abstract |
Disclosed is an oral dosage form comprising: (i) an opioid agonist in releasable form, and (ii) a sequestered opioid antagonist that is substantially not released when the dosage form is administered intact, such that the ratio of the amount of antagonist released from the dosage form after tampering to the amount of antagonist released from the intact dosage form is about 4:1 or greater, based on the in-vitro dissolution at 1 hour of the dosage form in 900ml of Simulated Gastric Fluid using a USP Type II (paddle) apparatus at 75 rpm at 37 degrees C. The above dosage form provides for methods for preventing abuse of an oral opioid dosage form by having the opioid antagonist interfere with the effect of the opioid agonist if the dosage form is tampered with. |