Immediate release tablet cores of acetaminophen having sustained-release coating
AssigneeEuro-Celtique S.A.
InventorsBenjamin Oshlack, Mark Chasin
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Abstract
A controlled release tablet for oral administration is disclosed which has a tablet core including an insoluble therapeutically active agent having an aqueous solubility of less than or equal to about 5 mg/ml in a sufficient amount to render a therapeutic effect. The core provides rapid release of said therapeutically active agent upon exposure to aqueous solutions. The tablet core is coated with a controlled release coating permitting sustained release of said therapeutically active agent when said coated tablet is exposed to aqueous solutions.
Claims16
A sustained release tablet for oral administration, comprising an immediate release tablet core containing a sufficient amount of acetaminophen to render a therapeutic effect, and a film coating formed over said core, said film coating comprising a sufficient amount of a hydrophobic material selected from the group consisting of waxes, shellac, zein, fatty alcohols, hydrogenated vegetable oils, water insoluble celluloses, acrylic polymers and mixtures thereof to provide a sustained release of said therapeutically active agent sufficient to provide a duration of effect from about 8 to about 24 hours when said coated tablet is exposed to aqueous solutions.
A sustained release tablet for oral administration, comprising an immediate release tablet core including a sufficient amount of acetaminophen to render a therapeutic effect, said tablet core coated with a sustained release film coating comprising a hydrophobic material selected from the group consisting of waxes, shellac, zein, fatty alcohols, hydrogenated vegetable oils, water insoluble celluloses, acrylic polymers and mixtures thereof permitting a dissolution rate in vitro of the acetaminophen dosage form, when measured by the USP Paddle Method at 100 rpm in 900 ml aqueous buffer, pH between 1.6 and about 7.2, at 37° C. between 12.5 and 42.5 % (by wt) released after 1 hour, between 45 and 56% (by wt) released after 2 hours, between 45 and 75% (by wt) released after 4 hours and between 55 and 85% (by wt) released after 6 hours, and providing a duration of effect of from about 8 to about 24 hours.
Dependencies are inferred from the claim text.