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Details for Patent: 9,040,084

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Details for Patent: 9,040,084

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)
Filing Date:Feb 12, 2013
Application Number:13/765,368
Claims:1. An immediate release oral dosage form comprising: a mixture of (i) a therapeutically effective amount of oxycodone hydrochloride; and (ii) a gelling agent comprising starch, the gelling agent in an effective amount to impart a viscosity of at least about 10 cP 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; wherein the weight ratio of the starch to the oxycodone hydrochloride is from less than 1:1 to about 1:3; and the dosage form provides an immediate release of the oxycodone hydrochloride when the dosage form is orally administered to a human patient.

2. The immediate release oral dosage form of claim 1, wherein the aqueous liquid is water.

3. The immediate release oral dosage form of claim 1, wherein the viscosity is attained when the dosage form is subject to tampering by dissolution in from about 1 to about 3 ml of aqueous liquid.

4. The immediate release oral dosage form of claim 1, wherein the solubilized mixture has a viscosity of at least about 60 cP.

5. The immediate release oral dosage form of claim 1, further comprising an additional drug selected from the group consisting of an NSAID, a COX-2inhibitor, acetaminophen, aspirin, an NMDA receptor antanalgesic, a drug that blocks a major intracellular consequence of NMDA-receptor activation, an antitussive, an expectorant, a decongestant, an antihistamine and mixtures thereof.

6. The immediate release oral dosage form of claim 1, wherein the solubilized mixture has a viscosity of 120 cP or greater.

7. The immediate release oral dosage form of claim 1, wherein the solubilized mixture has a viscosity of from 120 cP to 5,000 cP.

8. An immediate release oral dosage form comprising: a mixture of (i) a therapeutically effective amount of oxycodone hydrochloride; and (ii) a gelling agent comprising starch, the gelling agent in an effective amount to impart a viscosity of 120 cP or greater 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; wherein the weight ratio of the starch to the oxycodone hydrochloride is from less than 1:1 to about 1:3; and the dosage form provides an immediate release of the oxycodone hydrochloride when the dosage form is orally administered to a human patient.

9. A method of preventing abuse of an oral immediate release dosage form comprising: (i) mixing a therapeutically effective amount of oxycodone hydrochloride and a gelling agent comprising starch to form a mixture, and (ii) processing the mixture into a dosage form; wherein the gelling agent is in an effective amount to impart a viscosity of at least about 10 cP 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, wherein the weight ratio of the starch to the oxycodone hydrochloride is from less than 1:1to about 1:3, and the dosage form provides an immediate release of the oxycodone hydrochloride when orally administered to a human patient.
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