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BIOAVAILABLE SOLID DOSAGE FORMS OF METAXALONE
专利权人:
发明人:
申请号:
HK13112155.1
公开号:
HK1184690A
申请日:
2013.10.29
申请国别(地区):
HK
年份:
2014
代理人:
摘要:
Pharmaceutical compositions comprising metaxalone which demonstrate improved dissolution and bioavailability characteristics compared to the commercially available product, and methods of producing them are provided. In a preferred embodiment, a dosage form comprising metaxalone and at least one inactive powder excipient is bioequivalent to its commercially available counterpart (Skelaxin<(R)> 400-mg tablets) after oral administration to fasting or non-fasting human subjects, while at the same time displaying faster drug dissolution rates than the Skelaxin<(R)> tablets as demonstrated from three different dissolution tests. In another preferred embodiment, a dosage form comprising metaxalone, at least one inactive powder excipient and a nonvolatile liquid is significantly more bioavailable than the commercially available Skelaxin<(R)> 400-mg tablets after oral administration to fasting human subjects.
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