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The effect of the composition of polysorbate 80 grades on their physicochemical properties

Kollamaram, G; Williams, G; (2021) The effect of the composition of polysorbate 80 grades on their physicochemical properties. Journal of Excipients and Food Chemicals , 12 (3) pp. 32-40. Green open access

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Abstract

Polysorbate 80 is one of the most commonly used surfactants in the formulation of biotherapeutics, particularly those administered intravenously. It comprises a mixture of fatty acids but is not a precisely defined chemical entity. Hence, there are a range of different grades available in the market, all meeting compendial specifications. Polysorbate 80 is known to undergo auto degradation producing protein-damaging by-products, and to contain residual impurities that can have an impact on the stability and integrity of the active ingredients in the formulation. Given the variety of chemical compositions that polysorbate 80 can comprise, the degradation pathway and extent could vary depending on the grade used in the formulation. This study compared the physical and chemical properties of four commercially available polysorbate 80 grades with different degrees of purity and oleic acid content and investigated their degradation profiles. This study did not find any significant differences between the properties or degradation profiles of the four grades investigated. Further studies are underway to understand the formation of other reactive impurities and their impact on the model protein formulations.

Type: Article
Title: The effect of the composition of polysorbate 80 grades on their physicochemical properties
Open access status: An open access version is available from UCL Discovery
Publisher version: https://jefc.scholasticahq.com/article/28314-the-e...
Language: English
Additional information: This is an Open Access article published under a Attribution-NonCommercial-ShareAlike 4.0 International (CC BY-NC-SA 4.0) Licence (https://creativecommons.org/licenses/by-nc-sa/4.0/).
Keywords: Polysorbate 80, peroxide impurities, biotherapeutics, excipients, quality, auto-degradation
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Life Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Life Sciences > UCL School of Pharmacy
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Life Sciences > UCL School of Pharmacy > Pharmaceutics
URI: https://discovery.ucl.ac.uk/id/eprint/10135219
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