Influence of particle size, air flow, and inhaler device on the dispersion of mannitol powders as aerosols

Purpose. To study the effect of particle size, air now and inhaler type on the dispersion of spray dried mannitol powders into aerosols. Methods. Mannitol powders were prepared by spray drying. The solid state properties of the powders were determined by laser diffraction, X-ray powder diffraction, scanning electron microscopy, freeze fracture, Karl Fischer titration and gas pycnometry. The powders were dispersed using Rotahale(R) and Dinkihaler(R), connected to a multistage liquid impinger at different air flows. Results. Three crystalline mannitol powders with primary particle size (MMD) 2.7, 5.0, 7.3 mu m and a similar polydispersity were obtained. The particles were spherical with a density of 1.5 g/cm(3) and a moisture content of 0.4 wt.%. At an air flow of 30 L/min all the powders were poorly dispersed by both inhalers. With the Rotahaler(R) increasing the flow (60-120 L/min) increased the fine particle fraction (FPF) in the aerosols for the 2.7 mu m powder, and decreased the FPF for the 7.3 mu m powder; whereas the FPF for 5.0 mu m powder was unaffected. With the Dinkihaler(R), all the powders were near complete dispersion at greater than or equal to 60 L/min. Conclusions. The FPF in the mannitol powder aerosols was determined by an interplay of the particle size, air flow and inhaler design.