The influence of formulation and spacer device on the in vitro performance of solution chlorofluorocarbon-free propellant-driven metered dose inhalers |
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Authors: | Hugh D C Smyth Vance P Beck Dennis Williams Anthony J Hickey |
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Institution: | (1) School of Pharmacy & Chemistry, Liverpool John Moores University, Byrom Street, Liverpool, L3 3AF, UK;(2) School of Engineering, Liverpool John Moores University, Byrom Street, Liverpool, L3 3AF, UK;(3) Department of Child Health and Institute of Lung Health, University of Leicester, Leicester, LE2 7LX, UK |
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Abstract: | The purpose of this study was to evaluate the hypothesis that spacer devices have limited effect on the in vitro fine particle
dose emitted from solution metered dose inhalers containing different proportions of HFA134a 1,1,1,2-tetrafluoroethane] propellant.
Two solution formulations (80% and 97.5% wt/wt HFA134a) were tested across the actuator alone, actuator plus Aerochamber,
and Ace holding chamber. Particle size distributions were determined using laser diffraction (LD) and cascade impaction (CI).
Multimodal particle size distributions were identified using LD. CI analyses were characterized by a major mode located at
≈0.5 μm. The fine particle dose emitted from the inhaler spacer combinations containing 97.5% HFA134a was independent of the
device setup used. Fine particle doses were influenced by spacer setup in 80% HFA134a formulations, indicating different plume
dynamics of low vapor pressure formulations. Sampling inlet deposition was approximately O when spacer devices were used with
either formulation. When spacers were not used, sampling inlet deposition was increased significantly. However, inlet deposition
with the 97.5% HFA134a formulation was significantly less than that of the 80% HFA134a formulation (≈25% of emitted dose compared
with 69% respectively). Thus, high propellant concentration formulations appear to have more robust in vitro performance.
This is particularly important given the preponderance of poor patient compliance that is associated with spacer use. High
propellant concentrations had the advantage of fine particle doses that were independent of the device setup and significantly
lowered sampling inlet deposition when no spacer was used. |
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