Details for Patent: 9,861,582

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:	15/015,769
Claims:	1. A method of preparing an abuse deterrent controlled release oral dosage form comprising: preparing a matrix comprising oxycodone or a pharmaceutically acceptable salt thereof and a gelling agent comprising polyethylene oxide having a weight-average molecular weight of about 50,000 to about 750,000; and applying a coating comprising polyvinyl alcohol to the matrix, the abuse deterrent dosage form forming 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 polyethylene oxide to oxycodone or pharmaceutically acceptable salt thereof from about 1:1 to about 30:1; and the dosage form providing a therapeutic effect for about 12 hours or longer when orally administered to a human patient; and wherein the oxycodone or pharmaceutically acceptable salt thereof is the sole active agent in the dosage form. 2. The method of claim 1, wherein the gelling agent is in an effective amount to impart a viscosity of about 10 cP or more to the gel. 3. The method of claim 1, wherein the gelling agent is in an effective amount to impart a viscosity of about 60 cP or more to the gel. 4. The method of claim 1, wherein the gelling agent is in an effective amount to impart a viscosity of about 120 cP or more to the gel. 5. The method of claim 1, wherein the gelling agent is in an effective amount to impart a viscosity of about 2,000 cP or more to the gel. 6. The method of claim 1, wherein the mixture comprises from about 2.5 mg to about 320 mg oxycodone hydrochloride. 7. The method of claim 1, wherein the dosage form subjected to tampering is unsuitable for injection with an insulin syringe. 8. The method of claim 1, wherein the dosage form subjected to tampering is difficult to pull into an insulin syringe. 9. The method of claim 1, wherein the dosage form subjected to tampering cannot be filled into an insulin syringe without picking up pockets of air. 10. The method of claim 1, wherein the dosage form subjected to tampering has a milk-like color. 11. The method of claim 1, wherein the aqueous liquid is water. 12. The method of claim 1, wherein the viscosity is imparted when the dosage form is subjected to tampering by dissolution in about 1 ml to about 3 ml of aqueous liquid. 13. The method of claim 2, wherein the viscosity is imparted when the dosage form is subjected to tampering comprising crushing and dissolution in the aqueous liquid. 14. The method of claim 2, wherein the viscosity is imparted when the dosage form is subjected to tampering comprising dissolution in the aqueous liquid at ambient temperature. 15. The method of claim 2, wherein the viscosity is imparted when the dosage form is subjected to tampering comprising dissolution in the aqueous liquid with heating greater than 45.degree. C. 16. The method of claim 6, wherein the gelling agent is in an effective amount to impart a viscosity of about 10 cP or more to the gel. 17. The method of claim 6, wherein the gelling agent is in an effective amount to impart a viscosity of about 60 cP or more to the gel. 18. The method of claim 6, wherein the gelling agent is in an effective amount to impart a viscosity of about 120 cP or more to the gel. 19. The method of claim 6, 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. 20. A method of preparing an abuse deterrent controlled release oral dosage form comprising: preparing a matrix comprising from about 2.5 mg to about 320 mg oxycodone hydrochloride and a gelling agent comprising polyethylene oxide having a weight-average molecular weight of 50,000 to 750,000; and applying a coating comprising polyvinyl alcohol to the matrix; the abuse deterrent dosage form forming a gel having a viscosity of at least 10 cP when the dosage form is subjected to tampering by 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 oxycodone or pharmaceutically acceptable salt thereof from about 1:1 to about 30:1; the dosage form providing a therapeutic effect for about 12 hours or longer when orally administered to a human patient; and wherein the oxycodone or pharmaceutically acceptable salt thereof is the sole active agent in the dosage form. 21. The method of claim 1, wherein the gelling agent comprises a poloxamer. 22. The method of claim 20, wherein the gelling agent comprises a poloxamer.