Gurgul, SJ;
Kollamaram, G;
Zhang, C;
Williams, GR;
(2024)
An investigation into the effect of polysorbate 80 grade in biotherapeutic formulations.
Journal of Excipients and Food Chemicals
, 1
(1)
pp. 25-55.
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Abstract
Polysorbate 80 is a commonly used excipient in the food, cosmetics and pharmaceutical industries. In pharmaceutical formulations, the only requirement in the British Pharmacopeia and US Pharmacopeia is for the composition to be ≥ 58% oleic acid ester. However, there is a tendency for companies to prefer more refined materials. This study focused on whether this is necessary, and whether less refined materials could be used instead. To this end, we probed the chemical stability of four different polysorbate 80 samples and then explored the stability of the active ingredients in formulations of biologics containing the different polysorbate 80s. No chemical degradation could be identified by nuclear magnetic resonance or IR spectroscopy over storage for 44 weeks in the fridge or under accelerated aging conditions (30 °C/65% RH; 40 °C/75% RH). All the samples contain some water, with the water content greater than stated in the supplier datasheet (possibly because of adsorption upon storage at the supplier sites). No change in water content is noted upon the storage of polysorbate 80. With the super-refined grades, autoxidation can be seen to occur upon storage, with hydrogen peroxide, aldehydes and ketones produced. This is less noticeable with the less refined grades, likely because these already contain autoxidation products and there is an equilibrium in place. Increasing the temperature and humidity of the aging conditions causes an increase in the rate of autoxidation. We find that the grade of polysorbate 80 used as excipient does not affect the stability of biologic formulations, with no differences observed in terms of activity after combination with any of the polysorbates. It hence appears that less-refined polysorbates could be used in place of the more-expensive super-refined materials, reducing the cost and providing wider access to medicines.
| Type: | Article |
|---|---|
| Title: | An investigation into the effect of polysorbate 80 grade in biotherapeutic formulations |
| Open access status: | An open access version is available from UCL Discovery |
| Publisher version: | https://jefc.scholasticahq.com/article/120613-an-i... |
| Language: | English |
| Additional information: | This work is licensed under a Creative Commons Attribution 4.0 International License. The images or other third-party material in this article are included in the Creative Commons license, unless indicated otherwise in the credit line; if the material is not included under the Creative Commons license, users will need to obtain permission from the license holder to reproduce the material. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/ |
| Keywords: | Polysorbate, stability studies, biotherapeutics, excipients |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences UCL > Provost and Vice Provost Offices > UCL BEAMS 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 > UCL BEAMS > Faculty of Engineering Science > Dept of Biochemical Engineering 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/10195229 |
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