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Dynamical in-situ observation of the lyophilization and vacuum-drying processes of a model biopharmaceutical system by an environmental scanning electron microscope
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SYSNO ASEP 0531984 Document Type J - Journal Article R&D Document Type Journal Article Subsidiary J Článek ve WOS Title Dynamical in-situ observation of the lyophilization and vacuum-drying processes of a model biopharmaceutical system by an environmental scanning electron microscope Author(s) Vetráková, Ľubica (UPT-D) RID, ORCID, SAI
Neděla, Vilém (UPT-D) RID, ORCID, SAI
Runštuk, Jiří (UPT-D) RID, SAI, ORCID
Tihlaříková, Eva (UPT-D) RID, ORCID, SAI
Heger, D. (CZ)
Shalaev, E. (US)Number of authors 6 Article number 119448 Source Title International Journal of Pharmaceutics. - : Elsevier - ISSN 0378-5173
Roč. 585, JUL (2020)Number of pages 16 s. Publication form Print - P Language eng - English Country GB - United Kingdom Keywords bovine serum albumin ; freeze-drying ; vacuum-drying ; environmental scanning electron microscopy Subject RIV JA - Electronics ; Optoelectronics, Electrical Engineering OECD category Pharmacology and pharmacy R&D Projects GA19-08239S GA ČR - Czech Science Foundation (CSF) GA19-03909S GA ČR - Czech Science Foundation (CSF) Method of publishing Open access with time embargo (30.07.2021) Institutional support UPT-D - RVO:68081731 UT WOS 000547812700005 EID SCOPUS 85086463152 DOI 10.1016/j.ijpharm.2020.119448 Annotation 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. Workplace Institute of Scientific Instruments Contact Martina Šillerová, sillerova@ISIBrno.Cz, Tel.: 541 514 178 Year of Publishing 2021 Electronic address https://www.sciencedirect.com/science/article/abs/pii/S0378517320304324
Number of the records: 1