ReviewInternational journal of pharmaceutics: X2023
Oxidation of polysorbates - An underestimated degradation pathway?
Review in International journal of pharmaceutics: X, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
24 citing papers in PubMed, 48 citations in OpenAlex.
- Navigating Surfactant Selection in In Vitro Dissolution Testing: Mechanistic Insights and Practical Strategies.AAPS PharmSciTech · 2026Review
- Protective Effect ofFoods (Basel, Switzerland) · 2026Article
- Antibody-Drug Conjugates Drug Product Formulation and Process Development, Scalability and Stability Considerations.AAPS PharmSciTech · 2026Review
- From permeation enhancer to therapeutic enabler: Advances, applications, and translational perspectives in hyaluronidase-based drug delivery.Materials today. Bio · 2026Review
- Evaluating the effects of ultrasonic and high-pressure homogenization on the flavor profile of Wuliang Mountain black-boned chicken soup.Ultrasonics sonochemistry · 2026Article
- Phosphatidylcholine-Polysorbate 20-Based Mixed Micelles: A New Option to Prevent Protein Aggregation?Pharmaceutics · 2026Article
- Formulation Matters: The Overlooked Engine of Stability and Success in Antibody-Drug Conjugates.Pharmaceuticals (Basel, Switzerland) · 2026Review
- Influence of dietary fiber type and concentration on pesticide residue bioaccessibility in natural products consumed with emulsified foods.Food chemistry: X · 2026Article
- Adsorption of Mixed Micelles of Polysorbate 80 and Oleic Acid to the Air-Water Interface.Langmuir : the ACS journal of surfaces and colloids · 2026Article
- Review
- Extraction of the polysorbate 20 and 80 fingerprint via generative modeling.International journal of pharmaceutics: X · 2025Article
- Long-term Storage of Diluted Antibody in Tris-buffered Saline with Tween 20.Biological procedures online · 2025Article
- Insights into Photo Degradation and Stabilization Strategies of Antibody-Drug Conjugates with Camptothecin Payloads.Pharmaceutics · 2025Article
- Plant derived extract loaded nanostructured lipid carriers with enhanced oral delivery for the treatment of acute inflammation.Scientific reports · 2025Article
- Formulation of Recombinant Therapeutic Proteins: Technological Innovation, Regulations, and Evolution Towards Buffer-Free Formulations.Pharmaceutics · 2025Review
- Utilizing Octanoic Acid to Quantitatively Assess the Oxidation Status of PS80.Pharmaceutical research · 2025Article
- Extrusion-Based 3D Printing of Rutin Using Aqueous Polyethylene Oxide Gel Inks.Pharmaceutics · 2025Article
- Micellar Solvent Accessibility of Esterified Polyoxyethylene Chains as Crucial Element of Polysorbate Oxidation: A Density Functional Theory, Molecular Dynamics Simulation and Liquid Chromatography/Mass Spectrometry Investigation.Molecular pharmaceutics · 2025Article
- Bio-electrosynthesis of polyhydroxybutyrate and surfactants in microbial fuel cells: a preliminary study.Frontiers in microbiology · 2025Article
- Quality by design optimization of microemulsions for topical delivery ofBeilstein journal of nanotechnology · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
To ensure the stability of biologicals over their entire shelf-life, non-ionic surface-active compounds (surfactants) are added to protect biologics from denaturation and particle formation. In this context, polysorbate 20 and 80 are the most used detergents. Despite their benefits of low toxicity and high biocompatibility, specific factors are influencing the intrinsic stability of polysorbates, leading to degradation, loss in efficacy, or even particle formation. Polysorbate degradation can be categorized into chemical or enzymatic hydrolysis and oxidation. Under pharmaceutical relevant conditions, hydrolysis is commonly originated from host cell proteins, whereas oxidative degradation may be caused by multiple factors such as light, presence of residual metal traces, peroxides, or temperature, which can be introduced upon manufacturing or could be already present in the raw materials. In this review, we provide an overview of the current knowledge on polysorbates with a focus on oxidative degradation. Subsequently, degradation products and key characteristics of oxidative-mediated polysorbate degradation in respect of different types and grades are summarized, followed by an extensive comparison between polysorbate 20 and 80. A better understanding of the radical-induced oxidative PS degradation pathway could support specific mitigation strategies. Finally, buffer conditions, various stressors, as well as appropriate mitigation strategies, reagents, and alternative stabilizers are discussed. Prior manufacturing, careful consideration and a meticulous risk-benefit analysis are highly recommended in terms of polysorbate qualities, buffers, storage conditions, as well as mitigation strategies.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.