Effect of a Facemask Leak on Aerosol Delivery from a pMDI-Spacer System

Abstract

The objective of this investigation was to study the relation between size and position of a mask leak on spacer output and lung dose. An upper-airway model (SAINT model, Erasmus MC) was connected to a breathing simulator. Facemasks with leaks ranging between 0 and 1.5 cm(2) were examined. Leaks were located close to the nose or close to the chin. During simulated breathing, 200 microg budesonide (Pulmicort, AstraZeneca) was delivered to the model via NebuChamber (AstraZeneca) with facemask. Spacer output and lung dose were measured by placing a filter between spacer and facemask or between model and breathing simulator, respectively. Budesonide trapped on the filter was quantified by means of HPLC, and expressed as percentage of the nominal dose. Mean spacer output doses for the nose position were 50, 38, 28, 12, 10, 6, and 0%, and for the chin position were 50, 40, 31, 11, 9, 4, and 0% for leaks of 0, 0.05, 0.1, 0.16, 0.2, 0.3, and larger than 0.4 cm(2), respectively. Mean lung doses for the nose position were 10, 8, 6, 3, 3, 1, 0, 0, 0, and 0%, and for the chin position were 10, 9, 8, 6, 6, 5, 1, 1, 0, and 0% for leaks of 0, 0.05, 0.1, 0.16, 0.2, 0.3, 0.4, 0.5, 1, and 1.5 cm(2). Efficiency of a pMDI-spacer facemask strongly depends on the size of a facemask leak. Spacer output did not depend on the position of the leak. Lung dose was higher for leaks near the chin than for leaks near the nose.

In Vitro Evaluation of Aerosols Delivered via the Nasal Route

“…Crying and lack of proper mask seal are known to decrease intrapulmonary deposition. 17,18,20 An in vivo study by Esposito-Festen et al 21 demonstrated lack of acceptability and efficiency of aerosol delivery during sleep in a group of toddlers. This study highlighted the importance of interface acceptance to achieve good drug delivery.…”

Inhaled antibiotics: dry or wet?

“…The patient inhales the aerosol while tidal breathing from a reservoir through a mouthpiece or face mask. For children, a good face mask design is important to maximise efficiency [39,40]. A child old enough to inhale through a mouthpiece should do so, as the efficiency of aerosol delivery can be doubled relative to inhalation by face mask [41].…”

The Science Guiding Selection of an Aerosol Delivery Device

“…Even small leaks of 0.5 cm around the face mask decrease drug inhaled by children and infants by more than 50%. [30][31][32][33][34] Delivery of aerosolized medications in a blow-by fashion is commonly used for crying babies or uncooperative children, where the nebulization port of a nebulizer is directed toward the patient's face. Studies have documented blow-by medication administration is less efficient, compared with a face mask, as aerosol drug deposition decreases significantly with distance, and this use should be discouraged.…”

“…Studies have documented blow-by medication administration is less efficient, compared with a face mask, as aerosol drug deposition decreases significantly with distance, and this use should be discouraged. 30,[34][35][36] In summary, while the domain of SVNs can be highly variable, based on the nuances and characteristics described previously, the entire category has some common advantages and disadvantages, which are listed in Table 6.…”