Iloprost inhalation solution has been available in the US since 2005 as a 10 µg/mL solution for the treatment of pulmonary Rationale: arterial hypertension (WHO group I, New York Heart Association Functional Class III or IV symptoms). Currently, inhaled iloprost 10 µg/mL solution is administered 6 to 9 times a day with at least 2 hours between doses. Documented here, a more concentrated formulation of 20 µg/mL was recently approved by the FDA and has undergone evaluation, which could reduce treatment times by ~50% due to the in vitro lower inhaled volume needed to achieve a 5 µg dose.Using methodologies mimicking patient breathing, the aerosols emitted by the nebulizer (I-neb AAD System, Methods:in vitro Respironics Respiratory Drug Delivery, Philips Home Healthcare Solutions, Parsippany, NJ) with the 10 and 20 µg/mL iloprost solutions were captured on filters (n=18). The methods used were identical to those previously reported and served to bridge to the output of the predicate device, Halolite. The amount of iloprost on the filters was quantified with iloprost-specific HPLC methodology. Aerosol droplet sizes and distributions for both solutions were obtained with an Andersen Cascade Impactor at 28.3 L/min flow rate and a simulated breathing pattern. Iloprost was extracted from impactor stages and quantified by HPLC.The mean ± SD emitted doses of iloprost were 4.54 ± 0.3 µg for the 10 µg/mL solution and 4.97 ± 0.2 µg for the 20 µg/mL Results: solution. The nebulization times were 601 seconds for the 10 µg/mL solution and 229 seconds for the 20 µg/mL solution. The Mass in vitro Median Aerodynamic Diameters ± GSD of the iloprost inhalation solution droplets were 1.7 µm ± 1.5 for the 10 µg/mL solution and 1.9 µm ± 1.7 for the 20 µg/mL solution. The Fine Particle Fractions (percent of aerosol droplets <4.7 µm) were 95% and 90%, respectively.The results indicate that the emitted doses and aerosol droplet characteristics were similar for iloprost 10 µg/mL Conclusions:in vitro solution and 20 µg/mL solution and should result in similar lung depositions. The perceived clinical benefits may include a reduction in time spent on the inhalation of iloprost and, as a consequence, possibly higher adherence to treatment. This abstract is funded by: Actelion Am J Respir Crit Care Med
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