供雾化器用的液体制剂(溶液型)仿制药药学研发一般考虑

Pharmaceutical considerations on the development of generic drugs of nebules inhalation solution

通过文献调研及对目前申报资料的分析,分别从处方设计、工艺开发、质量研究、包装材料/容器以及稳定性等方面阐述了供雾化器用的液体制剂(溶液型)仿制药药学研发需关注的问题。

Based on literature research and analysis of the dossiers,the aspects which should be considered for the development of generic drugs of nebules inhalation solution,such as formulation design,manufacture development,quality research,enclosure system and stability,were discussed in this article.