Formulations containing salicylates and their use for treating inflammatory bowel disease

A pharmaceutical modified release composition comprising: a salicylate and / or salicylic acid chosen from 4-aminosalicylic acid, 5- prodrugs thereof selected from sulfasalazine, olsalazine, acid 4,5'- azo-bis salicylic acid, 4 , 4'-azo-bis salicylic acid, 5,5'-azo-bis-salicylic acid, 5,4'-azo-bis-salicylic and balsalazide; and at least one pharmaceutically acceptable excipient, and a polymer coating chosen from (a) at least one of methylcellulose and hydroxypropylmethylcellulose, or (b) two copolymers of ammonium methacrylate, and optionally at least one methacrylic acid copolymer, in which the composition shows a profile of drug release is independent of surrounding pH, and wherein the composition exhibits the following dissolution profile when tested in a USP apparatus Type II (paddles) at 37 ° C and 50 rpm, in pH 6.8 buffer for the test: 1 hour: less than or equal to 5% of drug released; 2 hours: from 0 to 25% drug released; 3 hours from 15 to 30% drug released; 4 hours: from 40 to 50% drug released; 6 hours: from 60 to 75% drug released; and 12 hours: from 90 to 100% drug released.