01) A61K 9/36 (2006.01) A61K 31/663 (2006.01)

Patent

CA 2412024

The present invention provides compacted pharmaceutical composition for oral administration to a patient which expands upon contact with gastric fluid to retain a dosage form in the patient's stomach for an extended period of time, the formulation comprising a non-hydrated hydrogel, a superdisintegrant and tannic acid. The present invention further provides a pharmaceutical dosage form containing an active ingredient, and the compacted pharmaceutical composition. The invention further provides a dosage form suitable for delivering a therapeutic bis-phosphonate such as alendronate to the stomach of a patient over an extended period.

La présente invention concerne une composition pharmaceutique compactée administrée par voie orale à un patient. Cette composition entre en expansion au contact d'un fluide gastrique et favorise la rétention d'une forme posologique dans l'estomac du patient pendant une durée prolongée, ladite composition comprenant un hydrogel non hydraté, un super-désintégrant et un acide tannique. La présente invention concerne également une forme posologique pharmaceutique contenant un ingrédient actif ainsi que cette composition pharmaceutique. L'invention se rapporte en outre à une forme posologique permettant de diffuser une bis-phosphonate thérapeutique telle que l'alendronate dans l'estomac d'un patient pendant une durée prolongée.

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