Chemical Properties
A soft, off-white solid. PH of 10% dispersion 7.26, saponification number variable. Soluble in chlorinated solvents, light esters, and acetone; slightly soluble in alcohols, insoluble in glycols, hydrocarbons, and vegetable oils. Combustible.
Uses
Pegosperse(R) 300 DS is used as an emulsifier for personal care and water treatment and as a processing aid in textile industry.
Uses
POLY(ETHYLENE GLYCOL) (N) DISTEARATE is used as an emulsifier for personal care and water treatment and as a processing aid in textile industry.
Definition
Distearate ester of polyglycol.
Production Methods
Polyethylene glycol distearate is prepared by the direct reaction of
fatty acids, particularly stearic acid, with ethylene oxide.
Pharmaceutical Applications
Polyethylene glycol distearate is generally used as emulsifiers in oil-inwater-
type creams and lotions. Its hydrophilicity or lipophilicity
depends on the number of ethylene oxide units present: the larger
the number, the greater the hydrophilic properties. Polyoxyl 40
stearate has been used as an emulsifying agent in intravenous
infusions.
Polyoxyethylene stearates are particularly useful as emulsifying
agents when astringent salts or other strong electrolytes are present.
It can also be blended with other surfactants to obtain any
hydrophilic–lipophilic balance for lotions or ointment formulations.
Safety Profile
Poison by intravenous
route. When heated to decomposition it
emits acrid smoke and irritating fumes. See
also POLYETHYLENE GLYCOL.
Safety
Although Polyethylene glycol distearate is primarily used as emulsifying
agents in topical pharmaceutical formulations, certain materials,
particularly polyoxyl 40 stearate, have also been used in
intravenous injections and oral preparations.
Polyethylene glycol distearate has been tested extensively for
toxicity in animals(8–13) and are widely used in pharmaceutical formulations and cosmetics. It is generally regarded as
essentially nontoxic and nonirritant materials.
Polyoxyl 8 stearate
(hamster, oral): 27 g/kg
(rat, oral): 64 g/kg
Polyoxyl 20 stearate
(mouse, IP): 0.2 g/kg
(mouse, IV): 0.87 g/kg
storage
Polyoxyethylene stearates are generally stable in the presence of electrolytes and weak acids or bases. Strong acids and bases can cause gradual hydrolysis and saponification.
The bulk material should be stored in a well-closed container, in a dry place, at room temperature.
Incompatibilities
Polyethylene glycol distearate is unstable in hot alkaline solutions
owing to hydrolysis, and will also saponify with strong acids or
bases. Discoloration or precipitation can occur with salicylates,
phenolic substances, iodine salts, and salts of bismuth, silver, and
tannins.Complex formation with preservatives may also
occur.The antimicrobial activity of some materials such as
bacitracin, chloramphenicol, phenoxymethylpenicillin, sodium
penicillin, and tetracycline may be reduced in the presence of
polyoxyethylene stearate concentrations greater than 5% w/w.
Regulatory Status
Included in the FDA Inactive Ingredients Database (dental
solutions; IV injections; ophthalmic preparations; oral capsules
and tablets; otic suspensions; topical creams, emulsions, lotions,
ointments, and solutions; and vaginal preparations). Included in
nonparenteral medicines licensed in the UK. Included in the
Canadian List of Acceptable Non-medicinal Ingredients.
