Tefose® 63

Access documents and technical information

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

sensorial map creamgel 3 with tefose 63

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

Scientific document

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