Improving usability and maintaining performance: human-factor and aerosol-performance studies evaluating the new reusable Respimat inhaler
Received 12 October 2018
Accepted for publication 31 January 2019
Published 5 March 2019 Volume 2019:14 Pages 509—523
Checked for plagiarism Yes
Review by Single-blind
Peer reviewers approved by Ms Justinn Cochran
Peer reviewer comments 4
Editor who approved publication: Dr Richard Russell
Rajiv Dhand,1 Joachim Eicher,2 Michaela Hänsel,3 Ingeborg Jost,4 Martin Meisenheimer,2 Herbert Wachtel2
1Department of Medicine, University of Tennessee Graduate School of Medicine, Knoxville, TN 37920, USA; 2Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein 55216, Germany; 3Boehringer Ingelheim International GmbH, Ingelheim am Rhein 55216, Germany; 4Boehringer Ingelheim Pharma, Biberach an der Riss 88397, Germany
Purpose: The Respimat is a handheld, propellant-free, soft-mist inhaler. Observations by patients and physicians prompted development of an improved second-generation Respimat inhaler. Human-factor studies assessing the usability of the new inhaler and in vitro assessment of aerosol performance are important to demonstrate functionality of the updated inhaler.
Methods: Studies were performed to assess any possible impact of the reusable Respimat inhaler design on aerosol performance (delivered dose [DD] and fine-particle dose [FPD]) and iteratively assess and improve usability of the new design. The tiotropium–olodaterol inhalation solution for Respimat was used as a model. The DD and FPD of the reusable Respimat inhaler (across multiple cartridges) and the disposable Respimat inhaler were determined by laser diffraction and with an alternative Andersen cascade impactor. Usability was measured across three studies involving health care professionals and patients with diagnoses of COPD, asthma, or combined disease (with and without experience with the Respimat inhaler). These studies measured performance of handling tasks and collected subjective feedback directly related to the inhaler’s new or altered features, which fed into optimization of the inhaler.
Results: DDs of tiotropium and olodaterol were stable up to 15 cartridges and consistently within the upper and lower limits of the disposable Respimat inhaler. The FPD was also found to be batch-consistent over the cartridges and comparable with the reference. The usability of the reusable Respimat inhaler compared with the disposable inhaler was improved in terms of assembly and daily use. Cartridge exchange was rated as intuitive and easy to very easy.
Conclusion: The new reusable Respimat is a medical inhaler developed with enhanced features that meets health care professionals’ and patients’ needs. Drug delivery across multiple cartridges is not affected by the design. Compared with the original disposable inhaler, the usability of the reusable inhaler has been improved, and cartridge exchange was rated as easy to perform. The reusable Respimat provides greater convenience for patients vs the disposable inhaler, with reduced environmental impact.
Keywords: inhalers, soft mist, SMI, handling, environment
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