Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives

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 said administering with food comprises administering balsalazide within 15 minutes after eating a meal, and wherein the administration results in an increase in the bioavailability of balsalazide and metabolites 5-aminosalicylic acid (5-ASA) and N-acetyl-5-ASA (NASA) to the colon of the subject as compared to administration of balsalazide in a fasted state.

2. The method according to claim 1 , wherein the balsalazide is administered 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 max ) of one or more of balsalazide, 5-ASA or NASA in a subject; delaying T max of one or more of balsalazide, 5-ASA or NASA in a subject; decreasing the extent of absorption (AUC 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.

3. 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.

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 food comprises one or more of applesauce or a high-fat meal.

9. 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.