Abstract

Rationale: The SMI platform is used to deliver inhaled medications to treat different disease conditions and patient populations. VHCs are also used to treat the same patient populations and questions have arisen regarding the applicability of the SMI+VHC particularly in pediatric and geriatric patients. This laboratory investigation was undertaken to assist practitioners with information regarding potential drug delivery from the SMI+VHC. Methods: AeroChamber Plus® Flow-Vu® Anti-Static VHCs (AC+FV, Trudell Medical International, London, Canada) were evaluated with Spiriva®, Inspiolto® and Combivent® Respimat® SMI formulations. Measurements of fine particle mass (FPM, 0.54-3.99 µm aerodynamic diameter) were made by means of a chilled Next Generation Pharmaceutical impactor (NGI) equipped with USP inlet operated at 30 L/min. Assay for APIs recovered from components of the apparatus was undertaken by HPLC. Results: The measures of FPM (µg/actuation; mean ± SD) are summarized in the Table.1. Conclusions: The small differences in FPM between the SMI and SMI+ VHC were within the typical magnitude of method variability. Healthcare providers can have assurance that the use of the SMI with AC+FV VHC should deliver a similar FPM of API compared to the SMI alone. C

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