Breath Hold Facilitates Targeted Deposition of Aerosolized Droplets in a 3D Printed Bifurcating Airway Tree

Sonnenberg, Adam; Taylor, Edward; Mondoñedo, Jarred R.; Jawde, Samer Bou; Amin, Samir D.; Song, Jiaxi; Grinstaff, Mark W.; Suki, Bélâ

doi:10.1007/s10439-020-02623-9

Cited by 6 publications

(3 citation statements)

References 30 publications

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“…With the accelerated development in recent years of 3D printers, various authors have made their own lung models [ 86 , 87 , 88 , 89 , 90 , 91 , 92 ]. The main problem with these models is the complex setup for their use, making them hardly reproducible.…”

Section: Alternative Methods For Bioequivalencementioning

confidence: 99%

Innovating on Inhaled Bioequivalence: A Critical Analysis of the Current Limitations, Potential Solutions and Stakeholders of the Process

Gallegos-Catalán

Warnken²,

Bahamondez-Canas

et al. 2021

Pharmaceutics

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Orally inhaled drug products (OIDPs) are an important group of medicines traditionally used to treat pulmonary diseases. Over the past decade, this trend has broadened, increasing their use in other conditions such as diabetes, expanding the interest in this administration route. Thus, the bioequivalence of OIDPs is more important than ever, aiming to increase access to affordable, safe and effective medicines, which translates into better public health policies. However, regulatory agencies leading the bioequivalence process are still deciding the best approach for ensuring a proposed inhalable product is bioequivalent. This lack of agreement translates into less cost-effective strategies to determine bioequivalence, discouraging innovation in this field. The Next-Generation Impactor (NGI) is an example of the slow pace at which the inhalation field evolves. The NGI was officially implemented in 2003, being the last equipment innovation for OIDP characterization. Even though it was a breakthrough in the field, it did not solve other deficiencies of the BE process such as dissolution rate analysis on physiologically relevant conditions, being the last attempt of transferring technology into the field. This review aims to reveal the steps required for innovation in the regulations defining the bioequivalence of OIDPs, elucidating the pitfalls of implementing new technologies in the current standards. To do so, we collected the opinion of experts from the literature to explain these trends, showing, for the first time, the stakeholders of the OIDP market. This review analyzes the stakeholders involved in the development, improvement and implementation of methodologies that can help assess bioequivalence between OIDPs. Additionally, it presents a list of methods potentially useful to overcome some of the current limitations of the bioequivalence standard methodologies. Finally, we review one of the most revolutionary approaches, the inhaled Biopharmaceutical Classification System (IBCs), which can help establish priorities and order in both the innovation process and in regulations for OIDPs.

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Section: Alternative Methods For Bioequivalencementioning

confidence: 99%

Innovating on Inhaled Bioequivalence: A Critical Analysis of the Current Limitations, Potential Solutions and Stakeholders of the Process

Gallegos-Catalán

Warnken²,

Bahamondez-Canas

et al. 2021

Pharmaceutics

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“…It should also be noted that some particles (mainly in the size range of 0.2-0.5 µm) are not deposited and are exhaled, since all deposition mechanisms for this size are ineffective. Most inhaled particles are deposited during aerosol entry into the lungs (inhalation), but some are also deposited during breath-holding [22,23] (which is often recommended as a good practice for patients using inhalers) as well as exhalation. Typical airflow during unforced inhalation (at rest) which is used, e.g., during nebulization, is characterized by the frequency (breathing rate, BR) of 12-15 min −1 and total inhaled volume per breath (tidal volume, TV) of 500 mL.…”

Section: Inhalation Dynamics and Particle Deposition Mechanismsmentioning

confidence: 99%

“…As seen in Figure 3, the shape of the exhalation curve is slightly different, especially in obstructive lung diseases when the duration of air outflow is extended, but, of course, all previously inhaled volume is forced out. Most inhaled particles are deposited during aerosol entry into the lungs (inhalation), but some are also deposited during breath-holding [22,23] (which is often recommended as a good practice for patients using inhalers) as well as exhalation. Typical airflow during unforced inhalation (at rest) which is used, e.g., during nebulization, is characterized by the frequency (breathing rate, BR) of 12-15 min −1 and total inhaled volume per breath (tidal volume, TV) of 500 mL.…”

Section: Inhalation Dynamics and Particle Deposition Mechanismsmentioning

confidence: 99%

Towards More Precise Targeting of Inhaled Aerosols to Different Areas of the Respiratory System

Sosnowski

2024

Pharmaceutics

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Pharmaceutical aerosols play a key role in the treatment of lung disorders, but also systemic diseases, due to their ability to target specific areas of the respiratory system (RS). This article focuses on identifying and clarifying the influence of various factors involved in the generation of aerosol micro- and nanoparticles on their regional distribution and deposition in the RS. Attention is given to the importance of process parameters during the aerosolization of liquids or powders and the role of aerosol flow dynamics in the RS. The interaction of deposited particles with the fluid environment of the lung is also pointed out as an important step in the mass transfer of the drug to the RS surface. The analysis presented highlights the technical aspects of preparing the precursors to ensure that the properties of the aerosol are suitable for a given therapeutic target. Through an analysis of existing technical limitations, selected strategies aimed at enhancing the effectiveness of targeted aerosol delivery to the RS have been identified and presented. These strategies also include the use of smart inhaling devices and systems with built-in AI algorithms.

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Characterization of dry powder inhaler performance through experimental methods

Ruzycki

Tavernini

Finlay

2022

Advanced Drug Delivery Reviews

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Breath Hold Facilitates Targeted Deposition of Aerosolized Droplets in a 3D Printed Bifurcating Airway Tree

Cited by 6 publications

References 30 publications

Innovating on Inhaled Bioequivalence: A Critical Analysis of the Current Limitations, Potential Solutions and Stakeholders of the Process

Innovating on Inhaled Bioequivalence: A Critical Analysis of the Current Limitations, Potential Solutions and Stakeholders of the Process

Towards More Precise Targeting of Inhaled Aerosols to Different Areas of the Respiratory System

Characterization of dry powder inhaler performance through experimental methods

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