ǂa ǂcontribution toward sustainability paradigm
Maja Bjelošević (Author), Pegi Ahlin Grabnar (Author), Mirjana Gašperlin (Author), Mirjam Gosenca (Author)

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.

Keywords

subcutaneous administration;bovine serum albumin;lyophilisation;viscosity;reconstitution time;stability;

Data

Language: English
Year of publishing:
Typology: 1.01 - Original Scientific Article
Organization: UL FFA - Faculty of Pharmacy
UDC: 542.47:615.45
COBISS: 197050627 Link will open in a new window
ISSN: 1846-9558
Views: 79
Downloads: 20
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Other data

Secondary language: Slovenian
Secondary keywords: subkutano dajanje;goveji serumski albumin;liofilizacija;viskoznost;čas rekonstitucije;stabilnost;Farmacevtske oblike;NUK;
Type (COBISS): Article
Pages: str. 289-300
Volume: ǂVol. ǂ74
Issue: ǂno. ǂ2
Chronology: 2024
DOI: 10.2478/acph-2024-0013
ID: 24230166