Mesalazine release from a pH dependent formulation: effects of omeprazole and lactulose co‐administration

Abstract

Aims Delayed-release formulations of mesalazine often rely on the gastrointestinal luminal pH profile to deliver 5-aminosalicylic acid (5ASA) to the colon. The aim of this study was to examine the influence of luminal pH on mesalazine release. Methods We studied the effect of co-administration of omeprazole and lactulose on the steady-state pharmacokinetics of Eudragit S-coated mesalazine in healthy volunteers. Results No significant changes in urinary or faecal levels of 5ASA or its main metabolite, N-acetyl 5ASA, were apparent. Conclusions This study suggests that co-administration of omeprazole and lactulose does not impair the release of delayed-release mesalazine.