Computer modeling of airway deposition distribution of Foster ® NEXThaler ® and Seretide ® Diskus ® dry powder combination drugs

Jókay, Ágnes; Farkas, Árpád; Füri, Péter; Horváth, Alpár; Tomisa, Gábor; Balásházy, Imre

doi:10.1016/j.ejps.2016.03.008

Cited by 12 publications

(11 citation statements)

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“…Carefully validated numerical models proved to be a powerful tool in the quantification of total respiratory tract, regional and local deposition distributions of different drugs (e.g. Jókay et al, 2016;Horváth et al,2017). However, most of the numerical models do not consider the growth of the inhaled particles due to the humid environment within the airways.…”

Section: Introductionmentioning

confidence: 99%

Experimental and computational study of the effect of breath-actuated mechanism built in the NEXThaler® dry powder inhaler

Farkas

Lewis

Church

et al. 2017

International Journal of Pharmaceutics

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Link to publication record in Explore Bristol Research PDF-document This is the final published version of the article (version of record). It first appeared online via Elsevier at https://www.sciencedirect.com/science/article/pii/S0378517317309237 . Please refer to any applicable terms of use of the publisher. University of Bristol -Explore Bristol Research General rightsThis document is made available in accordance with publisher policies. Please cite only the published version using the reference above. Full terms of use are available: http://www.bristol.ac.uk/pure/about/ebr-terms A B S T R A C TThe breath-actuated mechanism (BAM) is a mechanical unit included in NEXThaler ® with the role of delaying the emission of the drug until the inhalation flow rate of the patient is sufficiently high to detach the drug particles from their carriers.The main objective of this work was to analyse the effect of the presence of BAM on the size distribution of the emitted drug and its airway deposition efficiency and distribution. Study of the hygroscopic growth of the emitted drug particles and its effect on the deposition was another goal of this study.Size distributions of Foster ® NEXThaler ® drug particles emitted by dry powder inhalers with and without BAM have been measured by a Next Generation Impactor. Three characteristic inhalation profiles of asthmatic patients (low, moderate and high flow rates) were used for both experimental and modelling purposes. Particle hygroscopic growth was determined by a new method, where experimental measurements are combined with simulations. Upper airway and lung deposition fractions were computed assuming 5 s and 10 s breath-hold times.By the inclusion of BAM the fine particle fraction of the steroid component increased from 24 to 30% to 47-51%, while that of bronchodilator from 25-34% to 52-55%. The predicted upper airway steroid and bronchodilator doses decreased from about 60% to 35-40% due to BAM. At the same time, predicted lung doses increased from about 20%-35% (steroid) and from 22% to 38% (bronchodilator) for the moderate flow profile and from about 25% to 40% (steroid) and from 29% to 47% (bronchodilator) for the high inhalation flow profile. Although BDP and FF upper airway doses decreased by a factor of about two when BAM was present, lung doses of both components were about the same in the BAM and no-BAM configurations at the weakest flow profile. However, lung dose increased by 2-3% even for this profile when hygroscopic growth was taken into account.In conclusion, the NEXThaler ® BAM mechanism is a unique feature enabling high emitted fine particle fraction and enhanced drug delivery to the lungs.

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Section: Introductionmentioning

confidence: 99%

Experimental and computational study of the effect of breath-actuated mechanism built in the NEXThaler® dry powder inhaler

Farkas

Lewis

Church

et al. 2017

International Journal of Pharmaceutics

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“…As the action of inhaled medication is highly dependent on proper lung deposition of the drugs, intraindividual variability in inhalation maneuvers can lead to inconsistent pulmonary drug delivery and consequently to varying degrees of bronchodilation. (12,17) FIG. 2.…”

Section: Discussionmentioning

confidence: 99%

“…(12,30) The most important breath profile parameters influencing pulmonary drug deposition include IVC d , PIF d , and t in . (17,31) Inhalation parameters have an impact on fine-particle fraction, mass median aerodynamic diameter (MMAD), as well as on emitted dose, especially in DPIs. (17,31) MMAD can be determined by measurements with a cascade impactor at different flow rates and is highly influenced by PIF.…”

Section: Discussionmentioning

confidence: 99%

“…(14) A good repeatability of inhalation performance through a given device is a prerequisite for consistent delivery of inhaled medications to the airways and for effective inhalation therapy. (15) Previous studies examined lung deposition of drug particles inhaled through different devices, (12,16,17) but data on repeatability of inhalation performance through different inhalers in patients with COPD are lacking. Therefore, we aimed to test the repeatability of inhalation performances in control subjects and patients with stable COPD (S-COPD) and exacerbated COPD, using four commercially available inhalers.…”

Section: Introductionmentioning

confidence: 99%

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The Repeatability of Inspiration Performance Through Different Inhalers in Patients with Chronic Obstructive Pulmonary Disease and Control Volunteers

Erdélyi

Lázár

Odler

et al. 2020

Journal of Aerosol Medicine and Pulmonary Drug Delivery

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Background: Inhalation therapy is a cornerstone of treating patients with chronic obstructive pulmonary disease (COPD). Inhaler types and through-device inhalation parameters influence airway drug delivery. We aimed to measure the repeatability of inhalation performance through four different commercially available inhalers. Methods: We recruited control subjects (n ¼ 22) and patients with stable COPD (S-COPD, n ¼ 16) and during an acute exacerbation (AE-COPD, n ¼ 15). Standard spirometry was followed by through-device inhalation maneuvers using Ellipta Ò , Evohaler Ò , Respimat Ò , and Genuair Ò. Through-device inspiratory vital capacity (IVC d) and peak inspiratory flow (PIF d), as well as inhalation time (t in) and breath hold time (t bh), were recorded and all measurements were repeated in a random manner. Results: There was no difference in forced expiratory volume in 1 second (FEV 1) between patients (S-COPD: 39-5 vs. AE-COPD: 32%-5% predicted, p > 0.05). In controls, the IVC d was significantly reduced by all four devices in comparison with the slight reduction seen in COPD patients. In all subjects, PIF was lowered when inhaling through the devices in order of decreasing magnitude in PIF d : Evohaler, Respimat, Ellipta, and Genuair. The Bland-Altman analysis showed a highly variable coefficient of repeatability for IVC d and PIF d through the different inhalers for all COPD patients. Based on the intermeasurement differences in patients, Respimat and Genuair showed the highest repeatability for IVC d , while Genuair and Ellipta performed superior with regard to PIF d. Conclusions: Our study is the first to compare repeatability of inhalation performances through different inhalers in COPD patients, showing great individual differences for parameters influencing lung deposition of inhaled medication from a given device. Our data provide new insight into the characterization of inhaler use by patients with COPD, and might aid the selection of the most appropriate devices to ensure the adequate and consistent delivery of inhaled drugs.

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“…As mentioned before, the outputs of the in silico model is the fractions of drug doses deposited in the whole respiratory tract and in distinct regions of the airways (extrathoracic, lung and exhaled value)(Kerekes et al, 2013). Airway deposition of several commercially available DPIs and pMDIs were simulated by the Stochastic Lung Deposition Model(Jókay et al, 2015;Jókay et al, 2016;Farkas et al, 2015), which was previously validated against in vivo deposition data available in the open literature.…”

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Formulation and aerodynamic evaluation of carrier-free dry powder inhalation systems containing meloxicam

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Computer modeling of airway deposition distribution of Foster ® NEXThaler ® and Seretide ® Diskus ® dry powder combination drugs

Cited by 12 publications

References 36 publications

Experimental and computational study of the effect of breath-actuated mechanism built in the NEXThaler® dry powder inhaler

Experimental and computational study of the effect of breath-actuated mechanism built in the NEXThaler® dry powder inhaler

The Repeatability of Inspiration Performance Through Different Inhalers in Patients with Chronic Obstructive Pulmonary Disease and Control Volunteers

Formulation and aerodynamic evaluation of carrier-free dry powder inhalation systems containing meloxicam

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