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METHODS AND COMPOSITIONS FOR DELIVERY TO THE CNS IDURONATE-2-SULFATASE
专利权人:
ИНК. (US);ШИР ХЬЮМАН ДЖЕНЕТИК ТЕРАПИС
发明人:
ЧЖУ Гаочжун (US),ЛОУЭ Крис (US),ШАХРОКХ Захра (US),КРИСТИАН Джеймс (US),ФАРНЕР Рик (US),ПАН Цзинь (US),РАЙТ Тереса Леах (US),КАЛИАС Периклс (US)
申请号:
RU2012154575/15
公开号:
RU2012154575A
申请日:
2011.06.25
申请国别(地区):
RU
年份:
2014
代理人:
摘要:
1. A stable composition for intrathecal administration containing iduronate-2-sulfatase (I2S) protein, salt and a polysorbate surfactant. 2. A stable composition according to claim 1, characterized in that the I2S protein is present in a concentration from the range of about 1-300 mg / ml. A stable composition according to claim 1, characterized in that the I2S protein is present in a concentration selected from 2 mg / ml, 10 mg / ml, 30 mg / ml, 50 mg / ml or 100 mg / ml. The stable composition according to claim 1, characterized in that the I2S protein contains the amino acid sequence of SEQ ID NO: 1.5. A stable composition according to any one of claims 1 to 4, characterized in that the salt is NaCl. 6. A stable composition according to claim 5, characterized in that NaCl is present in a concentration from a range of about 0-300 mM. A stable composition according to claim 4, characterized in that NaCl is present in a concentration from the range of about 137-154 mm. A stable composition according to claim 7, characterized in that NaCl is present at a concentration of about 154 mm. A stable composition according to any one of claims 1 to 4, characterized in that the polysorbate surfactant is selected from the group consisting of polysorbate 20, polysorbate 40, polysorbate 60, polysorbate 80, and combinations thereof. The stable composition according to claim 9, characterized in that the polysorbate surfactant is polysorbate 20.11. A stable composition according to claim 10, characterized in that polysorbate 20 is present in a concentration from a range of about 0-0.02%. A stable composition according to claim 11, characterized in that polysorbate 20 is present at a concentration of about 0.005%. A stable composition according to any one of claims 1 to 4, characterized in that it further comprises a buffering agent. Stable composition according to item 13, wherein the buffering agent1. Стабильный состав для интратекального введения, содержащий белок идуронат-2-суль
来源网站:
中国工程科技知识中心
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