Abstract
Abstract The magnitude and effects of stage overload and particle re-entrainment in the new, Marple-Miller cascade impactor (MMI) were evaluated at 60 liter/min by sampling and determining the aerodynamic size distributions from two, excipient-free, powder inhalers (TurbohalerTM and SpinhalerTM) according to a variety of experimental protocols. Drug distributions were compared statistically, for both inhalers, following single dose experiments in the presence and absence of silicone oil impactor stage coating and between single dose and multiple dose experiments in its presence. Stage coating was found to be essential to prevent re-entrainment of drug from both inhalers. One or ≤ 25 dose sampling was shown to produce valid results provided impaction stages were coated for the 0.5 mg Bricanyl Turbohaler (44.7 ± 9.6% of emitted dose
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