Pamidronate solution
A stable injectable solution containing pamidronate and a method for preparing a therapeutic aqueous disodiurn pamidronate solution. The method comprises preparing a slurry of pamidronic acid in water, combining aqueous sodium hydroxide with the slurry in an amount about 2:1 molar ratio of sodium hydroxide to pamidronic acid to yield a solution of disodium pamidronate having visual clarity and a pH of about 6.5, and packaging the solution in sealed containers. A unit dosage form including the solution and a vial or ampule comprising the unit dosage form are also described.
1 . A method for preparing a therapeutic aqueous disodium pamidronate solution comprising:
(a) preparing a slurry of pamidronic acid in water, and
(b) combining aqueous sodium hydroxide with said slurry in an about 2:1 molar ratio of sodium hydroxide to pamidronic acid; to yield a solution of disodium pamidronate having visual clarity and a pH of about 6.5;
(c) packaging said solution in a plurality of sealed containers to yield a plurality of liquid unit dosage forms of pamidronate.
2 . The method of claim 1 wherein the slurry includes an effective stablizing amount of mannitol.
3 . A unit dosage form comprising a disodium pamidronte solution prepared by the method of claim 1 .
4 . A unit dosage form comprising a disodium pamidronate solution prepared by the method of claim 2 .
5 . A vial or ampule comprising a unit dosage form of the solution of claim 3 .
6 . A vial or ampule comprising a unit dosage form of the solution of claim 4 .
7 . The vial or ampule of claim 5 wherein the solution is packaged under an inert atmosphere.
8 . The dosage form of claim 3 wherein the container is free of CA +2 that can be sequestered by the disodium pamidronate.
9 . The dosage form of claim 8 wherein the container is a plastic vial or ampule.
10 . The dosage form of claim 8 wherein the container is a glass vial or ampule.