| abstract |
The stable, albumin-free, lyophilized, recombinant factor VIII (rFVIII) composition containing crystalline and amorphous stone pellets reconstituted with water is 65-400 mM glycine, up to 50 mM histidine, 15-60 mM sucrose, up to 50 mM glycine. chlorine time, up to 5 mM calcium chloride and 50-1500 IU / ml rFVIII. One preferred variant of the composition according to the invention is nominally 290 mM glycine, 20 mM histidine, 30 mM sucrose, 30 mM sodium chloride time, 2.5 mM calcium chloride time and 50-1500 IU / ml after reconstitution. It contains rFVIII. The residual water content of the pre-lyophilized formulation is 1-3% by weight. ŕ |