Advancement of a Positive-Pressure Dry Powder Inhaler for Children: Use of a Vertical Aerosolization Chamber and Three-D
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RESEARCH PAPER
Advancement of a Positive-Pressure Dry Powder Inhaler for Children: Use of a Vertical Aerosolization Chamber and Three-Dimensional Rod Array Interface Dale Farkas 1 & Serena Bonasera 2 & Karl Bass 1 & Michael Hindle 2 & P. Worth Longest 1,2
Received: 7 May 2020 / Accepted: 22 July 2020 # Springer Science+Business Media, LLC, part of Springer Nature 2020
ABSTRACT Purpose Available dry powder inhalers (DPIs) have very poor lung delivery efficiencies in children. The objective of this study was to advance and experimentally test a positivepressure air-jet DPI for children based on the use of a vertical aerosolization chamber and new patient interfaces that contain a three-dimensional (3D) rod array structure. Methods Aerosolization performance of different air-jet DPI designs was first evaluated based on a 10 mg powder fill mass of a spray-dried excipient enhanced growth (EEG) formulation. Devices were actuated with positive pressure using flow rate (10–20 L/min) and inhaled volume (750 ml) conditions consistent with a 5-year-old child. Devices with best performance were connected to different mouthpiece designs to determine the effect on aerosolization and tested for aerosol penetration through a realistic pediatric in vitro mouth-throat model. Results Use of the new vertical aerosolization chamber resulted in high quality aerosol formation. Inclusion of a 3D rod array structure in the mouthpiece further reduced aerosol size by approximately 20% compared to conditions without a rod array, and effectively dissipated the turbulent jet leaving the device. Best case device and mouthpiece combinations produced < 2% mouth-throat depositional loss and > 70% lung delivery efficiency based on loaded dose. Conclusions In conclusion, use of a 3D rod array in the MP of a positive-pressure air-jet DPI was found to reduce aerosol size by 20%, not significantly increase MP depositional loss, * P. Worth Longest [email protected] 1
Department of Mechanical and Nuclear Engineering, Virginia Commonwealth University, Richmond, Virginia, USA
2
Department of Pharmaceutics, Virginia Commonwealth University, 410 North 12th Street, P.O. Box 980533, Richmond 23298-0533, Virginia, USA
reduce mouth-throat deposition by 6.4-fold and enable lung delivery efficiency as high as 73.4% of loaded dose based on pediatric test conditions.
KEYWORDS Air-jet aerosolization . Dry powder inhaler (DPI) . Pediatric DPI . Positive-pressure DPI . Three-dimensional rod array
ABBREVIATIONS 3D AAV AS CFD DPI ED EEG FPF HPLC LPM MMAD MP MT NGI SD
Three dimensional Actuation air volume Albuterol sulfate Computational fluid dynamics Dry powder inhaler Emitted dose Excipient enhanced growth Fine particle fraction High performance liquid chromatography Liters per minute Mass median aerodynamic diameter Mouthpiece Mouth-throat Next Generation Impactor Standard deviation
INTRODUCTION Dry powder aerosols offer a number of advantages compared with other forms of respiratory drug delivery, including rapid administration of high dose medications, coo
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