POLYSORBATE 80(HX2)™ produced by NOF Corporation is a ultra purity product of the highest quality in the world, with extremely low aldehyde and peroxide levels, which contribute considerably to its safety. Compared to conventional Polysorbate 80 formulations, it triggers less histamine release from mast cells. The injectable grade has outstanding features as follows:
- Vegetable Source (No animal sources)
- Low Impurities
- Low Peroxide
- Colorless and Odorless
- High Stability
- Low Allergic Reaction (Low Degranulation)
- High Safety Features (Low Cell Toxicity & Hemolysis)
It can be used as emulsifier and solubilizer for peroxide sensitive drug to avoid oxidation or degradation of the drug, due to its low peroxide feature.
Additionally, because of high safety characteristic, concentration of Polysorbate80(HX2)™ can be increased for poorly water soluble drugs. The great feature of low allergy allows clients to use for drug formulations in safety.
For these outstanding characteristics of Polysorbate80(HX2)™ is recognized as worldwide standard product in pharmaceutical industry, especially for parenteral formulations.
Structure of Polysorbate 80(HX2)™
Low Allergic Reaction Proof: The effect of Polysorbate 80(HX2)™ on degranulation of RBL-2H3 mast cells can be seen in the image below (image 1). Cells were treated with different concentrations of Polysorbate 80 for 60 min. The degree of degranulation was determined by measurement of the released β-hexosaminidase into the supernatant.
High Safety Features Proof: The effect of Polysorbate 80 concentration on the cytotoxicity using SIRC Cells can be seen in image 2. Cells were treated with each Polysorbate 80 for 24 hours. The number of viable cells was determined by the Neutral Red Uptake method.
Image 1 (left) and Image 2 (right)
Below shown figures compare the features of NOF Polysorbate to conventional Polysorbates of two different grades. In image A the effect after a treatment of 60 minutes on red blood cells from the guinea pigs in the Hemolysis Test clearly shows the hemolytic ratio was determined by the absorbance of the solution at 576 nm. The survival rate of Polysorbate 80 concentration was tested on BALB/c mice, to be seen in image B. The with PBS diluted Polysorbate 80 was administered by intravenous injection. The stability was tested in a formaldehyde test preformed under N2 sealed conditions at 40°C (image C).
Left to right: Images A, B, C
Influence on Basophilic leukocyte:
Basophilic leucocytes were immersed in 1% Polysorbate 80 solution for 30 minutes. The cells were immobilized in glutaraldehyde and observed by SEM. The grey image in the middle shows off the non-treated status of the cells and the green on the left pictures the positive effect of the NOF product. The difference to conventional Polysorbate 80, shown on the right in red, leaving the cells damaged, is significant.
Status of Pharmacopeia's:
NOF Corporation's Polysorbate 80(HX2)™ meets the requirements stipulated in the Tripatite Compendia:
JP (Japanese Pharmacopeia), EP (European Pharmacopeia) and NF (National Formulary)