General Description
Synonyms: Fumaric acid, octadecyl ester, sodium salt; natrii stearylis fumaras; Pruv; sodium monostearyl fumarate.
Description: Sodium stearyl fumarate is a fine, white powder with agglomerates of flat, circular-shaped particles.
Chemical Name: 2-Butenedioic acid,monooctadecyl ester, sodium salt
Functions
Tablet and capsule lubricant.
Uses
Sodium stearyl fumarate is used as a lubricant in capsule and tablet formulations at 0.5–2.0% w/w concentration. It is also used in certain food applications
Incompatibilities
Sodium stearyl fumarate is reported to be incompatible with chlorhexidine acetate.
Safety
Sodium stearyl fumarate is used in oral pharmaceutical formulations and is generally regarded as a nontoxic and nonirritant material. Metabolic studies of sodium stearyl fumarate in the rat and dog indicated that approximately 80% was absorbed and 35% was rapidly metabolized. The fraction absorbed was hydrolyzed to stearyl alcohol and fumaric acid, with the stearyl alcohol further oxidized to stearic acid. In the dog, sodium stearyl fumarate that was not absorbed was excreted unchanged in the feces within 24 hours
Handling Precautions
Observe normal precautions appropriate to the circumstances and quantity of material handled. Sodium stearyl fumarate should be handled in a well-ventilated environment; eye protection is recommended.