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Inhalation February 2025 17 11. Patent WO 2005/064312 A1. Laser diffraction method for particle size distribution measurement in pharmaceutical aerosols. H. Wachtel and J. Ziegler. Published July 14, 2005. 12. USP <601> Inhalation and Nasal Drug Products- Aerosols, Sprays, and Powders-- Performance Qual- ity Test. 13. Ph.Eur. 2.9.18 Preparations for Inhalation (Inhalanda). 14. Stapleton KW, Finlay WH. Errors in characteriz- ing nebulized particle size distributions with cascade impactors. J Aerosol Med. 1998 11. Suppl 1:S80- S83. PMID: 10180737. 15. Kwong WT, Ho SL, Coates AL. Comparison of nebulized particle size distribution with Malvern laser diffraction analyzer versus Andersen cascade impac- tor and low-flow Marple personal cascade impactor. J Aerosol Med. 2000 Winter. 13(4):303-314. PMID: 11262437. 16. USP<1601> Products for Nebulization—Char- acterization Tests. 17. Wachtel H, Nagel M, Engel M, El Azzi G, Sharma A, Suggett J. In vitro and clinical characterization of the valved holding chamber AeroChamber Plus ® Flow-Vu ® or administrating tiotropium Respimat ® in 1-5-year-old children with persistent asthmatic symptoms. Respir Med. 2018 April. 137:181-190. PMID: 29605203. David Stadermann, Dipl. Ing. (FH), Director Prod- uct Development, Kenox Pharmaceuticals Inc., Mon- mouth Junction, New Jersey, US. Sitaram Velaga, PhD, CEO, Kenox Pharmaceuticals Inc., Monmouth Junction, New Jersey, US. Corresponding author, svelaga@kenoxpharma.us. Herbert Wachtel, PhD, Senior Principal Scientist, Boehringer Ingelheim, Ingelheim am Rhein, Germany. www.boehringer- ingelheim.com, www.kenoxpharma.us. and asthma, the low delivered volume/mass ex-device may pose analytical challenges in terms of signal-to- noise ratio and recovery. However, the spray dura- tion of approximately 1.5 seconds provides ample time for device activation and delivered dose testing according to the USP monograph, which requires 2 liters of air volume that corresponds to 4 seconds at a flow rate of 30 L/min. e analytical challenges and their corresponding regulatory considerations discussed in this article can serve as guidelines for development of other soft mist inhalers. References 1. Dalby RN, Eicher J, Zierenberg B. Development of Respimat ® Soft Mist™ Inhaler and its clinical util- ity in respiratory disorders. Med Devices (Auckl). 2011. 4:145-155. PMID: 22915941. 2. Levy ML, Carroll W, Izquierdo Alonso JL, Keller C, Lavorini F, Lehtimäki L. Understanding dry pow- der inhalers: Key technical and patient preference attributes. Adv er. 2019 October. 36(10):2547- 2557. PMID: 31478131. 3. Komalla V, Wong CYJ, Sibum I, Muellinger B, Nijdam W, Chaugule V, Soria J, Ong HX, Buch- mann NA, Traini D. Advances in soft mist inhalers. Expert Opin Drug Deliv. 2023. 20(8):1055-1070. PMID: 37385962. 4. Leiner S, Cipolla D, Eicher J, DeKruif W, Wach- tel H. Soft Mist Sprays, In A. J. Hickey & S.R.P. da Rocha (Eds.), Pharmaceutical Inhalation Aerosol Technology 2019, pp. 493-507, CRC Press. 5. Hochrainer D, Holz H, Kreher C, Scaffidi L, Spallek M, Wachtel H. Comparison of the aerosol velocity and spray duration of Respimat soft mist inhaler and pressurized metered dose inhalers. J Aerosol Med. 2005. 18:273-282. PMID: 16181002. 6. FDA Guidance for Industry – Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products – Chemistry, Manufacturing, and Controls Documentation. (June 2002.) 7. EMA Guideline for the Pharmaceutical Docu- mentation of Inhalation and Nasal Products. (June 2006.) EMEA/CHMP/QWP/49313/2005 Corr and Medical Device Regulation 2017/745. 8. FDA Draft Guidance on Tiotropium Bromide, Spray, metered, inhalation. (November 2002.) 9. ISO 13320:2020 – Particle size analysis – Laser diffraction methods. 10. Ziegler J, Wachtel H. Comparison of cascade impaction and laser diffraction for particle size dis- tribution measurements. J Aerosol Med. 2005 Fall. 18(3):311-324. PMID: 1618100.