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Lyophilised protein formulations as a patient-centric dosage form : a contribution toward sustainability paradigm
ID
Bjelošević Žiberna, Maja
(
Author
),
ID
Ahlin Grabnar, Pegi
(
Author
),
ID
Gašperlin, Mirjana
(
Author
),
ID
Gosenca Matjaž, Mirjam
(
Author
)
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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.
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
Views:
204
Downloads:
37
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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
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