Tefose® 63 – A nonionic oil-in-water emulsifier for topical formulations
Tefose® 63 is a physical mixture of three components: PEG-6 palmitostearate, ethylene glycol palmitostearate and PEG-32 palmitostearate. The exact quantity of each component has been carefully selected to obtain a self-emulsifying base.
Tefose® 63 is a non-ionic oil-in-water emulsifier used in topical dosage forms. It contains all the components to easily obtain fine and homogenous emulsions with pleasant texture. Traditionally emulsions are prepared using two surfactants; one with low HLB and one with high HLB. A series of emulsions using different ratios of these surfactants is prepared to determine the ratio at which the emulsion is stable (i.e. corresponding to the required HLB of the system).
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Tefose® 63 is composed of several fractions with different densities and crystallization temperatures. After production, the molten excipient is hot filled in the container. During cooling and crystallization the product stratifies resulting in a non-homogenous composition in the container. Therefore, the entire product in the original container must be fully melted at 70-80°C and homogenized before sampling and use.
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-3 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
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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.