title: Deposition and pharmacokinetics of budesonide from the Miat Monodose inhaler, a simple dry powder device.
abstract: 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 l/min; Turbuhaler DPI 60 vs 30 l/min. The formulations were radiolabelled with (99m)Tc, 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 (6.1)%; 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 inspiratory 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.
authors.affiliation: Pharmaceutical Profiles Ltd., Mere Way, Ruddington Fields, Nottingham, NG11 6JS, UK.
authors.forename: Denise J
authors.initials: DJ
authors.lastname: Ball
authors.forename: Peter H
authors.initials: PH
authors.lastname: Hirst
authors.forename: Stephen P
authors.initials: SP
authors.lastname: Newman
authors.forename: Bernard
authors.initials: B
authors.lastname: Sonet
authors.forename: Bruno
authors.initials: B
authors.lastname: Streel
authors.forename: Francis
authors.initials: F
authors.lastname: Vanderbist
mesh_terms: D000280:Administration, Inhalation; D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000336:Aerosols; D000893:Anti-Inflammatory Agents / Q000493:pharmacokinetics* / Q000627:therapeutic use; D001249:Asthma / Q000188:drug therapy / Q000378:metabolism* / Q000503:physiopathology; D019819:Budesonide / Q000493:pharmacokinetics* / Q000627:therapeutic use; D018592:Cross-Over Studies; D005260:Female; D005541:Forced Expiratory Volume; D005938:Glucocorticoids; D006801:Humans; D007553:Isotope Labeling; D008297:Male; D036501:Metered Dose Inhalers; D008875:Middle Aged; D016719:Radioimmunodetection; D016032:Randomized Controlled Trials as Topic; D013667:Technetium; D014018:Tissue Distribution
chemical_list: D000336:Aerosols; D000893:Anti-Inflammatory Agents; D005938:Glucocorticoids; D019819:Budesonide; D013667:Technetium