A nonionic oil-in-water emulsifier for topical formulations. It delivers high stability for a wide range of APIs in emulsions. Widely used in vaginal creams due to high mucosal tolerance.
Names & synonyms
| USP NF Name | Mixture of PEG-6 stearate (type I), Ethylene glycol palmitostearate and PEG-32 stearate (type I) |
|---|---|
| EP Name | Mixture of Macrogol-6 stearate type I (pending), Ethylene glycol palmitostearate and Macrogol-32 stearate type I (pending) |
| UNII Code (FDA) | 8LQC57C6B0 0324G66D0E 33GX5WQC0M |
| Preferred Substance Name (FDA) | GLYCOL STEARATE PEG-6 STEARATE PEG-32 STEARATE |
| Handbook of Pharmaceutical Excipients | Polyoxylethylene stearates |
| Chemical description | Consists of a mixture of PEG-6 (MW 300) esters of stearic (C18) acid and ethylene glycol esters of palmitic (C16) and stearic (C18) acids and PEG-32 (MW 1500) esters of stearic (C18) acid |
Key characteristics
| Product form | Waxy solid |
|---|---|
| Melting range (°C) | 46 - 53 |
| HLB | 9.5 |
Main functionalities
Versatile emulsifier for challenging topical formulations. Widely used with antimicrobials (azole family). Frequently used with the co-emulsifier Labrafil® M 1944 CS to improve stability. Delivers sensorial and texture properties. Safety of use is inferred by precedence of use in approved pharmaceutical products.
Main formulation technologies
Topical cream and foam (with aerosol). One-pot formulation process can facilitate manufacturing.
Resources
Technical documentation
Brochures
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