Patent ID: 7740881
Filing Date: 2010-06-22
Classification: A61K

Abstract:
1. A method for treating pain in humans for a time period of about 24 hours, comprising administering to a human patient at a dosing interval of about 24 hours a solid, controlled-release oral dosage form comprising 8 to 64 mg of hydromorphone or a pharmaceutically acceptable salt thereof incorporated into a controlled-release formulation comprising a tablet overcoated with a controlled-release coating derived from an aqueous dispersion of a hydrophobic polymer selected from the group consisting of a cellulosic polymer, an acrylic polymer, and mixtures thereof, wherein the coating has been stabilized by curing for about 24 hours or more at a temperature greater than the glass transition temperature of the hydrophobic polymer and a relative humidity from about 60% to about 100% such that the dosage form attains a dissolution profile which is substantially unaffected by exposure to storage conditions of at least one month at a temperature of 40° C. and a relative humidity of 75%, wherein (i) 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° C., is such that from 12.5% to 42.5% (by wt) hydromorphone is released after 1 hour, from 25% to 65% (by wt) hydromorphone is released after 2 hours, from 45% to 85% (by wt) hydromorphone is released after 4 hours and greater than 60% (by wt) hydromorphone is released after 8 hours, and (ii) the in-vitro release rate is substantially independent of pH in that a difference, at any given time, between an amount of hydromorphone 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 dosage form providing a duration of therapeutic effect of at least 24 hours and a mean C