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Last Updated: March 29, 2024

Details for Patent: 8,871,265


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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:Apr 17, 2014
Application Number:14/255,502
Claims:1. A controlled release oral dosage form comprising: from about 2.5 mg to about 320 mg oxycodone or a pharmaceutically acceptable salt thereof; acetaminophen; and a gelling agent comprising polyethylene oxide in an effective amount to impart a viscosity of at least about 10 cP when the dosage form is subjected to tampering by dissolution in 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.

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

3. The controlled release oral dosage form 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.

4. The controlled release oral dosage form of claim 1, wherein a viscosity of at least about 60 cP is imparted.

5. The controlled release oral dosage form of claim 1, wherein the oxycodone or pharmaceutically acceptable salt thereof comprises oxycodone hydrochloride.

6. The controlled release oral dosage form of claim 5, comprising from about 5 mg to about 10 mg oxycodone hydrochloride.

7. The controlled release oral dosage form of claim 1, wherein the viscosity is obtained when the dosage form is subjected to tampering by crushing and dissolution in the aqueous liquid.

8. The controlled release oral dosage form of claim 1, wherein the viscosity is obtained when the dosage form is subject to tampering by dissolution in the aqueous liquid with heating greater than 45.degree. C.

9. The controlled release oral dosage form of claim 1, wherein the dosage is in the form of a tablet.

10. The controlled release oral dosage form of claim 1, wherein the dosage form further comprises microcrystalline cellulose.

11. The controlled release oral dosage form of claim 1, wherein the dosage form further comprises hydroxypropyl cellulose.

12. The controlled release oral dosage form of claim 1, wherein the dosage form further comprises magnesium stearate.

13. The controlled release oral dosage form of claim 1, wherein the dosage form further comprises starch.

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