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An ex vivo study was designed to compare the dosing efficiency of different inhaler devices (soft mist inhaler [SMI], pressurized metered dose inhaler [pMDI] and dry powder inhaler [DPI]) and investigate their robustness to inhaler orientation. Stiolto® Respimat® SMI, Trimbow® pMDI, Fostair NEXTaler® DPI and Trelegy Ellipta® DPI were each tested using the Alberta Idealized Throat model, with realistic inhalation patterns for very severe COPD generated by a lung simulator. 10 June 2023 Inhalation The effects of inhaler type and orientation at inhalation on dosing efficiency—a study of the SMI, pMDI and DPI An investigation of factors to consider when choosing inhalers to optimize disease control—dose delivery to the lungs and inhaler robustness to misuse Sabrina Strohe, BSc a ; Herbert Wachtel, PhD b ; Rachel Emerson-Stadler, MSc b and Omar S. Usmani, MBBS, PhD, FHEA, FRCP, FERS c a Hochschule Darmstadt, University of Applied Sciences b Boehringer Ingelheim c National Heart and Lung Institute (NHLI), Imperial College London Abstract is ex vivo study was designed to compare the dos- ing efficiency of different inhaler devices (soft mist inhaler [SMI], pressurized metered dose inhaler [pMDI] and dry powder inhaler [DPI]) and inves- tigate their robustness to inhaler orientation. Sti- olto ® Respimat ® SMI, Trimbow ® pMDI, Fostair NEXaler ® DPI and Trelegy Ellipta ® DPI were each tested using the Alberta Idealized roat model, with realistic inhalation patterns for very severe chronic obstructive pulmonary disease generated by a lung simulator. e in vitro distribution of dose to the mouth/oropharynx and availability to the lungs were assessed with the inhalers adapted to the throat model in the normal upright orientation and effec- tively leaning forward at a 45-degree angle. e Stiolto Respimat SMI was superior in dosing effi- ciency and dose to the lungs compared with Trelegy Ellipta DPI, Fostair NEXaler DPI and Trimbow pMDI. Irrespective of the inhaler position, the Sti- olto Respimat SMI was associated with the lowest dose to the mouth/oropharynx and the highest dose delivered to the lungs. ese benefits are expected to translate into the robustness of Stiolto Respimat SMI in routine clinical use, ensuring consistently high dose delivery to the lungs even when patients do not follow instructions regarding inhaler orientation. Introduction Inhaled therapy is a key component in the man- agement of chronic obstructive pulmonary disease (COPD) and asthma, and many different delivery devices have been designed to optimize drug delivery to the target organ, the lungs [1, 2]. Selecting the optimum delivery system is essential to ensure that patients obtain the maximum benefit from inhaled therapies [1]. Multiple variations of three key design types are available, namely soft mist inhalers (SMIs), pressurized metered dose inhalers (pMDIs) and dry powder inhalers (DPIs) [1, 3]. Each inhaler has advantages and disadvantages, and it is important for physicians to optimally match not only the ther- apies to the condition to be treated (e.g., long-act- ing muscarinic antagonists or long-acting β 2 -agonists for COPD, with inhaled corticosteroids (ICS) for asthma), but also the type of inhaler with the specific patient [3, 4]. Patient-centered product design is also critical to ensure that the device remains robust for routine use by patients [5]. One of the principal differences between inhalers is the mechanism of drug delivery, which is active in the case of SMIs (mechanical energy) and pMDIs (propellant) and passive in the case of DPIs (aero- sol generated by the patient) [6, 7]. Consequently, the challenges of effective drug delivery associated with each inhaler type are different. In the case of the