Comparative Stability Study of Polysorbate 20 and Polysorbate 80 Related to Oxidative Degradation.
Tween®
autoxidation
biotherapeutic formulations
oxidative degradation
polysorbate stability
polysorbates
surfactants
Journal
Pharmaceutics
ISSN: 1999-4923
Titre abrégé: Pharmaceutics
Pays: Switzerland
ID NLM: 101534003
Informations de publication
Date de publication:
16 Sep 2023
16 Sep 2023
Historique:
received:
25
07
2023
revised:
01
09
2023
accepted:
06
09
2023
medline:
28
9
2023
pubmed:
28
9
2023
entrez:
28
9
2023
Statut:
epublish
Résumé
The surfactants polysorbate 20 (PS20) and polysorbate 80 (PS80) are utilized to stabilize protein drugs. However, concerns have been raised regarding the degradation of PSs in biologics and the potential impact on product quality. Oxidation has been identified as a prevalent degradation mechanism under pharmaceutically relevant conditions. So far, a systematic stability comparison of both PSs under pharmaceutically relevant conditions has not been conducted and little is known about the dependence of oxidation on PS concentration. Here, we conducted a comparative stability study to investigate (i) the different oxidative degradation propensities between PS20 and PS80 and (ii) the impact of PS concentration on oxidative degradation. PS20 and PS80 in concentrations ranging from 0.1 mg⋅mL
Identifiants
pubmed: 37765302
pii: pharmaceutics15092332
doi: 10.3390/pharmaceutics15092332
pmc: PMC10537708
pii:
doi:
Types de publication
Journal Article
Langues
eng
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