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• W2955162013 endingPage "118470" @default.
• W2955162013 startingPage "118470" @default.
• W2955162013 abstract "Powders containing one of four model proteins (myoglobin, bovine serum albumin, lysozyme, β-lactoglobulin) were formulated with either sucrose, trehalose, or mannitol and dried using lyophilization or spray-drying. The powders were characterized using solid-state Fourier transform infrared spectroscopy (ssFTIR), solid-state fluorescence spectroscopy, differential scanning calorimetry (DSC) and solid-state hydrogen/deuterium exchange mass spectrometry (ssHDX-MS). ssFTIR and fluorescence spectroscopy identified minor structural differences among powders with different excipients and drying methods for some proteins. Using ssHDX-MS, differences in protein structure were observed among protein formulations containing sucrose or trehalose and mannitol, and/or with varying processing conditions, including proteins like β-lactoglobulin, for which standard characterization techniques showed no differences. Proteins processed by spray-drying typically showed greater heterogeneity by ssHDX-MS than those lyophilized; these differences were not detected by ssFTIR or solid-state fluorescence spectroscopy. The ssHDX-MS metrics were better correlated with protein physical instability measured by size-exclusion chromatography in 90-day stability studies (40 °C, 33% RH) than with the results of DSC, ssFTIR, or fluorescence spectroscopy. Thus, ssHDX-MS detected subtle changes in conformation and/or matrix interactions for these proteins that were correlated with storage stability, suggesting that the method can be used to design robust solid-state pharmaceutical protein products more rapidly." @default.
• W2955162013 created "2019-07-12" @default.
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• W2955162013 date "2019-08-01" @default.
• W2955162013 modified "2023-10-17" @default.
• W2955162013 title "Effects of drying method and excipient on structure and stability of protein solids using solid-state hydrogen/deuterium exchange mass spectrometry (ssHDX-MS)" @default.
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• W2955162013 doi "https://doi.org/10.1016/j.ijpharm.2019.118470" @default.
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