Relative systemic availability of budesonide in patients with asthma after inhalation from two dry powder inhalers
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Abstract
Background: To improve dosing consistency and product features, budesonide inhalation powder delivered via a dry powder inhaler (DPI) (DPIA* 200 mu g) was redesigned to include lactose, a newly shaped mouthpiece, and a new dose indicator (DPIB dagger). Budesonide CPIB is available in two strengths (90 mu g, 180 mu g). Objective: To compare the relative rate and extent of the systemic availability of budesonide inhaled via DPIA and DPIB and test for systemic absorption bioequivalence. Methods: Adults (n = 37) with asthma as defined by the American Thoracic Society were randomized in an openlabel, crossover, singlecenter, singledose study to budesonide DPIA 200 mu g x 4 inhalations, budesonide DPIB 180 mu g x 4 inhalations, or budesonide DPIB 90 mu g x 8 inhalations, on 3 days, each separated by a washout period of >= 5 days. Plasma samples were collected immediately before and up to 12 h after dosing. Primary pharmacokinetic variables were area under the drug plasma concentrationtime curve from 0 to infinity (AUC(0infinity)) and maximum plasma concentration (Cmax); plasma concentration at 12 h (C12h) and time to maximum plasma concentration (Tmax) were secondary variables. Treatments were considered bioequivalent if the 90% confidence intervals (Cls) for their AUC(0infinity) and Cmax ratios fell between 80 and 125%. Adverse events were collected. Results: The 90% Cls for the ratios of AUC(0infinity) and Cmax for budesonide DPIA 200 mu g and DPIB 180 mu g and for both budesonide DPIB strengths fell between 80% and 125% (AUC(0infinity): budesonide DPIB 180 mu g x 4/DPIA 200 mu g x 4: 96.3% [90% Cl: 90.9,102,1]; budesonide DPIB 180 mu g x 4/DPIB 90 mu g x 8: 92.2% [90% Cl: 87.0, 97.7]; Cmax: (budesonide DPIB 180 mu g x 4/DPIA 200 mu g x 4:100.4% [95% Cl: 92.1, 109.4]; budesonide DPIB 180 mu g x 4/DPIB 90 mu g x 8: 94.4% [90% Cl: 86.6,102.9]). No differences in C12h and Tmax were found between treatments. All treatments were well tolerated. Conclusions: Budesonide DPIA 200 mu g and CPIB 180 mu g have systemic absorption bioequivalence, and DPIB 90 mu g and 180 mu g are dosestrength equivalent when administered at the same dose. These results may not be generalized to all patients with asthma, as this analysis included only patients with mildtomoderate asthma aged >= 19 years.
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Research areas and keywords  Subject classification (UKÄ) – MANDATORY
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Original language  English 

Pages (fromto)  15111517 
Journal  Current Medical Research and Opinion 
Volume  24 
Issue number  5 
Publication status  Published  2008 
Publication category  Research 
Peerreviewed  Yes 