How critical quality attributes and process variables drive the in-vitro performance of pMDIs: new technologies & methods
Poster presented at Inhalation Asia Conference 2015.
INTRODUCTION: Few published sources exist to help guide pMDI formulation and device development that incorporate an understanding of the complex relationships driving product performance. Current analytical methods are complicated and labor intensive, and provide little insight into commonly occurring defects in pMDIs or their performance during development and release testing. The three new measurement technologies and analysis techniques described in this poster rapidly promote a knowledge-driven understanding of the complex relationships between the critical quality attributes and process variables that drive pMDI in vitro performance This paper will examine the following:
1. The importance of shaking;
2. The connection between DCU and spray pattern using predictive models; and
3. New technology for rapidly screening for actuator mold defects to aid in APSD testing.