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Explore Polysorbates from Croda Pharma

Polysorbates are a family of synthetic, amphipathic, non-ionic surfactants and emulsifiers used mainly in the pharmaceutical industry. They are some of the most widely used surfactants in pharmaceutical formulations as they can help protect proteins from stressors such as denaturation, aggregation and surface adsorption (Yi et al., 2020).

Explore the range

What are polysorbates?

Polysorbates are ethoxylated sorbitan esters. They are created through the esterification of sorbitol with fatty acids to create sorbitan esters. The sorbitan esters are then ethoxylated using ethylene oxide to form polyoxyethylene sorbitan esters. Some chemicals in this family include polysorbate 20, polysorbate 60 and polysorbate 80. 

In the pharmaceutical industry, polysorbates are typically used as excipients to stabilize protein active pharmaceutical ingredients (APIs) (Yi et al., 2020).  

Super Refined Polysorbates range

Croda Pharma is an industry-leading manufacturer of pharmaceutical grade polysorbates and other excipients as a part of the Super Refined excipients range.

While polysorbates remain the industry standard as pharmaceutical excipients, well-known challenges such as oxidation, hydrolysis and enzymatic degradation can compromise stability. These degradation pathways may lead to particle formation, impacting both product quality and patient safety.

The Super Refined™ range, as Croda Pharma’s highest purity excipient offering, is recommended for use when formulating with sensitive APIs. These polysorbates offer a number of benefits such as increased batch-to-batch consistency, reduced potential for cellular irritation, prevention of protein aggregation and improved finished formulation integrity.

References

  1. Cosmetics Info, "Polysorbate 60", Cosmetic Info, 1 Sep 2023, View
  2. Ikeuchi-Takahashi, Y., Kobayashi, A., Ishihara, C., Matsubara, T., Matsubara, H., & Onishi, H. , "Influence of polysorbate 60 on formulation properties and bioavailability of Morin-loaded nanoemulsions with and without low-saponification-degree polyvinyl alcohol.", Biological & Pharmaceutical Bulletin, 41(5), 754–760., 24 Mar 2018, View
  3. Kerwin, B. A., " Polysorbates 20 and 80 used in the formulation of protein biotherapeutics: structure and degradation pathways.", Journal of Pharmaceutical Sciences, 97(8), 2924–2935., 24 Mar 2008, View
  4. Mashal, M., Attia, N., Puras, G., Martínez-Navarrete, G., Fernández, E., & Pedraz, J. L., "Retinal gene delivery enhancement by lycopene incorporation into cationic niosomes based on DOTMA and polysorbate 60", Journal of Controlled Release: Official Journal of the Controlled Release Society, 254, 55–64. , 24 Mar 2017, View
  5. Peng, T., "Polysorbates: Part(icle) of the Problem?", BioPharm International., 4 May 2024, View
  6. Wang, J., Sun, H., Yang, H., Yang, R., Zhu, X., Guo, S., Huang, Y., Xu, Y., Li, C., Tu, J., & Sun, C. , "Dessecting the toxicological profile of polysorbate 80 (PS80): comparative analysis of constituent variability and biological impact using a zebrafish model.", European Journal of Pharmaceutical Sciences: Official Journal of the European Federation for Pharmaceutical Sciences, 198(106796), 106796. , 14 Mar 2024, View
  7. Yi, Y. (linda), Jin, Y., Menon, R., & Yeung, B. , "Polysorbate, the Good, the Bad and the Ugly. ", 26 Oct 2020, View