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

Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...

Reexamination Certificate

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C546S022000

Reexamination Certificate

active

07858634

ABSTRACT:
A process for the preparation of 3-pyridil-1-hydroxyethyliden-1,1-biphosphonic acid monosodium salt of formulain 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 cationc) subjecting the solution to lyophilization.

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