LECLAIR, GREGOIRE,FRICIU, MARIA MIHAELA,MELKOUMOV, ALEXANDRE,DEBNATH, SMITA
申请号：
CA2946982
公开号：
CA2946982A1
申请日:
2016.10.31
申请国别(地区):
CA
年份:
2018
代理人:
摘要：
The present invention relates to a pharmaceutical formulation comprisingNystatinnanosuspension and process of manufacturing using High Pressure Homogenization(HPH).The nystatin nanosuspension comprising: a) an active pharmaceutical ingredienthaving lowsolubility that is nystatin b) at least one non-ionic or polymericstabilizer c) at least onesurfactant stabilizer and d) at least one other pharmaceutically acceptableexcipient, whereinsaid process comprises the following main steps:1) premix of the API with the stabilizers in water2) homogenization of Nanosuspension Intermediates (NSI) and addition of allotherconstituents3) addition of Water Solution Intermediate (WSI) and Ethanol SolutionIntermediate(ESI).The provided nystatin nanosuspension has a higher efficacy in the treatment offungalinfection.
