Pulmonary delivery of bronchodilators remains challenging due to dose variability and suboptimal deposition with conventional inhalers and nebulizers. Thermal aerosolization via vaping devices has emerged as a promising alternative for controlled and reproducible delivery of active pharmaceutical ingredients (APIs). This study evaluates a CE-marked medical-grade vaping device (BIKY Breathe) for pulmonary delivery of salbutamol sulfate and terbutaline sulfate, assessing aerosol performance, particle size, and transfer efficiency, with comparison to a standard pneumatic nebulizer (Cirrus™2). Aerosols were generated under standardized puffing conditions and analyzed using a Glass Twin Impinger (GTI) and a Next Generation Impactor (NGI). Four API concentrations were tested to determine respirable dose, mass median aerodynamic diameter (MMAD), and emitted-dose reproducibility. The Cirrus™2 nebulizer served as reference. The tested device produced aerosols with MMADs of 1.10 ± 0.10 µm (terbutaline) and 1.13 ± 0.14 µm (salbutamol) indicating suitability for deep-lung deposition. Average aerosol mass per puff was ∼ 6 mg for both APIs with low inter-puff variability. Terbutaline achieved a maximum transfer efficiency of ∼ 40% at 1.35-1.80 mg/mL, whereas salbutamol did not exceed 10%, likely due to physicochemical constraints. Compared with the Cirrus™2 nebulizer, the vaping device generated more efficient micron aerosols and provided higher reproducibility of respirable doses. Overall, the CE-marked device demonstrates robust and reproducible aerosolization of bronchodilators, with particle size appropriate for deep-lung delivery. Terbutaline shows strong translational potential, while salbutamol would benefit from further formulation optimization. These in vitro results support the use of medical-grade vaping devices as promising platforms for pulmonary delivery of conventional and novel APIs.
Keywords: Aerosol therapy; Bronchodilatators; Particle size distribution; Respirable dose; Vaping device.
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