New dissolution method for mesalamine tablets and capsules

Abstract

Dissolution methods are different for extended-release mesalamine capsules (pH 7.5 only) and delayed-release tablets (pH 1.4, 6.0, and 7.2). Mesalamine is used for the treatment of ulcerative colitis. The USP methods have several drawbacks in that they do not mimic gastrointestinal tract environments; tablets are removed from vessels to change dissolution medium; and neither method has been adopted to compare different formulations. This study proposed a method that reflects gastrointestinal transit time and pH, is easy to conduct, and may be used to test new delayed- or extended-release formulations and compare various dosage forms.