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Claims for Patent: 9,192,616

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Claims for Patent: 9,192,616

Title:Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives
Abstract: A method of increasing the bioavailability of balsalazide by administration of an oral dosage form with food is provided, as well as an article of manufacture comprising an oral dosage form of balsalazide 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)
Application Number:13/439,594
Patent Claims: 1. A method of treating a gastrointestinal disorder comprising administering to a subject in need of treatment a therapeutically effective amount of balsalazide with food, wherein the balsalazide is administered between about 30 minutes prior to about 2 hours after consuming the food, and wherein the administration of the balsalazide with food results in an increase in the bioavailability of balsalazide and metabolites 5-ASA and NASA to the colon of the subject as compared to administration of balsalazide in a fasted state.

2. The method of claim 1, further comprising informing the subject that the administration of a therapeutically effective amount of balsalazide in a pharmaceutical composition with food results in an increase in the bioavailability of balsalazide and metabolites 5-ASA and NASA.

3. The method according to claim 1, wherein the balsalazide is from a container with printed labeling advising that administration with food results in one or more of a delay of the transit of the balsalazide, 5-ASA or NASA in the colon of a subject; a decrease in the systemic level of one or more of 5-ASA or NASA in a subject; decrease in the maximal plasma concentration (C.sub.max) of one or more of balsalazide, 5-ASA or NASA in a subject; delaying T.sub.max of one or more of balsalazide, 5-ASA or NASA in a subject; decreasing the extent of absorption (AUC.sub.last) of one or more of 5-ASA or NASA in a subject; increasing conversion of balsalazide to 5-ASA and 5-ASA to NASA in a subject or increasing the systemic ratio of NASA to 5-ASA in a subject.

4. The method claim 1, wherein the therapeutically effective amount comprises from between about 6.25 mg to about 14000 mg/day; or from between about 750 mg to about 6750 mg/day; or from between about 1100 mg to about 13200 mg/day.

5. The method of claim 1, wherein the therapeutically effective amount is a dosage regimen of three capsules of the formulation three times each day, wherein each capsule comprises about 750 mg of balsalazide.

6. The method of claim 1, wherein the therapeutically effective amount is a dosage regimen of three tablets of the formulation two times each day, wherein each tablet comprises about 1100 mg of balsalazide.

7. The method of claim 1, wherein the therapeutically effective amount is a dosage regimen of one capsule three times each day, wherein each capsule comprises about 750 mg of balsalazide.

8. The method of claim 1, wherein the administration to the subject occurs between about 30 minutes prior to about 1 hour after consuming food.

9. The method of claim 1, wherein the food comprises one or more of applesauce or a high-fat meal.

10. The method of claim 1, wherein the gastrointestinal disorder comprises one or more of mild to moderately active ulcerative colitis, radiation proctosigmoiditis, and colon cancer.

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

12. The method of claim 1, wherein the administration to the subject is immediately after the consumption of food up to about 1 hour after the consumption.

13. A method of inhibiting the growth of a bacterial species in a subject, comprising administering to the subject a pharmaceutically acceptable composition comprising balsalazide in a dose effective to inhibit the growth of a bacterial species in the subject, wherein the pharmaceutically acceptable composition comprising balsalazide is administered with food, wherein the administration of the composition with food results in an increase in the bioavailability of balsalazide and metabolites 5-ASA and NASA to the colon of the subject as compared to administration of the composition in a fasted state.

14. The method of claim 13, wherein the bacterial species is a Clostridium species.

15. The method of claim 14, wherein the Clostridium species is Clostridium perfringens, Clostridium difficile, Clostridium botulinum, or Clostridium tetani.

16. The method of claim 13, wherein the administration to the subject occurs between about 30 minutes prior to about 1 hour after consuming food.

17. The method of claim 13, wherein the food comprises one or more of applesauce or a high-fat meal.

18. The method of claim 13, wherein the administration to the subject is substantially at the same time as the consumption of the food.

19. The method of claim 13, wherein the administration to the subject is immediately after the consumption of food up to about 1 hour after the consumption.

20. The method of claim 1, wherein the administration of the balsalazide with food results in an increase in the conversion of 5-ASA to NASA (N-acetyl-5-ASA) in the colon as compared to administration of balsalazide in a fasted state.

21. The method of claim 1, wherein the administration of the balsalazide with food results in a lower systemic 5-ASA level as compared to administration of balsalazide in a fasted state.

22. The method of claim 1, wherein the administration of the balsalazide with food results in an increase in the transit time of the balsalazide metabolite 5-ASA (5-aminosalicylic acid) in the colon as compared to administration of balsalazide in a fasted state.

23. The method of claim 1, wherein the administration of the balsalazide with food results in an increase in the ratio of NASA to 5-ASA in the systemic circulation as compared to administration of balsalazide in the fasted state.

24. A method of treating a gastrointestinal disorder comprising administering to a subject in need of treatment a therapeutically effective amount of balsalazide with food, wherein the balsalazide is administered between about 30 minutes prior to about 2 hours after consuming the food, and wherein the administration of the balsalazide with food results in a delay in the transit of 5-ASA in the colon of the subject as compared to administration of balsalazide in a fasted state.
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