Polysorbate 80: A Revolutionary Emulsifier for Vaccine Formulations

What is polysorbate 80?

What role does polysorbate 80 play in vaccines?

Polysorbate 80 is commonly used in the pharmaceutical industry as an excipient in the formulation of oral, topical, and parenteral medications. It acts as a solubilizing agent, helping to improve the solubility and bioavailability of poorly soluble drugs. It is also used as a stabilizer in vaccines, including the COVID-19 mRNA vaccines.

• Increase solubility
  One of the main roles of polysorbate 80 is to improve the solubility and dispersal of hydrophobic substances such as certain antigens and adjuvants in the vaccine formulation. It acts as a detergent, enabling the uniform dispersion of these substances throughout the vaccine solution. This is important because the antigens and adjuvants need to be evenly distributed to ensure consistent and optimal immune response upon administration.
• Improve stability
  Polysorbate 80 can also contribute to the stability of the vaccine by preventing aggregation or clumping of vaccine components, such as proteins or particles, which may occur during storage. It helps maintain the uniformity and homogeneity of the vaccine, ensuring that the intended dose of antigen or adjuvant is delivered.
• Enhance immune response
  Furthermore, polysorbate 80 can enhance the immune response to certain antigens by promoting the uptake of the antigen-presenting cells (APCs) and facilitating the presentation of the antigen to the immune system. It can increase the accessibility of antigens to immune cells, potentially leading to a stronger and more targeted immune response.

In which vaccine formulations can polysorbate 80 be found?

Polysorbate 80 has been widely used in a variety of vaccine formulations, including but not limited to COVID-19 vaccines, influenza vaccines, and human papillomavirus (HPV) vaccines. The excipient formulas contained in some common U.S. vaccines are listed below for reference only.

Useful link

It is always recommended to check the vaccine package insert on the FDA's official website.

Vaccines Licensed for Use in the United States

Detection method of polysorbate 80 in vaccine formulations

The identification and quantification of residual PS 80 often poses a challenge to the quantification of complex matrices of conjugated vaccines due to its structural heterogeneity. A number of assays are available for the analysis of residual polysorbate 80 (PS 80) in conjugate vaccines, such as:

• High performance liquid chromatography-evaporative light scattering detector (HPLC-ELSD)
• Gas Chromatography-Mass Spectrometry (GC-MS)
• Reversed Phase (RP)-HPLC and UV Detection in Drug Suspensions
• Hydrogen flame ionization detector (FID)

GC-MS and HPLC-ELSD method for polysorbate 80. [1]

Reference

1. Shende, Niraj, et al. Journal of Pharmaceutical and Biomedical Analysis, 2020, 183, 113126.

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