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The World Health Organization has assessed the acceptable daily intake of polysorbate 20, 40, 60, 65, 80, which can be as high as 25 mg per kilogram of body weight based on total polysorbate. The maximum dosage of oral granules is 20.00mg, the maximum dosage of oral tablets is 24.00mg, the maximum dosage of ear suspension is 5.00%, the maximum dosage of intramuscular injection is 12.00%, the maximum dosage of oral capsule is 6.00mg, and the maximum dosage of ophthalmic emulsion is 4.00%.
Polysorbate is stable to electrolyte, weak acid and weak base; It will gradually saponify in case of strong acid and alkali. Its oleate is easy to oxidize. Polysorbate is hygroscopic, and its water content shall be tested before use, and it shall be dried if necessary. Like other polyoxyethylene surfactants, polysorbate will produce peroxide if stored for too long. Polysorbate shall be stored in a sealed container, dark, cool and dry place.
Polysorbate 80 is listed in GRAS. In Europe, polysorbate 60 is approved for use as a food additive and it is included in the FDA's "Inactive Ingredients Guide" (for intramuscular, intravenous, oral, topical, rectal, and vaginal preparations). Approved for use in injectable and non-injectable preparations in the UK.
Polysorbates containing 20 oxyethylene units are hydrophilic nonionic surfactants widely used as emulsifiers for stable oil-in-water pharmaceutical emulsions. Polysorbates are also used as solubilizers for various substances, including essential oils and oil-soluble vitamins, and as wetting agents for oral or parenteral suspensions. Polysorbates have been found to help increase the oral bioavailability of p-glycoprotein substrate drug molecules.
The World Health Organization has assessed the acceptable daily intake of polysorbate 20, 40, 60, 65, 80, which can be as high as 25 mg per kilogram of body weight based on total polysorbate. The maximum dosage of oral granules is 20.00mg, the maximum dosage of oral tablets is 24.00mg, the maximum dosage of ear suspension is 5.00%, the maximum dosage of intramuscular injection is 12.00%, the maximum dosage of oral capsule is 6.00mg, and the maximum dosage of ophthalmic emulsion is 4.00%.
Polysorbate is stable to electrolyte, weak acid and weak base; It will gradually saponify in case of strong acid and alkali. Its oleate is easy to oxidize. Polysorbate is hygroscopic, and its water content shall be tested before use, and it shall be dried if necessary. Like other polyoxyethylene surfactants, polysorbate will produce peroxide if stored for too long. Polysorbate shall be stored in a sealed container, dark, cool and dry place.
Polysorbate 80 is listed in GRAS. In Europe, polysorbate 60 is approved for use as a food additive and it is included in the FDA's "Inactive Ingredients Guide" (for intramuscular, intravenous, oral, topical, rectal, and vaginal preparations). Approved for use in injectable and non-injectable preparations in the UK.
Polysorbates containing 20 oxyethylene units are hydrophilic nonionic surfactants widely used as emulsifiers for stable oil-in-water pharmaceutical emulsions. Polysorbates are also used as solubilizers for various substances, including essential oils and oil-soluble vitamins, and as wetting agents for oral or parenteral suspensions. Polysorbates have been found to help increase the oral bioavailability of p-glycoprotein substrate drug molecules.
