Francesco G. Salituro,Albert Jean Robichaud,Paul Steven Watson,William Hunke
申请号：
US16423976
公开号：
US20190350944A1
申请日:
2019.05.28
申请国别(地区):
US
年份:
2019
代理人:
摘要：
Provided herein are pharmaceutically acceptable aqueous solution comprising a neuroactive steroid, a sulfobutyl ether beta cyclodextrin and a buffer； wherein: the solution is a stable solution between a pH of about 3 and about 9, e.g., at room temperature, for at least 1, 2, 3, 4 weeks； 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 months； 1, 2, 3 years or more； the buffer is present at a concentration of at least 0.1 mM； or the solution remains substantially free of impurities (e.g., the solution is substantially free of impurities at room temperature for at least 1, 2, 3, 4 weeks； 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 months； 1, 2, 3 years or more).
