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The ELLIPTA® Dry Powder Inhaler: Design, Functionality, In Vitro Dosing Performance and Critical Task Compliance by Patients and Caregivers.

作者信息

Grant Andrew C, Walker Richard, Hamilton Melanie, Garrill Karl

机构信息

1 Engineering, Global Manufacture and Supply, GlaxoSmithKline Research and Development , Ware, Hertfordshire, United Kingdom .

2 Global Formulation, GlaxoSmithKline Research and Development , Ware, Hertfordshire, United Kingdom .

出版信息

J Aerosol Med Pulm Drug Deliv. 2015 Dec;28(6):474-85. doi: 10.1089/jamp.2015.1223. Epub 2015 Sep 15.


DOI:10.1089/jamp.2015.1223
PMID:26372466
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4685506/
Abstract

Dry powder inhalers (DPIs) are commonly used for the delivery of inhaled medications, and should provide consistent, efficient dosing, be easy to use correctly, and be liked by patients; these attributes can all affect patient compliance and therefore treatment efficacy. The ELLIPTA(®) DPI was developed for the delivery of once-daily therapies for the treatment of asthma and chronic obstructive pulmonary disease. It has moderate resistance to airflow and can hold one or two blister strips, with each blister containing a sealed single dose of medication. Monotherapies can be delivered by the single-strip configuration and, in the two-strip configuration, one dose from each strip can be aerosolized simultaneously to allow combination therapies to be delivered, which enables the formulations for each product to be developed individually, since they are stored separately until the point of administration. There are three principal operating steps to administer a dose: open, inhale, close. This article summarizes the design, functionality, and in vitro dose-delivery characteristics of the ELLIPTA inhaler, and describes the results of human factors validation tests, designed to assess the performance of critical tasks required to use the inhaler. Results from the in vitro studies indicate that the ELLIPTA inhaler performs consistently with respect to in vitro dose delivery characteristics at a range of flow rates that can be achieved by the target population (≥30 L/min) and over its 30-day in-use life. Data from the human factors validation tests demonstrated that almost all participants (≥97%) were able to complete each of the steps required to prepare a dose for inhalation without error. Overall, the ELLIPTA inhaler has a versatile single- or two-strip design that allows it to be used for the delivery of a range of treatment options. It also improves patient ease-of-use when compared with the DISKUS(®) DPI.

摘要
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c847/4685506/37916fbe888a/fig-6.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c847/4685506/d610c89b9928/fig-1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c847/4685506/bcd50db958ae/fig-2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c847/4685506/cd405de66f54/fig-3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c847/4685506/2dd84853895b/fig-4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c847/4685506/3c6ba2ed2311/fig-5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c847/4685506/94948402ba91/fig-7.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c847/4685506/37916fbe888a/fig-6.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c847/4685506/d610c89b9928/fig-1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c847/4685506/bcd50db958ae/fig-2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c847/4685506/cd405de66f54/fig-3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c847/4685506/2dd84853895b/fig-4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c847/4685506/3c6ba2ed2311/fig-5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c847/4685506/94948402ba91/fig-7.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c847/4685506/37916fbe888a/fig-6.jpg

相似文献

[1]
The ELLIPTA® Dry Powder Inhaler: Design, Functionality, In Vitro Dosing Performance and Critical Task Compliance by Patients and Caregivers.

J Aerosol Med Pulm Drug Deliv. 2015-12

[2]
Effect of Disease Severity in Asthma and Chronic Obstructive Pulmonary Disease on Inhaler-Specific Inhalation Profiles Through the ELLIPTA® Dry Powder Inhaler.

J Aerosol Med Pulm Drug Deliv. 2015-12

[3]
In Vitro Dosing Performance of the ELLIPTA® Dry Powder Inhaler Using Asthma and COPD Patient Inhalation Profiles Replicated with the Electronic Lung (eLung™).

J Aerosol Med Pulm Drug Deliv. 2015-12

[4]
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[5]
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[6]
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[7]
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BMC Pulm Med. 2013-12-7

[8]
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Int J Chron Obstruct Pulmon Dis. 2014-12-11

[9]
Dose emission characteristics of placebo PulmoSphere® particles are unaffected by a subject's inhalation maneuver.

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[10]
A randomized, open-label, single-visit, crossover study simulating triple-drug delivery with Ellipta compared with dual inhaler combinations in patients with COPD.

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引用本文的文献

[1]
Accuracy of Accuhaler, Ellipta, and Turbuhaler Testers in Patients with Chronic Obstructive Pulmonary Disease.

Med Sci (Basel). 2025-4-29

[2]
Scale-Up and Postapproval Changes in Orally Inhaled Drug Products: Scientific and Regulatory Considerations.

J Aerosol Med Pulm Drug Deliv. 2025-4

[3]
Effect of fluticasone propionate/formoterol and fluticasone furoate/vilanterol on adolescents with chronic bronchial obstruction.

J Allergy Clin Immunol Glob. 2024-4-26

[4]
The effect of exhalation before the inhalation of dry powder aerosol drugs on the breathing parameters, emitted doses and aerosol size distributions.

Int J Pharm X. 2023-2-4

[5]
Drug Delivery of a Fixed-Dose Combination of Fluticasone Furoate/Umeclidinium/Vilanterol from a Dry Powder Inhaler.

J Aerosol Med Pulm Drug Deliv. 2023-2

[6]
Advancements in the Design and Development of Dry Powder Inhalers and Potential Implications for Generic Development.

Pharmaceutics. 2022-11-17

[7]
A CFD-DEM investigation of powder transport and aerosolization in ELLIPTA® dry powder inhaler.

Powder Technol. 2022-9

[8]
Economic impact of implementing prescription of single-inhaler triple therapies versus current multiple-inhaler triple therapies for COPD in the Apulia Region.

BMC Health Serv Res. 2022-10-25

[9]
In Vitro Comparison of Two Blister-Type Inhalers.

Respir Care. 2023-3

[10]
Correct use and ease-of-use of placebo ELLIPTA dry-powder inhaler in adult patients with chronic obstructive pulmonary disease.

PLoS One. 2022

本文引用的文献

[1]
Fluticasone furoate-vilanterol 100-25 mcg compared with fluticasone furoate 100 mcg in asthma: a randomized trial.

J Allergy Clin Immunol Pract. 2014

[2]
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Respir Res. 2014-8-11

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Allergy. 2014-11

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BMC Pulm Med. 2014-7-9

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Technological and practical challenges of dry powder inhalers and formulations.

Adv Drug Deliv Rev. 2014-4-13

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Lancet Respir Med. 2013-4-12

[7]
Dose response of umeclidinium administered once or twice daily in patients with COPD: a randomised cross-over study.

BMC Pulm Med. 2014-1-6

[8]
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Chest. 2014-5

[9]
Qualitative assessment of attributes and ease of use of the ELLIPTA™ dry powder inhaler for delivery of maintenance therapy for asthma and COPD.

BMC Pulm Med. 2013-12-7

[10]
Efficacy and safety of fluticasone furoate 100 μg once-daily in patients with persistent asthma: a 24-week placebo and active-controlled randomised trial.

Respir Med. 2014-1

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