TAMPER-RESISTANT ORAL OPIOID AGONIST FORMULATION

摘要

PROBLEM TO BE SOLVED: To provide an opioid agonist enabling abuse inhibition.

SOLUTION: Disclosed is a dosage form comprising (i) an opioid agonist in releasable form and (ii) a sequestered opioid antagonist which 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 the antagonist released from the intact dosage form is about 4:1 or greater, based on the in vitro dissolution after 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 degrees C, wherein the agonist and antagonist are interdispersed and are not isolated from each other into two distinct layers.

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