Functional Category:
Film-forming agent; plasticizer; solvent.
Applications in Pharmaceutical Formulation
Diethyl phthalate is used as a plasticizer for film coatings on tablets, beads, and granules at concentrations of 10–30% by weight of polymer. Diethyl phthalate is also used as an alcohol denaturant and as a solvent for cellulose acetate in the manufacture of varnishes and dopes. In perfumery, diethyl phthalate is used as a perfume fixative at a concentration of 0.1–0.5% of the weight of the perfume used.
Description
Diethyl phthalate is a clear, colorless, oily liquid. It is practically odorless, or with a very slight aromatic odor and a bitter, disagreeable taste.
Stability and Storage Conditions
Diethyl phthalate is stable when stored in a well-closed container in a cool, dry place
Incompatibilities
Incompatible with strong oxidizing materials, acids, and permanganates.
Safety
Diethyl phthalate is used in oral pharmaceutical formulations and is generally regarded as a nontoxic and nonirritant material at the levels employed as an excipient. However, if consumed in large quantities it can act as a narcotic and cause paralysis of the central nervous system. Although some animal studies have suggested that high concentrations of diethyl phthalate may be teratogenic, other studies have shown no adverse effects.(1) LD50 (guinea pig, oral): 8.6 g/kg(2) LD50 (mouse, IP): 2.7 g/kg LD50 (mouse, oral): 6.2 g/kg LD50 (rat, IP): 5.1 g/kg LD50 (rat, oral): 8.6 g/kg