Influence of Respiratory Spacer Devices on Aerodynamic Particle Size Distribution and Fine Particle Mass of Beclomethasone from Metered-Dose Inhalers

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Abstract
Respiratory spacer devices are used mainly with pressurized metered dose inhalers, especially those containing corticosteroids, to assist with patient coordination and reduce oropharyngeal side effects. This investigation examines the influence of different spacer devices on the delivered fine particle mass (aerodynamic diameter of μm and μm) of the corticosteroid beclomethasone dipropionate, which approximates the respirable dose. The Anderson Mark II Cascade Impactor was used to characterise the deposition of single doses of beclomethasone dipropionate from several metered-dose inhalers. Following actuation of one single dose the amount of beclomethasone dipropionate deposited on each stage of the impactor was quantified using reverse phase high-performance liquid chromatography and ultraviolet detection. The fine particle mass smaller than 4.7 μm for Respocort® delivered by the Sanner® and Fisonair® spacer devices was 77.7% and 41.3% higher (p < 0.04), respectively, than the metered-dose inhaler alone, while the Breathatech® spacer delivered 21.4% lower (p < 0.01). The fine particle mass of Becotide® delivered by the Sanner®, Fisonair®, Nebuhaler®, and Volumatic® spacer devices were 81%, 42.4%, 46.9%, and 32.8% higher (p < 0.008), respectively, than be metered dose inhaler alone. The fine particle mass for Becloforte® delivered by the Sanner®, Fisonair®, and Volumatic® spacer devices was 82.8%, 36.9%, and 48.0% higher (p < 0.009) than that delivered by metered dose inhaler alone. This study suggests that there are significant differences in the fine particle mass of beclomethasone dipropionate delivered by respiratory spacer devices when used in conjunction with commercially available metered dose inhalers of this drug.