A nonionic oil-in-water emulsifier for topical emulsions. It provides excellent emulsion stability with difficult-to-formulate and combination APIs. Provides heat stability and high tolerance over a wide pH range.
Names & synonyms
| USP NF Name | Mixture of:
|
|---|---|
| EP Name | Glycerol monostearate and macrogol-75 stearate |
| UNII Code (FDA) | 230OU9XXE4 OT38R0N74H |
| Preferred Substance Name (FDA) | GLYCERYL MONOSTEARATE PEG-75 STEARATE |
| Handbook of Pharmaceutical Excipients | Glyceryl monostearate Polyoxylethylene stearates |
| Chemical description | Consists of a mixture of glycerol monostearate and PEG-75 (MW 3500) stearate (C18) |
Key characteristics
| Product form | Pellets |
|---|---|
| Melting range (°C) | 55.5 - 62.5 |
| HLB | 10 |
Main functionalities
Emulsifier for difficult-to-formulate APIs, API combinations, anhydrous emulsion. Associate with Emulcire™ 61 WL2659 to enhance sensorial and texture properties. Safety of use is inferred by precedence of use in approved pharmaceutical products.
Main formulation technologies
Topical cream, emulgel, and foam. One-pot formulation process can facilitate manufacturing.
Resources
Technical documentation
Brochures
Scientific document
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Poster PBP 2024 - Formulating pharmaceutical topical dosage forms with high level of solvents and minimal quantity of water
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Poster AAPS 2018_A systematic approach to formulate and evaluate the stability of topical creams with high concentrations of Transcutol® HP
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Poster Skin Formulation 2023 - Advanced rheological characterization of topical products
Associated content
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