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Details for Patent: 9,044,435

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Details for Patent: 9,044,435

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 (Bethesda, MD)
Assignee: Purdue Pharma L.P. (Stamford, CT) The P.F. Laboratories, Inc. (Totowa, NJ) Purdue Pharmaceuticals L.P. (Wilson, NC)
Filing Date:Sep 11, 2014
Application Number:14/484,077
Claims:1. A controlled release oral solid dosage form comprising particles comprising: (i) hydrocodone or a pharmaceutically acceptable salt thereof; (ii) a gelling agent comprising hydroxypropylmethylcellulose; (iii) ethylcellulose; and (iii) a glyceryl ester of a fatty acid; wherein the particles are overcoated with a controlled release material comprising ethylcellulose; the oral solid dosage form providing a therapeutic effect for at least about 12 hours when orally administered to a human patient and the oral solid dosage form when subjected to tampering by dissolution in from about 0.5 ml to about 10 ml of an aqueous liquid provides a viscosity of at least about 10 cP.

2. The controlled release oral solid dosage form of claim 1, providing a viscosity of at least about 60 cP.

3. The controlled release oral solid dosage form of claim 1, providing a viscosity of at least about 120 cP.

4. The controlled release oral solid dosage form of claim 1, providing a viscosity of at least about 375 cP.

5. The controlled release oral solid dosage form of claim 1, providing a viscosity of at least about 2,000 cP.

6. The controlled release oral solid dosage form of claim 1, providing a viscosity from about 120 cP to about 5,000 cP.

7. The controlled release oral solid dosage form of claim 1, comprising hydrocodone bitartrate.

8. The controlled release oral solid dosage form of claim 7, comprising from about 75 ng to about 750 mg hydrocodone bitartrate.

9. The controlled release oral solid dosage form of claim 7, comprising from about 2 mg to about 50 mg hydrocodone bitartrate.

10. The controlled release oral solid dosage form of claim 1, in the form of a tablet.

11. The controlled release oral solid dosage form of claim 1, wherein the particles are in granular form.

12. The controlled release oral solid dosage form of claim 11, wherein the coated particles are compressed into a tablet.

13. The controlled release oral solid dosage form of claim 12, wherein the tablet further comprising a pharmaceutically acceptable excipient.

14. The controlled release oral solid dosage form of claim 2, wherein the ratio of gelling agent to hydrocodone or pharmaceutically acceptable salt thereof is from about 1:40 to about 40:1.

15. The controlled release oral solid dosage form of claim 2, wherein the aqueous liquid is water.

16. The controlled release oral solid dosage form of claim 2, wherein the viscosity is provided when the dosage form is subjected to tampering by dissolution in about 1 ml to about 3 ml of aqueous liquid.

17. The controlled release oral solid dosage form of claim 2, wherein the viscosity is provided when the dosage form is subjected to tampering by dissolution and crushing in the aqueous liquid.

18. The controlled release oral solid dosage form of claim 2, wherein the viscosity is provided when the dosage form is subjected to tampering by dissolution in the aqueous liquid with heating at a temperature of greater than 45.degree. C.

19. The controlled release oral solid dosage form of claim 2, further comprising acetaminophen.

20. The controlled release oral solid dosage form of claim 2, further comprising ibuprofen.
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