Amorphous 3-pyridil-1-hydroxyethyliden-1,1-biphosphonic acid...

C - Chemistry – Metallurgy – 07 – F

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C07F 9/58 (2006.01) A61K 31/675 (2006.01)

Patent

CA 2498177

A process for the preparation of 3-pyridil-1-hydroxyethyliden-1,1-biphosphonic acid monosodium salt of formula (see formula I) in an amorphous form, preferably lyophilized, and its pharmaceutical compositions are described. Said amorphous form, characterized by stability and simplicity of preparation and formulation, can be obtained by an industrially applicable lyophilization process, which comprises the steps of: a) dissolving or suspending 3-pyridyl-1-hydroxyethyliden-1,1-biphosphonic acid in an aqueous solvent, b) adding one equivalent of a base having sodium as canon c) subjecting the solution to lyophilization

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