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• W2895571350 startingPage "122" @default.
• W2895571350 abstract "Early stages of crystallization from amorphous solid dispersion (ASD) are typically not detected by means of standard methods like powder X-ray diffraction (XRPD). The aim of this study is therefore to evaluate if fractal analysis based on energy dispersive X-ray imaging can provide the means to identify early signs of physical instability. ASDs of the poorly water-soluble compound, felodipine (FEL) were prepared by solvent evaporation using different grades of HPMCAS, at 50 wt% drug loading. Samples were stored at accelerated conditions of 40 °C. Scanning electron microscopy equipped with an energy-dispersive X-ray spectroscopy (SEM-EDS) was used for elemental mapping of tablet surfaces. Comparative data were generated with a standard XRPD and with more sensitive methods for detection of early instability, i.e. laser scanning confocal microscopy (LSM) and atomic force microscopy (AFM). The SEM-EDS identified changes of drug-rich domains that were confirmed by LSM and AFM. Early changes in drug clusters were also revealed by a multifractal analysis that indicated a beginning phase separation and drug crystallization. Therefore, the presented fractal cluster analysis based on chemical imaging bears much promise as a new method to detect early signs of physical instability in ASD, which is of great relevance for pharmaceutical development." @default.
• W2895571350 created "2018-10-12" @default.
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• W2895571350 date "2018-12-01" @default.
• W2895571350 modified "2023-10-14" @default.
• W2895571350 title "Early stages of drug crystallization from amorphous solid dispersion via fractal analysis based on chemical imaging" @default.
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• W2895571350 doi "https://doi.org/10.1016/j.ejpb.2018.10.007" @default.
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• W2895571350 hasPublicationYear "2018" @default.
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