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Relative systemic availability of budesonide in patients with asthma after inhalation from two dry powder inhalers

Persson, Gunnar; Ankerst, Jaro LU ; Gillen, Michael; Bengtsson, Thomas and Thorsson, Lars (2008) In Current Medical Research and Opinion 24(5). p.1511-1517
Abstract
Background: To improve dosing consistency and product features, budesonide inhalation powder delivered via a dry powder inhaler (DPI) (DPI-A* 200 mu g) was redesigned to include lactose, a newly shaped mouthpiece, and a new dose indicator (DPI-B dagger). Budesonide CPI-B 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 DPI-A and DPI-B and test for systemic absorption bioequivalence. Methods: Adults (n = 37) with asthma as defined by the American Thoracic Society were randomized in an open-label, crossover, single-center, single-dose study to budesonide DPI-A 200 mu g x 4 inhalations, budesonide DPI-B 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) (DPI-A* 200 mu g) was redesigned to include lactose, a newly shaped mouthpiece, and a new dose indicator (DPI-B dagger). Budesonide CPI-B 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 DPI-A and DPI-B and test for systemic absorption bioequivalence. Methods: Adults (n = 37) with asthma as defined by the American Thoracic Society were randomized in an open-label, crossover, single-center, single-dose study to budesonide DPI-A 200 mu g x 4 inhalations, budesonide DPI-B 180 mu g x 4 inhalations, or budesonide DPI-B 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 concentration-time curve from 0 to infinity (AUC(0-infinity)) and maximum plasma concentration (C-max); plasma concentration at 12 h (C-12h) and time to maximum plasma concentration (T-max) were secondary variables. Treatments were considered bioequivalent if the 90% confidence intervals (Cls) for their AUC(0-infinity) and C-max ratios fell between 80 and 125%. Adverse events were collected. Results: The 90% Cls for the ratios of AUC(0-infinity) and C-max for budesonide DPI-A 200 mu g and DPI-B 180 mu g and for both budesonide DPI-B strengths fell between 80% and 125% (AUC(0-infinity): budesonide DPI-B 180 mu g x 4/DPI-A 200 mu g x 4: 96.3% [90% Cl: 90.9,102,1]; budesonide DPI-B 180 mu g x 4/DPI-B 90 mu g x 8: 92.2% [90% Cl: 87.0, 97.7]; C-max: (budesonide DPI-B 180 mu g x 4/DPI-A 200 mu g x 4:100.4% [95% Cl: 92.1, 109.4]; budesonide DPI-B 180 mu g x 4/DPI-B 90 mu g x 8: 94.4% [90% Cl: 86.6,102.9]). No differences in C-12h and T-max were found between treatments. All treatments were well tolerated. Conclusions: Budesonide DPI-A 200 mu g and CPI-B 180 mu g have systemic absorption bioequivalence, and DPI-B 90 mu g and 180 mu g are dose-strength 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 mild-to-moderate asthma aged >= 19 years. (Less)
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author
organization
publishing date
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
1473-4877
DOI
10.1185/030079908X297312
language
English
LU publication?
yes
id
f08590ea-42e8-4dd9-bf2d-31173e3babe0 (old id 1202139)
date added to LUP
2008-09-15 14:41:32
date last changed
2017-01-01 04:40:47
@article{f08590ea-42e8-4dd9-bf2d-31173e3babe0,
  abstract     = {Background: To improve dosing consistency and product features, budesonide inhalation powder delivered via a dry powder inhaler (DPI) (DPI-A* 200 mu g) was redesigned to include lactose, a newly shaped mouthpiece, and a new dose indicator (DPI-B dagger). Budesonide CPI-B 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 DPI-A and DPI-B and test for systemic absorption bioequivalence. Methods: Adults (n = 37) with asthma as defined by the American Thoracic Society were randomized in an open-label, crossover, single-center, single-dose study to budesonide DPI-A 200 mu g x 4 inhalations, budesonide DPI-B 180 mu g x 4 inhalations, or budesonide DPI-B 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 concentration-time curve from 0 to infinity (AUC(0-infinity)) and maximum plasma concentration (C-max); plasma concentration at 12 h (C-12h) and time to maximum plasma concentration (T-max) were secondary variables. Treatments were considered bioequivalent if the 90% confidence intervals (Cls) for their AUC(0-infinity) and C-max ratios fell between 80 and 125%. Adverse events were collected. Results: The 90% Cls for the ratios of AUC(0-infinity) and C-max for budesonide DPI-A 200 mu g and DPI-B 180 mu g and for both budesonide DPI-B strengths fell between 80% and 125% (AUC(0-infinity): budesonide DPI-B 180 mu g x 4/DPI-A 200 mu g x 4: 96.3% [90% Cl: 90.9,102,1]; budesonide DPI-B 180 mu g x 4/DPI-B 90 mu g x 8: 92.2% [90% Cl: 87.0, 97.7]; C-max: (budesonide DPI-B 180 mu g x 4/DPI-A 200 mu g x 4:100.4% [95% Cl: 92.1, 109.4]; budesonide DPI-B 180 mu g x 4/DPI-B 90 mu g x 8: 94.4% [90% Cl: 86.6,102.9]). No differences in C-12h and T-max were found between treatments. All treatments were well tolerated. Conclusions: Budesonide DPI-A 200 mu g and CPI-B 180 mu g have systemic absorption bioequivalence, and DPI-B 90 mu g and 180 mu g are dose-strength 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 mild-to-moderate asthma aged >= 19 years.},
  author       = {Persson, Gunnar and Ankerst, Jaro and Gillen, Michael and Bengtsson, Thomas and Thorsson, Lars},
  issn         = {1473-4877},
  keyword      = {pharmacokinetics,corticosteroids,inhaled,dry powder inhaler,bioequivalence,budesonide},
  language     = {eng},
  number       = {5},
  pages        = {1511--1517},
  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},
}