Details for Patent: 9,693,961

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:	15/015,722
Claims:	1. A method of preparing an abuse deterrent controlled release dosage form comprising: combining oxycodone or a pharmaceutically acceptable salt thereof as active agent, polyglycolyzed glycerides, a C.sub.12 to C.sub.40 fatty acid or a mixture thereof, carnauba wax and beeswax, to form a homogenous mixture, wherein the oxycodone or pharmaceutically acceptable salt thereof is the sole active agent in the dosage form; preparing particles from the homogenous mixture; and containing the particles in a capsule; the abuse deterrent dosage form providing a therapeutic effect for about 12 hours or longer when orally administered to a human patient, and the abuse deterrent dosage form being abuse deterrent when subjected to tampering comprising heating at a temperature greater than about 45.degree. C. 2. The method of claim 1, wherein the particles comprise an organic acid salt of oxycodone. 3. The method of claim 1, wherein the oxycodone or pharmaceutically acceptable salt thereof is oxycodone base. 4. The method of claim 1, wherein the fatty acid comprises C.sub.14 fatty acid. 5. The method of claim 1, wherein the fatty acid comprises stearic acid. 6. The method of claim 1, wherein the fatty acid comprises C.sub.14 fatty acid and stearic acid. 7. The method of claim 1, wherein the combining comprises melting the C.sub.12 to C.sub.40 fatty acid or mixture thereof and incorporating oxycodone base therein. 8. The method of claim 7, wherein the fatty acid comprises C.sub.14 fatty acid. 9. The method of claim 7, wherein the fatty acid comprises stearic acid. 10. The method of claim 7, wherein the fatty acid comprises C.sub.14 fatty acid and stearic acid. 11. The method of claim 1, wherein the homogenous mixture comprises melted C.sub.12 to C.sub.40 fatty acid, melted carnauba wax, melted beeswax and oxycodone base. 12. The method of claim 11, wherein the fatty acid comprises C.sub.14 fatty acid. 13. The method of claim 11, wherein the fatty acid comprises stearic acid. 14. The method of claim 11, wherein the fatty acid comprises C.sub.14 fatty acid and stearic acid. 15. The method of claim 1, wherein the particles have a diameter from about 0.1 mm to about 2.5 mm. 16. A method of preparing an abuse deterrent controlled release dosage form comprising: combining oxycodone base as active agent, polyglycolyzed glycerides, C.sub.12 to C.sub.40 fatty acid or a mixture thereof, carnauba wax, and beeswax to form a homogenous mixture, wherein the oxycodone base is the sole active agent in the dosage form; preparing particles from the homogenous mixture; and containing the particles in a capsule; the abuse deterrent dosage form providing a therapeutic effect for about 12 hours or longer when orally administered to a human patient, the abuse deterrent dosage form having a viscosity of about 10 cP or more when subjected to tampering comprising heating at a temperature greater than about 45.degree. C. 17. The method of claim 16, wherein the particles have a diameter from about 0.1 mm to about 2.5 mm.