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Projects of the Faculty of Pharmacy and Biochemistry

Development of sophisticated analytical methods for drugs and biologically active compounds in inflammatory bowel disease treatment

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Status Finished
Acronym IBD Analytics
Summary Crohn's disease and ulcerative colitis are two major forms of chronic inflammatory bowel disease. The etiology and pathogenesis of inflammatory bowel disease are still poorly understood. In inflammatory bowel disease, treatment decision is dependent on the stage of the disease, laboratory findings, and endoscopic examination. There are several therapies available for treatment, depending on the stage of the disease and side effects. Choice of pharmacotherapy depends largely on the severity of the disease, and may also be influenced by factors such as disease location, side effects and adverse events, as well as cost. Immunosuppressants, azathioprine, and 6-thioguanine, are the most prescribed drug class in inflammatory bowel disease treatment as steroid-sparing therapy, effective in maintaining remission. The treatment of inflammatory bowel diseases with biological molecules, specifically with monoclonal antibodies, presents high specificity and directed mechanism of action, but the high cost of this therapy still represents a barrier. As the inflammatory process along the digestive tract disrupts the resorption of vitamins and minerals, additional supplementation with vitamins and minerals is recommended with pharmacotherapy. It should be pointed out that low folate intake has been associated with tumor growth in inflammatory bowel disease. The majority of the patients consider that herbal dietary supplements are safe and free of unwanted side effects. Therefore, many patients with inflammatory bowel diseases, in addition to prescribed therapy, take herbal dietary supplements such as gum resin of Indian frankincense, leaf and root extracts of Justicia, and Turmeric. The main objective of the proposed research is to develop new instrumental analytical methods that could be applied in the quality control of medicinal products and dietary supplements used in the treatment of inflammatory bowel disease. A new fixed-dose combination of two drugs an immunosuppressant and folic acid to improve patient's adherence to their prescribed treatment will be proposed. Several methods for investigation of pharmacokinetic behavior, quality control, and therapeutic drug monitoring will be developed. Furthermore, analytical methods for the determination of biologically active compounds as well as toxic ingredients (metal impurities and volatile organic solvents) of herbal dietary supplements will be developed. The proposed methods will be applied for the evaluation of quality assurance for dietary supplements in the Croatian marketplace. Finally, an advanced 2D-SE-RP-HPLC/DAD technique will be proposed for the determination of monoclonal antibodies and their impurities in biologic drugs and their biosimilars.
Line of financing

Croatian Science Foundation

Duration 01.01.2018. - 31.03.2023.
Budget amount 174.000,00 EUR
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Results