Tamper resistant oral opioid agonist formulations
AssigneePurdue Pharma L.P.
InventorsBenjamin Oshlack, Curtis Wright, J. David Haddox
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Abstract
Oral dosage forms containing an opioid antagonist in a sequestered form are described. The opioid antagonist is sequestered such that it is not released or substantially not released in the gastrointestinal tract from the dosage form which is administered orally intact. However, when the dosage form is chewed, crushed, heated or dissolved in a solvent, and then administered orally, intranasally, parenterally or sublingually, the opioid antagonist is released and at least partially blocks effects of the opioid agonist.
Claims20
An oral dosage form comprising:
- an opioid agonist, and
- multiparticulates comprising an opioid antagonist and a sequestering material, the sequestering material separating the opioid antagonist from the opioid agonist,
- wherein the multiparticulates are dispersed in a matrix comprising the opioid agonist, and the opioid antagonist is substantially not releasable from the dosage form which is administered orally intact such that the dosage form releases not more than 12.5% of the opioid antagonist at 1 hour when administered orally intact, and
- the opioid antagonist is naltrexone hydrochloride.
A method of preparing an oral dosage form comprising pretreating an opioid antagonist to render it substantially non-releasable;
- and combining the pretreated antagonist with a releasable form of an opioid agonist, wherein the pretreated opioid antagonist is in the form of multiparticulates comprising the opioid antagonist and a sequestering material, the sequestering material separating the opioid antagonist from the opioid agonist such that the oral dosage form releases not more than 12.5% of the opioid antagonist at 1 hour when administered orally intact.
Dependencies are inferred from the claim text.