caa a22 4500 477127118 CHVBK 20180405111653.0 cr unu---uuuuu 170330e19971001xx s 000 0 eng 10.1023/A:1012180924063 doi (NATIONALLICENCE)springer-10.1023/A:1012180924063 Effect of Drug Load and Plate Coating on the Particle Size Distribution of a Commercial Albuterol Metered Dose Inhaler (MDI) Determined Using the Andersen and Marple-Miller Cascade Impactors [Elektronische Daten] [Moheb Nasr, Danna Ross, Nicholas Miller] Purpose. The purpose of this study is to investigate the effect of drug load, the coating of impactor stages, and the design of cascade impactors on albuterol MDIs particle size distribution measurements. The results of the investigation will be used to explain the 'loading effect' recently reported. Methods. Particle size distribution parameters of a commercial albuterol MDI were measured using both Andersen (AI) and Marple-Miller (MMI) Cascade Impactors, where plates were either left uncoated or coated with silicone or glycerin. A previously validated HPLC-EC method was used for the assay of albuterol collected by the impactor and in single spray content determinations. Results. Coating impactor collection plates had an impact on measured MM AD and GSD values for single puff measurements but very little or no effect for the multi puff measurements. Due to particle bounce, the percent of albuterol fine particles deposited in the filter and impactor finer stages (<1.10 μm in AI and <1.25 μm in MMI) in uncoated single puff experiments was much higher in comparison to either coated single puff or multi-puff (coated and uncoated) measurements. Conclusions. Evaluation of drug load and plate coating are necessary to determine whether observed particle size distributions are representative of the generated aerosol or are the result of particle bounce and reentrainment. In order to minimize particle bounce, especially for single puff determinations, it may be useful to apply a thin layer of a sticky coating agent to the surfaces of impactor plates. Plenum Publishing Corporation, 1997 albuterol nationallicence MDI nationallicence particle size nationallicence cascade impactors nationallicence loading effect nationallicence particle bounce nationallicence Nasr Moheb Division of Testing and Applied Analytical Development (DTAAD), US Food and Drug Administration, CDER, 63101, St. Louis, Missouri aut Ross Danna Inhalation Drug Delivery, 3M Pharmaceuticals, St. Paul, Minnesota aut Miller Nicholas Nephele Enterprises, White Bear Lake, Minnesota aut Pharmaceutical Research Kluwer Academic Publishers-Plenum Publishers 14/10(1997-10-01), 1437-1443 0724-8741 14:10<1437 1997 14 11095 https://doi.org/10.1023/A:1012180924063 text/html Onlinezugriff via DOI 1 research-article jats NATIONALLICENCE 856 40 https://doi.org/10.1023/A:1012180924063 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Nasr Moheb Division of Testing and Applied Analytical Development (DTAAD), US Food and Drug Administration, CDER, 63101, St. Louis, Missouri aut NATIONALLICENCE 700 1- Ross Danna Inhalation Drug Delivery, 3M Pharmaceuticals, St. Paul, Minnesota aut NATIONALLICENCE 700 1- Miller Nicholas Nephele Enterprises, White Bear Lake, Minnesota aut NATIONALLICENCE 773 0- Pharmaceutical Research Kluwer Academic Publishers-Plenum Publishers 14/10(1997-10-01), 1437-1443 0724-8741 14:10<1437 1997 14 11095 Metadata rights reserved Springer special CC-BY-NC licence nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-springer