Controlled release hydrocodone formulations
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.
1. A solid oral controlled-release dosage form of hydrocodone, the dosage form comprising a hydrocodone or a pharmaceutically acceptable salt thereof and a gum, 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 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 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 , which comprises a fatty acid glyceride.
5. A solid oral controlled-release dosage form of hydrocodone, the dosage form comprising a hydrocodone or a pharmaceutically acceptable salt thereof and a gum, such that the dosage form provides a W 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 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 , which comprises a fatty acid glyceride.
10. The dosage form of claim 5 , wherein the dosage form provides a C 24 /C max hydrocodone ratio of from 0.55 to 1 after said administration.
11. A solid oral controlled-release dosage form of hydrocodone, the dosage form comprising hydrocodone or a pharmaceutically acceptable salt thereof and a gum, such that the dosage form provides a T max of 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 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 24 /C max hydrocodone ratio of from 0.55 to 1 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 24 /C max hydrocodone ratio of from 0.55 to 1 after administration to the human patient and the dosing interval is 24 hours.
17. The dosage form of claim 11 , which comprises a fatty acid glyceride.
18. A solid oral controlled-release dosage form of hydrocodone, the dosage form comprising hydrocodone bitartrate and a gum, such that the dosage form provides 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 tablet, and
the hydrocodone bitartrate is the only active agent in the dosage form.
19. The dosage form of claim 18 , which comprises a fatty acid glyceride.
20. The dosage form of claim 18 , wherein the amount of the hydrocodone bitartrate in the dosage form is equivalent to from about 5 mg to about 60 mg hydrocodone.
21. The dosage form of claim 18 , wherein the dosage form provides a mean C 24 /C max hydrocodone ratio of from 0.55 to 1 after administration to a patient population.
22. The dosage form of claim 1 , which comprises from about 5 to about 60 mg hydrocodone.
23. The dosage form of claim 18 , wherein 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 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 , which comprises a lubricant.
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 from 0.55 to 1 after administration to a patient population.
29. The dosage form of claim 28 , which provides a C 24 /C max hydrocodone ratio of from 0.55 to 1 after said administration and the dosing interval is 24 hours.
30. The dosage form of claim 18 , which comprises a lubricant.