ArticleAdvances in therapy2015
Release of 5-Aminosalicylic Acid (5-ASA) from Mesalamine Formulations at Various pH Levels.
Article in Advances in therapy, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis that pooled it.
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Who cites it
15 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Oral 5-aminosalicylic acid for maintenance of surgically-induced remission in Crohn's disease.The Cochrane database of systematic reviews · 2019Pooled it
- Understanding the High Pharmacokinetic Variability of 5-Aminosalicylic Acid Drug Products Using Compartmental, Semi-mechanistic, and Mechanistic Pharmacokinetic Models.AAPS PharmSciTech · 2026Article
- 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
- Process Optimisation, Pharmaceutical Characterisation, and in vitro Activity of Mesalamine Nanocrystals in PMA-differentiated THP-1 cell Lines in the Late Inflammatory and Profibrotic Phase.AAPS PharmSciTech · 2026Article
- Development of a pH Gradient Dissolution Condition to Predict the Behavior of Delayed Release Formulations under Fed In Vivo Condition.AAPS PharmSciTech · 2025Article
- In vitro evaluation of mesalazine enteric-coated tablet dissolution by the reciprocating cylinder method.Scientific reports · 2025Article
- Design, Development, and Optimisation of Smart Linker Chemistry for Targeted Colonic Delivery-In Vitro Evaluation.Pharmaceutics · 2023Article
- Effect of acid-reducing agents on clinical relapse in ulcerative colitis with pH-dependent-released 5-aminosalicylic acid: a multicenter retrospective study in Japan.Intestinal research · 2021Article
- Additive Manufacturing of Oral Tablets: Technologies, Materials and Printed Tablets.Pharmaceutics · 2021Review
- Protective Effect of Asacol in Combination with Pantoprazole in Ulcerative Colitis Patients Who Defecate Asacol Tablets Intactly: A Clinical Trial Study.Clinical and experimental gastroenterology · 2020Article
- Synthesis and evaluation of a prodrug of 5-aminosalicylic acid for the treatment of ulcerative colitis.Iranian journal of basic medical sciences · 2019Article
- Nanoparticle-Mediated Drug Delivery Systems For The Treatment Of IBD: Current Perspectives.International journal of nanomedicine · 2019Review
- Insights into the treatment of inflammatory bowel disease in pregnancy.Therapeutic advances in gastroenterology · 2019Review
- Colon-targeting mutual prodrugs of 5-aminosalicylic acid and butyrate for the treatment of ulcerative colitis.RSC advances · 2018Article
- Dissolution of Commercially Available Mesalamine Formulations at Various pH Levels.Drugs in R&D · 2015Article
Corrections and comments
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Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionOral formulations of 5-aminosalicylic acid (5-ASA) for treatment of ulcerative colitis have been developed to minimize absorption prior to the drug reaching the colon. In this study, we investigate the release of 5-ASA from available oral mesalamine formulations in physiologically relevant pH conditions.
methodsRelease of 5-ASA from 6 mesalamine formulations (APRISO®, Salix Pharmaceuticals, Inc., USA; ASACOL® MR, Procter & Gamble Pharmaceuticals UK Ltd.; ASACOL® HD, Procter & Gamble Pharmaceuticals, USA; MEZAVANT XL®, Shire US Inc.; PENTASA®, Ferring Pharmaceuticals, Ltd., UK; SALOFALK®, Dr. Falk Pharma UK Ltd.) was evaluated using United States Pharmacopeia apparatus I and II at pH values of 1.0 (2 h), 6.0 (1 h), and 6.8 (8 h). Dissolution profiles were determined for each formulation, respectively.
resultsOf the tested formulations, only the PENTASA formulation demonstrated release of 5-ASA at pH 1.0 (48%), with 56% cumulative release after exposure to pH 6.0 and 92% 5-ASA release after 6-8 h at pH 6.8. No other mesalamine formulation showed >1% drug release at pH 1.0. The APRISO formulation revealed 36% 5-ASA release at pH 6.0, with 100% release after 3 h at pH 6.8. The SALOFALK formulation revealed 11% 5-ASA release at pH 6.0, with 100% release after 1 h at pH 6.8. No 5-ASA was released by the ASACOL MR, ASACOL HD, and MEZAVANT XL formulations at pH 6.0. At pH 6.8, the ASACOL MR and ASACOL HD formulations exhibited complete release of 5-ASA after 4 and 2 h, respectively, and the MEZAVANT XL formulation demonstrated complete 5-ASA release over 6-7 h.
conclusion5-Aminosalicylic acid release profiles were variable among various commercially available formulations.
fundingShire Development LLC.
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