ArticleDrugs in R&D2015
Dissolution of Commercially Available Mesalamine Formulations at Various pH Levels.
Article in Drugs in R&D, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
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Who cites it
4 citing papers in PubMed.
- Understanding the Influence of Molarity, Buffer Capacity, and pH on Product-specific Guidance Dissolution Method for Developing a Discriminatory Dissolution Method for the Development of Mesalamine Products.AAPS PharmSciTech · 2026Article
- Influence of Milling Parameters on Crystal Morphology, Thermal Behavior, and Dissolution of Mesalamine Nanocrystals.Pharmaceutical research · 2025Article
- Modelling and Simulation of the Drug Release from a Solid Dosage Form in the Human Ascending Colon: The Influence of Different Motility Patterns and Fluid Viscosities.Pharmaceutics · 2021Article
- Patient Preference and Adherence to Aminosalicylates for the Treatment of Ulcerative Colitis.Clinical and experimental gastroenterology · 2021Review
Corrections and comments
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Authors and funding
1 author.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionMesalamine (5-aminosalicylic acid; 5-ASA) is recommended first-line therapy for mild-to-moderate ulcerative colitis. Many mesalamine formulations employ a pH-dependent release mechanism designed to maximize drug release in the colon. This study compared the in vitro release of 5-ASA from six commercially available mesalamine formulations at pH levels similar to those typically encountered in the human gastrointestinal tract.
methodsThe release of 5-ASA from six mesalamine formulations [Mesalazin-Kohlpharma (Kohlpharma, Germany), Mesalazin-Eurim (Eurimpharm, Germany), Mesalazina-Faes (Faes Farma, Spain), Mesalazine EC (Actavis B.V., Netherlands), Mesalazine EC 500 PCH (Pharmachemie B.V., Netherlands); multimatrix mesalamine (Shire US Inc., USA)] was monitored separately at three different pH levels [1.0 (2 h), 6.4 (1 h), and 7.2 (8 h)] using United States Pharmacopeia dissolution apparatus II. The dissolution percentage was calculated as a mean of 12 units for each formulation.
resultsAt pH 1.0 and 6.4, <1 % of 5-ASA release was observed for each of the mesalamine formulations tested. At pH 7.2, complete release of 5-ASA occurred within 1 h for Mesalazine EC and Mesalazine EC 500 PCH, and within 2 h for Mesalazin-Kohlpharma, Mesalazin-Eurim, and Mesalazina-Faes; complete release of 5-ASA from multimatrix mesalamine occurred within 7 h. Little variability in rate of 5-ASA dissolution was observed between tablets of each formulation.
conclusionAt pH 7.2, 5-ASA release profiles were variable among the commercially available mesalamine formulations that were tested.
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