Relative systemic availability of budesonide in patients with asthma after inhalation from two dry powder inhalers
(2008) In Current Medical Research and Opinion 24(5). p.15111517 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... (More)
 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. (Less)
Please use this url to cite or link to this publication:
http://lup.lub.lu.se/record/1202139
 author
 Persson, Gunnar; Ankerst, Jaro ^{LU} ; Gillen, Michael; Bengtsson, Thomas and Thorsson, Lars
 organization
 publishing date
 2008
 type
 Contribution to journal
 publication status
 published
 subject
 keywords
 pharmacokinetics, corticosteroids, inhaled, dry powder inhaler, bioequivalence, budesonide
 in
 Current Medical Research and Opinion
 volume
 24
 issue
 5
 pages
 1511  1517
 publisher
 LibraPharm
 external identifiers

 wos:000256189400030
 scopus:44349158930
 ISSN
 14734877
 DOI
 10.1185/030079908X297312
 language
 English
 LU publication?
 yes
 id
 f08590ea42e84dd9bf2d31173e3babe0 (old id 1202139)
 date added to LUP
 20080915 14:41:32
 date last changed
 20170101 04:40:47
@article{f08590ea42e84dd9bf2d31173e3babe0, 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.}, author = {Persson, Gunnar and Ankerst, Jaro and Gillen, Michael and Bengtsson, Thomas and Thorsson, Lars}, issn = {14734877}, keyword = {pharmacokinetics,corticosteroids,inhaled,dry powder inhaler,bioequivalence,budesonide}, language = {eng}, number = {5}, pages = {15111517}, publisher = {LibraPharm}, series = {Current Medical Research and Opinion}, title = {Relative systemic availability of budesonide in patients with asthma after inhalation from two dry powder inhalers}, url = {http://dx.doi.org/10.1185/030079908X297312}, volume = {24}, year = {2008}, }