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Claims for Patent: 7,714,006

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Claims for Patent: 7,714,006

Title:Methods of modifying the bioavailability of metaxalone
Abstract:A method of increasing the bioavailability, and decreasing the effect of age on the bioavailability, of metaxalone, by administration of an oral dosage form with food is provided, as well as an article of manufacture comprising an oral dosage form of metaxalone in a suitable container and associated with printed labeling which describes the increased bioavailability, and decreased effect of age on bioavailability, of the medication in the container, when taken with food.
Inventor(s): Scaife; Michael C. (Poway, CA), Davis; Charles C. (San Diego, CA)
Assignee: King Pharmaceuticals Research & Development, Inc. (Cary, NC)
Application Number:11/182,661
Patent Claims: 1. A method of reducing the effect of a patient's age on the oral bioavailability of metaxalone in a patient receiving metaxalone therapy comprising administering to the patient a therapeutically effective amount of metaxalone in a pharmaceutical composition with food over the course of said therapy.

2. The method of claim 1, wherein the therapeutically effective amount is 200 mg to 900 mg.

3. The method of claim 1, wherein the therapeutically effective amount is 400 mg to 800 mg.

4. The method of claim 1, wherein the administration to the patient occurs between 30 minutes prior to 2 hours after consuming food.

5. The method of claim 1, wherein the administration to the patient is substantially at the same time as the consumption of food.

6. The method of claim 4, wherein the administration to the patient is within 15 minutes of the consumption of food.

7. The method of claim 1, wherein the pharmaceutical composition comprises a tablet.

8. The method of claim 1, wherein the tablet is in unit dosage form.

9. The method of claim 1, further comprising informing the patient that the administration of a therapeutically effective amount of metaxalone in a pharmaceutical composition with food results in a decreased effect of patient's age on bioavailability of metaxalone, compared to administration without food.

10. The method of claim 1, wherein the metaxalone is from a container with printed labeling advising that administration of a therapeutically effective amount of metaxalone in a pharmaceutical composition with food results in a decreased effect of patient's age on bioavailability of metaxalone, compared to administration without food.

11. A method of using metaxalone in the treatment of musculoskeletal conditions comprising: administering to a patient with a therapeutically effective amount of metaxalone; and informing the patient that the administration of metaxalone with food results in a decrease in the effect of patient's age on at least one of C(max), AUC(last), and AUC(inf) of metaxalone compared to administration without food.

12. The method according to claim 11, wherein the therapeutically effective amount of metaxalone comprises 200 mg to 900 mg of metaxalone.

13. The method according to claim 12, wherein the therapeutically effective amount of metaxalone comprises 400 mg to 800 mg of metaxalone.

14. The method according to claim 11, wherein the metaxalone is provided in tablet form.

15. The method according to claim 14, wherein the tablet is in unit dosage form.

16. A method of using metaxalone in the treatment of musculoskeletal conditions comprising: informing a patient with musculoskeletal conditions that the administration of a therapeutically effective amount of metaxalone with food results in a decrease in the effect of patient's age on at least one of C(max), AUC(last), and AUC(inf) of metaxalone compared to administration without food, wherein the patient administers the metaxalone in accordance with the information provided.

17. A method of using metaxalone in the treatment of musculoskeletal conditions comprising: obtaining the metaxalone from a container providing information that the administration of metaxalone with food decreases the effect of patient's age on at least one of C(max), AUC(last), and AUC(inf) of metaxalone compared to administration without food, and ingesting the metaxalone with food.

18. A method of using metaxalone in the treatment of musculoskeletal conditions comprising: administering to a patient in need of treatment a therapeutically effective amount of metaxalone, with food; and informing the patient that the administration of a therapeutically effective amount of metaxalone in a pharmaceutical composition with food results in a decrease in the effect of patient's age on at least one of C(max), AUC(last), and AUC(inf) of metaxalone, as compared to administration of metaxalone in a fasted state; wherein the administration of metaxalone with food results in a decrease in the effect of patient's age on at least one of C(max), AUC(last), and AUC(inf) of metaxalone, as compared to administration of metaxalone in a fasted state.

19. The method according to claim 18, wherein the metaxalone is from a container with printed labeling advising that administration with food results in a decrease in the effect of patient's age on at least one of C(max), AUC(last), and AUC(inf) of metaxalone, as compared to administration of metaxalone in a fasted state.

20. The method according to claim 18, wherein the metaxalone is provided in tablet form.

21. The method according to claim 20, wherein the metaxalone is provided in 400 mg tablet form.

22. The method according to claim 18, wherein the printed labeling further advises that administration of the metaxalone with food results in an increase in the C(max) of 177.5%.

23. The method according to claim 18, wherein the printed labeling further advises that administration of the metaxalone with food results in an increase in the AUC(last) of 123.5%.

24. The method according to claim 18, wherein the printed labeling further advises that administration of the metaxalone with food results in an increase in AUC(inf) of 115.4%.

25. The method according to claim 18, wherein the metaxalone is provided in 400 mg tablet form, and the printed labeling further advises that administration of metaxalone with food results in an increase in the C(max), AUC(last), and AUC(inf), of 177.5%, 123.5%, and 115.4%, respectively, compared to administration of metaxalone in a fasted state.

26. A method of achieving consistent plasma levels of metaxalone in any given patient regardless of patient's age comprising administering to a patient a therapeutically effective amount of metaxalone with food, wherein said administration achieves consistent levels of metaxalone in any given patient regardless of patient's age.

27. A method of reducing variations in metaxalone bioavailability comprising administering to a patient with food a therapeutically effective amount of metaxalone in a pharmaceutical composition, wherein said administration reduces variations in metaxalone bioavailability.
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