TY - JOUR
T1 - Comparative in vitro evaluation of four corticosteroid metered dose inhalers
T2 - Consistency of delivered dose and particle size distribution
AU - de Vries, Tjalling W
AU - Rottier, Bart L
AU - Gjaltema, Doetie
AU - Hagedoorn, Paul
AU - Frijlink, Henderik W
AU - de Boer, Anne H
PY - 2009/8/1
Y1 - 2009/8/1
N2 - Introduction: Recent developments concerning pressurized metered dose inhalers (pMDIs) with inhaled corticosteroids (ICS) are the introduction of ciclesonide and the replacement of propellants. As the results of in vivo studies depend on pMDI performance, it is necessary to evaluate pMDIs in vitro for delivered dose and particle size distributions under different conditions.Methods: Fluticasone 125 mu g, budesonide 200 mu g, beclomethasone HFA100 mu g, and ciclesonide 160 mu g were compared for delivered dose and particle size using laser diffraction analysis with inspiratory flow rates of 10, 20 and 30 Us.Results: The volume median diameter of budesonide wits 3.5 mu m, fluticasone 2.8 mu m, beclomethasone and ciclesonide both 1.9 mu m. The mouthpiece retention was up to 30% of the nominal. dose for beclomethasone and ciclesonide, 11-19% for the other pMDIs. Lifespan, flow rate, and air humidity had no significant influence on particle size distribution. The delivered dose of beclomethasone, budesonide, and ciclesonide remained constant over the lifespan. The delivered dose of fluticasone 125 decreased from 106% to 63%; fluticasone 250 also decreased whereas fluticasone 50 remained constant.Conclusions: There is a significant difference in median particle size distribution between the different ICS pMDIs. Air humidity and inspiratory flow rate have no significant influence on particle size distribution. Ciclesonide 160 and beclomethasone 100 deliver the largest fine particle fractions of 1.1-3.1 mu m. The changes in delivered dose during the Lifespan for the fluticasone 125 and 250 may have implications for patient care. (C) 2009 Elsevier Ltd. All rights reserved.
AB - Introduction: Recent developments concerning pressurized metered dose inhalers (pMDIs) with inhaled corticosteroids (ICS) are the introduction of ciclesonide and the replacement of propellants. As the results of in vivo studies depend on pMDI performance, it is necessary to evaluate pMDIs in vitro for delivered dose and particle size distributions under different conditions.Methods: Fluticasone 125 mu g, budesonide 200 mu g, beclomethasone HFA100 mu g, and ciclesonide 160 mu g were compared for delivered dose and particle size using laser diffraction analysis with inspiratory flow rates of 10, 20 and 30 Us.Results: The volume median diameter of budesonide wits 3.5 mu m, fluticasone 2.8 mu m, beclomethasone and ciclesonide both 1.9 mu m. The mouthpiece retention was up to 30% of the nominal. dose for beclomethasone and ciclesonide, 11-19% for the other pMDIs. Lifespan, flow rate, and air humidity had no significant influence on particle size distribution. The delivered dose of beclomethasone, budesonide, and ciclesonide remained constant over the lifespan. The delivered dose of fluticasone 125 decreased from 106% to 63%; fluticasone 250 also decreased whereas fluticasone 50 remained constant.Conclusions: There is a significant difference in median particle size distribution between the different ICS pMDIs. Air humidity and inspiratory flow rate have no significant influence on particle size distribution. Ciclesonide 160 and beclomethasone 100 deliver the largest fine particle fractions of 1.1-3.1 mu m. The changes in delivered dose during the Lifespan for the fluticasone 125 and 250 may have implications for patient care. (C) 2009 Elsevier Ltd. All rights reserved.
KW - Administration, Inhalation
KW - Adrenal Cortex Hormones
KW - Androstadienes
KW - Asthma
KW - Beclomethasone
KW - Budesonide
KW - Drug Delivery Systems
KW - Equipment Design
KW - Humans
KW - Materials Testing
KW - Metered Dose Inhalers
KW - Particle Size
KW - Pregnenediones
U2 - 10.1016/j.rmed.2009.02.010
DO - 10.1016/j.rmed.2009.02.010
M3 - Article
C2 - 19269801
SN - 0954-6111
VL - 103
SP - 1167
EP - 1173
JO - Respiratory Medicine
JF - Respiratory Medicine
IS - 8
ER -