Tamper-resistant oral opioid agonist formulations

A dosage form comprising:

• particles, the particles consisting of
• (a) an opioid antagonist;
• (b) hydrophobic means for sequestering the opioid antagonist;
• and
• (c) one or more optional pharmaceutical excipients;
• the hydrophobic means for sequestering the opioid antagonist is such that
• an amount of the opioid antagonist released from the dosage form which has been orally administered intact is less than an amount bioequivalent to 0.125 mg 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., and is insufficient to produce a physiological effect of the opioid antagonist in a human patient, and
• an amount of the opioid antagonist released from the dosage form which has been subjected to tampering is an amount bioequivalent to 0.25 mg of naltrexone or more, 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., and will produce the physiological effect;
• wherein the tampering is by crushing, shearing, grinding, chewing, dissolving in a solvent, heating, or any combination thereof;
• and
• wherein the intact dosage form releases less than 15% by weight of the opioid antagonist within 36 hours, based on the in-vitro dissolution in a dissolution bath, and the dosage form is an oral dosage form.