Method of preventing abuse of opioid dosage forms
First Claim
1. A method of reducing the abuse potential of a sustained release oral dosage form of an opioid analgesic, comprisingcombining an analgesically effective amount of an orally active opioid agonist together with an opioid antagonist and a sustained release carrier into an oral dosage form;
- said dosage form providing a release of said opioid analgesic for about 12 to about 24 hours;
said opioid agonist/antagonist combination being chosen such that the opioid agonist and opioid antagonist are only extractable from the dosage form together, and at least a two-step extraction process is required to separate the opioid antagonist from the opioid agonist, the amount of opioid antagonist included being sufficient to counteract opioid effects if extracted together from the oral dosage form together with the opioid agonist and administered parenterally.
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Abstract
The invention relates in part to a method of reducing the abuse potential of an oral dosage form of an opioid analgesic, wherein an analgesically effective amount of an orally active opioid agonist is combined with an opioid antagonist into an oral dosage form which would require at least a two-step extraction process to be separated from the opioid agonist, the amount of opioid antagonist including being sufficient to counteract opioid effects if extracted together with the opioid agonist and administered parenterally.
357 Citations
23 Claims
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1. A method of reducing the abuse potential of a sustained release oral dosage form of an opioid analgesic, comprising
combining an analgesically effective amount of an orally active opioid agonist together with an opioid antagonist and a sustained release carrier into an oral dosage form; -
said dosage form providing a release of said opioid analgesic for about 12 to about 24 hours;
said opioid agonist/antagonist combination being chosen such that the opioid agonist and opioid antagonist are only extractable from the dosage form together, and at least a two-step extraction process is required to separate the opioid antagonist from the opioid agonist, the amount of opioid antagonist included being sufficient to counteract opioid effects if extracted together from the oral dosage form together with the opioid agonist and administered parenterally. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23)
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Specification