tamper resistant agonist opioid formulas, method for reducing abuse of an agonist opioid in an oral dosage formula, method of preparing an oral dosage formula and method of treating pain

摘要

"Tamper Resistant Agonist Opioid Formulas, Method for Reducing Abuse of an Agonist Opioid in an Oral Dosage Formula, Method of Preparation of an Oral Dosage Formula, and Pain Treatment Method". said oral dosage formula comprising (i) a releasable agonist opioid and (ii) a sequestered antagonist opioid which is substantially unreleased when the dosage formula is administered intact such that the proportion of the amount of said released antagonist of said formula after adulteration for the amount of said agonist released from said intact dosage formula is about 4: 1 or greater, based on 1 hour in vitro dissolution of said dosage formula in 900 ml simulated gastric fluid using a type ii (paddle) apparatus at 75rpm and 37Â ° C, characterized in that said agonist and antagonist are interdispersed and are not isolated from one another in two distinct layers. the method for decreasing abuse of an opioid containing incorporation of said agonist opioid into a dosage form defined above. the method of preparation comprising pretreatment of an antagonist opioid to make it substantially non-releasable; and combining the pretreated antagonist with a releasable form of an agonist opioid. the method of treating pain comprising administering to a human patient a dosage form defined above.