Stabilizing Polysorbate 20 and 80 Against Oxidative Degradation

Schmidt, Ariane and Koulov, Atanas and Huwyler, Joerg and Mahler, Hanns-Christian and Jahn, Michael. (2020) Stabilizing Polysorbate 20 and 80 Against Oxidative Degradation. Journal of Pharmaceutical Sciences, 109 (6). pp. 1924-1932.

Full text not available from this repository.

Official URL: https://edoc.unibas.ch/76737/

Downloads: Statistics Overview


Polysorbates are stabilizers typically required in therapeutic protein formulations. Due to their chemical structure, polysorbates are prone to degradation, which can render a pharmaceutical product instable or incompliant. The purpose of this study was to investigate if the addition of butylhydroxytoluene (BHT) and butylhydroxyanisole (BHA) protects Polysorbate 20 (PS20) and Polysorbate 80 (PS80) against oxidative degradation.; PS20 and PS80 solutions containing BHA, BHT - or as control without an antioxidant - were stressed by exposure to air at 40°C for seven weeks. The following assays were performed: ferrous oxidation-xylenol orange (FOX) assay, liquid chromatography coupled to ultraviolet (UV) and mass spectrometry (MS), pH-measurement, liquid chromatography fluorescence micelle assay (FMA), headspace-gas chromatography (HS-GC) coupled with MS.; PS20 and PS80 solutions containing an antioxidant were found to be more stable, demonstrated by lower peroxide levels, lower free fatty acid contents, stable pH, intact polysorbate micelle structure / composition, and less volatile degradants.; PS20 and PS80 solutions containing BHT or BHA are more stable against oxidative degradation compared to non-stabilized solutions. It might be beneficial to formulate bulk polysorbate with the antioxidant(s) to ensure stabilization during all process steps.
Faculties and Departments:05 Faculty of Science > Departement Pharmazeutische Wissenschaften > Pharmazie > Pharmaceutical Technology (Huwyler)
UniBasel Contributors:Huwyler, Jörg and Schmidt, Nina Ariane
Item Type:Article, refereed
Article Subtype:Research Article
Note:Publication type according to Uni Basel Research Database: Journal article
Identification Number:
Last Modified:17 Dec 2021 17:05
Deposited On:17 Dec 2021 17:05

Repository Staff Only: item control page