An aqueous solution formulation of alpha-interferon

Details An aqueous solution formulation of alpha-interferon An aqueous solution formulation of alpha-interferon

A - Human Necessities

61

K

A61K 38/21 (2006.01) A61K 9/08 (2006.01) A61K 47/26 (2006.01)

Patent

CA 2391889

The present invention relates to an aqueous solution formulation which can retain the biological activity and physicochemical properties of .alpha.- interferon for a long period. More particularly, the present invention relates to an aqueous solution formulation of .alpha.-interferon comprising .alpha.- interferon; a stabilizer; an osmotic pressure regulating agent; antimicrobial preservatives selected from the group consisting of phenol, m-cresol or mixture thereof; and a buffer system. The aqueous solution formulation of the present invention has many advantages because it retains the activity of .alpha.-interferon for a long period, eliminates potential harmfulness to human body by minimizing the amount of the preservatives, and is very stable.

L'invention concerne une formulation de solution aqueuse capable de retenir durablement l'activité biologique et les propriétés physico-chimiques de l'interféron-.alpha.. Plus précisément, l'invention concerne une formulation de solution aqueuse de l'interféron-.alpha. comprenant l'interféron-.alpha.; un stabilisant; un agent régulateur de pression osmotique; des conservateurs antimicrobiens choisis dans le groupe constitué de phénol, de m-crésol ou de mélange de ceux-ci; et un système tampon. Ladite formulation de solution aqueuse présente de nombreux avantages car elle retient durablement l'activité de l'interféron-.alpha., élimine la nocivité éventuelle pour le corps humain en réduisant la quantité de conservateurs. Elle est en outre très stable.

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