ХАССЛАХЕР Майнхард (AT),ЦИТКОВИЧ Анджей (US),УАЙТ Кэтрин (US),ФРАНКЕ Кен (US)
申请号：
RU2013157927/15
公开号：
RU2013157927A
申请日:
2012.06.04
申请国别(地区):
RU
年份:
2015
代理人:
摘要：
1. A stabilized aqueous recombinant furin (rfurin) composition, wherein the composition contains: (a) from 8,000 U / ml to 500,000 U / ml rfurin； (b) from 100 mmol to 300 mmol of a pharmaceutically acceptable salt； (c) from 0.5 mmol to 2 mmol of calcium； (d) 2% to 20% sugar or sugar alcohol； (e) 10 to 200 ppm non-ionic surfactant； (f) 10 to 200 mmol buffer substance； and (g) pH 5.5 to 7.5.2. A composition according to claim 1, containing from 150 mmol to 250 mmol of a pharmaceutically acceptable salt. A composition according to claim 2, containing 190 ± 10 mmol of a pharmaceutically acceptable salt. A composition according to claim 3, comprising 190 mmol of a pharmaceutically acceptable salt. A composition according to claim 1, wherein the pharmaceutically acceptable salt is sodium chloride. The composition of claim 1, wherein the pharmaceutically acceptable salt is potassium chloride. A composition according to claim 1, containing 0.9 ± 0.2 mmol of calcium. A composition according to claim 7, containing 0.92 mmol of calcium. A composition according to claim 1, containing from 5% to 15% sugar or sugar alcohol. A composition according to claim 9, containing 10 ± 2% sugar or sugar alcohol. 11. A composition according to claim 10, containing 10% sugar or sugar alcohol. The composition of claim 1, wherein the sugar or sugar alcohol is selected from the group consisting of sucrose, trehalose, mannitol, and a combination thereof. The composition of claim 1, wherein the sugar or sugar alcohol is trehalose. The composition of claim 1, wherein the sugar or sugar alcohol is sucrose. A composition according to claim 1, containing from 10 ppm to 100 ppm of a nonionic surfactant. A composition according to claim 15, containing from 50 ppm to 100 ppm of a nonionic surfactant. A composition according to claim 16, containing 75 ppm non-ionic over1. Стабилизированная водная композиция рекомбинантного фурина (рфурина), где композиция содержит:(a) от 8,000 Ед/мл до 500,000 Ед/мл рфури
