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Clinical trial shows consistent nebulization times for Revefenacin in Nebulizers, indicating safety and efficacy.
Background: Our facility has found that not all medications are suitable for delivery via vibrating mesh nebulizer (VMN). Clinical experience showed residual buildup of Amphotericin B on the VMN aperture resulting in little or no delivery of the medication. Our goal was to evaluate the nebulization of a new formulary medication, Revefenacin, with the VMN. Methods: Over a 7-day period, the same Aerogen Pro-X Mesh control module was used with 5 nebulizers, from the same lot, to deliver the medications. The medications used were NACL 0.9% BID, Budesonide .5mg BID, Arformoterol Tartrate 15 µg BID, and Revefenacin 175 µg QDAY. Medication delivery time and frequency were chosen to simulate clinical parameters. A visual inspection of the nebulizer was performed at the beginning and end of each trial. Duration of total nebulization time was measured via a stopwatch and the fluid temperature was taken within the nebulizer every minute. Results: The pre-visual inspection of the aperture for each of the nebulizers was clear throughout the study. The post-visual inspection noted foam present in the two nebulizers administering Budesonide, but no buildup on the aperture. The nebulization times for Revefenacin alone remained constant throughout the process with a mean delivery time of 7.28 min. The nebulization times of Revefenacin with other medications also remained constant throughout the study. The findings show that the temperature stayed within acceptable ranges according to the manufacturers’ package inserts. Conclusions: Visual inspection, temperature, and time were adequate throughout the study. Therefore, we believe Revefenacin can be adequately delivered through the vibrating mesh nebulizer.Table 1.VMN #Medication(s)Volume (mls)Min Delivery (min)Max Delivery (min)Mean (min)Stdev1NaCl (control)39.0912.3111.221.072Revefenacin36.798.747.28.673Revefenacin/Budesonide58.3010.548.96.764Revefenacin/Arformoterol55.269.058.081.305Revefenacin/Budesonide/Arformoterol719.1123.4120.231.45
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Walker et al. (2023) studied this question.
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