A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 38/21 (2006.01) A61K 47/26 (2006.01) A61K 9/19 (2006.01) A61K 47/42 (2006.01)
Patent
CA 2428144
Stabilized pharmaceutical formulations comprising IFN-.beta. and highly purified mannitol are provided. The highly purified mannitol stabilizes the compositions by reducing the formation of IFN-.beta. adducts in comparison with IFN-.beta. formulated with mannitol that has not been highly purified. Methods for increasing the stability of IFN-.beta. or a variant thereof in a liquid or lyophilized composition and for increasing storage stability of such a composition are also provided.
L'invention concerne des préparations pharmaceutiques stabilisées P comprenant IFN-.beta. et du mannitol fortement purifié. Le mannitol fortement purifié stabilise les préparations en réduisant la formation de produits d'additions IFN-.beta. par comparaison avec IFN-.beta. formulé avec le mannitol qui n'a pas été fortement purifié. L'invention concerne également des procédés d'augmentation de la stabilité de IFN-.beta. ou d'un variant de celui-ci dans une préparation liquide ou lyophilisée et pour accroître la stabilité de stockage de cette préparation.
Hora Maninder S.
Wolfe Sidney N.
Borden Ladner Gervais Llp
Chiron Corporation
Novartis Vaccines And Diagnostics Inc.
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