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Claims for Patent: 8,470,361

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Claims for Patent: 8,470,361

Title:Non-abusable pharmaceutical composition comprising opioids
Abstract: There is provided pharmaceutical compositions for the treatment of pain comprising a pharmacologically-effective amount of an opioid analgesic, or a pharmaceutically-acceptable salt thereof, presented in particulate form upon the surfaces of carrier particles comprising a pharmacologically-effective amount of an opioid antagonist, or a pharmaceutically-acceptable salt thereof, which carrier particles are larger in size than the particles of the opioid analgesic. The compositions are also useful in prevention of opioid abuse by addicts.
Inventor(s): Pettersson; Anders (Uppsala, SE)
Assignee: Orexo AB (Uppsala, SE)
Application Number:12/312,995
Patent Claims: 1. A particulate transmucosal pharmaceutical composition in the form of a tablet suitable for sublingual administration comprising a pharmacologically-effective amount of an opioid analgesic, or a pharmaceutically-acceptable salt thereof, presented in particulate form upon the surfaces of carrier particles comprising a pharmacologically-effective amount of an opioid antagonist, or a pharmaceutically-acceptable salt thereof, which carrier particles are larger in size than the particles of the opioid analgesic, wherein both of said opioid analgesic and said opioid antagonist are delivered transmucosally, wherein the dose of opioid analgesic active ingredient per unit dosage form is in the range of between about 1 .mu.g and about 20 mg, and the dose of opioid antagonist active ingredient per unit dosage form is in the range of between about 0.1 mg and about 4 mg, and wherein the opioid analgesic is selected from the group consisting of fentanyl, alfentanil, sufentanil, remifentanil and buprenorphine, and the opioid antagonist is selected from the group consisting of nalmefene, methylnaltrexone, naltrexone and naloxone.

2. The particulate transmucosal pharmaceutical composition of claim 1, wherein the opioid analgesic is in the form of microparticles.

3. The particulate transmucosal pharmaceutical composition of claim 1, wherein the carrier particles are of a size that is between about 50 and about 1,000 .mu.m.

4. The particulate transmucosal pharmaceutical composition of claim 1, which further comprises a bioadhesion or a mucoadhesion promoting agent, which agent is, at least in part, presented on the surfaces of the carrier particles.

5. The particulate transmucosal pharmaceutical composition of claim 4, wherein the amount of bioadhesion or mucoadhesion promoting agent present is in the range of about 0.1 to about 25% by weight based upon the total weight of the composition.

6. The particulate transmucosal pharmaceutical composition of claim 4, wherein the bioadhesion or mucoadhesion promoting agent has a particle size in the range of about 1 to about 100 .mu.m.

7. The particulate transmucosal pharmaceutical composition of claim 1, wherein the carrier particles further comprise a carbohydrate, a pharmaceutically-acceptable inorganic salt or a polymer.

8. The particulate transmucosal pharmaceutical composition of claim 1, wherein the relative sizes and amounts of the particles of opioid analgesic and the carrier particles that are employed are sufficient to ensure that the carrier particles are at least about 90% covered by the opioid analgesic particles.

9. The particulate transmucosal pharmaceutical composition of claim 1, wherein the composition further comprises a disintegrating agent.

10. The particulate transmucosal pharmaceutical composition of claim 9, wherein the disintegrating agent is selected from the group consisting of crosslinked polyvinylpyrrolidone, carboxymethyl starch, natural starch and mixtures thereof, wherein the amount of disintegrating agent is between about 2 and about 7% by weight based upon the total weight of the composition.

11. A method which comprises administration of the composition of claim 1 to a patient.

12. The method of claim 11, wherein said patient is suffering from or susceptible to pain.

13. The method of claim 12, wherein said pain is selected from the group consisting of severe pain, acute pain and breakthrough pain.

14. The method of claim 11, wherein said composition is resistant to abuse by an opioid addict.

15. The method of claim 11, wherein said patient is an opioid addict.

16. A method of reversing one or more of the pharmacological effects of an opioid analgesic, which method comprises providing for transmucosal administration to a patient the composition of claim 1.

17. The method of claim 16 wherein the pharmacological effect is euphoria.

18. A method of reversing the euphoric effects that may be produced by injection of a composition comprising an opioid analgesic, which method comprises providing for transmucosal administration to a patient the composition of claim 1.

19. A method of treating narcotic drug overdose or diagnosing suspected opioid addiction, which method comprises administering the composition of claim 1 to a patient.
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