Functional Category
Emulsifying agent; solubilizing agent; stiffening agent.
Applications in Pharmaceutical Formulation
Anionic emulsifying wax is used in cosmetics and topical pharmaceutical formulations primarily as an emulsifying agent. The wax is added to fatty or paraffin bases to facilitate the production of oil-in-water emulsions that are nongreasy. In concentrations of about 2%, emulsions are pourable; stiffer emulsions, e.g. aqueous cream BP, may contain up to 10% of anionic emulsifying wax. Creams should be adequately preserved and can usually be sterilized by autoclaving. A better-quality emulsion is produced by incorporating some alkali into the aqueous phase, although care should be taken not to use an excess. Anionic emulsifying wax (3–30%) may also be mixed with soft and liquid paraffins to prepare anhydrous ointment bases such as emulsifying ointment BP. A preparation of 80% anionic emulsifying wax in white soft paraffin has been used as a soap substitute in the treatment of eczema. In addition, anionic emulsifying wax (10%) has been added to theobroma oil (cocoa butter) to produce a suppository base with a melting point of 34 C.
Description
An almost white or pale yellow colored, waxy solid or flakes which when warmed become plastic before melting. Anionic emulsifying wax has a faint characteristic odor and a bland taste
Stability and Storage Conditions
Solid anionic emulsifying wax is chemically stable and should be stored in a well-closed container in a cool, dry place
Incompatibilities
Incompatibilities of anionic emulsifying wax are essentially those of sodium alkyl sulfates and include cationic compounds ( quaternary ammonium compounds, acriflavine, ephedrine hydrochloride, antihistamines, and other nitrogenous compounds), salts of polyvalent metals (aluminum, zinc, tin, and lead), and thioglycolates. Anionic emulsifying wax is compatible with most acids above pH 2.5. It is also compatible with alkalis and hard water. Iron vessels should not be used when heating anionic emulsifying wax; stainless steel containers are satisfactory
Safety
Anionic emulsifying wax is used primarily in topical pharmaceutical formulations and is generally regarded as a nontoxic and nonirritant material. However, sodium lauryl sulfate, a constituent of anionic emulsifying wax, is known to be irritant to the skin at high concentrations; sodium cetyl sulfate is claimed to be less irritating. Emulsifying ointment BP, which contains anionic emulsifying wax, has been found to have major sunscreen activity in clinically normal skin and should therefore not be used before phototherapy procedures.(1)