International Numbering System (INS) for Food Additives: 170
Food additives Europe numbers: E170
Functional Category
Buffering agent; coating agent; colorant; opacifier; tablet binder; tablet and capsule diluent; therapeutic agent
Applications in Pharmaceutical Formulation
Calcium carbonate, employed as a pharmaceutical excipient, is mainly used in solid-dosage forms as a diluent.(1–4) It is also used as a base for medicated dental preparations,(5) as a buffering agent, and as a dissolution aid in dispersible tablets. Calcium carbonate is used as a bulking agent in tablet sugar-coating processes and as an opacifier in tablet film-coating. Calcium carbonate is also used as a food additive and therapeutically as an antacid and calcium supplement.
Description
Calcium carbonate occurs as an odorless and tasteless white powder or crystals.
Stability and Storage Conditions
Calcium carbonate is stable and should be stored in a well-closed container in a cool, dry place.
Incompatibilities
Incompatible with acids and ammonium salts (see also Sections 10 and 18)
Safety
Calcium carbonate is mainly used in oral pharmaceutical formulations and is generally regarded as a nontoxic material. However, calcium carbonate administered orally may cause constipation and flatulence. Consumption of large quantities (4–60 g daily) may also result in hypercalcemia or renal impairment.(6) Therapeutically, oral doses of up to about 1.5 g are employed as an antacid. In the treatment of hyperphosphatemia in patients with chronic renal failure, oral daily doses of 2.5–17 g have been used. Calcium carbonate may interfere with the absorption of other drugs from the gastrointestinal tract if administered concomitantly. LD50 (rat, oral): 6.45 g/kg