<abstract xmlns="http://www.w3.org/1999/xhtml">

<p>At present, society has embraced the fact apropos population aging and climate changes, that demand, amongst others, innovative pharmaceutical technologies, emphasising the development of patient-specific delivery systems and thus the provision of efficient and sustainable drugs. Protein drugs for subcutaneous administration, by allowing less frequent application, represent one of the most important parts of the pharmaceutical field, but their development is inevitably faced with obstacles in providing protein stability and suitable formulation viscosity. To gain further knowledge and fill the gaps in the already constructed data platform for the development of monoclonal antibody formulations, we designed a study that examines small model proteins, <italic>i.e.,</italic> bovine serum albumin. The main aim of the presented work is to evaluate the effect of protein concentrations on critical quality attributes of both, pre-lyophilised liquid formulations, and lyophilised products. Through the study, the hypothesis that increasing protein concentration leads to higher viscosity and higher reconstitution time without affecting the stability of the protein was confirmed. The most important finding is that sucrose plays a key role in the lyophilisation of investigated protein, nevertheless, it can be predicted that, to ensure the beneficial effect of mannitol, its amount has to prevail over the amount of sucrose.</p>
</abstract>

At present, society has embraced the fact apropos population aging and climate changes, that demand, amongst others, innovative pharmaceutical technologies, emphasising the development of patient-specific delivery systems and thus the provision of efficient and sustainable drugs. Protein drugs for subcutaneous administration, by allowing less frequent application, represent one of the most important parts of the pharmaceutical field, but their development is inevitably faced with obstacles in providing protein stability and suitable formulation viscosity. To gain further knowledge and fill the gaps in the already constructed data platform for the development of monoclonal antibody formulations, we designed a study that examines small model proteins, i.e., bovine serum albumin. The main aim of the presented work is to evaluate the effect of protein concentrations on critical quality attributes of both, pre-lyophilised liquid formulations, and lyophilised products. Through the study, the hypothesis that increasing protein concentration leads to higher viscosity and higher reconstitution time without affecting the stability of the protein was confirmed. The most important finding is that sucrose plays a key role in the lyophilisation of investigated protein, nevertheless, it can be predicted that, to ensure the beneficial effect of mannitol, its amount has to prevail over the amount of sucrose.

Lyophilised protein formulations as a patient-centric dosage form: A contribution toward sustainability paradigm

University of Ljubljana, Faculty of Pharmacy

Acta Pharmaceutica

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

At present, society has embraced the fact apropos population aging and climate changes, that demand, amongst others, innovative pharmaceutical technologies,...

Lyophilised protein formulations as a patient-centric dosage form: A contribution toward sustainability paradigm

Published Online: May 30, 2024

Page range: 289 - 300

Accepted: Jan 08, 2024

DOI: https://doi.org/10.2478/acph-2024-0013

Keywords
subcutaneous administration, bovine serum albumin, lyophilisation, viscosity, reconstitution time, stability

© 2024 Maja Bjelošević Žiberna et al., published by Sciendo

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

Lyophilised protein formulations as a patient-centric dosage form: A contribution toward sustainability paradigm

Published Online: May 30, 2024

Page range: 289 - 300

Accepted: Jan 08, 2024

DOI: https://doi.org/10.2478/acph-2024-0013

Keywordssubcutaneous administration, bovine serum albumin, lyophilisation, viscosity, reconstitution time, stability

© 2024 Maja Bjelošević Žiberna et al., published by Sciendo

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

Keywords
subcutaneous administration, bovine serum albumin, lyophilisation, viscosity, reconstitution time, stability