Stable pharmaceutical composition containing factor viii

Details Stable pharmaceutical composition containing factor viii Stable pharmaceutical composition containing factor viii

A - Human Necessities

61

K

A61K 38/37 (2006.01) A61K 9/19 (2006.01) A61K 47/18 (2006.01) A61K 47/26 (2006.01) A61K 47/02 (2006.01)

Patent

CA 2480226

The invention relates to a stable solid pharmaceutical composition comprising factor VIII. Such a composition is devoid of amino acids and comprises: (a) factor VIII; (b) a surfactant; (c) calcium chloride; (d) sucrose; (e) sodium chloride; (f) trisodium citrate; and (g) a buffer devoid of amino acids; and has a pH from 6 to 8 prior to lyophilisation and after reconstitution in water for injection. The invention also relates to the liquid pharmaceutical composition obtainable after dilution of said stable solid pharmaceutical composition with sterile water optionally containing sodium chloride.

L'invention concerne une composition pharmaceutique solide et stable comprenant le facteur VIII. Cette composition ne comprend pas d'acides aminés et comporte (a) le facteur VIII, (b) un tensioactif; (c) du chlorure de calcium, (d) du sucrose, (e) du chlorure de sodium, (f) du citrate de trisodium et (g) un tampon dépourvu d'acides aminés. Cette composition présente un pH compris entre 6 et 8 avant lyophilisation et après reconstitution dans l'eau en vue de son injection. L'invention a aussi pour objet une composition pharmaceutique liquide pouvant être obtenue après dilution de ladite composition pharmaceutique solide et stable avec de l'eau stérile contenant éventuellement du chlorure de sodium.

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