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Designed for Molecular Recycling: A Lignin-Derived Semi-aromatic Biobased Polymer
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Oxidation of polysorbates - An underestimated degradation pathway?
Johanna Weber1, Julia Buske2, Karsten Mäder1
1Martin-Luther-University Halle-Wittenberg, Institute of Pharmacy, Faculty of Biosciences, Wolfgang-Langenbeck-Strasse 4, Halle (Saale) 06120, Germany.
International Journal of Pharmaceutics: X
|September 8, 2023
Summary
Polysorbates (PS) are crucial for biologic stability but can degrade via oxidation. Understanding oxidative degradation pathways for polysorbate 20 and 80 is key to preventing biologic instability and ensuring product quality.
Area of Science:
- Pharmaceutical Science
- Biochemistry
- Materials Science
Background:
- Non-ionic surfactants like polysorbates (PS) are vital excipients in biologic formulations, preventing denaturation and particle formation.
- Despite their utility, polysorbates are susceptible to degradation, impacting biologic stability, efficacy, and safety.
- Polysorbate degradation pathways include hydrolysis and oxidation, influenced by manufacturing processes and raw materials.
Purpose of the Study:
- To review current knowledge on polysorbate degradation, with a specific focus on oxidative pathways.
- To summarize degradation products and characteristics of oxidative-mediated polysorbate degradation.
- To compare polysorbate 20 and 80 regarding their oxidative stability and degradation.
Main Methods:
- Literature review focusing on polysorbate degradation mechanisms, particularly oxidation.
- Analysis of factors contributing to oxidative degradation, including light, metal traces, peroxides, and temperature.
- Comparison of polysorbate 20 and 80 stability under various stress conditions.
Main Results:
- Oxidative degradation of polysorbates can be triggered by various factors encountered during manufacturing and storage.
- Specific degradation products and characteristics differ between polysorbate grades and types, impacting their performance.
- Understanding radical-induced oxidative degradation pathways provides insights into mitigation strategies.
Conclusions:
- Oxidative degradation is a significant concern for polysorbate stability in biologic formulations.
- Detailed knowledge of polysorbate degradation pathways and products is essential for developing effective stabilization strategies.
- Careful selection of polysorbate quality, buffer conditions, and storage is recommended, alongside a thorough risk-benefit analysis.
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