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Claims for Patent: 9,283,216

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Claims for Patent: 9,283,216

Title:Abuse-resistant controlled-release opioid dosage form
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.
Inventor(s): Caruso; Frank S. (Colts Neck, NJ), Kao; Huai-Hung (Syosset, NY)
Assignee: Purdue Pharma L.P. (Stamford, CT)
Application Number:14/859,195
Patent Claims: 1. 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 45.4-78% of the naloxone is released from the composition over 2 hours.

2. The pharmaceutical composition of claim 1, wherein the oxycodone is present in an amount of 10-160 mg.

3. The pharmaceutical composition of claim 1, wherein the oxycodone is present in an amount of 10-80 mg.

4. The pharmaceutical composition of claim 1, wherein the oxycodone is present in an amount of 10-40 mg.

5. The pharmaceutical composition of claim 1, wherein the oxycodone is present in an amount of 10 mg and the naloxone is present in an amount of 2-10 mg.

6. The pharmaceutical composition of claim 1, wherein the oxycodone is present in an amount of 20 mg and the naloxone is present in an amount of 5-20 mg.

7. The pharmaceutical composition of claim 1, wherein the oxycodone is present in an amount of 40 mg and the naloxone is present in an amount of 8-40 mg.

8. The pharmaceutical composition of claim 1, wherein the oxycodone is present in an amount of 80 mg and the naloxone is present in an amount of 16-80 mg.

9. The pharmaceutical composition of claim 1, wherein the naloxone is present in an amount of 2-160 mg.

10. The pharmaceutical composition of claim 1, wherein the naloxone is present in an amount of 2-40 mg.

11. The pharmaceutical composition of claim 1, wherein the naloxone is present in an amount of 5-20 mg.

12. The pharmaceutical composition of claim 1, wherein the oxycodone and the naloxone are present in a ratio of 4:1 to 1:1.

13. The pharmaceutical composition of claim 1, wherein the oxycodone is in the form of oxycodone hydrochloride.

14. The pharmaceutical composition of claim 1, wherein the naloxone is in the form of a pharmaceutically acceptable salt thereof.

15. The pharmaceutical composition of claim 1, wherein the release rate of the naloxone is approximately 100 percent to approximately 25 percent of the release rate of the oxycodone.

16. The pharmaceutical composition of claim 1, wherein the release rate of the naloxone is approximately 100 percent of the release rate of the oxycodone.

17. The pharmaceutical composition of claim 1, wherein >90% of the oxycodone is released from the composition over 10 hours.

18. The pharmaceutical composition of claim 1, wherein >90% of the naloxone is released from the composition over 10 hours.

19. The pharmaceutical composition of claim 1, wherein the oxycodone and the naloxone are released over a period greater than 4 hours.

20. The pharmaceutical composition of claim 1, wherein the composition further comprises a controlled release matrix that contains the oxycodone and the naloxone.

21. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition is in the form of a tablet.

22. The pharmaceutical composition of claim 1, wherein the naloxone is not readily separable from the oxycodone.

23. The pharmaceutical composition of claim 1, wherein sufficient naloxone is released to block the opioid euphoric effect when the pharmaceutical composition is crushed.

24. The pharmaceutical composition of claim 1, wherein the naloxone is released as immediate release capable of inducing withdrawal in dependent individuals if the pharmaceutical composition is crushed and the controlled release properties broken.

25. The pharmaceutical composition of claim 1, wherein the naloxone is released at a rate ineffective for inducing withdrawal when the pharmaceutical composition is taken orally in intact form.

26. The pharmaceutical composition of claim 1, wherein the release of the naloxone does not block the action of the oxycodone when the controlled release properties are intact.

27. A method of treating pain comprising administering to a patient in need thereof the pharmaceutical composition of claim 1.

28. 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 45.4-78% of the pharmaceutically acceptable salt of naloxone is released from the composition over 2 hours.

29. The pharmaceutical composition of claim 28, wherein the oxycodone is present in an amount of 10, 20, 40, or 80 mg.

30. The pharmaceutical composition of claim 28, wherein the release rate of the naloxone is approximately 100 percent of the release rate of the oxycodone.
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