The Versatile Functions of Polysorbate 20 in Pharmaceuticals

Overview of Polysorbate 20

Polysorbate 20, also known as Tween 20, is a water-soluble nonionic surfactant derived from sorbitol and ethylene oxide. It belongs to the polysorbate family, consisting of a polyoxyethylene sorbitan monooleate structure, where twenty ethylene oxide units are attached to a sorbitan monooleate backbone.

Polysorbate 20 acts as an emulsifier, stabilizer, and dispersing agent due to its unique molecular structure. Polysorbate 20 has garnered significant attention as a multifunctional surfactant in various industries, such as pharmaceuticals, biomedicine, and cosmetics. In this article, Alfa Chemistry focuses on the use of polysorbate 20 in pharmaceuticals and vaccines.

Polysorbate 20 for Pharmaceuticals

Polysorbate 20 is one of the common excipients in pharmaceutical formulations and can be used as a solubilizer, emulsifier and stabilizer.

• Stabilizer
  Polysorbate 20 has a high hydrophilic-lipophilic balance value and a low critical micelle concentration. Therefore, it exhibits sufficiently high surface activity to act as a stabilizer in aqueous protein formulations at relatively low concentrations (0.001% to 0.01% w/v). [1]
• Drug carrier
  Polysorbate 20 acts as a drug carrier through distinct mechanisms. It forms micelles above its critical micelle concentration (CMC), encapsulating hydrophobic drugs in the hydrophobic core. The solubilized drugs can then be easily absorbed and transported across biological membranes. Additionally, polysorbate 20 can enhance drug dissolution rates, reduce particle size, and inhibit drug-crystal growth, thereby improving drug bioavailability. For example, polysorbate 20 can be used as a carrier for amphotericin B (AmB), a polyene antibiotic, to increase its solubility and reduce its toxicity. [2]

Polysorbate 20 vesicles for potential oral delivery. [3]

• Vaccine formulations
  In vaccine development, PS20 plays a pivotal role as an adjuvant and stabilizer, enhancing antigen presentation, and preserving vaccine integrity during storage and transportation. Its extensive usage in vaccine formulations is owing to its compatibility, non-reactivity, and ability to stabilize proteins and other biological molecules.

In Which Vaccines Can Polysorbate 20 Be Found?

Polysorbate 20 can be found in the excipient formulations of several common vaccines in the United States, such as Hep A (Havrix), Hep A/Hep B (Twinrix), and Influenza (Flublok) Quadrivalent. The following table shows some excipients of these vaccines for reference only.

Polysorbate 20 for Cosmetics

As an emulsifier, polysorbate 20 facilitates the uniform dispersion of immiscible substances, such as oil and water, in cosmetic formulations. Its amphiphilic nature allows it to stabilize emulsions, preventing phase separation and improving the overall texture and viscosity of cosmetic products. Additionally, polysorbate 20 enhances the spreadability of formulations, improving their application and absorption properties.

For example, for quercetin, which has low solubility in water, the solubility can be increased by adding both polysorbate 20 and polysorbate 80. [4]

Degradation Monitoring of Polysorbate 20

It is worth mentioning that the issue of polysorbate degradation in biotherapeutic formulations has recently surfaced. The presence of impurities from biological processes may hydrolyze the ester bonds in polysorbates and lead to the formation of free fatty acids (FFA). Therefore, methods for monitoring and quantifying the real-time storage stability of FFA were also developed. This method provides a high-throughput extraction procedure as well as a fast and simple HPLC method for FFA quantification.

Degradation of polysorbate 20. [5]

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References

1. Schmidt A, et al. Journal of pharmaceutical sciences, 2020, 109(6): 1924-1932.
2. Ravichandran V, et al. Current Drug Delivery, 2018, 15(7): 1028-1037.
3. Di Marzio L, et al. Colloids and Surfaces B: Biointerfaces, 2013, 104: 200-206.
4. Erawati T, et al. Journal of Public Health in Africa, 2023, 14(Suppl 1).
5. Tomlinson A, et al. Molecular pharmaceutics, 2015, 12(11): 3805-3815.

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