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Polysorbate 80, also known as Tween 80, is a synthetic non-ionic surfactant and emulsifier derived from polyethoxylated sorbitan and oleic acid. It is widely utilized as a pharmaceutical excipient to solubilize hydrophobic active ingredients, stabilize protein-based biotherapeutics against aggregation, and emulsify oil-in-water formulations. While not a therapeutic target itself, it plays a critical role in drug delivery, including enhancing the transport of drugs across biological membranes such as the blood-brain barrier and the intestinal lining. Its inclusion in various medications, including taxane chemotherapies and vaccines, is essential for formulation stability but is associated with significant safety concerns. Most notably, Polysorbate 80 has been implicated in hypersensitivity reactions and non-immunologic anaphylaxis, particularly in intravenous oncology treatments. Additionally, emerging research suggests it may influence the gut microbiome and promote intestinal inflammation, potentially impacting metabolic and inflammatory disease states.
As a non-ionic surfactant, Polysorbate 80 reduces surface tension and forms micelles to encapsulate and solubilize hydrophobic drug molecules. It also stabilizes proteins by forming a protective layer at liquid-air and liquid-container interfaces, preventing mechanical stress-induced aggregation. Furthermore, it can transiently increase the permeability of biological membranes to enhance drug absorption.
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