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US 2003/0069211 A1Published application
Injectable pamidronate disodium
AssigneeGensia Sicor Pharmaceuticals, Inc.
InventorDorla Mirejovsky
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Abstract
The invention includes a packaged liquid composition of a pamidronate alkaline salt in a sealed storage vessel having an inner surface which is non-reactive with the pamidronate alkaline salt composition.
Claims19
A packaged composition comprising:
- (a) an aqueous pamidronate disodium composition comprising:
- (i) disodium pamidronate;
- (ii) a sugar;
- (iii) a pharmaceutically acceptable base;
- and
- (iv) a pharmaceutically acceptable acid;
- (v) water;
- and
- (b) a sealed storage vessel having an inner surface which is non-reactive with said pamidronate disodium composition.
6 more elements
A method for preparing a packaged aqueous pamidronate disodium composition comprising:
- (a) combining a sugar with water;
- (b) combining the mixture of step (a) with pamidronic acid to form a pamidronic acid slurry;
- (c) adding to said pamidronic acid slurry sufficient aqueous solution of sodium hydroxide to yield a solution having a pH of about 8.5;
- (d) adding to the resultant solution a pharmaceutically acceptable acid in an amount sufficient to lower to pH of said solution to about 6.5;
- (e) transferring said solution having a pH of about 6.5 into a vessel having an inner surface which does not react with said solution;
- and
- (f) sealing said vessel.
4 more elements
Dependencies are inferred from the claim text.