Stable aqueous alfa interferon solution formulations

Details Stable aqueous alfa interferon solution formulations Stable aqueous alfa interferon solution formulations

A - Human Necessities

61

K

A61K 38/21 (2006.01) A61K 9/08 (2006.01) A61K 47/00 (2006.01)

Patent

CA 2201749

Stable aqueous solution formulations containing alfa-type interferon, e.g., interferon alfa-2a and interferon alfa-2b, a buffer to maintain the pH in the range of 4.5-7.1, polysorbate 80 as a stabilizer, edetate disodium as a chelating agent, sodium chloride as a tonicity agent, and m-cresol as an antimicrobial preservative and which maintain high chemical, physical and biological stability of the alfa-type interferon for an extended storage period of at least 24 months are disclosed.

L'invention concerne des formulations de solutions aqueuses stables contenant de l'interféron de type alpha, par exemple de l'interféron alpha-2a et de l'interféron alpha-2b, un tampon servant à maintenir le pH dans la plage 4,5-7,1, du polysorbate 80 en tant que stabilisant, du sel disodique d'EDTA en tant qu'agent chélateur, du chlorure de sodium en tant qu'agent de tonicité, et du m-crésol en tant que conservateur anti-microbien, lesdites formulations conférant un haute stabilité chimique, physique et biologique à l'interféron de type alpha, pour une période prolongée de stockage d'au moins 24 mois.

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