Stabilized interleukin 2

Details Stabilized interleukin 2 Stabilized interleukin 2

A - Human Necessities

61

K

A61K 38/00 (2006.01) A61K 38/20 (2006.01)

Patent

CA 2413334

A stable pharmaceutical preparation comprising Human interleukin-2 or a variant thereof and a stabilizing amount of histidine. A preferred formulation includes glycine and sucrose and a variant of IL-2 having a single mutation, N88R. The preferred formulation is in lyophilized form which, on reconstitution with an aqueous diluent, results in a solution having a pH ranging from about 5.0 to 6.5.

L'invention concerne une préparation pharmaceutique stable comprenant une interleukine 2 humaine ou un variant de celle-ci et une dose stabilisatrice d'histidine. Une formulation préférée comprend notamment de la glycine et de la saccharose ainsi qu'un variant d'IL-2 présentant une mutation simple, N88R. La formulation préférée se présente sous forme lyophilisée qui, après reconstitution à l'aide d'un diluant aqueux, produit une solution dont le pH se situe entre environ 5,0 et 6,5.

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