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

Bjelošević Žiberna, Maja (author), Ahlin Grabnar, Pegi (author), Gašperlin, Mirjana (author), Gosenca Matjaž, Mirjam (author)

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.

• Language: English
• Keywords: subcutaneous administration, bovine serum albumin, lyophilisation, viscosity, reconstitution time, stability
• Work type: Article
• Typology: 1.01 - Original Scientific Article
• Organization: FFA - Faculty of Pharmacy
• Publication status: Published
• Publication version: Version of Record
• Year: 2024
• Number of pages: Str. 269-287
• Numbering: Vol. 74, no. 2
• PID: 20.500.12556/RUL-158258
• UDC: 542.47:615.45
• ISSN on article: 1846-9558
• DOI: 10.2478/acph-2024-0013
• COBISS.SI-ID: 197050627
• Publication date in RUL: 31.05.2024

Record is a part of a journal

• Title: Acta pharmaceutica
• Shortened title: Acta pharm.
• Publisher: Croatian Pharmaceutical Society
• ISSN: 1846-9558
• COBISS.SI-ID: 3817585

Licences

• License: CC BY-ND 4.0, Creative Commons Attribution-NoDerivatives 4.0 International
• Link: http://creativecommons.org/licenses/by-nd/4.0/
• Description: Under the NoDerivatives Creative Commons license one can take a work released under this license and re-distribute it, but it cannot be shared with others in adapted form, and credit must be provided to the author.

Secondary language

• Language: Slovenian
• Keywords: farmaecvtske oblike, subkutano dajanje, goveji serumski albumin, liofilizacija, viskoznost, čas rekonstitucije, stabilnost

Projects

• Funder: ARIS - Slovenian Research and Innovation Agency
• Project number: P1-0189
• Name: Farmacevtska tehnologija: od dostavnih sistemov učinkovin do terapijskih izidov zdravil pri otrocih in starostnikih

• Funder: ARIS - Slovenian Research and Innovation Agency
• Project number: L1-3160
• Name: Razvoj visokokoncentriranih proteinskih formulacij in vrednotenje kinetike absorpcije po subkutani aplikaciji