Dynamical in-situ observation of the lyophilization and vacuum-drying processes of a model biopharmaceutical system by an environmental scanning electron microscope

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F68081731%3A_____%2F20%3A00531984" target="_blank" >RIV/68081731:_____/20:00531984 - isvavai.cz</a>

Alternative codes found

RIV/00216224:14310/20:00114307

Result on the web

<a href="https://www.sciencedirect.com/science/article/abs/pii/S0378517320304324" target="_blank" >https://www.sciencedirect.com/science/article/abs/pii/S0378517320304324</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1016/j.ijpharm.2020.119448" target="_blank" >10.1016/j.ijpharm.2020.119448</a>

Result language

angličtina

Original language name

Dynamical in-situ observation of the lyophilization and vacuum-drying processes of a model biopharmaceutical system by an environmental scanning electron microscope

Original language description

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.

Czech name

—

Czech description

—

Type

J_imp - Article in a specialist periodical, which is included in the Web of Science database

CEP classification

—

OECD FORD branch

30104 - Pharmacology and pharmacy

Project

Result was created during the realization of more than one project. More information in the Projects tab.

Continuities

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Publication year

2020

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

International Journal of Pharmaceutics

ISSN

0378-5173

e-ISSN

—

Volume of the periodical

585

Issue of the periodical within the volume

JUL

Country of publishing house

GB - UNITED KINGDOM

Number of pages

16

Pages from-to

119448

UT code for WoS article

000547812700005

EID of the result in the Scopus database

2-s2.0-85086463152