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  • Title: Through-vial impedance spectroscopy of critical events during the freezing stage of the lyophilization cycle: the example of the impact of sucrose on the crystallization of mannitol.
    Author: Arshad MS, Smith G, Polygalov E, Ermolina I.
    Journal: Eur J Pharm Biopharm; 2014 Aug; 87(3):598-605. PubMed ID: 24825125.
    Abstract:
    The aim of this work was to evaluate the application of through-vial impedance spectroscopy in the measurement of eutectic crystallization during the freezing stage of the lyophilisation cycle. Impedance measurements of various sugar solutions (mannitol 5%, 10% and 15% w/v, sucrose 5% w/v and mannitol 5% w/v, and sucrose 5% w/v solutions) were taken during a freeze-thaw cycle, over a frequency range 10-10(6) Hz with a scan interval of 1.5 min, using measurement vials with externally attached electrodes connected to a high resolution impedance analyzer. Estimates for the electrical resistance of the mannitol solutions record the exothermic crystallization of mannitol at a temperature of -24 °C during the temperature ramp down stage of the freezing cycle, which is in close agreement with the off-line DSC measurement of -22 °C. The freezing profile of a 5% mannitol solution with 5% sucrose (a component that does not crystallize in the frozen solution) demonstrated the inhibition of mannitol crystallization (with the implication that the product will then require sub-Tg' freezing and drying). The work suggests a role for through-vial impedance spectroscopy in the concurrent development of the product formulation and freeze drying cycle without the uncertainty introduced when using off-line date to define the critical process parameters.
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