Claims for Patent: 9,056,052

Summary for Patent: 9,056,052

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):	Benjamin Oshlack, Hua-pin Huang, John K. Masselink, Alfred Tonelli
Assignee:	Purdue Pharma LP
Application Number:	US14/612,483
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,056,052
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, a controlled release material and hydroxypropylcellulose or hydroxypropylmethylcellulose, such that the dosage form provides 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 about 0.55 to about 1 and an 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, the amount of hydrocodone in the dosage form is from about 0.5 mg to about 1250 mg, 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 material selected from the group consisting of gums, cellulose ethers, acrylic resins, waxes, shellac, and oils. 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 and hydroxypropylcellulose or hydroxypropylmethylcellulose, such that the dosage form provides a W50 of hydrocodone of between 4 and 22 hours and a plasma concentration of hydrocodone within a therapeutic range but below toxic concentrations 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, the amount of hydrocodone in the dosage form is from about 0.5 mg to about 1250 mg, 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 but below toxic concentrations 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 material selected from the group consisting of gums, cellulose ethers, acrylic resins, waxes, shellac and oils. 10. The dosage form of claim 5, wherein the dosage form provides a C24/Cmax hydrocodone ratio of from about 0.55 to about 1 after said administration. 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 and hydroxypropylcellulose or hydroxypropylmethylcellulose, such that the dosage form provides a Tmax of hydrocodone of from about 4 to about 14 hours and a plasma concentration of hydrocodone within a therapeutic range but below toxic concentrations 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, the amount of hydrocodone in the dosage form is from about 0.5 mg to about 1250 mg, 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 but below toxic concentrations 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 C24/Cmax hydrocodone ratio of from about 0.55 to about 1 after administration to a patient population. 16. The dosage form of claim 11, wherein the dosage form provides a C24/Cmax hydrocodone ratio of from about 0.55 to about 1 after administration to the human patient. 17. The dosage form of claim 11, wherein the controlled release material comprises a material selected from the group consisting of gums, cellulose ethers, acrylic resins, waxes, shellac, and oils. 18. A solid oral controlled-release dosage form of hydrocodone, the dosage form comprising a matrix comprising hydrocodone bitartrate, a controlled release material and hydroxypropylcellulose or hydroxypropylmethylcellulose, such that the dosage form provides a plasma concentration of hydrocodone within a therapeutic range but below toxic concentrations 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, the amount of hydrocodone bitartrate in the dosage form is equivalent to from about 0.5 mg to about 1250 mg hydrocodone, 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 material selected from the group consisting of gums, cellulose ethers, acrylic resins, waxes, shellac, and oils. 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 C24/Cmax hydrocodone ratio of from about 0.55 to about 1 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° 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 but below toxic concentrations 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 granulation comprising the hydrocodone or pharmaceutically acceptable salt thereof and the hydroxypropylcellulose or hydroxypropylmethylcellulose. 28. The dosage form of claim 1, 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 about 0.55 to about 1 after administration to a patient population. 29. The dosage form of claim 18, which provides a C24/Cmax hydrocodone ratio of from about 0.55 to about 1 after said administration. 30. The dosage form of claim 18, wherein the matrix comprises a granulation comprising the hydrocodone or pharmaceutically acceptable salt thereof and the hydroxypropylcellulose or hydroxypropylmethylcellulose.