International Numbering System (INS) for Food Additives: 339
Food additives Europe numbers: E339
Functional Category
Buffering agent; sequestering agent.
Applications in Pharmaceutical Formulation
Dibasic sodium phosphate is used in a wide variety of pharmaceutical formulations as a buffering agent and as a sequestering agent. Therapeutically, dibasic sodium phosphate is used as a mild laxative and in the treatment of hypophosphatemia.(1,2) Dibasic sodium phosphate is also used in food products; for example as an emulsifier in processed cheese.
Description
The USP 32 states that dibasic sodium phosphate is dried or contains, 1, 2, 7, or 12 molecules of water of hydration. Anhydrous dibasic sodium phosphate occurs as a white powder. The dihydrate occurs as white or almost white, odorless crystals. The heptahydrate occurs as colorless crystals or as a white granular or caked salt that effloresces in warm, dry air. The dodecahydrate occurs as strongly efflorescent, colorless or transparent crystals.
Stability and Storage Conditions
The anhydrous form of dibasic sodium phosphate is hygroscopic. When heated to 408C, the dodecahydrate fuses; at 1008C it loses its water of crystallization; and at a dull-red heat (about 2408C) it is converted into the pyrophosphate, Na4P2O7. Aqueous solutions of dibasic sodium phosphate are stable and may be sterilized by autoclaving. The bulk material should be stored in an airtight container, in a cool, dry place.
Incompatibilities
Dibasic sodium phosphate is incompatible with alkaloids, antipyrine, chloral hydrate, lead acetate, pyrogallol, resorcinol and calcium gluconate, and ciprofloxacin.(4) Interaction between calcium and phosphate, leading to the formation of insoluble calcium–phosphate precipitates, is possible in parenteral admixtures.
Safety
Dibasic sodium phosphate is widely used as an excipient in parenteral, oral, and topical pharmaceutical formulations. Phosphate occurs extensively in the body and is involved in many physiological processes since it is the principal anion of intracellular fluid. Most foods contain adequate amounts of phosphate, making hypophosphatemia (phosphate deficiency)(1) virtually unknown except for certain disease states(2) or in patients receiving total parenteral nutrition. Treatment is usually by the oral administration of up to 100 mmol of phosphate daily. Approximately two-thirds of ingested phosphate is absorbed from the gastrointestinal tract, virtually all of it being excreted in the urine, and the remainder is excreted in the feces. Excessive administration of phosphate, particularly intravenously, rectally, or in patients with renal failure, can cause hyperphosphatemia that may lead to hypocalcemia or other severe electrolyte imbalances.(5,6) Adverse effects occur less frequently following oral consumption, although phosphates act as mild saline laxatives when administered orally or rectally. Consequently, gastrointestinal disturbances including diarrhea, nausea, and vomiting may occur following the use of dibasic sodium phosphate as an excipient in oral formulations. However, the level of dibasic sodium phosphate used as an excipient in a pharmaceutical formulation is not usually associated with adverse effects. LD50 (rat, oral): 17 g/kg(7)