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US 9,801,828 B2Granted
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.
Claims19
An oral dosage form comprising:
- an opioid agonist selected from the group consisting of hydrocodone, hydromorphone, morphine, oxycodone, oxymorphone, and pharmaceutically acceptable salts thereof, and
- naltrexone hydrochloride sequestered such that 0.5 mg or more of naltrexone is released at 1 hour from the oral dosage form that is crushed, as measured by USP Type II (paddle) apparatus at 75 rpm at 37 ° C. in 900 ml of Simulated Gastric Fluid, but is substantially non-releasable from the oral dosage form that is administered orally intact,
- wherein naltrexone hydrochloride is coated with a coating comprising a sequestering material, and
- the coating separates the naltrexone hydrochloride from the opioid agonist.
1 more element
An oral dosage form comprising:
- an opioid agonist selected from the group consisting of hydrocodone, hydromorphone, morphine, oxycodone, oxymorphone, and pharmaceutically acceptable salts thereof,
- naltrexone hydrochloride sequestered such that from 0.025 mg to 0.125 mg of naltrexone is released at 1 hour from an intact dosage form in 900 ml of Simulated Gastric Fluid, as measured by USP Type II (paddle) apparatus at 75 rpm at 37 ° C., and
- a pharmaceutically acceptable hydrophobic material,
- wherein the pharmaceutically acceptable hydrophobic material separates the opioid agonist from naltrexone hydrochloride.
1 more element
Dependencies are inferred from the claim text.