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Details for Patent: 9,034,376

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Details for Patent: 9,034,376

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:Aug 14, 2014
Application Number:14/460,134
Claims:1. A controlled release oral solid dosage form comprising: a controlled release matrix comprising a mixture of (i) from 2.5 mg to 320 mg oxycodone or a pharmaceutically acceptable salt thereof; and (ii) a gelling agent comprising polyethylene oxide and hydroxypropylmethylcellulose, the gelling agent in an effective amount to impart a viscosity of at least 10 cP when the dosage form is subjected to tampering by dissolution in from 0.5 to 10 ml of an aqueous liquid; the controlled release matrix providing a therapeutic effect for at least 12 hours when orally administered to a human patient.

2. The controlled release oral solid dosage form of claim 1, wherein the gelling agent is in an effective amount to impart a viscosity of at least 60 cP when the dosage form is subjected to tampering by dissolution in from 0.5 to 10 ml of an aqueous liquid.

3. The controlled release oral solid dosage form of claim 1, wherein the gelling agent is in an effective amount to impart a viscosity of at least 120 cP when the dosage form is subjected to tampering by dissolution in from 0.5 to 10 ml of an aqueous liquid.

4. The controlled release oral solid dosage form of claim 1, wherein the gelling agent is in an effective amount to impart a viscosity of at least 375 cP when the dosage form is subjected to tampering by dissolution in from 0.5 to 10 ml of an aqueous liquid.

5. The controlled release oral solid dosage form of claim 1, wherein the gelling agent is in an effective amount to impart a viscosity of at least 2,000 cP when the dosage form is subjected to tampering by dissolution in from 0.5 to 10 ml of an aqueous liquid.

6. The controlled release oral solid dosage form of claim 1, wherein the gelling agent is in an effective amount to impart a viscosity from 120 cP to 5,000 cP when the dosage form is subjected to tampering by dissolution in from 0.5 to 10 ml of an aqueous liquid.

7. The controlled release oral solid dosage form of claim 3, wherein the ratio of gelling agent to oxycodone or pharmaceutically acceptable salt thereof is from 1:40 to about 40:1.

8. The controlled release oral solid dosage form of claim 3, wherein the aqueous liquid is water.

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

10. The controlled release oral solid dosage form of 3, wherein the oxycodone or pharmaceutically acceptable salt thereof comprises oxycodone hydrochloride.

11. The controlled release oral solid dosage form of claim 10, comprising from 10 mg to 80 mg oxycodone hydrochloride.

12. The controlled release oral solid dosage form of claim 3, wherein the viscosity is obtained when the dosage form is subjected to tampering by dissolution in the aqueous liquid after crushing.

13. The controlled release oral solid dosage form of claim 3, wherein the viscosity is obtained when the dosage form is subjected to tampering by dissolution in the aqueous liquid with heating at greater than 45 .degree. C.

14. The controlled release oral solid dosage form of claim 3, further comprising acetaminophen.

15. The controlled release oral solid dosage form of claim 3, further comprising ibuprofen.

16. The controlled release oral solid dosage form of claim 1, without a semipermeable wall.

17. The controlled release oral solid dosage form of claim 1, further comprising a film coat.

18. A controlled release oral solid dosage form comprising: a controlled release matrix comprising a mixture of (i) from 2.5 mg to 320 mg oxycodone or a pharmaceutically acceptable salt thereof; and (ii) a gelling agent comprising polyethylene oxide and hydroxypropylmethylcellulose, the gelling agent in an effective amount to impart a viscosity unsuitable for parenteral administration when the dosage form is subjected to tampering by dissolution in from 0.5 to 10 ml of an aqueous liquid; the oral solid dosage form does not comprise a semipermeable wall, the controlled release matrix providing a therapeutic effect for at least 12 hours when orally administered to a human patient.

19. A controlled release oral solid dosage form comprising: a controlled release matrix comprising a mixture of (i) from 2.5 mg to 320 mg oxycodone or a pharmaceutically acceptable salt thereof; and (ii) a gelling agent comprising polyethylene oxide and hydroxypropylmethylcellulose, the gelling agent in an effective amount to impart a viscosity unsuitable to pull into an insulin syringe when the dosage form is subjected to tampering by dissolution in from 0.5 to 10 ml of an aqueous liquid; the oral solid dosage form does not comprise a semipermeable wall, the controlled release matrix providing a therapeutic effect for at least 12 hours when orally administered to a human patient.
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