Amikacin Inhale Shows Promising Results in Phas...(cin Lung Deposition Correlates with in v...),Health

This study describes the in-vitro and in-vivo characterization of a handheld version of Amikacin Inhale, intended for use in extubated patients. In-vitro, amikacin 400 mg was aerosolized continuously, and emitted mass captured on absolute filters distal to the mouthpiece during simulated adult tidal breathing. Emitted mass was 87 percent of the 400 mg amikacin nominal dose, with a predicted lung dose of 45-50 percent. In-vivo, Amikacin Inhale (400 mg amikacin) labeled with 99mTc was administered to healthy subjects using the hand-held version. In these, mean amikacin lung dose determined via scintigraphy was 172.2 mg, 43 percent of the nominal dose. These results show that the hand-held drug-device combination delivered a large fraction of the starting dose, confirming the high delivery efficiency predicted by in-vitro aerosol characterization. The study also confirmed that the in-vitro model is predictive of the in-vivo experience. Lung doses in the range of those observed are expected to achieve bacteriological eradiation.

Copies of abstracts are available and can be viewed online at the ATS website: http://www.abstracts2view.com/ats08/

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Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals unit of Bayer HealthCare LLC, a division of Bayer AG. One of the world's leading, innovative companies in the healthcare and medical products industry, Bayer HealthCare combines the global activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. In the U.S., Bayer HealthCare Pharmaceuticals comprises the following business units: Diagnostic Imaging, General Medicine, Specialty Medicine and Women's Healthcare. The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing an
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