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Impact of Gamma Irradiation and Ethylene Oxide Sterilisation on the Stability of Crystalline and Amorphous Drug Solids
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DOI：10.1016/j.ejps.2026.107572.png)
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Abstract
En 中文
Terminal sterilisation is a critical process for pharmaceutical products intended for parenteral or invasive administration, yet conventional sterilisation approaches can compromise thermolabile or chemically sensitive drug substances. In this study, the compatibility of crystalline and amorphous solid forms of five drug substances (betamethasone dipropionate (BMD), estradiol (E2), itraconazole (ITZ), vismodegib (VDG), and zolmitriptan (ZMT)) with sterilising gamma irradiation and ethylene oxide (EtO) cycles was evaluated in terms of chemical and physical stability. Physical stability was assessed by visual inspection of crystalline powders and amorphous solids pre- and post-sterilisation and by differential scanning calorimetry (DSC) to characterise the melting behaviour of crystalline drugs, and glass transition and recrystallisation events in amorphous forms. Chemical stability was examined using reverse phase-high-performance liquid chromatography (RP-HPLC), liquid chromatography–mass spectrometry (LC-MS), and proton nuclear magnetic resonance spectroscopy (¹H-NMR).
Keywords:
Terminal sterilisation
Gamma irradiation
Ethylene oxide
physicochemical stability
solid-state characterisation
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