Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives for the treatment of males

Abstract

The instant application provides methods and compositions for the treatment of male subjects having ulcerative colitis.

What is claimed is: 
     
         1 . A method treating a gastrointestinal disorder comprising administering to a male subject in need of treatment a therapeutically effective amount of balsalazide. 
     
     
         2 . The method  claim 1 , wherein the therapeutically effective amount comprises about 6.5 to about 6.8 g per day. 
     
     
         3 . The method  claim 1 , wherein the therapeutically effective amount comprises about 6.6 g per day. 
     
     
         4 . The method  claim 1 , wherein the therapeutically effective amount comprises about 6.75 g per day. 
     
     
         5 . 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. 
     
     
         6 . The method of  claim 5 , wherein the balsalazide tablet is a film-coated tablet. 
     
     
         7 . 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. 
     
     
         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 gastrointestinal disorder comprises ulcerative colitis. 
     
     
         10 . The method of  claim 9 , wherein the ulcerative colitis is mild to moderately active ulcerative colitis. 
     
     
         11 . A method of decreasing a MMDAI score in a male subject having ulcerative colitis comprising administering to the subject a therapeutically effective amount of balsalazide, thereby decreasing the MMDAI score. 
     
     
         12 . The method  claim 11 , wherein the therapeutically effective amount comprises between about 6.5 to about 6.8 g per day. 
     
     
         13 . The method  claim 11 , wherein the therapeutically effective amount comprises about 6.6 g per day. 
     
     
         14 . The method  claim 11 , wherein the therapeutically effective amount comprises about 6.75 g per day. 
     
     
         15 . The method of  claim 12 , 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. 
     
     
         16 . The method of  claim 15 , wherein the balsalazide tablet is a film-coated tablet. 
     
     
         17 . The method of  claim 11 , 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. 
     
     
         18 . The method of  claim 11 , wherein the MMDAI score is decreased by 3 or more points. 
     
     
         19 . The method of  claim 11 , wherein the rectal bleeding component of the MMDAI score is decreased by 1 or more points. 
     
     
         20 . A method of inducing clinical remission of ulcerative colitis in a male subject comprising; administering to the subject a therapeutically effective amount of balsalazide, thereby inducing remission in the subject. 
     
     
         21 . The method  claim 20 , wherein the therapeutically effective amount comprises between about 6.5 to about 6.8 g per day. 
     
     
         22 . The method  claim 20 , wherein the therapeutically effective amount comprises about 6.6 g per day. 
     
     
         23 . The method  claim 20 , wherein the therapeutically effective amount comprises about 6.75 g per day. 
     
     
         24 . The method of  claim 21 , 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. 
     
     
         25 . The method of  claim 24 , wherein the balsalazide tablet is a film-coated tablet. 
     
     
         26 . The method of  claim 20 , 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. 
     
     
         27 . The method of  claim 20 , wherein remission is defined by MMDAI component scores of zero for rectal bleeding and a combined score of 2 or less for bowel frequency and physician's assessment. 
     
     
         28 . A method of inducing mucosal healing in a male subject having ulcerative colitis comprising administering to the subject a therapeutically effective amount of balsalazide, thereby inducing mucosal healing in the subject. 
     
     
         29 . The method  claim 28 , wherein the therapeutically effective amount comprises between about 6.5 to about 6.8 g per day. 
     
     
         30 . The method  claim 28 , wherein the therapeutically effective amount comprises about 6.6 g per day. 
     
     
         31 . The method  claim 28 , wherein the therapeutically effective amount comprises about 6.75 g per day. 
     
     
         32 . The method of  claim 29 , 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. 
     
     
         33 . The method of  claim 32 , wherein the balsalazide tablet is a film-coated tablet. 
     
     
         34 . The method of  claim 28 , 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. 
     
     
         35 . The method of  claim 28 , wherein the mucosal healing is defined as an improvement in endoscopy/sigmoidoscopy score to 0 or 1.