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

Overview

Journal J Aerosol Med Pulm Drug Deliv

Specialties Pharmacology
Pulmonary Medicine

Date 2015 Sep 16

PMID 26372466

Citations 29

Authors

Andrew C Grant

Richard Walker

Melanie Hamilton

Karl Garrill

Affiliations

Soon will be listed here.

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.

Citing Articles

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

Tanninen T, Pelkonen A, Malmberg L, Makela M J Allergy Clin Immunol Glob. 2024; 3(3):100268.

PMID: 38826625 PMC: 11141437. DOI: 10.1016/j.jacig.2024.100268.

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

Farkas A, Tomisa G, Kugler S, Nagy A, Vasko A, Kis E Int J Pharm X. 2023; 5:100167.

PMID: 36824288 PMC: 9941374. DOI: 10.1016/j.ijpx.2023.100167.

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

Hamilton M, Anderson M, Dhand R, Patmore O, Prime D, Taylor E J Aerosol Med Pulm Drug Deliv. 2023; 36(1):34-43.

PMID: 36695722 PMC: 9942181. DOI: 10.1089/jamp.2021.0061.

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

Mohan A, Wang Q, Dhapare S, Bielski E, Kaviratna A, Han L Pharmaceutics. 2022; 14(11).

PMID: 36432683 PMC: 9695470. DOI: 10.3390/pharmaceutics14112495.

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

Sulaiman M, Liu X, Sundaresan S Powder Technol. 2022; 409.

PMID: 36348745 PMC: 9638990. DOI: 10.1016/j.powtec.2022.117817.

References

Oliver A, Quinn D, Goldfrad C, van Hecke B, Ayer J, Boyce M . Combined fluticasone furoate/vilanterol reduces decline in lung function following inhaled allergen 23 h after dosing in adult asthma: a randomised, controlled trial. Clin Transl Allergy. 2012; 2(1):11. PMC: 3483689. DOI: 10.1186/2045-7022-2-11. View

Chrischilles E, Gilden D, Kubisiak J, Rubenstein L, Shah H . Delivery of ipratropium and albuterol combination therapy for chronic obstructive pulmonary disease: effectiveness of a two-in-one inhaler versus separate inhalers. Am J Manag Care. 2002; 8(10):902-11. View

Trivedi R, Richard N, Mehta R, Church A . Umeclidinium in patients with COPD: a randomised, placebo-controlled study. Eur Respir J. 2013; 43(1):72-81. DOI: 10.1183/09031936.00033213. View

Boscia J, Pudi K, Zvarich M, Sanford L, Siederer S, Crim C . Effect of once-daily fluticasone furoate/vilanterol on 24-hour pulmonary function in patients with chronic obstructive pulmonary disease: a randomized, three-way, incomplete block, crossover study. Clin Ther. 2012; 34(8):1655-66.e5. DOI: 10.1016/j.clinthera.2012.06.005. View

Miravitlles M, Soler-Cataluna J, Calle M, Soriano J . Treatment of COPD by clinical phenotypes: putting old evidence into clinical practice. Eur Respir J. 2012; 41(6):1252-6. DOI: 10.1183/09031936.00118912. View

OByrne P, Bleecker E, Bateman E, Busse W, Woodcock A, Forth R . Once-daily fluticasone furoate alone or combined with vilanterol in persistent asthma. Eur Respir J. 2013; 43(3):773-82. PMC: 3938760. DOI: 10.1183/09031936.00064513. View

Bleecker E, Lotvall J, OByrne P, Woodcock A, Busse W, Kerwin E . Fluticasone furoate-vilanterol 100-25 mcg compared with fluticasone furoate 100 mcg in asthma: a randomized trial. J Allergy Clin Immunol Pract. 2014; 2(5):553-61. DOI: 10.1016/j.jaip.2014.02.010. View

Kelleher D, Mehta R, Jean-Francois B, Preece A, Blowers J, Crater G . Safety, tolerability, pharmacodynamics and pharmacokinetics of umeclidinium and vilanterol alone and in combination: a randomized crossover trial. PLoS One. 2013; 7(12):e50716. PMC: 3524248. DOI: 10.1371/journal.pone.0050716. View

Dransfield M, Bourbeau J, Jones P, Hanania N, Mahler D, Vestbo J . Once-daily inhaled fluticasone furoate and vilanterol versus vilanterol only for prevention of exacerbations of COPD: two replicate double-blind, parallel-group, randomised controlled trials. Lancet Respir Med. 2014; 1(3):210-23. DOI: 10.1016/S2213-2600(13)70040-7. View

10.

Donohue J, Anzueto A, Brooks J, Mehta R, Kalberg C, Crater G . A randomized, double-blind dose-ranging study of the novel LAMA GSK573719 in patients with COPD. Respir Med. 2012; 106(7):970-9. DOI: 10.1016/j.rmed.2012.03.012. View

11.

Agusti A, de Teresa L, De Backer W, Zvarich M, Locantore N, Barnes N . A comparison of the efficacy and safety of once-daily fluticasone furoate/vilanterol with twice-daily fluticasone propionate/salmeterol in moderate to very severe COPD. Eur Respir J. 2013; 43(3):763-72. DOI: 10.1183/09031936.00054213. View

12.

Rau J . Practical problems with aerosol therapy in COPD. Respir Care. 2006; 51(2):158-72. View

13.

Kerwin E, Scott-Wilson C, Sanford L, Rennard S, Agusti A, Barnes N . A randomised trial of fluticasone furoate/vilanterol (50/25 μg; 100/25 μg) on lung function in COPD. Respir Med. 2013; 107(4):560-9. DOI: 10.1016/j.rmed.2012.12.014. View

14.

Hoppentocht M, Hagedoorn P, Frijlink H, de Boer A . Technological and practical challenges of dry powder inhalers and formulations. Adv Drug Deliv Rev. 2014; 75:18-31. DOI: 10.1016/j.addr.2014.04.004. View

15.

Gabrio B, Stein S, Velasquez D . A new method to evaluate plume characteristics of hydrofluoroalkane and chlorofluorocarbon metered dose inhalers. Int J Pharm. 1999; 186(1):3-12. DOI: 10.1016/s0378-5173(99)00133-7. View

16.

Boyd G . The continued need for metered dose inhalers. J Aerosol Med. 1996; 8 Suppl 1:S9-12. DOI: 10.1089/jam.1995.8.suppl_1.s-9. View

17.

Woodcock A, Bleecker E, Lotvall J, OByrne P, Bateman E, Medley H . Efficacy and safety of fluticasone furoate/vilanterol compared with fluticasone propionate/salmeterol combination in adult and adolescent patients with persistent asthma: a randomized trial. Chest. 2013; 144(4):1222-1229. PMC: 3787916. DOI: 10.1378/chest.13-0178. View

18.

Svedsater H, Dale P, Garrill K, Walker R, Woepse M . 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; 13:72. PMC: 4029771. DOI: 10.1186/1471-2466-13-72. View

19.

Laube B, Janssens H, de Jongh F, Devadason S, Dhand R, Diot P . What the pulmonary specialist should know about the new inhalation therapies. Eur Respir J. 2011; 37(6):1308-31. DOI: 10.1183/09031936.00166410. View

20.

Woodcock A, Lotvall J, Busse W, Bateman E, Stone S, Ellsworth A . Efficacy and safety of fluticasone furoate 100 μg and 200 μg once daily in the treatment of moderate-severe asthma in adults and adolescents: a 24-week randomised study. BMC Pulm Med. 2014; 14:113. PMC: 4107726. DOI: 10.1186/1471-2466-14-113. View