A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 38/37 (2006.01) A61K 9/19 (2006.01) A61K 47/00 (2006.01) A61K 47/26 (2006.01) A61K 47/02 (2006.01) A61K 47/18 (2006.01)
Patent
CA 2210038
A stable albumin-free Recombinant Factor VIII (rFVIII) formulation in lyophilized form having both crystalline and amorphous components and comprising, when reconstituted with water, about 65 to 400 mM glycine, up to 50 mM histidine, 15 to 60 mM sucrose, up to 50 mM NaCI, up to 5 mM CaCl2 and 50 to 1500 IU/ml of rFVIII. A very preferred formulation comprises upon reconstitution with water about 290 mM glycine, 20 mM histidine, 30 mM sucrose, 30 mM NaCI, 2.5 mM CaCl2 and 50 to 1500 IU/ml of rFVIII. The residual water content of the lyophilized preparation is about 1 to 3% by weight, preferably about 1% by weight.
Corporation Bayer
Norton Rose Or S.e.n.c.r.l. S.r.l./llp
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