Claims for Patent: 8,551,520

Summary for Patent: 8,551,520

Title:	Controlled release hydrocodone
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 (New York, NY), 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:	13/721,293
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,551,520
Patent Claims:	1. A solid oral controlled-release dosage form comprising a matrix comprising an analgesically effective amount of hydrocodone or a pharmaceutically acceptable salt thereof and an amount of a controlled release material sufficient to render the dosage form suitable for once-a-day administration, wherein the matrix is compressed into a tablet, and the dosage form provides an in-vitro release rate of hydrocodone or a pharmaceutically acceptable salt thereof, when measured by the USP Basket Method at 100 rpm in 900 ml aqueous buffer at a pH of between 1.6 and 7.2 at 37.degree. C., of from 0% to about 35% at 1 hour, from about 10% to about 70% at 4 hours, from about 20% to about 75% at 8 hours, from about 30% to about 80% at 12 hours, from about 40% to about 90% at 18 hours, and greater than about 60% at 24 hours, and, after a first administration to an individual patient or a patient population, a C.sub.24/C.sub.max ratio of about 0.55 to about 1.0. 2. The dosage form of claim 1, which provides a C.sub.24/C.sub.max ratio of 0.55 to 0.85 after said administration. 3. The dosage form of claim 1, which provides a C.sub.24/C.sub.max ratio of 0.55 to 0.75 after said administration. 4. The dosage form of claim 1, which provides a C.sub.24/C.sub.max ratio of 0.6 to 0.7 after said administration. 5. The dosage form of claim 1, which provides a C.sub.24/C.sub.max ratio of 0.7 to 0.85 after said administration. 6. The dosage form of claim 1, wherein the controlled release material comprises a material selected from the group consisting of gums, cellulose ethers, acrylic resins, waxes, shellac and oils. 7. The dosage form of claim 6, wherein the cellulose ether is an alkylcellulose, a hydroxyalkylcellulose, or a carboxyalkylcellulose. 8. The dosage form of claim 1, wherein the matrix further comprises a hydrophobic material having a melting point of from about 30.degree. C. to about 200.degree. C. 9. The dosage form of claim 1, wherein the matrix further comprises a fatty acid, a fatty alcohol, a glyceryl ester of fatty acid, a wax, a polyalkylene glycol, or a mixture of any of the foregoing materials. 10. The dosage form of claim 9, wherein the matrix comprises the glyceryl ester of a fatty acid. 11. The dosage form of claim 1, wherein the matrix further comprises microcrystalline cellulose. 12. The dosage form of claim 11, wherein the matrix further comprises hydroxypropylcellulose. 13. The dosage form of claim 1, wherein said C.sub.24/C.sub.max ratio is provided after the first administration to the individual patient. 14. The dosage form of claim 1, wherein said C.sub.24/C.sub.max ratio is provided after the first administration to the patient population. 15. A solid oral controlled-release dosage form comprising a matrix comprising hydrocodone bitartrate in an amount equivalent to from about 0.5 mg to about 1250 mg of hydrocodone and an amount of a controlled release material sufficient to render the dosage form suitable for once-a-day administration, wherein the matrix is compressed into a tablet, and the dosage form provides an in-vitro release rate of hydrocodone bitartrate, when measured by the USP Basket Method at 100 rpm in 900 ml aqueous buffer at a pH of between 1.6 and 7.2 at 37.degree. C., of from 0% to about 35% at 1 hour, from about 10% to about 70% at 4 hours, from about 20% to about 75% at 8 hours, from about 30% to about 80% at 12 hours, from about 40% to about 90% at 18 hours, and greater than about 60% at 24 hours, and, after a first administration to an individual patient or a patient population, a C.sub.24/C.sub.max ratio of about 0.55 to about 1.0. 16. The dosage form of claim 15, which provides a C.sub.24/C.sub.max ratio of 0.55 to 0.85 after said administration. 17. The dosage form of claim 15, 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 comprising a matrix comprising hydrocodone bitartrate in an amount equivalent to from about 0.5 mg to about 1250 mg of hydrocodone and an amount of a controlled release material sufficient to render the dosage form suitable for once-a-day administration, wherein the matrix is compressed into a tablet, and the dosage form provides an in-vitro release rate of hydrocodone bitartrate, when measured by the USP Basket Method at 100 rpm in 900 ml aqueous buffer at a pH of between 1.6 and 7.2 at 37.degree. C., of from 0% to about 35% at 1 hour, from about 10% to about 70% at 4 hours, from about 20% to about 75% at 8 hours, from about 30% to about 80% at 12 hours, from about 40% to about 90% at 18 hours, and greater than about 60% at 24 hours. 19. The dosage form of claim 18, which provides a C.sub.24/C.sub.max ratio of 0.55 to 0.75 after a first administration to an individual patient or a patient population.