Effect of AeroChamber Plus™ on the lung and systemic bioavailability of beclometasone dipropionate/formoterol pMDI

AIM To assess the effect of AeroChamber Plus (TM) on lung deposition and systemic exposure to extra-fine beclometasone dipropionate (BDP)/formoterol (100/6 mu g) pMDI (Foster (R)). The lung deposition of the components of the combination given with the pMDI was also evaluated using the charcoal block technique. METHODS Twelve healthy male volunteers received four inhalations of extra-fine BDP/formoterol (100/6 mu g) using (i) pMDI alone, (ii) pMDI and AeroChamber Plus (TM) and (iii) pMDI and charcoal ingestion. RESULTS Compared with pMDI alone, use of AeroChamber Plus T increased the peak plasma concentrations (C-max) of BDP (2822.3 +/- 1449.9 vs. 5454.9 +/- 3197.1 pg ml(-1)), its active metabolite beclometasone 17-monopropionate (17-BMP) (771.6 +/- 288.7 vs. 1138.9 +/- 495.6 pg ml(-1)) and formoterol (38.4 +/- 17.8 vs. 54.7 +/- 20.0 pg ml(-1)). For 17-BMP and formoterol, the AUC(0,30 min), indicative of lung deposition, was increased in the AeroChamber Plus (TM) group by 41% and 45%, respectively. This increase was mainly observed in subjects with inadequate inhalation technique. However, use of AeroChamber Plus (TM) did not increase the total systemic exposure to 17-BMP and formoterol. Results after ingestion of charcoal confirmed that AUC(0,30 min) can be taken as an index of lung bioavailability and that more than 30% of the inhaled dose of extra-fine BDP/formoterol 100/6 mu g was delivered to the lung using the pMDI alone. CONCLUSIONS The use of AeroChamber Plus (TM) optimizes the delivery of BDP and formoterol to the lung in subjects with inadequate inhalation technique. The total systemic exposure was not increased, supporting the safety of extra-fine BDP/formoterol pMDI with AeroChamber Plus (TM).