Experimental Evaluation of Dry Powder Inhalers during Inhalation and Exhalation Using a Model of the Human Respiratory System (xPULM™)

Dry powder inhalers are used by a large number of patients worldwide to treat respiratory diseases. The objective of this work is to experimentally investigate changes in aerosol particle diameter and particle number concentration of pharmaceutical aerosols generated by four dry powder inhalers unde...

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Main Authors: Richard Pasteka, Lara Alina Schöllbauer, Joao Pedro Santos da Costa, Radim Kolar, Mathias Forjan
Format: Article
Language:English
Published: MDPI AG 2022-02-01
Series:Pharmaceutics
Subjects:
Online Access:https://www.mdpi.com/1999-4923/14/3/500
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author Richard Pasteka
Lara Alina Schöllbauer
Joao Pedro Santos da Costa
Radim Kolar
Mathias Forjan
author_facet Richard Pasteka
Lara Alina Schöllbauer
Joao Pedro Santos da Costa
Radim Kolar
Mathias Forjan
author_sort Richard Pasteka
collection DOAJ
description Dry powder inhalers are used by a large number of patients worldwide to treat respiratory diseases. The objective of this work is to experimentally investigate changes in aerosol particle diameter and particle number concentration of pharmaceutical aerosols generated by four dry powder inhalers under realistic inhalation and exhalation conditions. To simulate patients undergoing inhalation therapy, the active respiratory system model (xPULM™) was used. A mechanical upper airway model was developed, manufactured, and introduced as a part of the xPULM™ to represent the human upper respiratory tract with high fidelity. Integration of optical aerosol spectrometry technique into the setup allowed for evaluation of pharmaceutical aerosols. The results show that there is a significant difference (<i>p</i> < 0.05) in mean particle diameter between inhaled and exhaled particles with the majority of the particles depositing in the lung, while particles with the size of (>0.5 μm) are least influenced by deposition mechanisms. The fraction of exhaled particles ranges from 2.13% (HandiHaler<sup>®</sup>) over 2.94% (BreezHaler<sup>®</sup>), and 6.22% (Turbohaler<sup>®</sup>) to 10.24% (Ellipta<sup>®</sup>). These values are comparable to previously published studies. Furthermore, the mechanical upper airway model increases the resistance of the overall system and acts as a filter for larger particles (>3 μm). In conclusion, the xPULM™ active respiratory system model is a viable option for studying interactions of pharmaceutical aerosols and the respiratory tract regarding applicable deposition mechanisms. The model strives to support the reduction of animal experimentation in aerosol research and provides an alternative to experiments with human subjects.
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spelling doaj.art-d2cdd78001be48bf9ab3b9c8b6b42c102023-11-30T21:55:47ZengMDPI AGPharmaceutics1999-49232022-02-0114350010.3390/pharmaceutics14030500Experimental Evaluation of Dry Powder Inhalers during Inhalation and Exhalation Using a Model of the Human Respiratory System (xPULM™)Richard Pasteka0Lara Alina Schöllbauer1Joao Pedro Santos da Costa2Radim Kolar3Mathias Forjan4Department Life Science Engineering, University of Applied Sciences Technikum Wien, Höchstaedtplatz 6, 1200 Vienna, AustriaDepartment Life Science Engineering, University of Applied Sciences Technikum Wien, Höchstaedtplatz 6, 1200 Vienna, AustriaDepartment Life Science Engineering, University of Applied Sciences Technikum Wien, Höchstaedtplatz 6, 1200 Vienna, AustriaDepartment of Biomedical Engineering, Brno University of Technology, Technicka 3058, 616 00 Brno, Czech RepublicDepartment Life Science Engineering, University of Applied Sciences Technikum Wien, Höchstaedtplatz 6, 1200 Vienna, AustriaDry powder inhalers are used by a large number of patients worldwide to treat respiratory diseases. The objective of this work is to experimentally investigate changes in aerosol particle diameter and particle number concentration of pharmaceutical aerosols generated by four dry powder inhalers under realistic inhalation and exhalation conditions. To simulate patients undergoing inhalation therapy, the active respiratory system model (xPULM™) was used. A mechanical upper airway model was developed, manufactured, and introduced as a part of the xPULM™ to represent the human upper respiratory tract with high fidelity. Integration of optical aerosol spectrometry technique into the setup allowed for evaluation of pharmaceutical aerosols. The results show that there is a significant difference (<i>p</i> < 0.05) in mean particle diameter between inhaled and exhaled particles with the majority of the particles depositing in the lung, while particles with the size of (>0.5 μm) are least influenced by deposition mechanisms. The fraction of exhaled particles ranges from 2.13% (HandiHaler<sup>®</sup>) over 2.94% (BreezHaler<sup>®</sup>), and 6.22% (Turbohaler<sup>®</sup>) to 10.24% (Ellipta<sup>®</sup>). These values are comparable to previously published studies. Furthermore, the mechanical upper airway model increases the resistance of the overall system and acts as a filter for larger particles (>3 μm). In conclusion, the xPULM™ active respiratory system model is a viable option for studying interactions of pharmaceutical aerosols and the respiratory tract regarding applicable deposition mechanisms. The model strives to support the reduction of animal experimentation in aerosol research and provides an alternative to experiments with human subjects.https://www.mdpi.com/1999-4923/14/3/500dry powder inhaler resistanceinspiratory flow rateinspiratory pressureaerosol particle depositionmechanical upper airway modeloptical aerosol spectrometry
spellingShingle Richard Pasteka
Lara Alina Schöllbauer
Joao Pedro Santos da Costa
Radim Kolar
Mathias Forjan
Experimental Evaluation of Dry Powder Inhalers during Inhalation and Exhalation Using a Model of the Human Respiratory System (xPULM™)
Pharmaceutics
dry powder inhaler resistance
inspiratory flow rate
inspiratory pressure
aerosol particle deposition
mechanical upper airway model
optical aerosol spectrometry
title Experimental Evaluation of Dry Powder Inhalers during Inhalation and Exhalation Using a Model of the Human Respiratory System (xPULM™)
title_full Experimental Evaluation of Dry Powder Inhalers during Inhalation and Exhalation Using a Model of the Human Respiratory System (xPULM™)
title_fullStr Experimental Evaluation of Dry Powder Inhalers during Inhalation and Exhalation Using a Model of the Human Respiratory System (xPULM™)
title_full_unstemmed Experimental Evaluation of Dry Powder Inhalers during Inhalation and Exhalation Using a Model of the Human Respiratory System (xPULM™)
title_short Experimental Evaluation of Dry Powder Inhalers during Inhalation and Exhalation Using a Model of the Human Respiratory System (xPULM™)
title_sort experimental evaluation of dry powder inhalers during inhalation and exhalation using a model of the human respiratory system xpulm™
topic dry powder inhaler resistance
inspiratory flow rate
inspiratory pressure
aerosol particle deposition
mechanical upper airway model
optical aerosol spectrometry
url https://www.mdpi.com/1999-4923/14/3/500
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