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
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®.