Polysorbate and Solubilizer

　1) Allergic Reaction Test (Degranulation Test)

1) We would like to introduce some new data relating to the safety features of Polysorbate80, our firm's product.
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, and during recent years, a number of cases of allergy have also been reported in relation to the use of Polysorbate80. We therefore performed an evaluation test on our highly pure Polysorbate80 to determine whether allergic reactions occurred.
We measured the amounts of histamine released when mast cells were exposed to two samples of Polysorbate80: a competitor's injection-grade Polysorbate80 and highly pure Polysorbate80, our firm's original product. As shown in the chart below, the competitor's Polysorbate80 showed a considerable stimulation of the release of histamine, whereas our highly pure Polysorbate80 caused almost no release of histamine.
It is surprising that there is evidence of such a big difference in allergenic potential depending on the quality of the surfactant.
We are sure that this additional safety feature will open the way to studies of new applications of our high-purity Polysorbate80 as a component of medications, such as injectable products.

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