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Article

Drug–Drug Compatibility Evaluation of Sulfasalazine and Folic Acid for Fixed-Dose Combination Development Using Various Analytical Tools

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Faculty of Pharmacy and Biochemistry, University of Zagreb, A. Kovačića 1, 10000 Zagreb, Croatia
2
Faculty of Chemical Engineering and Technology, University of Zagreb, Marulić Square 19, 10000 Zagreb, Croatia
*
Author to whom correspondence should be addressed.
Academic Editor: Beverley D. Glass
Pharmaceutics 2021, 13(3), 400; https://doi.org/10.3390/pharmaceutics13030400
Received: 26 February 2021 / Revised: 11 March 2021 / Accepted: 16 March 2021 / Published: 17 March 2021
(This article belongs to the Special Issue Drug Stability and Stabilization Techniques Volume II)
The simultaneous administration of sulfasalazine and folic acid is regular practice in the therapy of inflammatory bowel diseases in order to maintain sufficient folate concentration in patients. Having multiple drugs in the therapy increases the possibility of patients failing adherence, thus unintentionally endangering their health. A fixed-dose combination of sulfasalazine and folic would simplify the classical polytherapeutic approach; however, the physicochemical compatibility investigation of two active pharmaceutical ingredients plays an important role in the development of such a product. In this work, various analytical tools were used to determine the physicochemical compatibility of sulfasalazine and folic acid. For the evaluation of chemical compatibility, infrared spectroscopy in combination with advanced statistical methods, such as the principal component analysis and cluster analysis, were used, whilst a simultaneous thermogravimetry/differential thermal analysis gave us an insight into the physical compatibility of two drugs. Isothermal stress testing, forced degradation and dissolution studies, followed by the analysis with a developed chromatographic method for the monitoring of folic acid, sulfasalazine and two of its related impurities, sulfapyridine and salicylic acid, gave us an insight into its chemical compatibility. The combination of the results obtained from the used techniques implies a satisfactory physicochemical compatibility between sulfasalazine and folic acid, which opens the path to the development of the proposed fixed-dose combination. View Full-Text
Keywords: sulfasalazine; folic acid; fixed-dose combination; physicochemical compatibility; thermal techniques; spectroscopy; chromatography sulfasalazine; folic acid; fixed-dose combination; physicochemical compatibility; thermal techniques; spectroscopy; chromatography
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MDPI and ACS Style

Jeličić, M.-L.; Brusač, E.; Kurajica, S.; Cvetnić, M.; Amidžić Klarić, D.; Nigović, B.; Mornar, A. Drug–Drug Compatibility Evaluation of Sulfasalazine and Folic Acid for Fixed-Dose Combination Development Using Various Analytical Tools. Pharmaceutics 2021, 13, 400. https://doi.org/10.3390/pharmaceutics13030400

AMA Style

Jeličić M-L, Brusač E, Kurajica S, Cvetnić M, Amidžić Klarić D, Nigović B, Mornar A. Drug–Drug Compatibility Evaluation of Sulfasalazine and Folic Acid for Fixed-Dose Combination Development Using Various Analytical Tools. Pharmaceutics. 2021; 13(3):400. https://doi.org/10.3390/pharmaceutics13030400

Chicago/Turabian Style

Jeličić, Mario-Livio, Edvin Brusač, Stanislav Kurajica, Matija Cvetnić, Daniela Amidžić Klarić, Biljana Nigović, and Ana Mornar. 2021. "Drug–Drug Compatibility Evaluation of Sulfasalazine and Folic Acid for Fixed-Dose Combination Development Using Various Analytical Tools" Pharmaceutics 13, no. 3: 400. https://doi.org/10.3390/pharmaceutics13030400

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