FATTY ACID ETHOXYLATE

  PHYSICAL AND ANALYTICAL DATA

 FUNCTIONAL CATEGORY
Emulsifying agent; solubilizing agent; wetting agent.

 APPLICATIONS IN PHARMACEUTICAL FORMULATION OR TECHNOLOGY

SHREE CHEM-SEA are generally used as emulsifiers in oil-in-water type creams and lotions. Their hydrophilicity or lipophilicity depends on the number of ethylene oxide units present; the larger the number, the greater the hydrophilic properties. SHREE CHEM-SEA-40 has also been used as an emulsifying agent in intravenous infusions.

SHREE CHEM-SEA are particularly useful as emulsifying agents when astringent salts or other strong electrolytes are present.

They can also be blended with other surfactants to obtain any hydrophilic-lipophilic balance for lotions or ointment formulations.

SOLUBILITY

Where
D = Dispersible, S = Soluble, I = Insoluble and DH = Dispersible (with Heat)

 STABILITY AND STORAGE

SHREE CHEM-SEA 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

SHREE CHEM-SEA are unstable in hot alkaline solutions due 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 antimicorbial activity of some materials such as bacitracin, chloramphenicol, phenoxymethylpenicillin, sodium penicillin and tetracycline may be, reduced in the presence of SHREE CHEM-SEA concentrations greater than 5% w/w.

 SAFETY

Although SHREE CHEM-SEA are primarily used as emulsifying agents in topical pharmaceutical formulations certain materials, particularly SHREE CHEM-SEA-40 have also been used intravenous injections and oral preparations.

SHREE CHEM-SEA have been extensively tested for toxicity in animals and are widely used in pharmaceutical formulations and cosmetics. They are generally regarded as essentially nontoxic and nonirritant materials.

 HANDLING PRECAUTIONS

Observe normal precautions appropriate to the circumstances and quantity of material handled.

SHREE CHEM-SEA that contain greater than 100 ppm of free ethylene oxide may present an explosion hazard when stored in a closed container. This is due to the release of ethylene oxide into the container headspace where it can accumulate, and so exceed the explosion limit.