Functional Category
Plasticizer
Applications in Pharmaceutical Formulation
Tributyl citrate is used to plasticize polymers in formulated pharmaceutical coatings. The coating applications include capsules, tablets, beads, and granules for taste masking, immediate release, sustained-release, and enteric formulations.(1–6)
Description
Tributyl citrate is a clear, odorless, practically colorless, oily liquid.
Stability and Storage Conditions
Tributyl citrate should be stored in well-closed containers in a cool, dry location at temperatures not exceeding 388C. When stored in accordance with these conditions, tributyl citrate is a stable material.
Incompatibilities
Tributyl citrate is incompatible with strong alkalis and oxidizing materials
Safety
Tributyl citrate is used in oral pharmaceutical formulations. It is generally regarded as an essentially nontoxic and nonirritating material. However, ingestion of large quantities may be harmful. LD50 (cat, oral): >50 mL/kg(7) LD50 (mouse, IP): 2.9 g/kg LD50 (rat, oral): >30 mL/kg