Comparison of Deposition in the USP and Physical Mouth–Throat Models with Solid and Liquid Particles

Zhou, Yue; Sun, Jaijie; Cheng, Yung‐Sung

doi:10.1089/jamp.2011.0882

Cited by 101 publications

(55 citation statements)

References 41 publications

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“…The size intervals corresponding to the throat, preseparator, impactor stages and MOC (micro-orifice collector) are also provided. The cut-off diameter values of the throat and prseparator were derived from the works of Roberts et al (2000), Zhou et al (2011), Marple et al (2003) and Cheng et al (2015).…”

Section: Resultsmentioning

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: Resultsmentioning

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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“…This idealized model has been the basis of many deposition studies, including deposition in aerosol drug delivery devices (14,56,57). A recent study showed that aerosol deposition in the idealized replica is in close agreement with those in the LRRI realistic mouth-throat replica for liquid aerosol and solid aerosol when the idealized replica is coated to prevent particle bounce (58). The same study also showed that the deposition in USP induction port was much lower.…”

Section: Deposition In the Oropharyngeal Regionsmentioning

confidence: 90%

Mechanisms of Pharmaceutical Aerosol Deposition in the Respiratory Tract

Cheng

2014

AAPS PharmSciTech

167

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Abstract. Aerosol delivery is noninvasive and is effective in much lower doses than required for oral administration. Currently, there are several types of therapeutic aerosol delivery systems, including the pressurized metered-dose inhaler, the dry powder inhaler, the medical nebulizer, the solution mist inhaler, and the nasal sprays. Both oral and nasal inhalation routes are used for the delivery of therapeutic aerosols. Following inhalation therapy, only a fraction of the dose reaches the expected target area. Knowledge of the amount of drug actually deposited is essential in designing the delivery system or devices to optimize the delivery efficiency to the targeted region of the respiratory tract. Aerosol deposition mechanisms in the human respiratory tract have been well studied. Prediction of pharmaceutical aerosol deposition using established lung deposition models has limited success primarily because they underestimated oropharyngeal deposition. Recent studies of oropharyngeal deposition of several drug delivery systems identify other factors associated with the delivery system that dominates the transport and deposition of the oropharyngeal region. Computational fluid dynamic simulation of the aerosol transport and deposition in the respiratory tract has provided important insight into these processes. Investigation of nasal spray deposition mechanisms is also discussed.

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“…For the experimental assessment of drug deposition in the human throat, different anatomical models are used [125][126][127] …”

Section: Dpi Design and Pulmonary Drug Deposition And Distributionmentioning

confidence: 99%

Dry powder inhalation: past, present and future

Boer

Hagedoorn

Hoppentocht

et al. 2016

Expert Opinion on Drug Delivery

223

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Introduction: Early dry powder inhalers (DPIs) were designed for low drug doses in asthma and COPD therapy. Nearly all concepts contained carrier-based formulations and lacked efficient dispersion principles. Therefore, particle engineering and powder processing are increasingly applied to achieve acceptable lung deposition with these poorly designed inhalers. Areas covered: The consequences of the choices made for early DPI development with respect of efficacy, production costs and safety and the tremendous amount of energy put into understanding and controlling the dispersion performance of adhesive mixtures are discussed. Also newly developed particle manufacturing and powder formulation processes are presented as well as the challenges, objectives, and new tools available for future DPI design. Expert opinion: Improved inhaler design is desired to make DPIs for future applications cost-effective and safe. With an increasing interest in high dose drug delivery, vaccination and systemic delivery via the lungs, innovative formulation technologies alone may not be sufficient. Safety is served by increasing patient adherence to the therapy, minimizing the use of unnecessary excipients and designing simple and self-intuitive inhalers, which give good feedback to the patient about the inhalation maneuver. For some applications, like vaccination and delivery of hygroscopic formulations, disposable inhalers may be preferred. ARTICLE HISTORY

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Comparison of Deposition in the USP and Physical Mouth–Throat Models with Solid and Liquid Particles

Cited by 101 publications

References 41 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

Mechanisms of Pharmaceutical Aerosol Deposition in the Respiratory Tract

Dry powder inhalation: past, present and future

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