Importance

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Abstract

Disclosed is a sustained release pharmaceutical dosage form including a drug and adapted to release the drug over an extended period of time. The dosage form comprises a capsule including a non-compressed bi-layer formulation; one layer comprising a drug release layer and the other a buoyant or floating layer, the pharmaceutical dosage form providing extended gastric residence time of the bi-layer formulation so that substantially all of the drug is released in the stomach over an extended period. The dosage form has a large diameter in relation to its size and an initial density of less than 1. The floating layer of the described pharmaceutical dosage form is formulated to provide buoyancy to the dosage form and diametral increase, the floating layer including a polymer which has the properties of a gelling agent and which upon contact with gastric fluid hydrates and forms a gelatinous barrier. The pharmaceutical dosage form is buoyant in gastric fluid for a period up to about 13 hours.

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First Claim