Claims for Patent: 9,023,401

Summary for Patent: 9,023,401

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:	US14/581,175
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,023,401
Patent Claims:	1. A solid oral controlled-release dosage form of hydrocodone, the dosage form comprising a plurality of multiparticulates comprising an amount of a hydrocodone bitartrate salt equivalent to from about 5 mg to about 60 mg of hydrocodone and a controlled release material, the plurality of multiparticulates compressed into a tablet, 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 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 or a population of patients, 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, wherein said hydrocodone bitartrate salt 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 plurality of multiparticulates comprising an amount of a hydrocodone bitartrate salt equivalent to from about 5 mg to about 60 mg of hydrocodone and a controlled release material, the multiparticulates individually coated with a controlled-release coating and compressed into a tablet, the controlled release material included in an effective amount 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 or a population of patients, wherein said hydrocodone bitartrate salt 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 or the population of patients. 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 9, wherein the acrylic resins are selected from the group consisting of ammonio methacrylate copolymers. 11. A solid oral controlled-release dosage form of hydrocodone, the dosage form comprising a plurality of pharmaceutically acceptable matrices comprising an amount of a hydrocodone bitartrate salt equivalent to from about 5 mg to about 60 mg of hydrocodone and a controlled release material, the pharmaceutically acceptable matrices individually coated with a controlled-release coating and compressed into a tablet, the dosage form providing a Tmax of hydrocodone of from about 4 to about 10 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 or a population of patients, wherein said hydrocodone bitartrate salt 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 or the population of patients. 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 12, wherein the pharmaceutically acceptable matrices further comprise hydroxypropylmethylcellulose. 16. 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. 17. A solid oral controlled-release dosage form of hydrocodone, the dosage form comprising a plurality of pharmaceutically acceptable matrices comprising an amount of a hydrocodone bitartrate salt equivalent to from about 5 mg to about 60 mg of hydrocodone and a controlled release material, the pharmaceutically acceptable matrices compressed into a tablet, the controlled release material included in an effective amount such that the dosage form provides a Tmax of hydrocodone of from about 4 to about 10 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 or a population of patients, wherein said hydrocodone bitartrate salt is the only active agent in the dosage form. 18. The dosage form of claim 17, wherein the controlled release material comprises a material selected from the group consisting of gums, cellulose ethers, acrylic resins, waxes, shellac and oils. 19. The dosage form of claim 18, wherein the material comprises ethylcellulose. 20. The dosage form of claim 19, wherein the pharmaceutically acceptable matrices further comprise hydroxypropylmethylcellulose. 21. The dosage form of claim 15, wherein the controlled release material comprises ethylcellulose. 22. The dosage form of claim 17, 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. 23. The dosage form of claim 17, 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 or the population of patients. 24. The dosage form of claim 23, wherein said administration is first administration. 25. The dosage form of claim 17, wherein said administration is first administration. 26. The dosage form of claim 4, wherein the controlled release material comprises ethylcellulose. 27. The dosage form of claim 26, wherein the multiparticulates further comprise hydroxypropylmethylcellulose. 28. The dosage form of claim 17, which provides a W50 of hydrocodone of between 4 and 22 hours. 29. The dosage form of claim 5, which provides a Tmax of hydrocodone of from about 4 to about 10 hours. 30. The dosage form of claim 16, wherein the acrylic resin comprises an ammonio methacrylate copolymer.