2007 OPEN FORUM Abstracts
IN VITRO COMPARISON OF ALBUTEROL DOSE OUTPUT FOR STANDARD MDI WITH LITEAIRE SPACER VERSUS MISTY MAX 10 NEBULIZER.
S. Dhuper1, 2, S. K. Arora3, A. Ahmed3, 2, A. Chandra3, 2, C. Chong3, 2, C. Shim4, 2, H. Cohen2, S. Foss1, S. Choksi3, 2
Background: Though there is a tremendous variability in number of MDI actuations ( 2-12) used in studies comparing beta agonist delivery via MDI/spacer and a nebulizer , literature supports the use of 6 MDI actuations . As delivery systems may influence dose output, prior to conducting a clinical efficacy comparison study, it would be prudent to determine the in vitro dose outputs using the two systems.
Objective: The purpose of this study was to perform an in-vitro B-agonist dose output comparison between 6 actuations of âMDI with âLiteAire Spacerâ versus 1 Unit dose with a âNebulizerâ.
Method: A Standard MDI/LiteAire Spacer combination and Nebulizer were tested using the Michigan Instrument Dual Test Lungs driven by a Puritan Bennett 7200 ventilator set at 14 breaths/minute, TV of 600 ml and I:E ratio of 1:4. The LiteAire was tested with 6 MDI actuations, one puff/respiratory cycle and the Nebulizer with one 3-ml vial (0.833mg/ml) Albuterol Solution. Nebulization with oxygen (8L/min) was run (sputtering time) for five minutes. Each dose deposition filter was washed with 0.05mM KCl with 1% acetic acid buffer and samples were analyzed by UV spectrophotometer, at a wavelength of 276nm Â±1nm to calculate the total dose output. The above experiment was repeated for a total of three times (N=3) for both devices.
Results: The average total dose output Â± Standard Deviation was 176 micrograms Â± 27 micrograms for 6 puffs of MDI/LiteAire Spacer versus 220 micrograms Â± 14 micrograms for Nebulizer (P value 0.067), respectively.
Conclusion: We recommend using 6 albuterol MDI actuations with LiteAire spacer, when conducting a clinical efficacy study as the in vitro dose outputs using 6 MDI actuations and a unit dose of nebulizer are comparable. We cannot comment on effective Respirable dose output equivalency as particle size distribution studies were not conducted.