摘要 |
PROBLEM TO BE SOLVED: To provide a stable pharmaceutical composition containing a factor VIII, ensuring formulation stability which is always the matter of problem in the pharmaceutical industry dealing with a factor VIII pharmaceutical composition. SOLUTION: The solid pharmaceutical composition includes (a) the factor VIII, (b) a surfactant, (c) calcium chloride, (d) sucrose, (e) sodium chloride, (f) trisodium citrate, and (g) a buffer devoid of amino acids; is obtained by lyophilizing a solution free of amino acids; and has a pH of from 6 to 8 prior to the lyophilization and after reconstitution in water for injection. COPYRIGHT: (C)2011,JPO&INPIT |