Patent ID: 6024982
Filing Date: 2000-02-15
Classification: A61K

Abstract:
A method for preparing an oral, sustained release formulation of an insoluble, therapeutically active agent, comprisingcoating an immediate release tablet core including acetaminophen in an amount sufficient to render a therapeutic effect with a controlled release coating on the tablet core comprising a hydrophobic material such that said formulation reproducibly provides a dissolution rate in-vitro of the 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.degree. C. between 12.5 and 42.5 (by wt) released after 1 hour, between 25 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.