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AssigneeTeva Pharmaceutical Industries Ltd.
InventorsMoshe Flashner-Barak, Vered Rosenberger, Mazal Dahan, Yitzhak Lerner
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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 and extended period.
A pharmaceutical dosage form for oral administration to a patient which provides delayed gastric release of a therapeutically effective amount of a therapeutic bis-phosphonate, the dosage form comprising the bis-phosphonate and a drug delivery vehicle comprising a non-hydrated hydrogel, a superdisintegrant and tannic acid wherein upon contact with gastric fluid or simulated gastric fluid the non-hydrated hydrogel hydrates and the delivery vehicle expands.
A coated pharmaceutical dosage form comprising a core which contains a therapeutic bis-phosphonate and optionally other pharmaceutical excipients and a coating around the core, wherein the coating comprises a hydrogel, a superdisintegrant and tannic acid.
A coated pharmaceutical dosage form having a core comprising about 18 wt. % sodium alendronate monohydrate, about 48 wt. % microcrystalline cellulose and about 32 wt. % lactose, the core having a coating thereon which comprises about 17 wt. % HPMC, about 10 wt. % tannic acid, about 50 wt. % HPC and about 22 wt. % crosslinked carboxymethyl cellulose sodium.
A coated pharmaceutical dosage form having a core comprising about 18 wt. % sodium alendronate monohydrate, about 41 wt. % microcrystalline cellulose and about 41 wt. % lactose, the core having a coating thereon which comprises about 17 wt. % HPMC, about 10 wt. % tannic acid, about 50 wt. % HPC and about 22 wt. % crosslinked carboxymethyl cellulose sodium.
Dependencies are inferred from the claim text.