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Thermal Stability of Dexamethasone-Evaluation with Regard to Modern Medicinal and Pharmaceutical 3D-Printing Applications
Authors: Svoboda Roman | Vrbensky Roman | Honzíček Jan | Chromcikova Maria
Year: 2025
Type of publication: článek v odborném periodiku
Name of source: Molecules
Publisher name: MDPI (Multidisciplinary Digital Publishing Institute)
Place: Basel
Page from-to: 4234
Titles:
Language Name Abstract Keywords
cze Tepelná stabilita dexamethasonu - hodnocení s ohledem na moderní lékařské a farmaceutické 3D tiskové aplikace Tepelná stabilita dexamethasonu (DEX) za vysokých teplot byla systematicky zkoumána v dusíkové a vzdušné atmosféře za použití neizotermické termogravimetrie při rychlostech ohřevu 0,1–20 °C center dot min(-1). Bylo zjištěno, že termický rozklad začíná pod teplotou tání a probíhá třístupňovou cestou, která generuje komplexní směs těkavých a kondenzovaných vedlejších produktů (podobně jako 10 % pevného zbytku při 550 °C). Kinetické modelování bylo provedeno pomocí jednokřivkové multivariační kinetické analýzy (sc-MKA) a bylo založeno na autokatalytickém rámci s teplotně závislými parametry v kombinaci s následnými reakčními mechanismy. dexamethason; TG; tepelný rozklad; kinetická predikce
eng Thermal Stability of Dexamethasone-Evaluation with Regard to Modern Medicinal and Pharmaceutical 3D-Printing Applications The high-temperature thermal stability of dexamethasone (DEX) was systematically investigated under nitrogen and air atmospheres using non-isothermal thermogravimetry at heating rates of 0.1-20 degrees C center dot min(-1). The thermal decomposition was found to initiate below the melting temperature, proceeding via a three-step pathway that generated a complex mixture of volatile and condensed by-products (similar to 10% solid residuum at 550 degrees C). Kinetic modeling was realized using the single-curve multivariate kinetic analysis (sc-MKA), and was based on the autocatalytic framework with temperature-dependent parameters, combined with consequent reaction mechanisms. An excellent agreement of the theoretical model with the experimental data enabled reliable predictive extrapolations to pharmaceutical processing conditions. Whereas the onset of degradation was observed at similar to 180-190 degrees C, significant decomposition rates (>1% mass loss during first 5 min) were only reached above 220 degrees C, well above the processing windows of most pharmaceutical polymers. Consequently, dexamethasone can be considered thermally stable for hot-melt extrusion and fused deposition modeling, except in high-temperature-processing applications involving polymers such as, e.g., polylactic acid, polyvinyl alcohol, or thermoplastic polyurethanes. Importantly, the study highlights that reliable kinetic predictions require measurements across a broad heating-rate range and in both oxidizing and inert atmospheres, with special emphasis on low heating rates (<= 0.2 degrees C center dot min(-1)), which proved critical for capturing early-stage degradation. These findings provide a rigorous kinetic framework for ensuring safe incorporation of DEX into advanced pharmaceutical and medical device formulations. dexamethasone; thermogravimetry; thermal decomposition; kinetic predictions

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