Bioaequivalente Zusammensetzung in der Form einer festen Dispersion enthaltend Itraconazol und ein hydrophiles Polymer

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专利权人:

Acino Pharma AG

发明人:

Pawan Seth

申请号：

DE60312636

公开号：

DE60312636T3

申请日:

2003.01.14

申请国别(地区):

DE

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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