Abuse-resistant controlled-release opioid dosage form
AssigneePurdue Pharma L.P.
InventorsFrank S. Caruso, Huai-Hung Kao
Life of this patent
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Abstract
Abuse-resistant, controlled release opioid tablets are a combination containing an opioid antagonist such as naloxone at a level above that needed to suppress the euphoric effect of the opioid, if the combination were crushed to break the controlled release properties causing the opioid and opioid antagonist to be released as a immediate release product as a single dose. The controlled release nature of the table prevents the accumulation of orally effective amounts of opioid antagonist when taken normally. The opioid antagonist is contained in a controlled-release matrix and released, over time, with the opioid.
Claims30
An oral controlled release pharmaceutical composition comprising:
- oxycodone;
- and
- naloxone;
- wherein the oxycodone and the naloxone are present in a ratio of 5:1 to 1:1;
- and
- wherein the composition releases the naloxone and the oxycodone such that at least 87.5% of the naloxone is released from the composition over 8-12 hours.
An oral controlled release pharmaceutical composition comprising:
- oxycodone hydrochloride;
- and
- 2-40 mg of a pharmaceutically acceptable salt of naloxone;
- wherein the oxycodone hydrochloride and the pharmaceutically acceptable salt of naloxone are present in a ratio of 4:1 to 1:1;
- wherein the composition releases the pharmaceutically acceptable salt of naloxone and the oxycodone hydrochloride such that at least 87.5% of the pharmaceutically acceptable salt of naloxone is released from the composition over 8-12 hours.
An oral controlled release pharmaceutical composition comprising:
- oxycodone;
- and
- 2-40 mg of naloxone;
- wherein the oxycodone and the naloxone are present in a ratio of 5:1 to 1:1;
- and
- wherein composition releases the naloxone and the oxycodone such that
- 20-30% of the oxycodone and 20-30% of the naloxone are released from the composition over 1 hour;
- 60-70% of the oxycodone and 60-70% of the naloxone are released from the composition over 4 hours;
- and
- >90% of the oxycodone and >90% of the naloxone are released from the composition over 10 hours.
Dependencies are inferred from the claim text.