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Details for Patent: 8,609,683

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Details for Patent: 8,609,683

Title:Pharmaceutical formulation 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 (Greenwich, CT)
Assignee: Purdue Pharma L.P. (Stamford, CT) The P.F. Laboratories, Inc. (Totowa, NJ) Purdue Pharmaceuticals L.P. (Wilson, NC)
Filing Date:May 30, 2013
Application Number:13/905,922
Claims:1. A controlled release oral dosage form comprising: from about 2.5 mg to about 800 mg morphine or a pharmaceutically acceptable salt thereof; and a gelling agent comprising polyethylene oxide in an effective amount to impart a viscosity of at least about 10 cP when the dosage form is subjected to tampering by dissolution in 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.

2. The controlled release oral dosage form of claim 1, wherein the ratio of polyethylene oxide to morphine or pharmaceutically acceptable salt thereof is from about 1:40 to about 40:1.

3. The controlled release oral dosage form of claim 1, wherein the ratio of polyethylene oxide to morphine or pharmaceutically acceptable salt thereof is from about 1:1 to about 30:1.

4. The controlled release oral dosage form of claim 1, wherein the ratio of polyethylene oxide to morphine or pharmaceutically acceptable salt thereof is from about 2:1 to about 10:1.

5. The controlled release oral dosage form of claim 1, wherein the aqueous liquid is water.

6. The controlled release oral dosage form of claim 1, wherein the viscosity is imparted when the dosage form is subjected to tampering by dissolution in about 1 to about 3 ml of aqueous liquid.

7. The controlled release oral dosage form of claim 1, wherein a viscosity of at least about 60 cP is imparted.

8. The controlled release oral dosage form of claim 1, wherein the polyethylene oxide possesses a weight-average molecular weight of from about 1,000,000 to about 10,000,000.

9. The controlled release oral dosage form of claim 8, wherein the polyethylene oxide possesses a weight-average molecular weight of from about 1,000,000 to about 7,000,000.

10. The controlled release oral dosage form of claim 8, wherein the polyethylene oxide possesses a weight-average molecular weight of about 5,000,000.

11. The controlled release oral dosage form of claim 1, wherein the morphine or pharmaceutically acceptable salt thereof comprises morphine sulfate.

12. The controlled release oral dosage form of claim 11, comprising from about 2.5 mg to about 30 mg morphine sulfate.

13. The controlled release oral dosage form of claim 11, comprising about 2.5 mg morphine sulfate.

14. The controlled release oral dosage form of claim 11, comprising about 30 mg morphine sulfate.

15. The controlled release oral dosage form of claim 11, wherein the polyethylene oxide:morphine sulfate ratio is from about 1:40 to about 40:1 by weight.

16. The controlled release oral dosage form of claim 11, wherein the polyethylene oxide:morphine sulfate ratio is from about 1:1 to about 30:1 by weight.

17. The controlled release oral dosage form of claim 11, wherein the polyethylene oxide:morphine sulfate ratio is from about 2:1 to about 10:1 by weight.

18. The controlled release oral dosage form of claim 11, wherein the polyethylene oxide:morphine sulfate ratio is from about 1:15 to about 15:1 by weight.

19. The controlled release oral dosage form of claim 11, wherein the polyethylene oxide:morphine sulfate ratio is from about 1:8 to about 8:1 by weight.

20. The controlled release oral dosage form of claim 11, wherein the polyethylene oxide:morphine sulfate ratio is from about 1:3 to about 3:1 by weight.

21. The controlled release oral dosage form of claim 1, wherein the viscosity is obtained when the dosage form is subjected to tampering by crushing and dissolution in the aqueous liquid.

22. The controlled release oral dosage form of claim 1, wherein the viscosity is obtained when the dosage form is subjected to tampering by dissolution in the aqueous liquid with heating greater than 45.degree. C.
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