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Consistent Pulmonary Drug Delivery with Whole Lung Deposition Using the Aerosphere Inhaler: A Review of the Evidence

Authors Usmani OS, Roche N, Jenkins M, Stjepanovic N, Mack P, De Backer W

Received 18 August 2020

Accepted for publication 24 November 2020

Published 18 January 2021 Volume 2021:16 Pages 113—124


Checked for plagiarism Yes

Review by Single anonymous peer review

Peer reviewer comments 4

Editor who approved publication: Dr Richard Russell

Omar S Usmani,1 Nicolas Roche,2 Martin Jenkins,3 Neda Stjepanovic,4 Peter Mack,5 Wilfried De Backer6

1National Heart and Lung Institute (NHLI), Imperial College London, and Royal Brompton Hospital, London, UK; 2Respiratory Medicine, Cochin Hospital, University Paris Descartes, Paris, France; 3AstraZeneca, Cambridge, UK; 4AstraZeneca, Gothenburg, Mölndal, Sweden; 5AstraZeneca, Durham, NC, USA; 6Department of Pulmonary Medicine, Faculty of Medicine, University of Antwerp, Antwerp, Belgium

Correspondence: Wilfried De Backer
Department of Pulmonary Medicine, Faculty of Medicine, University of Antwerp, Lange Lozanastraat 142, Antwerp 2018, Belgium
Tel +32 468 195206

Abstract: Metered dose inhalers (MDIs) are one of the most common device types for delivering inhaled therapies. However, there are several technical challenges in development and drug delivery of these medications. In particular, suspension-based MDIs are susceptible to suspension heterogeneity, in vitro drug–drug interactions, and patient handling errors, which may all affect drug delivery. To overcome these challenges, new formulation approaches are required. The AerosphereTM inhaler, formulated using co-suspension delivery technology, combines drug crystals with porous phospholipid particles to create stable, homogenous suspensions that dissolve once they reach the airways. Two combination therapies using this technology have been developed for the treatment of COPD: glycopyrrolate/formoterol fumarate (GFF MDI; dual combination) and budesonide/glycopyrrolate/formoterol fumarate (BGF MDI; triple combination). Here, we review the evidence with a focus on studies assessing dose delivery, lung deposition, and effects on airway geometry. In vitro assessments have demonstrated that the Aerosphere inhaler provides consistent dose delivery, even in the presence of simulated patient handling errors. Combination therapies delivered with this technology also show a consistent fine particle fraction (FPF) and an optimal particle size distribution for delivery to the central and peripheral airways even when multiple drugs are delivered via the same inhaler. Studies using gamma scintigraphy and functional respiratory imaging have demonstrated that GFF MDI is effectively deposited in the central and peripheral airways, and provides clinically meaningful benefits on airway volume and resistance throughout the lung. Overall, studies suggest that the Aerosphere inhaler, formulated using co-suspension delivery technology, may offer advantages over traditional formulations, including consistent delivery of multiple components across patient handling conditions, optimal particle size and FPF, and effective delivery to the central and peripheral airways. Future studies may provide additional evidence to further characterize the clinical benefits of these technical improvements in MDI drug delivery.

Keywords: Aerosphere, BGF MDI, co-suspension delivery technology, FRI, GFF MDI, metered dose inhaler

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