Details for Patent: 9,872,836

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:	Feb 04, 2016
Application Number:	15/015,735
Claims:	1. A method of preparing an abuse deterrent controlled release dosage form comprising: preparing a mixture comprising an opioid agonist and a gelling agent comprising polyethylene oxide, polyethylene glycol and hydroxypropylmethylcellulose; heating the mixture to a temperature to at least soften the mixture; extruding the heated mixture to form an extrudate; formulating the extrudate into a tablet; and coating the tablet with a coating comprising polyvinyl alcohol polyethylene glycol and talc, wherein the opioid agonist is the sole active agent in the dosage form; and wherein the dosage form forms a gel when subjected to tampering comprising dissolution in from about 0.5 ml to about 10 ml of an aqueous liquid; the dosage form having a ratio of gelling agent to opioid agonist from about 8:1 to about 1:8; the dosage form providing a therapeutic effect for about 12 hours or longer when orally administered to a human patient. 2. The method of claim 1, wherein the mixture further comprises alpha-tocopherol. 3. The method of claim 2, wherein the dosage form subjected to tampering is unsuitable for injection with an insulin syringe. 4. The method of claim 2, wherein the dosage form subjected to tampering is difficult to pull into an insulin syringe. 5. The method of claim 2, wherein the dosage form subjected to tampering cannot be filled into an insulin syringe without picking up pockets of air. 6. The method of claim 2, wherein the dosage form subjected to tampering has a milk like color. 7. The method of claim 2, wherein the aqueous liquid is water. 8. The method of claim 2, wherein the gel is formed when the dosage form is subjected to tampering comprising dissolution in about 1 ml to about 3 ml of aqueous liquid. 9. The method of claim 2, wherein the gel is formed when the dosage form is subjected to tampering comprising crushing and dissolution in the aqueous liquid. 10. The method of claim 2, wherein the gel is formed when the dosage form is subjected to tampering comprising dissolution in the aqueous liquid at ambient temperature. 11. The method of claim 2, wherein the gel is formed when the dosage form is subjected to tampering comprising dissolution in the aqueous liquid with heating greater than 45.degree. C. 12. The method of claim 2, wherein the gelling agent is in an effective amount to impart a viscosity of about 10 cP or more to the gel. 13. The method of claim 2, wherein the gelling agent is in an effective amount to impart a viscosity of about 60 cP or more to the gel. 14. The method of claim 2, wherein the gelling agent is in an effective amount to impart a viscosity of about 120 cP or more to the gel. 15. The method of claim 1, wherein the gelling agent is in an effective amount to impart a viscosity from about 120 cP to about 5,000 cP to the gel. 16. The method of claim 1, wherein the polyethylene oxide has a weight average molecular weight from about 100,000 daltons to about 1,000,000 daltons. 17. The method of claim 1, wherein the polyethylene oxide has a weight average molecular weight from about 1,000,000 daltons to about 10,000,000 daltons. 18. A method of preparing an abuse deterrent controlled release dosage form comprising: preparing a mixture comprising an opioid agonist and a gelling agent comprising polyethylene oxide, hydroxypropylmethylcellulose and polyethylene glycol; and heating the mixture to a temperature to at least soften the mixture; extruding the heated mixture to form an extrudate; formulating the extrudate into a tablet; and coating the tablet with a coating comprising polyvinyl alcohol, polyethylene glycol and talc, wherein the opioid agonist is the sole active agent in the dosage form; and wherein the dosage form forms a gel when subjected to tampering comprising dissolution in from about 0.5 ml to about 10 ml of an aqueous liquid; the dosage form having a ratio of gelling agent to opioid agonist from about 8:1 to about 1:1; the dosage form providing a therapeutic effect for about 12 hours or longer when orally administered to a human patient. 19. The method of claim 1, wherein the ratio of gelling agent to opioid agonist is from about 3:1 to about 1:1. 20. The method of claim 18, wherein the mixture further comprises alpha-tocopherol. 21. The method of claim 18, wherein the aqueous liquid is water. 22. The method of claim 21, wherein the gel is formed when the dosage form is subjected to tampering comprising crushing and dissolution in the water. 23. The method of claim 21, wherein the gel is formed when the dosage form is subjected to tampering comprising dissolution in the water with heating greater than 45.degree. C. 24. The method of claim 21, wherein the gelling agent is in an effective amount to impart a viscosity of about 10 cP or more to the gel.