Usage
cationic transfection agent, bile acid sequestrant, vaccine adjuvant, protein stabilizer
Chemical Properties
Sodium stearyl fumarate is a fine, white powder with agglomerates
of flat, circular-shaped particles.
Chemical Properties
White or off-white crystalline powder
Production Methods
Stearyl alcohol is reacted with maleic anhydride. The product of this
reaction then undergoes an isomerization step followed by salt
formation to produce sodium stearyl fumarate.
General Description
Sodium Stearyl Fumarate is commonly used in tablet formulations as a lubricant and anti-adherent to improve powder flowability, reduce tablet sticking, and enhance the dissolution properties of the tablet.
Pharmaceutical Applications
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.
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.
Stearyl alcohol and stearic acid are naturally occurring
constituents in various food products, while fumaric acid is a
normal constituent of body tissue. Stearates and stearyl citrate have
been reviewed by the WHO and an acceptable daily intake for
stearyl citrate has been set at up to 50 mg/kg body-weight. The
establishment of an acceptable daily intake for stearates and
fumaric acid was thought unnecessary.
Disodium fumarate has been reported to have a toxicity not
greatly exceeding that of sodium chloride.
storage
At ambient temperature, sodium stearyl fumarate is stable for up to
3 years when stored in amber glass bottles with polyethylene screw
caps.
The bulk material should be stored in a well-closed container in a
cool, dry place.
Incompatibilities
Sodium stearyl fumarate is reported to be incompatible with
chlorhexidine acetate.
Regulatory Status
GRAS listed. Permitted by the FDA for direct addition to food for
human consumption as a conditioning or stabilizing agent in
various bakery products, flour-thickened foods, dehydrated potatoes,
and processed cereals up to 0.2–1.0% by weight of the food.
Included in nonparenteral medicines licensed in the UK. Included in
the FDA Inactive Ingredients Database (oral capsules and tablets).
Included in the Canadian List of Acceptable Non-medicinal
Ingredients.
