Pulmonary Drug Delivery System for inhalation therapy in mechanically ventilated patients.

The Pulmonary Drug Delivery System (PDDS) Clinical represents a newer generation of electronic nebulizers that employ a vibrating mesh or aperture plate to generate an aerosol. The PDDS Clinical is designed for aerosol therapy in patients receiving mechanical ventilation. The components of the device include a control module that is connected to the nebulizer/reservoir unit by a cable. The nebulizer contains Aerogen's OnQ aerosol generator. A pressure sensor monitors the pressure in the inspiratory limb of the ventilator circuit and provides feedback to the control module. Based on the feedback from the pressure sensor, aerosol generation occurs only during a specific part of the respiratory cycle. In bench models, the PDDS Clinical has high efficiency for aerosol delivery both on and off the ventilator, with a lower respiratory tract delivery of 50-70% of the nominal dose. Currently, the PDDS Clinical is being evaluated for the treatment of ventilator-associated pneumonia with aerosolized amikacin, an aminoglycoside antibiotic. Preliminary studies in patients with ventilator-associated pneumonia found that the administration of amikacin via PDDS reduced the need for concomitant intravenous antibiotics; however, more definitive clinical studies are needed. The PDDS Clinical delivers a high percentage of the nominal dose to the lower respiratory tract, and is well suited for inhalation therapy in mechanically ventilated patients.