Disodium pamidronate

Chemical properties

White or almost white, crystalline powder.

Originator

Aredia,Novartis,India

The Uses of Disodium pamidronate

Bone resorption inhibitor.

The Uses of Disodium pamidronate

Pamidronate Disodium Salt Pentahydrate is a calcium metabolism regulator.

What are the applications of Application

Pamidronate, Disodium Salt is a calcium metabolism regulator

Definition

ChEBI: Pamidronate disodium is a 1,1-bis(phosphonic acid).

Manufacturing Process

For a batch size of 5 L, 587.5 g (3.2 moles) of mannitol is dissolved in 3.5 L of water. Pamidronic acid (31.6 g, 0.133 moles) is mixed with a 1.0 L aliquot of the mannitol solution to form a slurry. The slurry is then transferred into the remainder of the mannitol solution, and stirred for at least 15 min. Aqueous 1 N sodium hydroxide (270 ml) is then added and the mixture is stirred until a clear, colorless solution results. The pH is then adjusted to 6.50.1 using either 1 M aqueous phosphoric acid or 1 N aqueous sodium hydroxide, as needed. The solution is then filtered through a 0.22 micron filter, and filled at 20°C into vials at 4.0 ml (4.172 g)/vial, under sterile conditions. The aqueous solution is frozen at -37°C and lyophilized (20 mbar, 20°-40°C) to yield 1,250 vials, each containing 30 mg of amorphous disodium pamidronate. The vials are sealed under positive nitrogen pressure. The disodium pamidronate is amorphous (noncrystalline) by X-ray diffraction and contains 0.7 wt-% water.

brand name

Aredia (Novartis).

Therapeutic Function

Bone resorption suppressant

Clinical Use

Pamidronate, a second-generation bisphosphonate, is 100-fold more potent than etidronate. It has been approved for the treatment of hypercalcemia of malignancy, for Paget's disease, and for osteolytic bone metastases of breast cancer and osteolytic lesions of multiple myeloma. When used to treat bone metastases, pamidronate decreases osteoclast recruitment, decreases osteoclast activity and increases osteoclast apoptosis. Erosive esophagitis has been reported with the use of pamidronate sodium.

Metabolism

Pamidronate is not metabolised, and about 20-55% of the dose is excreted in the urine unchanged within 72 hours; the remainder is mainly sequestered to bone and only very slowly eliminated.