Facemasks and aerosol delivery in vivo.

It has been shown in vitro that even a small air leak in the facemask can drastically reduce the efficiency of drug delivery. In addition, it has been shown that drug deposition on the face does significantly add to overall drug loss and has the potential of local side effects. The aim of this study is therefore to verify these findings in vivo. Eight asymptomatic recurrently wheezy children, aged 18-36 months, inhaled a radiolabeled salbutamol formulation either from a pressurized metered-dose inhaler through a spacer with attached facemask or from a nebulizer with attached facemask. Drug deposition of radiolabeled salbutamol was assessed with a gamma camera and expressed as a percentage of the total dose. Lung deposition expressed as a percentage of the total dose (metered dose and nebulizer fill, respectively) was 0.2% and 0.3% in children who inhaled with a non-tightly fitted facemask. Lung deposition was 0.6% and 1.4% in screaming children with a tightly fitted facemask and between 4.8% and 8.2% in patients breathing normally. Overall mask deposition was between 0.8% and 5.2%. Overall face deposition was between 2.6% and 8.4%. The results from this pilot study support the results found in in vitro studies, where a facemask leak greatly reduces drug delivery to the patient.