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Details for Patent: 8,921,344

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Details for Patent: 8,921,344

Title:Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives
Abstract: A method of increasing the bioavailability of 5-aminosalicylate compound by administration of an oral dosage form with food is provided, as well as an article of manufacture comprising an oral dosage form of 5-aminosalicylate compound 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): Johnson; Lorin (Palo Alto, CA)
Assignee: Salix Pharmaceuticals, Inc. (Raleigh, NC)
Filing Date:Nov 03, 2006
Application Number:11/592,854
Claims:1. A method of decreasing the systemic absorption of balsalazide and metabolites 5-aminosalicylic acid (5-ASA) and N-acetyl-5-ASA (NASA) comprising administering to a subject a therapeutically effective amount of at least one tablet or capsule comprising balsalazide with food, wherein administering balsalazide with food comprises administering balsalazide at the same time as the food, or immediately after the food, and wherein the systemic absorption of balsalazide, 5-ASA or NASA is decreased compared to administering balsalazide without food.

2. The method of claim 1, wherein the food is a high fat meal.

3. The method of claim 1, wherein the tablet or capsule comprises sodium lauryl sulfate.

4. The method of claim 1, wherein the tablet or capsule comprises magnesium stearate.

5. The method of claim 1, wherein the therapeutically effective amount is a dosage regimen of three capsules of about 750 mg of balsalazide with food administered three times a day.

6. The method of claim 1, wherein the therapeutically effective amount is a dosage regimen of three tablets of about 750 mg of balsalazide with food administered three times a day.

7. The method of claim 1, wherein the therapeutically effective amount is a dosage regimen of three tablets of balsalazide twice a day, wherein each capsule comprises about 1100 mg of balsalazide.

8. The method of claim 1, wherein the therapeutically effective amount is administered to the subject for a duration of between about 6 weeks and about 12 weeks.

9. The method of claim 1, wherein the therapeutically effective amount is administered to a subject for about 8 weeks.

10. A method of decreasing the systemic absorption of 5-aminosalicylic acid (5-ASA) or N-acetyl-5-ASA (NASA) in a subject comprising administering to said subject a tablet or capsule of balsalazide with food.

11. The method of claim 10, wherein the systemic absorption of the 5-ASA is decreased.

12. The method of claim 10, wherein the systemic absorption of the NASA is decreased.

13. A method for increasing the time to maximum plasma concentration (Tmax) of a metabolite of balsalazide in a subject comprising administering to the subject at least one tablet or capsule of balsalazide with food, wherein the Tmax of the metabolite is increased as compared to administering the balsalazide without food.

14. The method of claim 13, wherein the food is a high fat meal.

15. The method of claim 13, wherein administering balsalazide with food comprises administering balsalazide within 15 minutes of the food, at the same time as the food, or immediately after the food.

16. The method of claim 13, wherein the pill or capsule comprises sodium lauryl sulfate.

17. The method of claim 13, wherein the pill or capsule comprises magnesium stearate.

18. The method of claim 13, wherein the balsalazide is administered in a dosage regimen of three capsules of about 750 mg of balsalazide with food administered three times a day.

19. The method of claim 13, wherein the balsalazide is administered in a dosage regimen of three tablets of about 750 mg of balsalazide with food administered three times a day.

20. The method of claim 13, wherein the balsalazide is administered in a dosage regimen of three tablets of balsalazide twice a day, wherein each tablet comprises about 1100 mg of balsalazide.

21. A method for affecting the time to maximum plasma concentration (Tmax) of a metabolite of balsalazide in a subject, comprising: administering to the subject a therapeutically effective amount of at least one pill or capsule of balsalazide with or without food, wherein the Tmax of the metabolite 5-aminosalicylic acid (5-ASA) or N-acetyl-5-ASA (NASA) is increased if the balsalazide is administered with food in comparison to administering the balsalazide without food.

22. The method of claim 21, wherein the food is a high fat meal.

23. The method of claim 21, wherein administering balsalazide with food comprises administering balsalazide within 15 minutes of the food, at the same time as the food, or immediately after the food.

24. The method of claim 21, wherein the at least one pill or capsule of balsalazide comprises sodium lauryl sulfate.

25. The method of claim 21, wherein the at least one pill or capsule of balsalazide comprises magnesium stearate.

26. The method of claim 21, wherein the therapeutically effective amount is a dosage regimen of three capsules of about 750 mg of balsalazide administered three times a day.

27. The method of claim 21, wherein the therapeutically effective amount is a dosage regimen of three pills of about 750 mg of balsalazide administered three times a day.

28. The method of claim 21, wherein the therapeutically effective amount is a dosage regimen of three tablets of balsalazide twice a day, wherein each tablet comprises about 1100 mg of balsalazide.

29. The method of claim 21, wherein the therapeutically effective amount is administered to the subject for a duration of between about 6 weeks and about 12 weeks.

30. The method of claim 21, wherein the therapeutically effective amount is administered to a subject for about 8 weeks.
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