Sodium Stearyl Fumarate

Описание

Sodium Stearyl Fumarate (SSF) is used as a lubricant in tableting to reduce the friction between the tablet and the die wall and to prevent adhesion of the material to punches or the die wall in the pharmaceutical industries. It is used also as a lubricant in the manufacturing of capsules and other oral dosage forms. Sodium stearyl fumarate is also used in food production as a dough conditioner, a conditioning agent, and a stabilizing agent.

Химические свойства

Sodium stearyl fumarate is a fine, white powder with agglomerates of flat, circular-shaped particles.

Использование

Sodium Stearyl Fumarate is a dough conditioner and conditioning agent that is a white powder practically insoluble in water. It is used as a dough conditioner in yeast-raised baked goods. It is used as a conditioning agent in dehydrated potatoes. It also functions as a maturing and bleaching agent.

Методы производства

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.

Общее описание

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.

Фармацевтические приложения

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.

Безопасность

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.

хранилище

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.

Несовместимости

Sodium stearyl fumarate is reported to be incompatible with chlorhexidine acetate.

Регуляторный статус

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.

использованная литература

[1] Arne W. Hölzer and John Sjögren, Evaluation of sodium stearyl fumarate as a tablet lubricant, International Journal of Pharmaceutics, 1979, vol. 2, 145-153
[2] Holger Zorn and Peter Czermak, Biotechnology of Food and Feed Additives, 2014
[3] https://www.fda.gov