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Details for Patent: 8,231,898

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Details for Patent: 8,231,898

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): Oshlack; Benjamin (New York, NY), Huang; Hua-Pin (Engelwood Cliffs, NJ), Masselink; John K. (Old Tappan, NJ), Tonelli; Alfred P. (Congers, NY)
Assignee: Purdue Pharma L.P. (Stamford, CT)
Filing Date:Oct 28, 2010
Application Number:12/914,054
Claims:1. A solid oral controlled-release dosage form comprising an extrudate, the extrudate comprising an analgesically effective amount of hydrocodone or a pharmaceutically acceptable salt thereof and a controlled release material; the dosage form providing a dissolution release rate in-vitro of the hydrocodone or salt thereof, when measured by the USP Basket Method at 100 rpm in 700 ml Simulated Gastric Fluid (SGF) at 37.degree. C. for 1 hour and thereafter switching to 900 ml with Phosphate Buffer to a pH of 7.5 at 37.degree. C., such that at least 20% by weight hydrocodone or salt thereof is released at 4 hours, from about 20% to about 65% by weight hydrocodone or salt thereof is released at 8 hours, from about 45% to about 85% by weight hydrocodone or salt thereof is released at 12 hours, and at least 80% by weight hydrocodone or salt thereof is released at 24 hours, and, after administration to a human patient, providing a C.sub.24/C.sub.max ratio of about 0.55 to about 0.85 and a therapeutic effect for at least about 24 hours.

2. The dosage form of claim 1, which provides a C.sub.24/C.sub.max ratio of 0.55 to 0.75.

3. The dosage form of claim 1, wherein the extrudate is in the form of a pharmaceutically acceptable matrix comprising the hydrocodone or salt thereof and the controlled release material.

4. The dosage form of claim 3, wherein the matrix comprises a plurality of multiparticulate matrices.

5. The dosage form of claim 4, wherein the multiparticulate matrices are compressed into a tablet.

6. The dosage form of claim 4, wherein the multiparticulate matrices are disposed in a pharmaceutically acceptable capsule.

7. The dosage form of claim 1, further comprising a non-opioid drug.

8. The dosage form of claim 1, which provides a C.sub.24/C.sub.max ratio of 0.60 to 0.70.

9. The dosage form of claim 1, which provides a dissolution release rate in-vitro of the hydrocodone or salt thereof, when measured by the USP Basket method at 100 rpm in 700 ml aqueous buffer at a pH of 1.2 at 37.degree. C., such that at least 10% to about 45% by weight hydrocodone or salt thereof is released at 1 hour.

10. The dosage form of claim 1, which provides a time to maximum plasma concentration (T.sub.max) of hydrocodone at about 4 to about 14 hours after oral administration of the dosage form.

11. The dosage form of claim 1, which provides a time to maximum plasma concentration (T.sub.max) of hydrocodone at about 6 to about 12 hours after oral administration of the dosage form.

12. The dosage form of claim 1, which provides a C.sub.max of hydrocodone which is less than 60% of the C.sub.max of an equivalent dose of an immediate release hydrocodone reference formulation.

13. The dosage form of claim 1, wherein said administration is first administration.

14. The dosage form of claim 1, wherein said administration is steady state administration.

15. The dosage form of claim 1, wherein said ratio is obtained from a population of patients.

16. The dosage form of claim 7, wherein the non-opioid drug is selected from the group consisting of a non-steroidal anti-inflammatory agent, an NMDA receptor antagonist, acetaminophen, aspirin, a neuro-active steroid, a non-opioid analgesic, their mixtures and pharmaceutically acceptable salts thereof.

17. The dosage form of claim 1, the dosage form providing a rate of absorption during the time period from T.sub.max to about 24 hours after oral administration of the dosage form which is from about 45% to about 85% of the rate of elimination during the same time period.

18. A process for preparing a solid oral controlled-release dosage form, the process comprising combining hydrocodone or a pharmaceutically acceptable salt thereof and a controlled release material to form an extrudate, and incorporating the extrudate into a solid oral controlled-release dosage from, the resulting dosage form providing a dissolution release rate in-vitro of the hydrocodone or salt thereof, when measured by the USP Basket Method at 100 rpm in 700 ml Simulated Gastric Fluid (SGF) at 37.degree. C. for 1 hour and thereafter switching to 900 ml with Phosphate Buffer to a pH of 7.5 at 37.degree. C., such that at least 20% by weight hydrocodone or salt thereof is released at 4 hours, from about 20% to about 65% by weight hydrocodone or salt thereof is released at 8 hours, from about 45% to about 85% by weight hydrocodone or salt thereof is released at 12 hours, and at least 80% by weight hydrocodone or salt thereof is released at 24 hours, and after administration to a human patient, providing a C.sub.24/C.sub.max ratio of about 0.55 to about 0.85 and a therapeutic effect for at least about 24 hours.

19. The dosage form of claim 1, wherein the pharmaceutically acceptable salt is hydrocodone bitartrate.

20. The dosage form of claim 1, comprising from about 5 to about 60 mg of said hydrocodone.
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