Physicochemical Compatibility Investigation of Mesalazine and Folic Acid Using Chromatographic and Thermoanalytical Techniques.

作者: Mario-Livio Jeličić , Edvin Brusač , Daniela Amidžić Klarić , Biljana Nigović , Sabina Keser

DOI: 10.3390/PH13080187

关键词: VitaminColorectal cancerFixed-dose combinationUlcerative colitisInflammatory bowel diseaseMalabsorptionPharmacologyForced degradationChemistryMesalazine

摘要: Inflammatory bowel disease is a common name for Crohn’s and ulcerative colitis. These inflammatory states cause damage in the sidewalls of gastrointestinal tract, resulting malabsorption food vitamins. Folic acid (Vitamin B9) often associated with diseases since reduced overall folate concentration human body may lead to development colorectal cancer megaloblastic anaemia. However, its deficiency easily compensated by taking an additional folic pill during regular therapy. At moment, there are no studies that have examined compatibility 5-aminosalicylate drugs used treatment diseases. In this work, differential scanning calorimetry, forced degradation studies, isothermal stress testing dissolution stability were determine one most commonly 5-aminosalicylates, mesalazine, when present same solution or blend. To monitor assay acid, mesalazine nine related impurities, single HPLC method was developed. Results showed physicochemical interaction between occurs combined, opening path new formulations, such as mesalazine/folic fixed-dose combination.

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