Patent ID: 7825106

Claim:
A pharmaceutical composition for administration to a subject in need thereof comprising a dose of an aminosalicylate active agent chosen from 4-amino salicylic acid, 5-amino salicylic acid, and pharmaceutically acceptable salts, esters and pro-drugs thereof; at least one polymer chosen from water-soluble cellulosic polymers, polyvinyl alcohol, polyvinylpyrrolidone, polyethylene glycol, water-insoluble acrylate polymers, water-insoluble cellulosic polymers, and mixtures thereof; and at least one pharmaceutically acceptable excipient chosen from carriers, fillers, extenders, binders, absorbents, lubricants, and stabilizers; wherein the composition exhibits: (a) a drug-release profile that is independent of surrounding pH; and (b) a dissolution profile, when tested in a U.S.P. Type II apparatus (paddles) at 37° C and 50 rpm, in pH 6.8 buffer for the test: 1 hour: less than or equal to about 20% drug released; 2 hours: less than or equal to about 35% drug released; 3 hours: less than or equal to about 50% drug released; 4 hours: less than or equal to about 60% drug released; 6 hours: less than or equal to about 75% drug released; and 12 hours: from about 25% to about 100% drug released; and wherein upon administration, the composition exhibits: (c) at least one ratio chosen from a total urine recovery or total plasma (AUC) ratio of metabolite of the active agent to the active agent greater than or equal to 10:1, and a Cmax ratio of metabolite of the active agent to the active agent greater than or equal to 5:1; and (d) from greater than 30% to about 100% of the dose of the active agent excreted in the urine as metabolite of the active agent and the active agent, wherein the composition comprises a modified-release matrix core.