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Bioequivalent composition of itraconazole dispersed in a hydrophilic polymer
专利权人:
发明人:
申请号:
EP03290092.0
公开号:
EP1438961B2
申请日:
2003.01.14
申请国别(地区):
EP
年份:
2014
代理人:
摘要:
The invention provides an itraconazole composition comprising itraconazole dispersed in a hydrophilic polymer, and, optionally, a surfactant, having a dissolution at 30 minutes between 10 and 40%, at 45 minutes between 25 and 80%, at 60 minutes between 60 and 95%, at 90 minutes at least 80%, as measured using the type II paddle method at 100 rpm according to the US Pharmacopoeia, in a dissolution medium comprised of 1000 ml HCl 0.1N.The invention also provides a process for manufacturing this composition.
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