Controlled release hydrocodone

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° 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 24 /C max ratio of about 0.55 to about 1.0.

2. The dosage form of claim 1 , which provides a C 24 /C max ratio of 0.55 to 0.85 after said administration.

3. The dosage form of claim 1 , which provides a C 24 /C max ratio of 0.55 to 0.75 after said administration.

4. The dosage form of claim 1 , which provides a C 24 /C max ratio of 0.6 to 0.7 after said administration.

5. The dosage form of claim 1 , which provides a C 24 /C 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° C. to about 200° 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 24 /C max ratio is provided after the first administration to the individual patient.

14. The dosage form of claim 1 , wherein said C 24 /C 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° 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 24 /C max ratio of about 0.55 to about 1.0.

16. The dosage form of claim 15 , which provides a C 24 /C 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° 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 24 /C max ratio of 0.55 to 0.75 after a first administration to an individual patient or a patient population.