Functional Category
Plasticizer
Applications in Pharmaceutical Formulation
Acetyltributyl citrate is used to plasticize polymers in formulated pharmaceutical coatings,(1–5) including capsules, tablets, beads, and granules for taste masking, immediate release, sustained-release and enteric formulations.
Description
Acetyltributyl citrate is 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
Acetyltributyl citrate is incompatible with strong alkalis and oxidizing materials.
Safety
Acetyltributyl citrate is used in oral pharmaceutical formulations and films intended for direct food contact. It is also used in selfadhesive thin films used for topical delivery systems.(6) It is generally regarded as a relatively nontoxic and nonirritating material.However, ingestion of large quantities may be harmful.LD50 (cat, oral): >50 mL/kg(7)LD50 (mouse, IP): >4 g/kg LD50 (rat, oral): >31.5 g/kg