Selective crystallization of 3-pyridyl-1-hydroxyethylidene-1,1-bisphosphonic acid sodium as the hemipentahydrate or monohydrate
AssigneeThe Procter & Gamble Company
InventorsFrederick Dana Cazer, Gregory Eugene Parry, Dennis Michael Billings, Nancy Lee Redman-Furey
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Abstract
The present invention discloses 3-pyridyl-1-hydroxyethylidene-1,1-bisphosphonic acid sodium hemipentahydrate and monohydrate, methods of preparing the hemipentahydrate or monohydrate through control of the nucleation temperature and rate of crystallization and pharmaceutical compositions containing one or both of the hydrate forms.
Claims18
A process for selectively producing 3-pyridyl-1-hydroxyethlidene-1,1-bisphosphonic acid sodium hemipentahydrate and monohydrate comprising the steps of:
- (a) providing an aqueous solution of 3-pyridyl-1-hydroxyethlidene-1,1-bisphosphonic acid sodium;
- (b) heating the aqueous solution to a temperature from about 45° C. to about 75° C.;
- (c) adding a solvent to the aqueous solution;
- and
- (d) optionally cooling the aqueous solution.
A pharmaceutical composition comprising 3-pyridyl-1-hydroxyethlidene-1,1-bisphosphonic acid sodium wherein the 3-pyridyl-1-hydroxyethlidene-1,1-bisphosphonic acid sodium is from about 50% to about 100% hemipentahydrate and from about 50% to about 0% monohydrate.
Dependencies are inferred from the claim text.