Patent ID: 7842311
Filing Date: 2010-11-30
Classification: A61K,A61P

Abstract:
1. An oral dosage form comprising (i) an opioid agonist in releasable form, and (ii) particles consisting of an opioid antagonist, a sequestering material and one or more additional pharmaceutically acceptable excipients, wherein the sequestering material separates the antagonist from the agonist and substantially prevents the release of the antagonist from the dosage form which has been administered intact such that an amount of the antagonist released at 1 and 2 hours from the dosage form which has been administered intact is undetectable by High Performance Liquid Chromatography, and less than 15% by weight of the opioid antagonist is released within 36 hours after the administration of the intact dosage form, based on an in-vitro dissolution of the intact dosage form in a dissolution bath; and a ratio of the amount of the antagonist released from the dosage form after tampering to the amount of the antagonist released from the intact dosage form is about 4:1 or greater, based on the in-vitro dissolution of the dosage form at 1 hour in 900 ml of Simulated Gastric Fluid using a USP Type II (paddle) apparatus at 75 rpm at 37 degrees C.; wherein the agonist and the particles are interdispersed and are not isolated from each other in two distinct layers.