Polysorbate 80 solubilizer

master.on

New Member
Polysorbate 80, also sold as Tween 80 has been used as a solubilizer/emulsifier in injectable formulations

What are the ingredients in Estrasorb?
17ß-estradiol, Soybean oil, Water, Polysorbate 80, Ethanol

https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21371_estrasorb_lbl.pdf
This is interesting because it being an eumsifier, it's a water/oil formulation so PS80 might be used for non-ester suspensions.

Despite all the scaremongering online pseudoscience, PS80 is safe for injection.
Polysorbate 80: a pharmacological study. - PubMed - NCBI

It is soluble in both water and oil
Very soluble in water; soluble in alcohol, cottonseed oil, corn oil, ethyl acetate, methanol, toluene; insoluble in mineral oil
Tween 80
 
While 54% Polysorbate80 and 39.5% dehydrated alcohol weren't toxic, hypersensitivity reactions were reported (expected)

Similarly, docetaxel is another widely used anticancer drug and the original formulations of taxotere contains ethanol and Tween 80 to solubilize the drug (0.54 g polysorbate 80 and 0.395 g dehydrated alcohol)38. However, hypersensitivity reactions using this product were reported due to the surfactants in the formulation. Sandoz, Inc., Hospira Inc. and Apotex Inc. each has docetaxel containing a new drug product approved under section 505(b)(2)39, 40, 41. Most of the new formulations have PEG 300 as additional cosolvent and Tween 80 content significantly less than taxotere. These new formulations were claimed to be safer and stable than taxotere.

Solvent Percentage in marketed formulation (%) Percentage administered (%) Route of administration Example
Polysorbate 80 0.075–100 ≤4 IM Chlordiazepoxide


https://www.sciencedirect.com/science/article/pii/S2211383515001069#bib38
 
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