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

Faculty of Pharmacy and Biochemistry, University of Zagreb, A. Kovačića 1, 10000 Zagreb, Croatia
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Pharmaceuticals 2020, 13(8), 187; https://0-doi-org.brum.beds.ac.uk/10.3390/ph13080187
Received: 16 July 2020 / Revised: 5 August 2020 / Accepted: 7 August 2020 / Published: 8 August 2020
(This article belongs to the Section Pharmaceutical Technology)
Inflammatory bowel disease is a common name for Crohn’s disease and ulcerative colitis. These inflammatory states cause damage in the sidewalls of the gastrointestinal tract, resulting in malabsorption of food and vitamins. Folic acid (Vitamin B9) is often associated with inflammatory bowel diseases since reduced overall folate concentration in the human body may lead to the development of colorectal cancer and megaloblastic anaemia. However, its deficiency is easily compensated by taking an additional folic acid pill during regular therapy. At the moment, there are no studies that have examined the compatibility of folic acid with 5-aminosalicylate drugs used in the treatment of inflammatory bowel diseases. In this work, differential scanning calorimetry, forced degradation studies, isothermal stress testing and dissolution stability testing were used to determine the stability of folic acid and one of the most commonly used 5-aminosalicylates, mesalazine, when present in the same solution or blend. To monitor the assay of folic acid, mesalazine and nine of its related impurities, a single HPLC method was developed. Results of compatibility studies showed that no physicochemical interaction between mesalazine and folic acid occurs when combined, opening the path to the development of new formulations, such as a mesalazine/folic acid fixed-dose combination. View Full-Text
Keywords: mesalazine; folic acid; inflammatory bowel disease; drug compatibility; fixed-dose combination mesalazine; folic acid; inflammatory bowel disease; drug compatibility; fixed-dose combination
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MDPI and ACS Style

Jeličić, M.-L.; Brusač, E.; Amidžić Klarić, D.; Nigović, B.; Keser, S.; Mornar, A. Physicochemical Compatibility Investigation of Mesalazine and Folic Acid Using Chromatographic and Thermoanalytical Techniques. Pharmaceuticals 2020, 13, 187. https://0-doi-org.brum.beds.ac.uk/10.3390/ph13080187

AMA Style

Jeličić M-L, Brusač E, Amidžić Klarić D, Nigović B, Keser S, Mornar A. Physicochemical Compatibility Investigation of Mesalazine and Folic Acid Using Chromatographic and Thermoanalytical Techniques. Pharmaceuticals. 2020; 13(8):187. https://0-doi-org.brum.beds.ac.uk/10.3390/ph13080187

Chicago/Turabian Style

Jeličić, Mario-Livio, Edvin Brusač, Daniela Amidžić Klarić, Biljana Nigović, Sabina Keser, and Ana Mornar. 2020. "Physicochemical Compatibility Investigation of Mesalazine and Folic Acid Using Chromatographic and Thermoanalytical Techniques" Pharmaceuticals 13, no. 8: 187. https://0-doi-org.brum.beds.ac.uk/10.3390/ph13080187

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