Developing clinically relevant methodology for existing pMDI aerosol products when coupled to the Intelligent Control Inhaler

Developing clinically relevant methodology for existing pMDI aerosol products when coupled to the Intelligent Control Inhaler  

Russell Down¹, Hayden Beresford¹, Chris Blatchford¹, Andy Cooper¹ & Stewart Griffiths¹

¹3M Drug Delivery Systems Ltd, Charnwood Campus, 10 Bakewell Road, Loughborough, Leicestershire LE11 5RB

Summary

The Intelligent Control Inhaler (ICI) is a next generation breath actuated pressurised metered dose inhaler (pMDI) device. A rapid screening method has been developed to compare the ICI to the commercial press and breathe (P&B) actuator devices for Dulera® and QVAR® aerosols. The methodology is designed to be clinically relevant, including accelerated impactor measurements (AIM), an anatomical throat and breath inhalation profile, in order to gain understanding of the in vitro-in vivo relationship (IVIVR).

For Dulera®, no statistical differences were determined for FPM and MMAD between the ICI and P&B devices. For QVAR®, no statistical differences were determined for MMAD; however, there was a statistically significant difference in FPM. There was also a statistically significant lower throat deposition using the ICI, in comparison to the P&B device, for both Dulera® and QVAR®. It is not clear how these differences would impact clinical equivalence.

The analysis shows that further method development is required to potentially allow a prediction of clinical equivalence between ICI and commercial P&B actuator devices for Dulera® and QVAR®.