Polysorbate 80 in parenteral medications

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Jessica Marquez
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Joined: 02/25/2025 - 13:04
Polysorbate 80 in parenteral medications

Hello,

Our institution is evaluating the safety of polysorbate 80 in parenteral medications. While the excipient is used in many products (including foods, lotions, makeup, etc), there are concerns about parenteral administration and the risk for severe hypersensitivity reactions.

The excipient functions as an emulsifier or solubilizing agent and may be required to keep some medications in solution (e.g. docetaxel). For other parenteral medications, inclusion of polysorbate 80 varies by manufacturer.

We are having difficulty finding data to support a "safe" threshold for use in other medications and how to approach procurement of products that contain this excipient. Can anyone share additional data on polysorbate 80 safety thresholds and/or how their institutions have approached this?

Thank you,
Jessica Marquez