Process for making a lyophilized product for use in skeletal ima

Drug – bio-affecting and body treating compositions – Radionuclide or intended radionuclide containing; adjuvant...

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424 9, A61K 4300, A61K 4900

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active

045044635

ABSTRACT:
A process for making a lyophilized composition, useful for skeletal imaging, containing diphosphonates, stannous reductant, and optionally, a gentisate stabilizer. The process comprises (1) preparing an aqueous solution of diphosphonate, reductant, and optional stabilizer, (2) adjusting the pH of the solution formed in step one to a pH in the range from about 4.2 to about 4.8, and (3) lyophilizing the pH-adjusted solution.

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