Polysorbate and Solubilizer

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Low Allergic Reaction

It has been reported in the medical field that allergic reactions can be produced as a result of the combined use of certain drugs and additive agents. Many cases of allergy have been reported following the use of polyoxyethylene-castor oil series. In recent years, a number of cases of allergy have also been reported in relation to the use of Polysorbate80. We therefore performed evaluation tests on NOF ultra-pure Polysorbate80 to determine whether allergic reactions occurred.

 Low Degranulation

Measuring amounts of histamine released when mast cells were exposed to two samples of Polysorbate80: conventional injectable Polysorbate80 and NOF ultra-pure Polysorbate80.
As shown in the chart below, conventional Polysorbate80 showed a considerable stimulation of release of histamine, whereas NOF Polysorbate80 caused almost no histamine release.


Effect of Polysorbate 80 on degranulation in RBL-2H3 mast cells. The cells were treated with different concentration of polysorbate 80 for 60 mins. The degree of degranulation was determined by measurement of released β-hexosaminidase into supernatants.
 Influence on Basophillic Leukocyte


Basophilic leukocytes were immersed in 1% polysorbate 80 solution for 30 min.
The cells were immobilized in glutaraldehyde and observed by SEM.
Leukocyte granules treated with conventional grade of polysorbate 80 dropped off, whereas surface of the cell treated with NOF Polysorbate80 was almost same as non treated. This result shows remarkable low allergic reaction of NOF Polysorbate80.
It is surprising that there are evidences of such big differences in allergenic potential depending on quality of surfactant.
We are sure that these safety features will open the way to studies of new applications of our ultra-pure Polysorbate80 as a component of medications, such as injectable products.