Calcium phosphate tribasic

Chemical Properties

The PhEur 6.4 states that tribasic calcium phosphate consists of a mixture of calcium phosphates. It contains not less than 35.0% and not more than the equivalent of 40.0% of calcium. The USP32– NF27 specifies that tribasic calcium phosphate consists of variable mixtures of calcium phosphates having the approximate composition 10CaO·3P₂O₅·H₂O. This corresponds to a molecular formula of Ca₅(OH)(PO₄)₃ or Ca₁₀(OH)₂(PO₄)₆.
Tribasic calcium phosphate is a white, odorless and tasteless powder. col hexagonal crystal(s) [CRC10]

Uses

Si-substituted hydroxyapatite (Si-HAp) nanopowder can be incorporated in biodegradable polymer composites or deposited on biocompatible surfaces similar to pure HAp nanopowder (cat. no. 677418). Biological activity of HAp was shown to be enhanced by substitution of silicon ions into a fraction of HAp lattice phosphate sites.1,2

Uses

Calcium phosphate tribasic (C3161) is plant cell culture tested (0.2 mg/ml) and is appropriate for use in plant cell culture experiments. Calcium phosphate tribasic is utilized to engineer new biomaterials for applications such as bone grafts and fillers.

Production Methods

Tribasic calcium phosphate occurs naturally as the minerals hydroxylapatite, voelicherite, and whitlockite. Commercially, it is prepared by treating phosphate-containing rock with sulfuric acid. Tribasic calcium phosphate powder is then precipitated by the addition of calcium hydroxide. Tribasic calcium phosphate is alternatively prepared by treating calcium hydroxide from limestone with purified phosphoric acid. It may also be obtained from calcined animal bones. Some tribasic calcium phosphate products may be prepared in coarser, directly compressible forms by granulating the powder using roller compaction or spray drying.

Application

Calcium phosphate tribasic is the mineral component of bones and teeth; it has been used therapeutically as a prosthetic aid and in the prevention and treatment of osteoporosis. Employed in tissue replacement for repairing bony defects and acts as drug carrier for drug delivery to the bone. Hydroxyapatite nanopowders, incorporated in biodegradable polymer composites or deposited on biocompatible substrates, have been shown to promote adhesions and proliferation of bone-forming (osteoblast) cells. It is also the starting material for the production of phosphoric acid and fertilizers.

General Description

Hydroxyapatite is a key inorganic phosphate that has chemical and structural resemblance to bone. HAp is a popular biomaterial which finds use as a bone or teeth replacement and repair, hard tissue repair.

Flammability and Explosibility

Non flammable

Pharmaceutical Applications

Tribasic calcium phosphate is widely used as a capsule diluent and tablet filler/binder in either direct-compression or wet-granulation processes. The primary bonding mechanism in compaction is plastic deformation. As with dibasic calcium phosphate, a lubricant and a disintegrant should usually be incorporated in capsule or tablet formulations that include tribasic calcium phosphate. In some cases tribasic calcium phosphate has been used as a disintegrant.It is most widely used in vitamin and mineral preparations as a filler and as a binder. It is a source of both calcium and phosphorus, the two main osteogenic minerals for bone health. The bioavailability of the calcium is well known to be improved by the presence of cholecalciferol. Recent research reports that combinations of tribasic calcium phosphate and vitamin D3 are a cost-effective advance in bone fracture prevention.
In food applications, tribasic calcium phosphate powder is widely used as an anticaking agent.

Safety

Tribasic calcium phosphate is widely used in oral pharmaceutical formulations and food products, and is generally regarded as nontoxic and nonirritant at the levels employed as a pharmaceutical excipient.
Ingestion or inhalation of excessive quantities may result in the deposition of tribasic calcium phosphate crystals in tissues. These crystals may lead to inflammation and cause tissue lesions in the areas of deposition.
Oral ingestion of very large quantities of tribasic calcium phosphate may cause abdominal discomfort such as nausea and vomiting.
No teratogenic effects were found in chicken embryos exposed to a dose of 2.5 mg of tribasic calcium phosphate.
LD₅₀ (rat, oral): >1 g/kg

storage

Tribasic calcium phosphate is a chemically stable material, and is also not liable to cake during storage.
The bulk material should be stored in a well-closed container in a cool, dry place.

Incompatibilities

All calcium salts are incompatible with tetracycline antibiotics. Tribasic calcium phosphate is incompatible with tocopheryl acetate (but not tocopheryl succinate). Tribasic calcium phosphate may form sparingly soluble phosphates with hormones.

Regulatory Status

GRAS listed. Accepted for use as a food additive in Europe. Included in the FDA Inactive Ingredients Database (oral capsules and tablets). Included in nonparenteral medicines licensed in the UK. Included in the Canadian List of Acceptable Non-medicinal Ingredients.