Details for Patent: 9,867,783

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 (Greenwich, CT)
Assignee:	Purdue Pharma L.P. (Stamford, CT) The P.F. Laboratories, Inc. (Totowa, NJ) Purdue Pharmaceuticals L.P. (Wilson, NC)
Filing Date:	Mar 04, 2015
Application Number:	14/638,685
Claims:	1. An oral dosage form comprising: a therapeutically effective amount of an active agent comprising an opioid analgesic selected from hydrocodone, morphine, oxycodone or pharmaceutically acceptable salts thereof; a gelling agent comprising xanthan gum, mannitol, alginate and hydroxypropylmethylcellulose, the gelling agent in an effective amount to impart a viscosity unsuitable for parenteral administration to a solubilized mixture formed when the dosage form is subject to tampering by dissolution in from about 0.5 to about 10 ml of an aqueous liquid; and a copolymer comprising ethyl acrylate and methyl methacrylate; wherein the oral dosage form is a solid dosage form, wherein the opioid analgesic is the sole active agent in the dosage form, wherein the ratio of the gelling agent to the opioid analgesic is from about 1:15 to about 15:1; and the dosage form providing a sustained release of the opioid analgesic and providing a therapeutic effect for 12 hours or more when orally administered to a human patient. 2. The oral dosage form of claim 1, wherein the ratio of the gelling agent to the opioid analgesic is from about 2:1 to about 10:1. 3. The oral dosage form of claim 1, wherein the aqueous liquid is water. 4. The oral dosage form of claim 1, wherein the unsuitable viscosity is attained when about 1 to about 3 ml of aqueous liquid is mixed with the dosage form. 5. The oral dosage form of claim 1, wherein the addition of from about 0.5 to about 10 ml of the aqueous liquid causes the solubilized mixture to have a viscosity of at least about 10 cP. 6. The oral dosage form of claim 1, wherein the addition of from about 0.5 to about 10 ml of the aqueous liquid causes the solubilized mixture to have a viscosity of at least about 60 cP. 7. The oral dosage form of claim 1, further comprising an effective amount of an irritant to impart an irritating or burning sensation upon administration of a tampered dosage form. 8. The oral dosage form of claim 1, in the form of a tablet. 9. The oral dosage form of claim 1, wherein the solubilized mixture has a viscosity of 120 cP or greater. 10. The oral dosage form of claim 1, wherein the solubilized mixture has a viscosity of from 120 cP to 5,000 cP. 11. The oral dosage form of claim 1, comprising hydrocodone bitartrate. 12. The oral dosage form of claim 1, comprising morphine sulfate. 13. The oral dosage form of claim 1, comprising oxycodone hydrochloride. 14. An oral dosage form comprising: an active agent comprising from about 2.5 mg to about 800 mg morphine sulfate; a gelling agent comprising xanthan gum, mannitol, alginate and hydroxypropylmethylcellulose; and a copolymer comprising ethyl acrylate and methyl methacrylate, wherein the oral dosage form is a solid dosage form, wherein the morphine sulfate is the sole active agent in the dosage form, wherein the ratio of the gelling agent to the morphine sulfate is from about 1:15 to about 15:1; and the dosage form providing a sustained release of the morphine sulfate and providing a therapeutic effect for 12 hours or more when orally administered to a human patient. 15. An oral dosage form comprising: an active agent comprising from about 2.5 mg to about 320 mg oxycodone hydrochloride; a gelling agent comprising xanthan gum, mannitol, alginate and hydroxypropylmethylcellulose; and a copolymer comprising ethyl acrylate and methyl methacrylate, wherein the oral dosage form is a solid dosage form, wherein the oxycodone hydrochloride is the sole active agent in the dosage form, wherein the ratio of the gelling agent to the oxycodone hydrochloride is from about 1:15 to about 15:1; and the dosage form providing a sustained release of the oxycodone hydrochloride and providing a therapeutic effect for 12 hours or more when orally administered to a human patient.