HASSLACHER MEINHARD,CITKOWICZ ANDRZEJ,WHITE CATHERINE,FRANKE KEN
申请号:
ARP120101976
公开号:
AR086672A1
申请日:
2012.06.04
申请国别(地区):
AR
年份:
2014
代理人:
摘要:
Furin formulations (e.g., rfurina) containing a stabilized Sugar alcohol, Sugar and / or a non-ionic surfactant. Provide methods to dilute Furin compositions (e.g. Rfurina).Reivindicaci u00f3n 1: an aqueous composition stabilized recombinant Furin (rfurina), where the composition comprises: (a) between 8000 U / ml and 500.000 U / ml rfurina; (b) between 100 mm and 300 mm of a pharmaceutically acceptable salt; (c) between 0.5 mm and 2 mm Calcium; (d) between 2% and 20% of Sugar and sugar alcohol; (e) between 10 and 200 ppm of nonionic Surfactant; (f) between 10 and 200 mm of buffering agent; and (g) at a pH between 5.5 and 7.5.Claim 12: According to the composition of any of claims 1 to 11, in which the sugar or Sugar alcohol is selected from the group consisting of sucrose, Trehalose, mannitol, and a combination thereof. Claim 18: the composition according to any one of claims 1 to 17, where the non-ionic Surfactant is Polysorbate - 80.Claim 42: an aqueous composition stabilized recombinant Furin (rfurina), where the composition comprises: (a) between 8000 U / ml and 500 U / ml rfurina; (b) Sodium Chloride 190 mm; (c) Calcium 0.92 mm; (d) 10% Trehalose; (e) 75 Polysorbate 80 ppm; 45 (f) acetic acid Mm, 46 mm HEPES (g) and (H) a pH between 5.5 and 7.5.Formulaciones de furina (por ej., rFurina) estabilizadas que contienen un azúcar, alcohol de azúcar y/o tensioactivo no-iónico. Se proveen métodos para diluir composiciones de furina (por ej. rFurina).Reivindicación 1: Una composición acuosa de furina recombinante (rFurina) estabilizada, en donde la composición comprende: (a) entre 8.000 U/mL y 500.000 U/mL de rFurina; (b) entre 100 mM y 300 mM de una sal farmacéuticamente aceptable; (c) entre 0,5 mM y 2 mM de calcio; (d) entre 2% y 20% de azúcar o alcohol de azúcar; (e) entre 10 y 200 ppm de tensioactivo no iónico; (f) entre 10 y 200 mM de agente amortiguador; y (g) a pH entre 5,5 y 7,5. Reivindicación 12: La composición de acuerdo a cualquiera de las reivindicaci