Patent ID: 8236351

Claim:
An oral dosage form comprising (i) an opioid agonist, and (ii) a sequestered opioid antagonist composition comprising an opioid antagonist and a hydrophobic material in an amount which substantially prevents release of the opioid antagonist from the dosage form which has been orally administered intact, wherein the opioid agonist is coated over the sequestered opioid antagonist composition and is separated from the opioid antagonist by the hydrophobic material, such that an amount of the opioid antagonist released from the dosage form which has been orally administered intact is less than 0.125 mg of naltrexone, based on an in-vitro dissolution at 1 hour of the dosage form in 900 ml of Simulated Gastric Fluid using a USP Type II (paddle) apparatus at 75 rpm at 37° C., when the opioid antagonist is naltrexone or a pharmaceutically acceptable salt thereof, or less than an amount bioequivalent to 0.125 mg of naltrexone, when the dosage form comprises a different opioid antagonist, and an amount of the opioid antagonist released from the dosage form which has been subjected to tampering is 0.25 mg or more of naltrexone, based on the in-vitro dissolution at 1 hour of the dosage form in 900 ml of Simulated Gastric Fluid using a USP Type II (paddle) apparatus at 75 rpm at 37° C., when the opioid antagonist is naltrexone or a pharmaceutically acceptable salt thereof, or an amount bioequivalent to 0.25 mg or more of naltrexone, when the dosage form comprises a different opioid antagonist.