Comparative In Vitro Performance of Valved and Valve-less, Durable and Disposable Spacers

Mark Sanders, Ronald Bruin

Valved holding chamber (VHC)/spacer devices help mitigate poor pressurised metered dose inhaler (pMDI) technique. We have developed a simple, valve-less, fully-recyclable spacer, comprising a paper body and interchangeable plastic end-fittings (DispozABLE Spacer), and wished to compare its performance with commercially available spacers. This new spacer has been compared with rigid plastic re-useable devices (OptiChamber Diamond VHC and valve-less Nessi Spacer), and the collapsible, cardboard disposable VHC, Lite-Aire using in vitro Andersen Cascade Impactor salbutamol sulphate pMDI (Ventolin and ProAir) aerosol performance data. Research has focussed on the 12 L/min flow rate relevant to paediatric and emergency use situations. Initial experiments at 28 L/min, however, established that the DispozABLE Spacer delivered salbutamol reproducibly, was comparable to pMDIs alone, and the plastic-bodied VHC and valve-less spacer. At 12 L/min, DispozABLE and Nessi (the two valve-less Spacers) were not significantly different. DispozABLE Spacer was superior to both plastic and cardboard VHCs (OptiChamber and Lite-Aire) suggesting that, at paediatric flow rates, valve-less spacers perform better than VHCs, and that body-component material is not a main influence. The general performance of spacers and VHCs conducted in vitro at conditions that do not reflect the low flow rate of young children or the tidal breathing pattern are not likely to be predictive of clinical efficacy. Young children are likely to use VHCs with a low flow, multiple tidal breathing technique rather than a single inhalation, leading to poor drug delivery, and with poor face-mask seal additionally affecting the inspiratory manoeuvre. The current research, comparing delivery at paediatric-representative flow rates, suggests that valve-less spacers perform better than VHCs.

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