Partially lyophilized fructose-1,6-diphosphate (FDP) for injection into humans

摘要

A method is disclosed for preparing a partially lyophilized (freeze-dried) fructose-1,6-diphosphate (FDP) or pharmacologically acceptable salt thereof wherein an aqueous solution of FDP or salt thereof is lyophilized until a solidified material is produced have a residual water content of 10% to 25% (by weight). This high moisture content does not degrade or limit the stability or shelf life of the product. FDP preparations having residual water content in the range of 12% to 16% by weight are especially preferred. A caked, powdered, or other solidified formulation of the FDP containing less than 5% percent total impurities, and less than 1% of any one single impurity, is useful in various ways, such as (1) in an injection kit for rapid (e.g., pre-diagnostic) injection of FDP into people suffering medical crises such as heart attacks, severe blood loss, suffocation, etc, and (2) in the treatment of patients preparing to undergo circulatory bypass of the heart, during surgery.