Imperial College London
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Professor Omar Usmani

Faculty of Medicine, National Heart & Lung Institute

Professor of Respiratory Medicine
 
 
 
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Contact

 

+44 (0)20 7351 8051o.usmani

 
 
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Location

 

Asthma LabSouth BlockRoyal Brompton Campus

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Summary

 

Publications

Citation

BibTex format

@article{Israel:2020:10.1016/j.ejps.2020.105472,
author = {Israel, S and Kumar, A and DeAngelis, K and Aurivillius, M and Dorinsky, P and Roche, N and Usmani, OS},
doi = {10.1016/j.ejps.2020.105472},
journal = {European Journal of Pharmaceutical Sciences},
title = {Pulmonary deposition of budesonide/glycopyrronium/formoterol fumarate dihydrate metered dose inhaler formulated using co-suspension delivery technology in healthy male subjects},
url = {http://dx.doi.org/10.1016/j.ejps.2020.105472},
volume = {153},
year = {2020}
}
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RIS format (EndNote, RefMan)

TY  - JOUR
AB  - This gamma scintigraphy imaging study assessed pulmonary, extrathoracic and regional lung deposition patterns of a radiolabelled inhaled corticosteroid/long-acting muscarinic antagonist/long-acting β2-agonist triple fixed-dose combination budesonide/glycopyrronium/formoterol fumarate dihydrate (BGF 320/14.4/10 μg), delivered by pressurised metered dose inhaler (pMDI) using innovative co-suspension delivery technology (Aerosphere™). In this Phase I, randomised, single-centre, single-dose, two-period, crossover study (NCT03740373), 10 healthy male adults received two actuations of BGF MDI (160/7.2/4.8 μg per actuation) radiolabelled with 99mTc, not exceeding 5 MBq per actuation. Immediately following each inhalation, subjects performed a 10- or 3-second breath-hold, then exhaled into an exhalation filter. The primary objective was to assess the pulmonary deposition of BGF MDI following the 10-second breath-hold. The secondary objectives were to assess deposition after the 3-second breath-hold and lung regional and extrathoracic deposition after each breath-hold length. Imaging of the lungs, stomach, head and neck was recorded by gamma scintigraphy immediately after exhalation. The mean BGF MDI emitted dose deposited in the lungs was 37.7% for the 10-second breath-hold and 34.5% for the 3-second breath-hold. Emitted dose detected in the exhalation filter was ≤0.4% for both breath-hold lengths. The mean normalised peripheral/central ratio was 0.65 and 0.75 for the 10- and 3-second breath-holds, respectively, while the standardised central/peripheral ratios were 1.79 and 1.40, respectively. There were no new or unexpected safety findings. In conclusion, BGF MDI was efficiently deposited in the central and the peripheral regions of the lungs, with similar regional deposition patterns following a 10- and 3-second breath-hold.
AU  - Israel,S
AU  - Kumar,A
AU  - DeAngelis,K
AU  - Aurivillius,M
AU  - Dorinsky,P
AU  - Roche,N
AU  - Usmani,OS
DO  - 10.1016/j.ejps.2020.105472
PY  - 2020///
SN  - 0928-0987
TI  - Pulmonary deposition of budesonide/glycopyrronium/formoterol fumarate dihydrate metered dose inhaler formulated using co-suspension delivery technology in healthy male subjects
T2  - European Journal of Pharmaceutical Sciences
UR  - http://dx.doi.org/10.1016/j.ejps.2020.105472
UR  - https://www.ncbi.nlm.nih.gov/pubmed/32682074
UR  - http://hdl.handle.net/10044/1/83080
VL  - 153
ER  -
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