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.

DOCUMENTATION

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Names and synonyms

USP NF Name

Mixture of Polyoxyl 6 Stearate Type I, Ethylene Glycol Stearates and Polyoxyl 32 Stearate Type I

EP Name

Mixture of Macrogol-6 stearate type I (pending), Ethylene glycol monopalmitostearate 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 emulsion and foam (with aerosol). One-pot formulation process can facilitate manufacturing.

Tefose® 63

Names and synonyms

Key characteristics

Main functionalities

Main formulation technologies

Sensorial map

Topical range of products

PRODUCT DOCUMENTATION