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Claims for Patent: 6,407,128

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Claims for Patent: 6,407,128

Title: Method for increasing the bioavailability of metaxalone
Abstract:A method of increasing 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 of the medication in the container when taken with food.
Inventor(s): Scaife; Michael (Poway, CA), Shah; Jaymin (Sunnyvale, CA)
Assignee: Elan Pharmaceuticals, Inc. (South San Francisco, CA)
Application Number:09/998,206
Patent Claims: 1. A method of increasing the oral bioavailability of metaxalone to a patient receiving metaxalone therapy comprising administering to the patient a therapeutically effective amount of metaxalone in a pharmaceutical composition with food.

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 the food.

6. The method of claim 1 wherein the administration to the patient is immediately after the consumption of food up to 1 hour after said consumption.

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

8. The method of claim 7 wherein the tablet is in unit dosage form.

9. A method of increasing the rate and extent of absorption of an oral dosage form of metaxalone as measured by the drug concentration attained in the blood stream over time in a patient in need of a therapeutic effect thereof comprising, administering to the patient a therapeutically effective amount of metaxalone in a pharmaceutical composition with food.

10. The method of claim 9 wherein the therapeutically effective amount is about 200 mg to about 900 mg.

11. The method of claim 9 wherein the therapeutically effective amount is from about 400 mg to about 800 mg.

12. The method of claim 9 wherein the administration to the patient occurs between about 30 minutes prior to about 2 hours after consuming food.

13. The method of claim 9 wherein the administration to the patient is substantially at the same time as the consumption of the food.

14. The method of claim 9 wherein the administration to the patient is immediately after the consumption of food up to about one hour after said consumption.

15. The method of claim 9 wherein the pharmaceutical composition comprises a tablet.

16. The method of claim 15 wherein the pharmaceutical composition comprises a unit dosage form.

17. A method of increasing the oral bioavailability of metaxalone to a patient receiving metaxalone therapy comprising administering to the patient a pharmaceutical tablet comprising 400 mg to 800 mg of metaxalone, with food, wherein the administration results in an increase in the maximal plasma concentration (Cmax) and extent of absorption (AUC(last)) of metaxalone compared to administration without food.

18. The method of claim 17 wherein the administration to the patient occurs between 30 minutes prior to 2 hours after consuming food.

19. The method of claim 17 wherein the administration to the patient is substantially at the same time as the consumption of the food.

20. The method of claim 17 wherein the administration to the patient is immediately after the consumption of food up to 1 hour after said consumption.

21. 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 an increase in the maximal plasma concentration (Cmax) and extent of absorption (AUC(last)) of metaxalone compared to administration without food.

22. The method of claim 1, wherein the metaxalone is from a container with printed labeling advising that administration with food results in an increase in the maximal plasma concentration (Cmax) and extent of absorption (AUC(last)) of metaxalone compared to administration without food.
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