| 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. |
