Functional Category
Plasticizer
Applications in Pharmaceutical Formulation
Acetyltriethyl citrate is used to plasticize polymers in formulated pharmaceutical coatings.(1) The coating applications include capsules, tablets, beads and granules for taste masking, immediate release, sustained-release and enteric formulations.(2–5) It is also used in diffusion-controlled release drug delivery systems.
Description
Acetyltriethyl citrate occurs as a clear, odorless, practically colorless oily liquid.
Stability and Storage Conditions
Acetyltriethyl citrate should be stored in dry, closed containers attemperatures not exceeding 388C. When stored in accordance with these conditions, acetyltriethyl citrate is a stable product.
Incompatibilities:
Acetyltriethyl citrate is incompatible with strong alkalis and oxidizing materials.
Safety
Acetyltriethyl citrate is used in oral pharmaceutical formulations and is generally regarded as a nontoxic and nonirritating material.However, ingestion of large quantities may be harmful.LD50 (cat, oral): 8.5 g/kg(7)LD50 (mouse, IP): 1.15 g/kgLD50 (rat, oral): 7 g/kg