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Development of Dry Powder Inhaler Patient Interfaces for Improved Aerosol Delivery to Children

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Abstract

The objective of this study was to explore different internal flow passages in the patient interface region of a new air-jet–based dry powder inhaler (DPI) in order to minimize device and extrathoracic aerosol depositional losses using computational fluid dynamics (CFD) simulations. The best-performing flow passages were used for oral and nose-to-lung (N2L) aerosol delivery in pediatric extrathoracic airway geometries consistent with a 5-year-old child. Aerosol delivery conditions were based on a previously developed and tested air-jet DPI device and included a base flow rate of 13.3 LPM (delivered from a small ventilation bag) and an inhaled air volume of 750 mL. Initial CFD models of the system clearly established that deposition on either the back of the throat or nasal cannula bifurcation was strongly correlated with the maximum velocity exiting the flow passage. Of all designs tested, the combination of a 3D rod array and rapid expansion of the flow passage side walls was found to dramatically reduce interface and device deposition and improve lung delivery of the aerosol. For oral aerosol administration, the optimal flow passage compared with a base case reduced device, mouthpiece, and mouth-throat deposition efficiencies by factors of 8-, 3-, and 2-fold, respectively. For N2L aerosol administration, the optimal flow pathway compared with a base case reduced device, nasal cannula, and nose-throat deposition by 16-, 6-, and 1.3-fold, respectively. In conclusion, a new patient interface design including a 3D rod array and rapid expansion dramatically improved transmission efficiency of a dry powder aerosol.

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Acknowledgments

Dr. Dale Farkas is gratefully acknowledged for helpful discussions and input related to the development of the air-jet DPI, patient interface devices, and pediatric airway models. Spray-dried powder from the VCU Department of Pharmaceutics (Hindle Lab) generated by Serena Bonasera and experimental lab access are also gratefully acknowledged. Finally, the authors wish to thank Dr. Michael Hindle for helpful insights and guidance in support of this work.

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The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Funding

Research reported in this publication was supported by the Eunice Kennedy Shriver National Institute of Child Health & Human Development of the National Institutes of Health under Award Number R01HD087339 and by the National Heart, Lung and Blood Institute of the National Institutes of Health under Award Number R01HL139673.

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Correspondence to Worth Longest.

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Virginia Commonwealth University is currently pursuing patent protection of EEG aerosol delivery, DPI aerosol generation devices and patient interfaces, which if licensed, may provide a future financial interest to the authors.

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Bass, K., Longest, W. Development of Dry Powder Inhaler Patient Interfaces for Improved Aerosol Delivery to Children. AAPS PharmSciTech 21, 157 (2020). https://doi.org/10.1208/s12249-020-01667-3

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