20.500.12556/RUL-158258 Lyophilised protein formulations as a patient-centric dosage form a contribution toward sustainability paradigm 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. subcutaneous administration bovine serum albumin lyophilisation viscosity reconstitution time stability farmaecvtske oblike subkutano dajanje goveji serumski albumin liofilizacija viskoznost čas rekonstitucije stabilnost true false true Angleški jezik Slovenski jezik Članek v reviji 2024-05-31 09:39:03 2024-05-31 09:39:09 2024-06-18 03:23:43 0000-00-00 00:00:00 2024 0 0 Str. 269-287 no. 2 Vol. 74 2024 0000-00-00 Zaloznikova Objavljeno NiDoloceno 0000-00-00 0000-00-00 0000-00-00 542.47:615.45 1846-9558 10.2478/acph-2024-0013 197050627 28924.pdf 28924.pdf 1 003DC50C2A3153DAD23FC03E1844A222 6f4e6b1bbb24412f2a218c6f3a157aa67fb530f1d9aae9a15274a774441c0029 42e848b2-1f21-11ef-850b-0050569b8976 https://repozitorij.uni-lj.si/Dokument.php?lang=slv&id=185785 https://acta.pharmaceutica.farmaceut.org/wp-content/uploads/2024/05/28924.pdf 1 dee95e2b-1f20-11ef-850b-0050569b8976 https://repozitorij.uni-lj.si/Dokument.php?lang=slv&id=185784 Fakulteta za farmacijo 0 0 0