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Oral baclofen solutions
专利权人:
Metacel Pharmaceuticals; LLC
发明人:
Thomas Jeffrey Bryant,H. Greg Thomas
申请号:
US16556893
公开号:
US10610502B1
申请日:
2019.08.30
申请国别(地区):
US
年份:
2020
代理人:
摘要:
The present disclosure relates to aqueous oral solutions comprising baclofen. In one embodiment, the aqueous oral solutions comprise a buffer comprising citric acid, a salt of citric acid, or any combination thereof, and are stored at from about 2° C. to about 8° C. The present disclosure also relates to buffer free aqueous oral solutions comprising baclofen. Additionally, the present disclosure relates to an assay for determining the amount of an impurity, 4-(3-carboxymethyl)-3-hydroxy-2,5-dioxopyrrolidin-1-yl)-3-(4-chlorophenyl)butanoic acid, in a baclofen containing solution, and to methods of treatment using such aqueous oral solutions.
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