Performance of amikacin inhale: impact of supplemental oxygen and device orientation

Amikacin Inhale is an integrated drug-device combination in development by Bayer HealthCare through a collaboration with Nektar Therapeutics, to improve clinical outcome in intubated and mechanically ventilated patients with Gram-negative pneumonia. It is available in two configurations: on-vent for intubated patients and hand-held for extubated patients to complete aerosolized antibiotic therapy. Amikacin Inhale is a smart system that consists of the pulmonary drug delivery system with a vibrating mesh nebulizer and the specially formulated Amikacin Inhalation Solution (400 mg every 12 hours for 10 days). The objectives of this study were to evaluate the performance of the Amikacin Inhale hand-held configuration with supplemental O2 concentration supplied at different flow rates and in different orientations. We hypothesize that the delivered dose of amikacin will not significantly change with increased O2 flow rate or varying orientation.