Ultra-purity Polysorbate 80 (HX2)™ for pharmaceutical
POLYSORBATE 80 (HX2)™ made from 99% purity oleic acid is a ultra purity product of the highest quality in the world, with extremely low aldehyde and peroxide levels. These characteristics contribute to its safety; in a rat study, Polysorbate 80 (HX2)™, as compared to conventional Polysorbate 80 formulations, triggered less histamine release from mast cells.
In vitro dog study has also indicated less histamine release
with our Polysorbate 80 (HX2) TM; as a natural consequence, because of
the lower incidence of allergy noted, our Polysorbate 80 (HX2) TM has
drawn worldwide attention.
Polysorbate 80 formula
Features of Polysorbate 80 (HX2)™
The Polysorbate 80 (HX2) TM has outstanding features as follows:
- Low Allergic Reaction (Low Degranulation)
- High Safety Features (Low Cell Toxicity & Hemolysis)
- Low Impurities
- Low Peroxide
- High Stability
Source (No animal sources)
We would like to show these features in detail with technical data as follows.
1. Low allergic reaction of Polysorbate 80(HX2)™
Basophilic leukocytes and mast cells are responsible for
allergic reaction. Since the basophilic leukocytes and mast cells release granules in response to antigens, degranulation provides an indication of allergic reaction. NOF Polysorbate 80 shows significant lower allergic reaction in comparison with conventional grade as following data.
1-1. SEM images of Basophilic Leukocytes treated with Polysorbate 80
pictures are SEM images of basophilic leukocytes treated with polysorbate 80.
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 Polysorbate 80. The difference to conventional Polysorbate
80, shown on the right in red, leaving the granules, is significant.
<<method>> Basophilic leukocytes were immersed in 1% Polysorbate 80 solution for 30 minutes. The cells were immobilized in glutaraldehyde and observed by SEM.
1-2. Degranulation test of Polysorbate 80
The effect of Polysorbate 80 on degranulation of
RBL-2H3 mast cells can be seen in the image below. Degree of degranulation of NOF Polysorbate 80 is significantly lower than conventional grade, and it is almost same as non treated.
<<method>> 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.
2. High safety of Polysorbate 80 (HX2)™
NOF Polysorbate 80 shows low cell toxicity, low hemolytic ratio, and high survival rate as following test results. These results mean that NOF's Polysorbate 80 (HX2)™ is useful for pharma grade polysorbate 80.
2-1. Cell Toxicity test of Polysorbate 80 (HX2)™
The effect of Polysorbate 80 concentration on the cytotoxicity using SIRC Cells can be seen bellow. NOF Polysorbate 80 shows higher survival rate than conventional grade.
<<method>> Cells were treated with each Polysorbate 80 for 24 hours. The number of viable cells was determined by the Neutral Red Uptake method.
2-2. Hemolysis Test of Polysorbate 80 (HX2)™
Below shows hemolytic ratio of various polysorbate 80. The hemolytic ratio of NOF Polysorbate 80 is lower than conventional grades in high concentration (5%, 10%).
<<method>> Treatment of 60 minutes on red blood cells from the guinea pigs. The hemolytic ratio is determined by the absorbance of the solution at 576 nm.
2-3. Survival rate of mice treated with Polysorbate 80 (HX2)™
Survival rate of mice treated with NOF Polysorbate is significantly higher than conventional grades in high dosages.
<<method>> The survival rate of Polysorbate 80 concentration was tested on BALB/c mice. PBS diluted Polysorbate 80 was administered by intravenous injection.
3. High stability of Polysorbate 80 (HX2)™
Formaldehyde concentration provides an indication of stability or shelf life of polysorbate 80. NOF Polysorbate 80 is stabler than conventional grade.
<<method>> Tested under nitrogen condition at 40℃. (NOF product is sealed with nitrogen.)
Usage of Polysorbate 80 (HX2)™
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.
Status of Pharmacopeia's of Polysorbate 80 (HX2)™
NOF Corporation's Polysorbate 80(HX2)™ meets the requirements stipulated in the Tripatite Compendia:
JP (Japanese Pharmacopeia), EP (European Pharmacopeia) and NF (National Formulary)