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In-situ Observation of Lyophilization Process in Environmental Scanning Electron Microscope

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    0493330 - ÚPT 2019 US eng A - Abstract
    Vetráková, L'. - Neděla, Vilém - Runštuk, Jiří
    In-situ Observation of Lyophilization Process in Environmental Scanning Electron Microscope.
    Microscopy and Microanalysis. Cambridge University Press. Roč. 24, S1 (2018), s. 1406-1407. ISSN 1431-9276. E-ISSN 1435-8115.
    [Microscopy & Microanalysis 2018 Meeting. 05.08.2018-09.08.2018, Baltimore]
    R&D Projects: GA MŠMT(CZ) LO1212; GA MŠMT ED0017/01/01
    Institutional support: RVO:68081731
    Keywords : in-situ observation * lyophilization process * ESEM
    OECD category: Organic chemistry

    Lyophilization (freeze-drying) is nowadays the most common formulation strategy to prepare pharmaceuticals as in the solid state chemical or physical degradation reactions are inhibited or sufficiently decelerated. However, it is a very time-consuming and expensive process. Lyophilisation at elevated temperatures can be used to accelerate the cost-intensive drying step and thus reduce the overall time and cost of the process (increase in temperature of 1 °C was reported to decrease the drying time by about 13%). Nonetheless, it is recommended to keep the product temperature just below the collapse temperature (Tc) during primary drying to avoid an undesirable collapse of a freeze-dried cake. Scanning electron microscopy (SEM) is usually used to examine the resulting morphology of the freeze-dried cake and to determine the product quality. However, SEM cannot be used to monitor the product structure during the lyophilisation process at the temperatures close to Tc due to difficulties with maintaining the SEM vacuum because of excessive ice sublimation. To monitor potential collapse, freeze-drying microscopy (FDM) is commonly applied.
    Permanent Link: http://hdl.handle.net/11104/0286713

     
     
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