Consistency of dosing with a thermal aerosol generation system: in vitro and in vivo correlation

Dosing consistency and reproducibility are presented for a novel pharmaceutical inhaler technology based on a thermal condensation process. Two different device platforms producing thermally generated aerosols have been created and used in clinical studies with a number of different drug compounds. Because this approach does not rely on energy from the user to disperse the aerosol particles, aerosol production is reliable, reproducible and virtually user independent following actuation. Pharmacokinetic data from multiple clinical studies show rapid absorption, dose proportionality, and concentration levels and variability similar to intravenous injection. In addition, products used in clinical trials show excellent subject consistency with the vast majority of devices delivering greater than 90% of the loaded dose and little drug exhaled.