Pamidronic Acid → Pamidronate Disodium Anhydrous

HRID 49739

Reaction equation

HRID 49739 reaction equation
[CH2:1]([C:4]([P:10]([OH:13])([OH:12])=[O:11])([P:6]([OH:9])([OH:8])=[O:7])[OH:5])[CH2:2][NH2:3].[OH-].[Na+:15].[OH-].[K+]>>[CH2:1]([C:4]([P:10]([O-:13])([OH:12])=[O:11])([P:6]([O-:8])([OH:9])=[O:7])[OH:5])[CH2:2][NH2:3].[Na+:15].[Na+:15]

Participants

4

Reactant 3

HCID 4674Pamidronic Acid2×HCID 14797Potassium Hydroxide2×HCID 14798Sodium Hydroxide2×

Product 1

HCID 73351Pamidronate Disodium Anhydrous

Procedure

In another embodiment, the invention is directed to a method for preparing a packaged liquid pamidronate alkaline salt composition by (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 the pamidronic acid slurry sufficient aqueous solution of sodium hydroxide or potassium 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 the pH of the solution to about 6.5; (e) transferring the solution having a pH of about 6.5 into a vessel having an inner surface which does not react with the solution; and (f) sealing the vessel. Alternatively, a pamidronic acid aqueous slurry can be treated with aqueous sodium hydroxide or potassium hydroxide to form an aqueous solution of pamidronate disodium or pamidronate dipotassium. This solution can then be combined with mannitol and the resulting solution acidified to a pH of about 6.5 with, for example, phosphoric acid.

Workup

  1. customto yield a solution
  2. customdoes not react with the solution

Sources & evidence

ORD record
ord-32f9453e79b94d618306116a93a906f4
Source dataset
uspto-grants-2004_03
Patent number
US06709674B2

Linked notes

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