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Claims for Patent: 6,455,557

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Claims for Patent: 6,455,557

Title: Method of reducing somnolence in patients treated with tizanidine
Abstract:An article and method for reducing somnolence in a patient receiving tizanidine therapy. Tizanidine may be administered in the form of an immediate release multiparticulate composition at or around the time food is consumed. The composition may be packaged in a container for distribution.
Inventor(s): Pellegrini; Cara A. (San Diego, CA), Stark; Paul (Westmeath, IE)
Assignee: Elan Pharmaceuticals, Inc. (San Francisco, CA)
Application Number:09/994,837
Patent Claims: 1. A method of reducing somnolence in a patient receiving tizanidine therapy comprising administering to the patient a therapeutically effective amount of tizanidine in an immediate release multiparticulate pharmaceutical composition with food, wherein administration of the composition with food produces a peak plasma tizanidine concentration earlier than about 4 hours from administration.

2. The method of claim 1 wherein the therapeutically effective amount is 0.5 mg to 12 mg.

3. The method of claim 1 wherein the therapeutically effective amount is 2 mg to 8 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 immediate release multiparticulate formulation comprises a multiparticulate form of tizanidine on beads.

8. The method of claim 7 wherein the immediate release multiparticulate formulation is in unit dosage form.

9. The method of claim 8 wherein the unit dosage form contains from 2 to 6 milligrams of tizanidine.

10. A method of reducing the peak plasma concentration from an oral dosage form of tizanidine in a patient in need of a therapeutic effect thereof comprising administering to the patient a therapeutically effective amount of tizanidine in an immediate release multiparticulate pharmaceutical composition with food, wherein administration of the composition with food produces a peak plasma tizanidine concentration earlier than about 4 hours from administration.

11. The method of claim 10 wherein the therapeutically effective amount is about 0.5 mg to about 12 mg.

12. The method of claim 10 wherein the therapeutically effective amount is from about 2 mg to about 8 mg.

13. The method of claim 10 wherein the administration to the patient occurs between about 30 minutes prior to about 2 hours after consuming food.

14. The method of claim 10 wherein the administration to the patient is substantially at the same time as the consumption of the food.

15. The method of claim 10 wherein the administration to the patient is immediately after the consumption of food up to about one hour after said consumption.

16. The method of claim 10 wherein the immediate release multiparticulate formulation comprises a multiparticulate form of tizanidine on beads.

17. The method of claim 16 wherein the immediate release multiparticulate formulation is in unit dosage form.

18. The method of claim 17 wherein the unit dosage form contains from 2 to 6 milligrams of tizanidine.

19. A method of reducing the peak plasma concentration from an oral dosage form of tizanidine in a patient in need of a therapeutic effect thereof comprising administering to the patient a therapeutically effective amount of tizanidine in an immediate release multiparticulate pharmaceutical composition with food, wherein the composition produces a peak plasma tizanidine concentration earlier than about 2 hours from administration when administered without food.

20. A method of reducing the peak plasma concentration from an oral dosage form of tizanidine in a patient in need of a therapeutic effect thereof comprising administering to the patient a therapeutically effective amount of tizanidine in an immediate release multiparticulate pharmaceutical composition with food, wherein the composition releases substantially all of its tizanidine contents within 60 minutes of administration.

21. A method of reducing the peak plasma concentration from an oral dosage form of tizanidine in a patient in need of a therapeutic effect thereof comprising administering to the patient a therapeutically effective amount of tizanidine in an immediate release multiparticulate pharmaceutical composition with food, wherein the composition releases at least 75% of its tizanidine contents within 60 minutes of administration.
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