Tefose® 63

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 and synonyms

USP NF Name

Mixture of PEG-6 stearate and ethylene glycol palmitostearate and PEG-32 stearate

EP Name

Mixture of PEG-6 stearate (pending) ethylene glycol palmitostearate/PEG-32 stearate (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 emulsion and foam (with aerosol).
One-pot formulation process can facilitate manufacturing.