Experimental Evaluation of Dry Powder Inhalers during Inhalation and Exhalation Using a Model of the Human...

Area of Science:

• Pharmaceutical Sciences
• Biomedical Engineering
• Respiratory Medicine

Background:

• Dry powder inhalers (DPIs) are crucial for respiratory disease treatment.
• Understanding aerosol behavior in the respiratory tract is vital for effective drug delivery.

Purpose of the Study:

• To experimentally investigate aerosol particle diameter and concentration changes from four DPIs.
• To evaluate DPI performance under realistic inhalation and exhalation conditions using the xPULM™ model.

Main Methods:

• Utilized the xPULM™ active respiratory system model with a high-fidelity mechanical upper airway model.
• Integrated optical aerosol spectrometry for pharmaceutical aerosol evaluation.
• Simulated realistic inhalation and exhalation conditions.

Main Results:

• Significant differences observed in mean particle diameter between inhaled and exhaled aerosols (p < 0.05).
• Majority of particles deposited in the lung; particles >0.5 μm showed least deposition.
• Exhaled particle fractions ranged from 2.13% (HandiHaler®) to 10.24% (Ellipta®).
• The mechanical upper airway model filtered larger particles (>3 μm) and increased system resistance.

Conclusions:

• The xPULM™ model effectively simulates pharmaceutical aerosol-respiratory tract interactions and deposition mechanisms.
• This model offers a viable alternative to animal and human subject experiments in aerosol research.
• Findings support DPI optimization for improved respiratory drug delivery.