Details for Patent: 9,757,341
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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: | Oct 04, 2016 |
Application Number: | 15/284,711 |
Claims: | 1. A solvent system comprising: (a) a solvent; and (b) a solute comprising: (i) an opioid analgesic in an effective amount to provide an analgesic effect upon oral administration, (ii) a gelling agent comprising an emulsifier; and (iii) a fatty acid ester; the solvent system having a ratio of emulsifier to opioid analgesic from about 15:1 to about 1:1 by weight, and the solvent system having a viscosity unsuitable for parenteral administration. 2. The solvent system of claim 1, wherein the ratio of emulsifier to opioid analgesic is from about 8:1 to about 1:1 by weight. 3. The solvent system of claim 1, wherein the ratio of emulsifier to opioid analgesic is from about 8:1 to about 2:1 by weight. 4. The solvent system of claim 1, wherein the ratio of emulsifier to opioid analgesic is from about 8:1 to about 5:1 by weight. 5. The solvent system of claim 1, further comprising a cellulosic polymer. 6. The solvent system of claim 5, wherein the cellulosic polymer is hydroxyethylcellulose. 7. The solvent system of claim 1, further comprising silicon dioxide. 8. The solvent system of claim 1, further comprising hydroxyethylcellulose and silicon dioxide. 9. The solvent system of claim 1, further comprising cellulose acetate butyrate. 10. The solvent system of claim 1, further comprising triacetin. 11. The solvent system of claim 1, further comprising a surfactant. 12. The solvent system of claim 1, further comprising triacetin and a surfactant. 13. The solvent system of claim 1, further comprising cellulose acetate butyrate, triacetin and a surfactant. 14. The solvent system of claim 1, wherein the opioid analgesic comprises oxycodone base. 15. The solvent system of claim 12, comprising from about 2.5 mg to about 320 mg of oxycodone base. 16. The solvent system of claim 14, comprising about 10 mg, about 20 mg, about 40 mg or about 80 mg oxycodone base. 17. The solvent system of claim 1, further comprising a capsule containing the opioid analgesic, the gelling agent and the fatty acid ester. 18. A solvent system comprising: (a) a solvent; and (b) a solute comprising: (i) oxycodone base in an effective amount to provide an analgesic effect upon oral administration; (ii) a gelling agent comprising an emulsifier; and (iii) a fatty acid ester, the solvent system having a ratio of emulsifier to opioid analgesic from about 8:1 to about 1:1 by weight, and the solvent system having a viscosity unsuitable for parenteral administration. 19. The solvent system of claim 18, wherein the ratio of emulsifier to opioid analgesic is from about 8:1 to about 2:1 by weight. 20. The solvent system of claim 18, further comprising hydroxyethylcellulose and silicon dioxide. |