Development and Evaluation of a Time-Sensitive Nebulization Mode Converter for Optimized Aerosol Drug Delivery

Nebulization is essential for aerosol drug delivery in respiratory diseases. However, conventional jet nebulizers operate continuously, leading to significant wastage and inefficient drug delivery. This study evaluates a novel nebulization mode converter that synchronizes aerosol generation with inhalation to optimize drug delivery and minimize wastage. A combination of in-vitro and ex-vivo models was used for evaluation. The in-vitro study employed a breathing simulator with a controlled respiratory pattern to assess aerosol deposition in an inhalation filter, residual drug volume in the nebulizer chamber, and aerosol loss within the delivery system. The ex-vivo study involved healthy human volunteers inhaling aerosolized salbutamol sulfate, while an inhalation filter was used to collect the drug reaching the respiratory tract. The drug retained in the nebulizer and delivery tubing was also quantified. High-performance liquid chromatography was used to analyze drug concentrations. The nebulization mode converter significantly increased inhaled drug compared to conventional continuous nebulization (MD = 2734.7 µg, p < 0.001). Drug loss due to exhalation was reduced, and there was no significant increase in residual drug retention in the nebulizer chamber or tubing. In the ex-vivo study, volunteers receiving intermittent nebulization showed higher inhaled drug amounts than those using continuous nebulization, supporting in-vitro findings. The reduction in exhaled aerosol also suggests lower secondary exposure risks for healthcare providers. The nebulization mode converter improves drug delivery by synchronizing aerosol release with inhalation, reducing medication waste, and enhancing inhaled amount of drug. It is cost-effective and compatible with standard nebulizers, offering strong clinical potential.