Mechanism
of glass ampoule breakage prevention during the freeze-drying process of sodium
thiopental lyophilization products on addition of sodium chloride |
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Authors: | T Ito Y Yoshioka T Sonoda Y Yoshihashi E Yonemochi K Terada |
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Institution: | (1) Pharmaceutical Development Labs, Tanabe Seiyaku Co., Ltd., Osaka, Japan, 3-16-89, Kashima, Yodogawaku;(2) Department of Pharmaceutics, School of Pharmaceutical Sciences, Toho University, Chiba, Japan, 2-2-1, Miyama, Funabashi |
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Abstract: | Glass
ampoule breakage during the freeze-drying process was prevented by the addition
of sodium chloride to the formulation of lyophilization products of sodium
thiopental. In order to clarify the ampoule breakage prevention mechanism,
the physicochemical behavior of the freeze-drying process was monitored by
simultaneous XRD-DSC measurements and thermal mechanical analysis (TMA). During
the freezing process of formulated solution, the smaller heat of fusion of
crystallized ice with the addition of sodium chloride was observed in comparison
to that without sodium chloride. Although a greater amorphous portion remained,
a higher crystal habit of hexagonal ice was reproducibly observed in the XRD
patterns with the addition of sodium chloride during the freezing process.
In the measurement of TMA, the scattering of the thermal expansion rate of
formulated solution was significantly reduced by the addition of sodium chloride.
These observations indicated that the addition of sodium chloride minimized
the scattering of the thermal expansion rate and might be a cause for the
inhibition of glass ampoule breakage during the freeze-drying process. |
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Keywords: | freeze-drying sodium carbonate sodium chloride sodium thiopental TMA XRD-DSC |
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