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Claims for Patent: 9,421,200

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Claims for Patent: 9,421,200

Title:Treating pain in patients with hepatic impairment
Abstract: An extended release composition for an analgesic active pharmaceutical ingredient which may be an opioid, preferably hydrocodone as the only active ingredient. The extended release composition preferably comprises a extended release composition which may be in the form of beads contained in an oral dosage form such as gelatin capsules. The composition is designed to release hydrocodone in a way such that the increase in hydrocodone exposure in hepatically impaired patients is not clinically significant. The oral dosage units are supplied as part of a kit, which also includes a primary package and a package insert all sold as a commercially marketed product. The primary package and package insert are contained in an optional secondary package and the package insert does not contain a warning, a dosing instruction, or a dosing table specifically directed to patients suffering from mild, moderate or severe hepatic impairment, and preferably explicitly states that dosing adjustment is not required for mild or moderate hepatic impairment.
Inventor(s): Hartman; Andrew (Belmont, CA), Rubino; Christopher M. (Williamsville, NY), Robinson; Cynthia Y. (Burlingame, CA)
Assignee: Pernix Ireland Pain Limited (Dublin, IE)
Application Number:15/154,524
Patent Claims: 1. A method of treating pain in a patient having mild or moderate hepatic impairment, the method comprising: administering to the patient having mild or moderate hepatic impairment an oral dosage unit having hydrocodone bitartrate as the only active ingredient, wherein the dosage unit comprises an extended release formulation of hydrocodone bitartrate, wherein the dose is not adjusted for the patient having mild or moderate hepatic impairment and wherein the dosage unit provides a plasma half-life of hydrocodone of about 8 hours in patients without hepatic impairment.

2. The method of claim 1, wherein the dosage unit provides a plasma half-life of hydrocodone of about 9 hours in patients with mild hepatic impairment.

3. The method of claim 1, wherein the dosage unit provides a plasma half-life of hydrocodone of about 10 hours in patients with moderate hepatic impairment.

4. The method of claim 1, wherein the dosage unit comprises about 20 mg of hydrocodone bitartrate.

5. A method of treating pain in a patient having mild hepatic impairment, the method comprising: administering to the patient having mild hepatic impairment an oral dosage unit having about 20 mg of hydrocodone bitartrate as the only active ingredient, wherein the dosage unit comprises an extended release formulation of hydrocodone bitartrate.

6. A method of treating pain in a patient having moderate hepatic impairment, the method comprising: administering to the patient having moderate hepatic impairment an oral dosage unit having about 20 mg of hydrocodone bitartrate as the only active ingredient, wherein the dosage unit comprises an extended release formulation of hydrocodone bitartrate.

7. A method of treating pain in a patient having mild or moderate hepatic impairment, the method comprising: administering to the patient having mild or moderate hepatic impairment an oral dosage unit having hydrocodone bitartrate as the only active ingredient, wherein the dosage unit comprises a first formulation of hydrocodone bitartrate and a second formulation of hydrocodone bitartrate, and wherein the dose is not adjusted relative to a patient without hepatic impairment.

8. The method of claim 7, wherein the dosage unit provides a release profile of hydrocodone such that: (1) the mean hydrocodone AUC.sub.0-inf per 20 mg of hydrocodone bitartrate dosed to subjects not suffering from renal or hepatic impairment is in the range of about 317 ng*h/mL to about 466 ng*h/mL; and (2) the mean hydrocodone AUC.sub.0-inf per 20 mg of hydrocodone bitartrate dosed to subjects suffering from moderate hepatic impairment is in the range of about 352 ng*h/mL to about 666 ng*h/mL.

9. The method of claim 7, wherein the first formulation comprises an immediate release component and the second formulation comprises a sustained release component.

10. The method of claim 9, wherein the immediate release component comprises a first population of particles and the sustained release component comprises a second population of particles.

11. The method of claim 7, wherein the first formulation comprises 15 to 25 percent by weight of the total hydrocodone in the oral dosage unit and the second formulation comprises 75 to 85 percent by weight of the total hydrocodone in the oral dosage unit.

12. The method of claim 7, wherein the dosage unit comprises a multiparticulate modified release composition.

13. The method of claim 12, wherein the dosage unit comprises a capsule containing the multiparticulate modified release composition.

14. The method of claim 13, wherein the multiparticulate modified release composition comprises a first population of beads containing 15 to 25% by weight of the total hydrocodone in the oral dosage unit as an immediate release population, and a second population of beads containing 75 to 85 percent by weight of the total hydrocodone in the oral dosage unit as a sustained release population.

15. The method of claim 14, wherein the multiparticulate modified release composition comprises a third population of beads which are different from beads in the first and second populations of beads.

16. The method of claim 14, wherein the second population of beads comprises a polymer coating comprising one or more of cellulose acetate phthalate, cellulose acetate trimaletate, hydroxy propyl methylcellulose phthalate, polyvinyl acetate phthalate, ammonio methacrylate copolymers, polyacrylic acid, polyacrylate and methacrylate copolymers, polyvinyl acetaldiethylamino acetate, hydroxypropyl methylcellulose acetate succinate and shellac.

17. The method of claim 16, wherein the polymer coating comprises ammonio methacrylate copolymers.

18. The method of claim 17, wherein the first population of beads and the second population of beads comprise sugar spheres as an inert core.

19. The method of claim 18, wherein the dosage unit provides a release profile of hydrocodone such that: (1) the mean hydrocodone AUC.sub.0-inf per 20 mg of hydrocodone bitartrate dosed to subjects not suffering from renal or hepatic impairment is in the range of about 317 ng*h/mL to about 466 ng*h/mL; and (2) the mean hydrocodone AUC.sub.0-inf per 20 mg of hydrocodone bitartrate dosed to subjects suffering from moderate hepatic impairment is in the range of about 352 ng*h/mL to about 666 ng*h/mL.

20. The method of claim 19, wherein the dosage unit provides a release profile of hydrocodone such that the mean hydrocodone AUC.sub.0-inf per 20 mg of hydrocodone bitartrate subjects suffering from mild hepatic impairment is in the range of about 316 ng*h/mL to about 563 ng*h/mL.
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