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@article{1678759,
author = {Vetráková, Ľubica and Neděla, Vilém and Runštuk, Jiří and Tihlaříková, Eva and Heger, Dominik and Shalaev, Evgenyi},
article_location = {Amsterdam},
article_number = {JUL 30 2020},
doi = {http://dx.doi.org/10.1016/j.ijpharm.2020.119448},
keywords = {Bovine serum albumin; Freeze-drying; Vacuum-drying; Environmental scanning electron microscopy},
language = {eng},
issn = {0378-5173},
journal = {International Journal of Pharmaceutics},
title = {Dynamical in-situ observation of the lyophilization and vacuum-drying processes of a model biopharmaceutical system by an environmental scanning electron microscope},
url = {https://doi.org/10.1016/j.ijpharm.2020.119448},
volume = {585},
year = {2020}
}
TY - JOUR
ID - 1678759
AU - Vetráková, Ľubica - Neděla, Vilém - Runštuk, Jiří - Tihlaříková, Eva - Heger, Dominik - Shalaev, Evgenyi
PY - 2020
TI - Dynamical in-situ observation of the lyophilization and vacuum-drying processes of a model biopharmaceutical system by an environmental scanning electron microscope
JF - International Journal of Pharmaceutics
VL - 585
IS - JUL 30 2020
SP - 1-16
EP - 1-16
PB - Elsevier science BV
SN - 03785173
KW - Bovine serum albumin
KW - Freeze-drying
KW - Vacuum-drying
KW - Environmental scanning electron microscopy
UR - https://doi.org/10.1016/j.ijpharm.2020.119448
L2 - https://doi.org/10.1016/j.ijpharm.2020.119448
N2 - The paper discusses the real-time monitoring of the changing sample morphology during the entire lyophilization (freeze-drying) and vacuum-drying processes of model biopharmaceutical solutions by using an environmental scanning electron microscope (ESEM); the device's micromanipulators were used to study the interior of the samples in-situ without exposing the samples to atmospheric water vapor. The individual collapse temperatures (T-c) of the formulations, pure bovine serum albumin (BSA) and BSA/sucrose mixtures, ranged from - 5 to - 29 degrees C. We evaluated the impact of the freezing method (spontaneous freezing, controlled ice nucleation, and spray freezing) on the morphologies of the lyophiles at the constant drying temperature of - 20 degrees C. The formulations with T-c above - 20 degrees C resulted in the lyophiles' morphologies significantly dependent on the freezing method. We interpret the observations as an interplay of the freezing rates and directionalities, both of which markedly influence the morphologies of the frozen formulations, and, subsequently, the drying process and the mechanical stability of the freeze-dried cake. The formulation with T-c below - 20 degrees C yielded a collapsed cake with features independent of the freezing method. The vacuum-drying produced a material with a smooth and pore-free surface, where deep cracks developed at the end of the process.
ER -
VETRÁKOVÁ, Ľubica, Vilém NEDĚLA, Jiří RUNŠTUK, Eva TIHLAŘÍKOVÁ, Dominik HEGER a Evgenyi SHALAEV. Dynamical in-situ observation of the lyophilization and vacuum-drying processes of a model biopharmaceutical system by an environmental scanning electron microscope. \textit{International Journal of Pharmaceutics}. Amsterdam: Elsevier science BV, 2020, roč.~585, JUL 30 2020, s.~1-16. ISSN~0378-5173. Dostupné z: https://dx.doi.org/10.1016/j.ijpharm.2020.119448.
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