2020
DOI: 10.3390/ph13080187
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Physicochemical Compatibility Investigation of Mesalazine and Folic Acid Using Chromatographic and Thermoanalytical Techniques

Abstract: 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 a… Show more

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Cited by 9 publications
(13 citation statements)
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“…The TG measurements in the range of 0–175 °C showed a weight loss of 8.4%, which suited the declared value of the water content in the used FA standard of 8.0% [ 20 ]. The endothermic peak at 199.0 °C corresponded to the FA melting temperature, followed by a slow degradation as the heating continued, which could be seen as a constant loss of weight in the range of 200–400 °C [ 12 ]. The weight of the FA sample upon the end of measurements was reduced to 63% of its starting weight ( Figure 3 b).…”
Section: Resultsmentioning
confidence: 99%
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“…The TG measurements in the range of 0–175 °C showed a weight loss of 8.4%, which suited the declared value of the water content in the used FA standard of 8.0% [ 20 ]. The endothermic peak at 199.0 °C corresponded to the FA melting temperature, followed by a slow degradation as the heating continued, which could be seen as a constant loss of weight in the range of 200–400 °C [ 12 ]. The weight of the FA sample upon the end of measurements was reduced to 63% of its starting weight ( Figure 3 b).…”
Section: Resultsmentioning
confidence: 99%
“…The incompatibility of two drugs can result in the change of their physical characteristics, which can be observed as a shift in the characteristic peak temperature (±5 °C) or if the peak notably changes its shape, disappears or a new peak occurs [ 12 , 19 , 21 , 22 ]. In the provided measurements, a shift of the peak temperature was observed for SASP (9.6 °C); on the other hand, the FA characteristic melting peak did not shift notably (1.6 °C), which implies that the two drugs might be compatible.…”
Section: Resultsmentioning
confidence: 99%
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“…As previously mentioned, isothermal stress testing is often used in assessing the compatibility of drug substances with other substances and excipients potentially used in the formulation [ 16 , 18 ]. When coupled with a technique such as chromatography, its advantages are its high accuracy and precision, as well as ability to detect and identify possible interaction products present in small amounts.…”
Section: Resultsmentioning
confidence: 99%
“…In the case of incompatibility, technological solutions such as bilayer tablets should be considered. On the other hand, a number of techniques such as thermogravimetric analysis, differential scanning calorimetry (DSC), isothermal stress testing (IST) followed by Fourier-transform infrared spectroscopy (FTIR) or high-performance liquid chromatography (HPLC) assay, X-ray diffraction, dissolution testing and others are used to screen and assess the compatibility of the active substances and planned excipients but, also, of the two or more active substances [ 15 , 16 , 17 , 18 ]. Therefore, the aim of this work was to investigate the compatibility of FA and 6-mercaptopurine (6MP) ( Figure 1 ), a drug from the thiopurine class, as a prerequisite for FDC development.…”
Section: Introductionmentioning
confidence: 99%