Claims for Patent: 9,517,236

Summary for Patent: 9,517,236

Title:	Controlled release hydrocodone formulations
Abstract:	A solid oral controlled-release dosage form of hydrocodone is disclosed, the dosage form comprising an analgesically effective amount of hydrocodone or a pharmaceutically acceptable salt thereof, and controlled release material.
Inventor(s):	Oshlack; Benjamin (Boca Raton, FL), Huang; Hua-Pin (Englewood Cliffs, NJ), Masselink; John K. (Old Tappan, NJ), Tonelli; Alfred (Congers, NY)
Assignee:	Purdue Pharma L.P. (Stamford, CT)
Application Number:	15/019,695
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,517,236
Patent Claims:	1. A solid oral controlled-release dosage form of hydrocodone, the dosage form comprising a matrix comprising hydrocodone or a pharmaceutically acceptable salt thereof and a controlled release material comprising a material selected from the group consisting of gums, cellulose ethers, acrylic resins, waxes, shellac, oils, and mixtures thereof, the dosage form providing a ratio of a plasma concentration of hydrocodone at the end of a dosing interval to a maximum plasma concentration of hydrocodone during the dosing interval of from 0.55 to 1 and effective pain relief over a period of time of about 12 hours or longer after administration to a human patient, wherein the dosage form is a compressed tablet, and the hydrocodone or pharmaceutically acceptable salt thereof is the only active agent in the dosage form. 2. The dosage form of claim 1, wherein the effective pain relief is provided for about 12 hours. 3. The dosage form of claim 2, wherein said administration is first administration. 4. The dosage form of claim 3, wherein the controlled release material comprises a cellulose ether. 5. A solid oral controlled-release dosage form of hydrocodone, the dosage form comprising a matrix comprising hydrocodone or a pharmaceutically acceptable salt thereof, a controlled release material comprising a material selected from the group consisting of gums, cellulose ethers, acrylic resins, waxes, shellac, oils, and mixtures thereof, the dosage form providing a W.sub.50 of hydrocodone of between 4 and 22 hours and a plasma concentration of hydrocodone within a therapeutic range over a period of time of about 12 hours or longer after administration to a human patient, wherein the dosage form is a compressed tablet, and the hydrocodone or pharmaceutically acceptable salt thereof is the only active agent in the dosage form. 6. The dosage form of claim 5, wherein the dosage form provides the plasma concentration of hydrocodone within the therapeutic range over a period of time of about 12 hours after administration to the human patient. 7. The dosage form of claim 6, wherein said administration is first administration. 8. The dosage form of claim 5, wherein said administration is first administration. 9. The dosage form of claim 5, wherein the controlled release material comprises a cellulose ether. 10. The dosage form of claim 7, wherein the dosage form provides a C.sub.24/C.sub.max hydrocodone ratio of from 0.55 to 1 after said administration and a therapeutic effect for about 24 hours. 11. A solid oral controlled-release dosage form of hydrocodone, the dosage form comprising a matrix comprising hydrocodone or a pharmaceutically acceptable salt thereof, a controlled release material comprising a material selected from the group consisting of gums, cellulose ethers, acrylic resins, waxes, shellac, oils, and mixtures thereof, the dosage form providing a T.sub.max hydrocodone of from about 4 to about 14 hours and a plasma concentration of hydrocodone within a therapeutic range over a period of time of about 12 hours or longer after administration to a human patient, wherein the dosage form is a compressed tablet, and the hydrocodone or a pharmaceutically acceptable salt thereof is the only active agent in the dosage form. 12. The dosage form of claim 11, wherein the dosage form provides the plasma concentration of hydrocodone within the therapeutic range over a period of time of about 12 hours after administration to the human patient. 13. The dosage form of claim 12, wherein said administration is first administration. 14. The dosage form of claim 11, wherein said administration is first administration. 15. The dosage form of claim 1, wherein the dosage form provides a mean C.sub.24/C.sub.max hydrocodone ratio of from 0.55 to 1 and a therapeutic effect for about 24 hours after administration to a patient population and the dosing interval is 24 hours. 16. The dosage form of claim 1, wherein the dosage form provides a C.sub.24/C.sub.max hydrocodone ratio of from 0.55 to 1 and a therapeutic effect for about 24 hours after administration to the human patient and the dosing interval is 24 hours. 17. The dosage form of claim 11, wherein the controlled release material comprises a cellulose ether. 18. A solid oral controlled-release dosage form of hydrocodone, the dosage form comprising a matrix comprising hydrocodone bitartrate, a controlled release material comprising a material selected from the group consisting of gums, cellulose ethers, acrylic resins, waxes, shellac, oils, and mixtures thereof, the dosage form providing a plasma concentration of hydrocodone within a therapeutic range over a period of time of about 12 hours or longer after administration to a human patient, wherein the dosage form is a compressed tablet, and the hydrocodone bitartrate is the only active agent in the dosage form. 19. The dosage form of claim 18, wherein the controlled release material comprises a cellulose ether. 20. The dosage form of claim 18, wherein the controlled release material comprises ethylcellulose. 21. The dosage form of claim 18, wherein the dosage form provides a mean C.sub.24/C.sub.max hydrocodone ratio of from 0.55 to 1 and a therapeutic effect for about 24 hours after administration to a patient population. 22. The dosage form of claim 1, wherein the controlled release material comprises ethylcellulose. 23. The dosage form of claim 18, wherein the controlled release material is included in an effective amount such that the dosage form provides an in-vitro release of hydrocodone when measured by the USP Basket method at 100 rpm in 700 ml aqueous buffer at a pH of 1.2 at 37.degree. C. of from 10% to about 45% by weight hydrocodone released at 1 hour. 24. The dosage form of claim 18, wherein the dosage form provides the plasma concentration of hydrocodone within the therapeutic range over a period of time of about 12 hours after administration to the human patient. 25. The dosage form of claim 24, wherein said administration is first administration. 26. The dosage form of claim 18, wherein said administration is first administration. 27. The dosage form of claim 1, wherein the matrix comprises a hydroxyalkylcellulose. 28. The dosage form of claim 3, wherein the dosage form provides a mean ratio of mean plasma concentrations of hydrocodone at the end of a dosing interval to mean maximum plasma concentrations of hydrocodone during the dosing interval of 0.55 to 1 after administration to a patient population. 29. The dosage form of claim 28, which provides a C.sub.24/C.sub.max hydrocodone ratio of from 0.55 to 1 and a therapeutic effect for about 24 hours after said administration and the dosing interval is 24 hours. 30. The dosage form of claim 18, wherein the matrix comprises a hydroxyalkylcellulose.