Chemical Properties
White or almost white, crystalline powder.
Originator
Aredia,Novartis,India
Uses
Bone resorption inhibitor.
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.
Drug interactions
Potentially hazardous interactions with other drugs
None known
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.
