Abstract: A stable injectable solution containing pamidronate and a method for preparing a therapeutic aqueous disodium 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.
Type:
Application
Filed:
November 6, 2002
Publication date:
July 24, 2003
Applicant:
Mayne Pharma Pty Ltd.
Inventors:
Gregory Paul Handreck, Wei Zhou, Russell John Tait
Abstract: A stable injectable solution containing pamidronate and a method for preparing a therapeutic aqueous disodium 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 parnidronic 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.
Type:
Application
Filed:
November 6, 2002
Publication date:
July 3, 2003
Applicant:
Mayne Pharma Pty Ltd.
Inventors:
Gregory Paul Handreck, Wei Zhou, Russell John Tait