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Croatica Chemica Acta, Vol. 94 No. 1, 2021.

Original scientific paper

https://doi.org/10.5562/cca3799

Thermoanalytical, Spectroscopic and Chromatographic Approach to Physicochemical Compatibility Investigation of 5-Aminosalicylates and Folic Acid

Mario-Livio Jeličić orcid id orcid.org/0000-0002-5331-2281 ; Department of Pharmaceutical Analysis, University of Zagreb, Faculty of Pharmacy and Biochemistry, Zagreb, Croatia
Edvin Brusač orcid id orcid.org/0000-0001-7295-5023 ; Department of Pharmaceutical Analysis, University of Zagreb, Faculty of Pharmacy and Biochemistry, Zagreb, Croatia
Stanislav Kurajica orcid id orcid.org/0000-0002-7066-1213 ; Department of Inorganic Chemical Technology and Non-Metals, University of Zagreb, Faculty of Chemical Engineering and Technology, Zagreb, Croatia
Matija Cvetnić orcid id orcid.org/0000-0002-0168-8092 ; Department of Pharmaceutical Analysis, University of Zagreb, Faculty of Pharmacy and Biochemistry, Zagreb, Croatia
Daniela Amidžić Klarić orcid id orcid.org/0000-0002-1695-6950 ; Department of Pharmaceutical Analysis, University of Zagreb, Faculty of Pharmacy and Biochemistry, Zagreb, Croatia
Biljana Nigović orcid id orcid.org/0000-0001-8249-5921 ; Department of Pharmaceutical Analysis, University of Zagreb, Faculty of Pharmacy and Biochemistry, Zagreb, Croatia
Ana Mornar orcid id orcid.org/0000-0002-3944-697X ; Department of Analytical Chemistry, University of Zagreb, Faculty of Chemical Engineering and Technology, Zagreb, Croatia

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Abstract

Fixed-dose combinations have shown to be a great alternative to traditional polytherapy; however, development of such formulation requires thorough physicochemical compatibility investigation of active pharmaceutical ingredients to provide a stable, safe and therapeutically effective product. In this work, differential scanning calorimetry, X-ray powder diffraction, isothermal stress testing followed by Fourier-transform infrared spectroscopy and chromatographic analysis as well as dissolution studies were used for physicochemical compatibility investigation of folic acid and balsalazide or olsalazine. Balsalazide and olsalazine as well as their blend were successfully characterised regarding their physicochemical properties using the mentioned techniques. Differential scanning calorimetry gave ambiguous results due to premature degradation of balsalazide. On the contrary, other techniques have implied the absence of any chemical reactions or physical changes in prepared blends. Obtained result imply that folic acid is compatible with both balsalazide and olsalazine which goes in favour of developing proposed fixed-dose combinations.

This work is licensed under a Creative Commons Attribution 4.0 International License.

Keywords

balsalazide; olsalazine; folic acid; fixed-dose combination; physicochemical compatibility; FTIR; DSC; XRPD; chromatography

Hrčak ID:

265048

URI

https://hrcak.srce.hr/265048

Publication date:

28.6.2021.

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