Deposition and pharmacokinetics of budesonide from the Miat Monodose inhaler, a simple dry powder device

Dry powder inhalers (DPIs) are used to deliver asthma drugs to patients. but lung deposition may depend upon the degree of inspiratory effort. The pulmonary deposition of the glucocorticosteroid budesonide (SMB-Galephar) has been assessed in 12 asthmatic patients when delivered by the Monodose inhaler (Miat, Milan. Italy): the Pulmicort Turbuhaler DPI (AstraZeneca, Lund. Sweden) was used as a comparator product. Patients inhaled from each device with maximal or sub-maximal inspiratory effort: Monodose inhaler 90 vs 45 1/min Turbuhaler DPI 60 vs 30 1/min. The formulations were radiolabelled with Tc-99m, and deposition of budesonide was quantified by gamma scintigraphy, Mean (SD) whole lung deposition for the Monodose inhaler (% capsule dose), was independent of inspiratory effort (maximal: 21.4 (4.3)%; sub-maximal: 21.4 (7.5)%), while lung deposition for the Turbuhaler DPI (% metered dose) fell significantly with decreasing inspiratory effort (maximal: 25.1 sub-maximal: 18.5 (6.5)%: P < 0.05). The plasma concentrations of budesonide showed the same trends as the whole lung deposition data. The Monodose inhaler showed inspirator, effort-independent drug delivery characteristics, and could prove be a valuable low-cost alternative to more complex devices such as the turbuhaler DPI. The Monodose inhaler may be especially useful in groups of patients unable to inhale maximally through DPIs, including young children and adult patients with severe respiratory impairment. (C) 2002 Elsevier Science B.V. All rights reserved.