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Lyophilised protein formulations as a patient-centric dosage form [Elektronski vir] : a contribution toward sustainability paradigmBjelošević Žiberna, Maja ...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.Source: Acta pharmaceutica. - ISSN 1846-9558 (Vol. 74, no. 2, 2024, str. 289-300)Type of material - e-article ; adult, seriousPublish date - 2024Language - englishCOBISS.SI-ID - 197050627
Author
Bjelošević Žiberna, Maja |
Ahlin Grabnar, Pegi |
Gašperlin, Mirjana |
Gosenca Matjaž, Mirjam
Topics
Farmacevtske oblike |
NUK |
subcutaneous administration |
bovine serum albumin |
lyophilisation |
viscosity |
reconstitution time |
stability |
subkutano dajanje |
goveji serumski albumin |
liofilizacija |
viskoznost |
čas rekonstitucije |
stabilnost
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Author | Bjelošević Žiberna, Maja ... |
Title | Lyophilised protein formulations as a patient-centric dosage form [Elektronski vir] : a contribution toward sustainability paradigm |
Publication date | |
COBISS.SI-ID | 197050627 |
Publication version in repository | Publisher's version |
Publication licence | Creative Commons Attribution-NoDerivatives 4.0 International |
Embargo | Immediate publication for public |
Project(s) from which the publication was funded
Title | Acronym | Project ID | Funder |
---|---|---|---|
Farmacevtska tehnologija: od dostavnih sistemov učinkovin do terapijskih izidov zdravil pri otrocih in starostnikih | P1-0189-2018 |
Javna agencija za znanstvenoraziskovalno in inovacijsko dejavnost Republike Slovenije |
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Razvoj visokokoncentriranih proteinskih formulacij in vrednotenje kinetike absorpcije po subkutani aplikaciji | L1-3160-2021 |
Javna agencija za znanstvenoraziskovalno in inovacijsko dejavnost Republike Slovenije |
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Database name | Field | Year |
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Bjelošević Žiberna, Maja | 38497 |
Ahlin Grabnar, Pegi | 15490 |
Gašperlin, Mirjana | 11789 |
Gosenca Matjaž, Mirjam | 29887 |
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