Overview
Polysorbate, a substance formulated by the reaction of sorbitan fatty acid ester (a nonionic surfactant) with ethylene oxide, is used in many foreign countries, including the U.S. and the EU, where it acts as an emulsifier, a solubilizer in many foods, including bread, cake mix, salad dressing, shortening oil and chocolate . Polysorbate 80 is a hydrophilic nonionic surfactant. It is utilized as a surfactant in soaps and cosmetics and also as a lubricant in eye drops. In food or pharmaceutical products, it can act as an emulsifier. Polysorbate 80 is an excipient that is used to stabilize aqueous formulations of medications for parenteral administration or vaccinations. A solubilizing agent acts as a surfactant and increases the solubility of one agent in another. A substance that would not normally dissolve in a particular solution is able to dissolve with the use of a solubilizing agent. It is also known as an emulsifier, which helps ingredients mix together and prevent separation, and water-containing small amounts of salts, and is included in several vaccines licensed in the USA.
Indication
It is used as a solubilizer, antimicrobial preservative and disinfectant .
Associated Conditions
- Eye lubrication
- Eye discomfort
Clinical Trials
| Title | Posted | Study ID | Phase | Status | Sponsor | 
|---|
No clinical trials found
No clinical trials found for this drug
FDA Drug Approvals
| Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date | 
|---|---|---|---|---|---|
| Innate Pharma, Inc. | 73380-4715 | INTRAVENOUS | 6.5 mg in 1 mL | 8/31/2020 | |
| Allergan, Inc. | 0023-9235 | OPHTHALMIC | 1 g in 100 mL | 1/17/2023 | |
| AstraZeneca Pharmaceuticals LP | 0310-4715 | INTRAVENOUS | 6.5 mg in 1 mL | 2/8/2022 | 
EMA Drug Approvals
| Approved Product | Authorization Holder | Status | Issued Date | 
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
| Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date | 
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
| Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date | 
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| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
| Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date | 
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
| Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date | 
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
| Approved Product | Company | DIN | Dosage Form | Strength | Market Date | 
|---|---|---|---|---|---|
| POLYSORBATE | pharma stulln inc. | 02026538 | Solution - Ophthalmic | 0.8 % | 12/31/1994 | 
| REFRESH OPTIVE ADVANCED SENSITIVE | 02425815 | Emulsion - Ophthalmic | 0.5 % / W/W | 10/14/2014 | |
| REFRESH OPTIVE ADVANCED | 02399148 | Solution - Ophthalmic | 0.5 % | 3/6/2013 | 
CIMA AEMPS Drug Approvals
| Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status | 
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
| Approved Product | Company | License Number | Dosage Form | Strength | Approval Date | 
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
| Approved Product | Company | License Number | Dosage Form | Strength | Approval Date | 
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
| Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date | 
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
| Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date | 
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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