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Details for Patent: 8,389,007

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Details for Patent: 8,389,007

Title:Pharmaceutical composition containing gelling agent
Abstract: Disclosed in certain embodiments is a controlled release oral dosage form comprising a therapeutically effective amount of a drug susceptible to abuse together with one or more pharmaceutically acceptable excipients; the dosage form further including a gelling agent in an effective amount to impart a viscosity unsuitable for administration selected from the group consisting of parenteral and nasal administration to a solubilized mixture formed when the dosage form is crushed and mixed with from about 0.5 to about 10 ml of an aqueous liquid; the dosage form providing a therapeutic effect for at least about 12 hours when orally administered to a human patient.
Inventor(s): Wright; Curtis (Rockport, MA), Oshlack; Benjamin (Boca Raton, FL), Breder; Christopher (Bethesda, MD)
Assignee: Purdue Pharma L.P. (Stamford, CT) The P.F. Laboratories, Inc. (Totowa, NJ) Purdue Pharmaceuticals, L.P. (Wilson, NC)
Filing Date:Oct 30, 2008
Application Number:12/262,015
Claims:1. A tamper-resistant immediate release pharmaceutical tablet comprising a compressed mixture comprising: (a) oxycodone hydrochloride; (b) polyethylene oxide in a ratio to oxycodone hydrochloride from about 1:1 to about 40:1 by weight; (c) polyvinylpyrrolidone; and (d) a surfactant; wherein the polyethylene oxide forms a gel upon tampering with the tablet by solvent extraction such that when the tampered tablet is dissolved in about 1 ml to about 5 ml of an aqueous liquid the resultant mixture has a viscosity of at least 10 cP.

2. A tamper-resistant immediate release pharmaceutical tablet according to claim 1, comprising from about 5 mg to about 20 mg oxycodone hydrochloride.

3. A tamper-resistant immediate release pharmaceutical tablet according to claim 1, wherein the surfactant is sodium lauryl sulfate.

4. A tamper-resistant immediate release pharmaceutical tablet according to any one of claims 1 to 3, wherein the polyethylene oxide possesses a weight-average molecular weight of about 1,000,000 to about 10,000,000.

5. A tamper-resistant immediate release pharmaceutical tablet according to claim 4, wherein the polyethylene oxide possesses a weight-average molecular weight of about 1,000,000 to about 7,000,000.

6. A tamper-resistant immediate release pharmaceutical tablet according to claim 4, wherein the polyethylene oxide possesses a weight-average molecular weight of about 5,000,000.

7. A tamper-resistant immediate release pharmaceutical tablet according to any one of claims 1 to 3 comprising about 5 mg oxycodone hydrochloride.

8. A tamper-resistant immediate release pharmaceutical tablet of any one of claims 1 to 3, wherein the resultant mixture has a viscosity of at least 60 cP.

9. A tamper-resistant immediate release pharmaceutical tablet according to any one of claims 1 to 3, further comprising a film coating overcoated on the compressed mixture.

10. A tamper-resistant immediate release pharmaceutical tablet according to any one of claims 1-3, wherein the tablet does not comprise an opioid antagonist.

11. The tamper-resistant immediate release pharmaceutical tablet according to any one of claims 1-3, wherein the tablet imparts an irritating sensation to an abuser upon nasal administration of the tablet after tampering.

12. A tamper-resistant immediate release pharmaceutical tablet of claim 1, consisting of a compressed mixture consisting of: (a) oxycodone hydrochloride; (b) polyethylene oxide having a weight-average molecular weight of about 1,000,000 to about 10,000,000 in a ratio to oxycodone hydrochloride from about 1:1 to about 40:1 by weight; (c) polyvinylpyrrolidone; and (d) sodium lauryl sulfate.

13. A tamper-resistant immediate release pharmaceutical tablet of claim 9, consisting of (I) a compressed mixture consisting of: (a) oxycodone hydrochloride; (b) polyethylene oxide having a weight-average molecular weight of about 1,000,000 to about 10,000,000 in a ratio to oxycodone hydrochloride from about 1:1 to about 40:1 by weight; (c) polyvinylpyrrolidone; (d) sodium lauryl sulfate; and (II) a film coating overcoated on the compressed mixture.

14. The tamper-resistant immediate release pharmaceutical tablet according to any one of claims 1-3, wherein the polyethylene oxide: oxycodone hydrochloride ratio is from about 1:1 to about 30:1 by weight.

15. The tamper-resistant immediate release pharmaceutical tablet according to claim 14, wherein the polyethylene oxide: oxycodone hydrochloride ratio is from about 2:1 to about 10:1 by weight.

16. The tamper-resistant immediate release pharmaceutical tablet according to claim 14, wherein the polyethylene oxide: oxycodone hydrochloride ratio is from about 1:15 to about 15:1 by weight.

17. The tamper-resistant immediate release pharmaceutical tablet according to claim 14, wherein the polyethylene oxide: oxycodone hydrochloride ratio is from about 1:8 to about 8:1 by weight.

18. The tamper-resistant immediate release pharmaceutical tablet according to claim 14, wherein the polyethylene oxide: oxycodone hydrochloride ratio is from about 1:3 to about 3:1 by weight.

19. The tamper-resistant immediate release pharmaceutical tablet according to claim 14, wherein the polyethylene oxide: oxycodone hydrochloride ratio is from about 2:1 to about 30:1 by weight.

20. The tamper-resistant immediate release pharmaceutical tablet according to claim 14, wherein the polyethylene oxide: oxycodone hydrochloride ratio is from about 3:1 to about 15:1 by weight.
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