Глицерил моностеарат

Описание

§184.1324(a) Glyceryl monostearate, also known as monostearin, is a mixture of variable proportions of glyceryl monostearate (C21H42O4), and glyceryl esters of fatty acids present in commercial stearic acid. Glyceryl monostearate is prepared by glycerolysis of certain fats or oils that are derived from edible sources or by esterification, with glycerin, of stearic acid that is derived from edible sources.

Химические свойства

While the names glyceryl monostearate and mono- and diglycerides are used for a variety of esters of long-chain fatty acids, the esters fall into two distinct grades:
40–55 percent monoglycerides The PhEur 6.0 describes glyceryl monostearate 40–55 as a mixture of monoacylglycerols, mostly monostearoylglycerol, together with quantities of di- and triacylglycerols. It contains 40–55% of monoacylglycerols, 30–45% of diacylglycerols, and 5–15% of triacylglycerols. This PhEur grade corresponds to mono- and di-glycerides USP– NF, which has similar specifications (not less than 40% monoglycerides).
90 percent monoglycerides The USP32–NF27 describes glyceryl monostearate as consisting of not less than 90% of monoglycerides of saturated fatty acids, chiefly glyceryl monostearate (C21H42O4) and glyceryl monopalmitate (C19H38O4).
The commercial products are mixtures of variable proportions of glyceryl monostearate and glyceryl monopalmitate.
Glyceryl monostearate is a white to cream-colored, wax-like solid in the form of beads, flakes, or powder. It is waxy to the touch and has a slight fatty odor and taste.

Использование

Commercially, glyceryl monostearate is synthesized from mono triglycerides, diglycerides, and triglycerides of palmitic acid and stearic acid. Glycerol monostearate is often used as an emulsifier to stabilize the product and prevent separation. It is found in many personal care products such as moisturizers, eye creams, sunscreens, cosmetics, and hand creams. Glycerol monostearate is also used as a preservative.

Использование

glyceryl monostearate (glycerin monostearate; glyceryl stearate) is widely used in cosmetics. It is an emulsifying and solubilizing ingredient, dispersing agent, emollient, formula stabilizer, and surface-action agent. employed in baby creams, face masks, foundation, and hand lotions, it is often derived from hydrogenated soybean oil. glyceryl monostearate has little or no G toxicity.

Методы производства

Glyceryl monostearate is prepared by the reaction of glycerin with triglycerides from animal or vegetable sources, producing a mixture of monoglycerides and diglycerides. The diglycerides may be further reacted to produce the 90% monoglyceride grade. Another process involves reaction of glycerol with stearoyl chloride.
The starting materials are not pure substances and therefore the products obtained from the processes contain a mixture of esters, including palmitate and oleate. Consequently, the composition, and therefore the physical properties, of glyceryl monostearate may vary considerably depending on the manufacturer.

Определение

An intermediate chemical.

Фармацевтические приложения

The many varieties of glyceryl monostearate are used as nonionic emulsifiers, stabilizers, emollients, and plasticizers in a variety of food, pharmaceutical, and cosmetic applications. It acts as an effective stabilizer, that is, as a mutual solvent for polar and nonpolar compounds that may form water-in-oil or oil-in-water emulsions.These properties also make it useful as a dispersing agent for pigments in oils or solids in fats, or as a solvent for phospholipids, such as lecithin.
Glyceryl monostearate has also been used in a novel fluidized hot-melt granulation technique for the production of granules and tablets.
Glyceryl monostearate is a lubricant for tablet manufacturing and may be used to form sustained-release matrices for solid dosage forms. Sustained-release applications include the formulation of pellets for tablets or suppositories, and the preparation of a veterinary bolus. Glyceryl monostearate has also been used as a matrix ingredient for a biodegradable, implantable, controlledrelease dosage form.
When using glyceryl monostearate in a formulation, the possibility of polymorph formation should be considered. The aform is dispersible and foamy, useful as an emulsifying agent or preservative. The denser, more stable, b-form is suitable for wax matrices. This application has been used to mask the flavor of clarithromycin in a pediatric formulation.

Профиль безопасности

Poison by intraperitoneal route. When heated to decomposition it emits acrid smoke and irritating fumes. See also ESTERS.

Безопасность

Glyceryl monostearate is widely used in cosmetics, foods, and oral and topical pharmaceutical formulations, and is generally regarded as a nontoxic and nonirritant material.
LD50 (mouse, IP): 0.2 g/kg

хранилище

If stored at warm temperatures, glyceryl monostearate increases in acid value upon aging owing to the saponification of the ester with trace amounts of water. Effective antioxidants may be added, such as butylated hydroxytoluene and propyl gallate.
Glyceryl monostearate should be stored in a tightly closed container in a cool, dry place, and protected from light.

Несовместимости

The self-emulsifying grades of glyceryl monostearate are incompatible with acidic substances.

Регуляторный статус

GRAS listed. Included in the FDA Inactive Ingredients Database (oral capsules and tablets; ophthalmic, otic, rectal, topical, transdermal, and vaginal preparations). Included in nonparenteral medicines licensed in the UK. Included in the Canadian List of Acceptable Non-medicinal Ingredients.
If glyceryl monostearate is produced from animal fats (tallow), there may be additional regulatory requirements that the source be free of contamination from bovine spongiform encephalopathy.