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...
Gespeichert in:
| Hauptverfasser: | , , , , , |
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| Dokumenttyp: | Article (Journal) |
| Sprache: | Englisch |
| Veröffentlicht: |
16 September 2022
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| In: |
International journal of pharmaceutics
Year: 2022, Jahrgang: 626, Pages: 1-9 |
| ISSN: | 1873-3476 |
| DOI: | 10.1016/j.ijpharm.2022.122204 |
| Online-Zugang: | 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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| Verfasserangaben: | Niels Banik, Stefan Braun, Jan Gerit Brandenburg, Gert Fricker, Devendra S. Kalonia, Tobias Rosenkranz |
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| 520 | |a 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. | ||
| 650 | 4 | |a Dynamic light scattering | |
| 650 | 4 | |a High concentration monoclonal antibody formulation | |
| 650 | 4 | |a Pharmaceutical excipients | |
| 650 | 4 | |a Protein-protein interactions | |
| 650 | 4 | |a Viscosity | |
| 700 | 1 | |a Braun, Stefan |e VerfasserIn |4 aut | |
| 700 | 1 | |a Brandenburg, Jan Gerit |e VerfasserIn |0 (DE-588)1074974255 |0 (DE-627)832795143 |0 (DE-576)443177481 |4 aut | |
| 700 | 1 | |a Fricker, Gert |d 1956- |e VerfasserIn |0 (DE-588)1042227675 |0 (DE-627)768469465 |0 (DE-576)393783464 |4 aut | |
| 700 | 1 | |a Kalonia, Devendra S. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Rosenkranz, Tobias |e VerfasserIn |4 aut | |
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