Abstract
Mesalamine (5-aminosalicylic acid) is widely used for the treatment of inflammatory bowel disease (IBD), including ulcerative colitis. Commercially available mesalamine delayed-release formulations, such as LIALDA (Mesalamine) Delayed-Release Tablets 1.2 g, utilize a pH-dependent polymer film, which breaks down at or above pH 6.8, normally in the terminal ileum where mesalamine then begins to be released from the tablet core, enabling controlled drug release. However, the drug release profile of such formulations has been observed to change with storage, particularly at elevated temperatures. This article presents findings from formulation studies demonstrating that incorporating sodium ascorbate or sodium benzoate as stabilizers in conjunction with sodium carboxymethyl cellulose effectively maintains drug release consistency over time.
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Recommended Citation
Anonymous, "Stability Enhancement of Mesalamine Delayed-Release Tablets 1.2g", Technical Disclosure Commons, (March 10, 2025)
https://www.tdcommons.org/dpubs_series/7888