Technology development to evaluate the effectiveness of viscosity reducing excipients

Addition of pharmaceutical excipients is a commonly used approach to decrease the viscosity of highly concentrated protein formulations, which otherwise could not be subcutaneously injected or processed. The variety of protein-protein interactions, which are responsible for increased viscosities, ma...

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Main Authors: Banik, Niels (Author) , Braun, Stefan (Author) , Brandenburg, Jan Gerit (Author) , Fricker, Gert (Author) , Kalonia, Devendra S. (Author) , Rosenkranz, Tobias (Author)
Format: Article (Journal)
Language:English
Published: 16 September 2022
In: International journal of pharmaceutics
Year: 2022, Volume: 626, Pages: 1-9
ISSN:1873-3476
DOI:10.1016/j.ijpharm.2022.122204
Online Access:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1016/j.ijpharm.2022.122204
Verlag, lizenzpflichtig, Volltext: https://www.sciencedirect.com/science/article/pii/S037851732200758X
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Author Notes:Niels Banik, Stefan Braun, Jan Gerit Brandenburg, Gert Fricker, Devendra S. Kalonia, Tobias Rosenkranz
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Summary:Addition of pharmaceutical excipients is a commonly used approach to decrease the viscosity of highly concentrated protein formulations, which otherwise could not be subcutaneously injected or processed. The variety of protein-protein interactions, which are responsible for increased viscosities, makes a portfolio approach necessary. Screening of several excipients to develop such a portfolio is time and money consuming in industrial settings. Responsible protein-protein interactions were investigated using the interaction parameter kD obtained from dynamic light scattering measurements in the studies presented herein. Together with in-silico calculated excipient parameter, kD could be used as a screening tool accelerating screening and formulation development as kD is suitable to high-throughput formats using small quantities of protein and low concentrations. A qualitative correlation between kD and high-concentration viscosity behavior could be shown in our case.
Item Description:Gesehen am 07.12.2022
Physical Description:Online Resource
ISSN:1873-3476
DOI:10.1016/j.ijpharm.2022.122204