Patent ID: 6103261
Filing Date: 2000-08-15
Classification: A61K,A61P

Abstract:
A solid, controlled release, oral dosage form, the dosage form comprising an analgesically effective amount of an opioid analgesic or a salt thereof said opioid analgesic being contained in a controlled-release matrix, wherein the dissolution rate in-vitro of the dosage form, when measured by the USP Paddle Method of U.S. Pharmacopeia XXII (1990) at 100 rpm at 900 ml aqueous buffer at pH 1.6 and 7.2 and at 37.degree. C. is from about 12.5% to about 42.5% (by wt) opioid released after 1 hour, from about 25% to about 65% (by wt) opioid released after 2 hours, from about 45% to about 85% (by wt) opioid released after 4 hours and greater than 60% (by wt) opioid released after 8 hours, the in-vitro release rate being substantially independent of pH in that a difference, at any given time, between an amount of opioid released at one pH and an amount released at any other pH, when measured in-vitro using the USP Paddle Method of U.S. Pharmacopeia XXII (1990) at 100 rpm in 900 ml aqueous buffer is no greater than 10%, the in-vitro release rate being chosen such that the peak plasma level of said opioid obtained in-vivo occurs at least 4 to about 8 hours after administration of the dosage form, said dosage form providing a duration of therapeutic effect of about 24 hours.