Advancements in Mesalazine Formulations: Implications for Clinical Prescribing and Adherence

A single-dose mesalazine 1500 mg tablet is bioequivalent to three 500 mg tablets, providing equivalent systemic exposure while substantially reducing daily pill burden — a practical simplification for prescribing.

Historically, clinicians have used three 500 mg tablets to reach a 1500 mg dose; this randomized, single‑dose pharmacokinetic crossover in healthy volunteers compared systemic exposure measures such as AUC and Cmax and clarifies a straightforward formulation choice for practice.

The PK analysis showed comparable AUC and Cmax between the single 1500 mg tablet and three 500 mg tablets, meeting predefined bioequivalence criteria with point estimates and 90% confidence intervals within accepted ranges for rate and extent of exposure. Secondary PK parameters and safety signals were consistent across formulations. As this was a single‑dose study, clinical efficacy and long‑term tolerability were not assessed, so interchangeability in routine prescribing should be considered in that context.

Operational considerations for prescribing the higher‑strength tablet include limited titration flexibility, potential swallowability concerns with a larger tablet, local cost and coverage differences, and possible dispensing confusion when switching strengths. A brief follow‑up after transition to confirm tolerability and correct use is advisable to balance convenience with safe implementation.