Aerosol Output Performance of the Micro Device at High and Low Temperatures

J. Parker, L.E.A. Hardaker, R.H.M. Hatley

The Micro device is being developed for the delivery of aerosolized drugs. We tested 3 Micro devices at 5°C and 30°C to evaluate the impact of temperature on the performance of the Micro device. The devices were placed in a 5°C refrigerator for over 2 hours before being weighed, filled with 300 μL of 5 mg/2.5 mL salbutamol sulphate solution equilibrated to 5°C, and reweighed. The Micro device was connected to a Malvern Spraytec laser diffraction system via a custom connector and was operated until completion of treatment. Aerosolization time was recorded and the device was reweighed before being placed in a 30°C incubator for at least 2 hours, and the test was then repeated. This protocol was repeated for each of the 3 devices. The delivered dose and volume median diameter particle size results were consistent across the 3 Micro devices tested and with the 2 different temperatures. Output rate was lower at 5°C; however, as the delivered dose was unchanged, this only resulted in an increased aerosol delivery time (from 29 seconds at 30°C, to 39 seconds at 5°C). Overall, the results indicate that the Micro device performance was consistent in the key parameters of aerosol output at temperatures of 5°C and 30°C, which are outside the typical operating range of the Micro device.

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