Using dextran of different molecular weights to achieve faster freeze-drying and improved storage stability of lactate dehydrogenase

Pharmaceutical Development and Technology
Bjarke Strøm LarsenKorbinian Löbmann

Abstract

Freeze-drying of protein formulations is frequently used to maintain protein activity during storage. The freeze-drying process usually requires long primary drying times because the highest acceptable drying temperature to obtain acceptable products is dependent on the glass transition temperature of the maximally freeze-concentrated solution (Tg'). On the other hand, retaining protein activity during storage is related to the glass transition temperature (Tg) of the final freeze-dried product. In this study, dextrans with different molecular weight (1 and 40 kDa) and mixtures thereof at the ratio 3:1, 1:1, and 1:3 (w/w) were used as cryo-/lyoprotectant and their impact on the stability of the model protein lactate dehydrogenase (LDH) was investigated at elevated temperatures (40 °C and 60 °C). The dextran formulations were then compared to formulations containing sucrose as cryo-/lyoprotectant. Because of the higher Tg' values of the dextrans, the primary drying times could be reduced compared to freeze-drying with sucrose. Similarly, the higher Tg and Tg' of dextrans relative to sucrose led to benefits during storage which was shown through improved protection of LDH activity.

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Citations

Dec 25, 2019·Pharmaceutical Research·Nathan E WilsonQi Tony Zhou
Jan 8, 2020·Micromachines·Andreas M A O PolletJaap M J den Toonder
Jan 25, 2021·International Journal of Pharmaceutics·Rishabh TukraElizabeth M Topp
Jan 29, 2021·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Tobias Palle HolmHolger Grohganz
May 3, 2021·Journal of Pharmaceutical Sciences·Ute RockingerGerhard Winter

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