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Details for Patent: 7,172,767

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Details for Patent: 7,172,767

Title:Opioid agonist / antagonist combinations
Abstract: The invention is directed in part to oral dosage forms comprising a combination of an orally analgesically effective amount of an opioid agonist and an orally active opioid antagonist, the opioid antagonist being included in a ratio to the opioid agonist to provide a combination product which is analgesically effective when the combination is administered orally, but which is aversive in a physically dependent subject. Preferably, the amount of opioid antagonist included in the combination product provides at least a mildly negative, "aversive" experience in physically dependent addicts (e.g., precipitated abstinence syndrome).
Inventor(s): Kaiko; Robert F. (Weston, CT), Colucci; Robert D. (Newtown, CT)
Assignee: Purdue Pharma L.P. (Norwalk, CT)
Filing Date:Oct 27, 2003
Application Number:10/694,559
Claims:1. A solid oral dosage form, comprising a combination of an opioid agonist and naltrexone or a pharmaceutically acceptable salt thereof; wherein the combination is orally therapeutically effective for the treatment of pain and is selected from the group consisting of: naltrexone or a pharmaceutically acceptable salt thereof and hydrocodone or a pharmaceutically acceptable salt thereof, in a weight ratio of from about 0.03:1 to about 0.27:1; naltrexone or a pharmaceutically acceptable salt thereof and oxycodone or a pharmaceutically acceptable salt thereof, in a weight ratio of from about 0.037:1 to about 0.296:1; naltrexone or a pharmaceutically acceptable salt thereof and hydromorphone or a pharmaceutically acceptable salt thereof, in a weight ratio of from about 0.148:1 to about 1.185:1; naltrexone or a pharmaceutically acceptable salt thereof and levorphanol or a pharmaceutically acceptable salt thereof, in a weight ratio of from about 0.278:1 to about 2.222:1; naltrexone or a pharmaceutically acceptable salt thereof and morphine or a pharmaceutically acceptable salt thereof, in a weight ratio of from about 0.018:1 to about 0.148:1.

2. The oral dosage form of claim 1, wherein the opioid agonist is hydrocodone or a pharmaceutically acceptable salt thereof.

3. The oral dosage form of claim 2, wherein the ratio of naltrexone or pharmaceutically acceptable salt thereof to hydrocodone or pharmaceutically acceptable salt thereof is from about 0.05:1 to about 0.20:1.

4. The oral dosage form of claim 1, further comprising an additional non-opioid drug selected from the group consisting of an NSAID, a COX-2 inhibitor, acetaminophen, aspirin, an NMDA receptor antagonist, a drug that blocks a major intracellular consequence of NMDA-receptor activation, an antitussive, an expectorant, a decongestant, an antihistamine and mixtures thereof.

5. The oral dosage form of claim 1, further comprising one or more pharmaceutically acceptable inert excipients.

6. The oral dosage form of claim 1, wherein said naltrexone or pharmaceutically acceptable salt thereof is naltrexone hydrochloride.

7. The oral dosage form of claim 1, further comprising a sustained release carrier which imparts sustained release properties to said opioid agonist.

8. The oral dosage form of claim 1, wherein said opioid agonist is oxycodone or a pharmaceutically acceptable salt thereof.

9. The oral dosage form of claim 1, wherein said opioid agonist is hydromorphone or a pharmaceutically acceptable salt thereof.

10. The oral dosage form of claim 1, wherein said opioid agonist is levorphanol or a pharmaceutically acceptable salt thereof.

11. The oral dosage form of claim 1, wherein said opioid agonist is morphine or a pharmaceutically acceptable salt thereof.

12. The oral dosage form of claim 1, wherein said opioid agonist is oxycodone or a pharmaceutically acceptable salt thereof, and the weight ratio of naltrexone or pharmaceutically acceptable salt thereof to oxycodone or pharmaceutically acceptable salt thereof is from about 0.056:1 to about 0.222:1.

13. The oral dosage form of claim 2, wherein said naltrexone or pharmaceutically acceptable salt thereof is naltrexone hydrochloride.

14. The oral dosage form of claim 8, wherein said naltrexone or pharmaceutically acceptable salt thereof is naltrexone hydrochloride.

15. The oral dosage form of claim 9, wherein said naltrexone or pharmaceutically acceptable salt thereof is naltrexone hydrochloride.

16. The oral dosage form of claim 10, wherein said naltrexone or pharmaceutically acceptable salt thereof is naltrexone hydrochloride.

17. The oral dosage form of claim 11, wherein said naltrexone or pharmaceutically acceptable salt thereof is naltrexone hydrochloride.

18. The oral dosage form of claim 2, wherein the opioid agonist is hydrocodone bitartrate.

19. The oral dosage form of claim 9, wherein the weight ratio of naltrexone or pharmaceutically acceptable salt thereof to hydromorphone or pharmaceutically acceptable salt thereof is from about 0.222:1 to about 0.889:1.

20. The oral dosage form of claim 10, wherein the weight ratio of naltrexone or pharmaceutically acceptable salt thereof to levorphanol or pharmaceutically acceptable salt thereof is from about 0.417:1 to about 1.667:1.

21. The oral dosage form of claim 11, wherein the weight ratio of naltrexone or pharmaceutically acceptable salt thereof to morphine or pharmaceutically acceptable salt thereof is from about 0.028:1 to about 0.111:1.
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