Polysorbate 80 (CAS NO:9005-65-6)

Critical in stabilizing biologics in vaccine formulations (COVID-19 vaccines, flu vaccines). Acts as a solubilizing agent, preventing aggregation of sensitive biologics. Helps keep vaccines stable and effective, improving vaccine shelf life and safety.

Widely used as an emulsifier and solubilizer in pharmaceutical injectables, food emulsions, and cosmetic formulations. Key for enhancing solubility and stability of hydrophobic compounds in drug formulations and biological products like vaccines. Found in ice creams, salad dressings, and cosmetics like lotions and shampoos for better texture and consistency.

Recognized as GRAS by the US FDA and compliant with global regulatory bodies for food and pharma. Demonstrated low toxicity and high biocompatibility in preclinical and clinical studies. Commonly used in food and skincare products, considered safe and well-tolerated when used as directed.

Polysorbates are widely used to protect biological drug products from protein unfolding, aggregation, and precipitation during both shipping and handling. The polysorbates are amphipathic, nonionic surfactants made of fatty acid esters of polyoxyethylene sorbitan. Polysorbate 80 is one of the most common surfactants currently used in the formulation of protein-based biopharmaceuticals.

Polysorbate 80 is one of the primary components of protein formulations. This drug inhibits interfacial damage of the protein molecule that undergoes mechanical stress during shipping and handling. Polysorbate 80 also affects the formulation photostability. Exposure to light of polysorbate 80 aqueous solution results in peroxide generation, which in turn may lead to oxidation of the susceptible amino acid residues in the protein molecule. One study on rats found that Polysorbate 80 increased apical to basolateral membrane permeability of digoxin in Caco-2 cells suggesting that Ps 80 is an in vitro inhibitor of P-glycoprotein. It concluded that PS 80 may influence in vivo absorption of P-gp substrates, and this could be translated to human applications.

A mixture of the partial esters of sorbitol and its mono- and dianhydrides with edible commercial oleic acid and condensed with approximately 20 moles of ethylene oxide per mole of sorbitol and its anhydrides

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1= Practically nontoxic: probable oral lethal dose (human) above 15 g/kg, more than 1 quart (2.2 lb) for 70 kg person (150 lb).