Skip to main content
SpringerLink
Log in

Effect of Human Error, Inhalation Flow, and Inhalation Volume on Dose Delivery from Ellipta® Dry-Powder Inhaler

  • Original Article
  • Published:
Journal of Pharmaceutical Innovation Aims and scope Submit manuscript

Abstract

Purpose

Ellipta® is a new dry-powder inhaler (DPI), with medium flow resistance. The present study aimed to evaluate Ellipta® dose preparation and inhalation technique and determine the effect of human factor, inhalation flow, and inhalation volume on total emitted dose (TED).

Methods

Two-hundred obstructive lung disease patients were asked to load Ellipta® dose and inhale from placebo Ellipta®, without receiving counseling (first attempt). They were divided into patients who previously used DPI (100 patients) and others who never used DPI before (100 patients). Secondly, TED of single-loaded dose from Relvar-Ellipta® was determined at different inhalation flows (20, 40, and 60 L/min) and inhalation volumes (2 and 4 L). TED was also determined after loading the dose twice at inhalation flows of 40 and 60 L/min and inhalation volume of 4 L. Doses were prepared while Ellipta® is in upright and horizontal positions.

Results

The number of handling errors performed by patients who previously used DPI was lower compared to others who never used DPI before. No significant difference was found between TEDs of 40 and 60 L/min inhalation flow at 2 or 4 L inhalation volume when loading Ellipta®, once or twice, in an upright or horizontal position. TED at inhalation flow of 20 L/min was significantly lower than at 40 and 60 L/min (p < 0.001). A 4-L inhalation volume significantly increased TED than 2 L/min only at inhalation flow of 20 L/min (p = 0.001).

Conclusions

Ellipta® is a consistent DPI. It can be used to deliver inhaled medication at a flow of ≥ 40 L/min without fear of not receiving the needed dose. It does not allow delivering double dosing.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1

Similar content being viewed by others

References

  1. Ibrahim M, Verma R, Garcia-Contreras L. Inhalation drug delivery devices: technology update. Med Devices (Auckland, NZ). 2015;8:131.

    CAS  Google Scholar 

  2. Dal Negro RW. Dry powder inhalers and the right things to remember: a concept review. Multidiscip Respir Med. 2015;10(1):13.

    Article  PubMed  PubMed Central  Google Scholar 

  3. Abdelrahim M, Assi K, Chrystyn H. Dose emission and aerodynamic characterization of the terbutaline sulphate dose emitted from a Turbuhaler at low inhalation flow. Pharm Dev Technol. 2013;18(4):944–9.

    Article  CAS  PubMed  Google Scholar 

  4. Ali AMA, Abdelrahim MEA. Modeling and optimization of terbutaline emitted from a dry powder inhaler and influence on systemic bioavailability using data mining technology. J Pharm Innov. 2014;9(1):38–47.

    Article  Google Scholar 

  5. Abdelrahim ME. Emitted dose and lung deposition of inhaled terbutaline from Turbuhaler at different conditions. Respir Med. 2010;104(5):682–9.

    Article  PubMed  Google Scholar 

  6. Chapman KR, Fogarty CM, Peckitt C, Lassen C, Jadayel D, Dederichs J, et al. Delivery characteristics and patients’ handling of two single-dose dry-powder inhalers used in COPD. Int J Chron Obstruct Pulmon Dis. 2011;6(1):353–63.

    PubMed  PubMed Central  Google Scholar 

  7. Lavorini F, Magnan A, Dubus JC, Voshaar T, Corbetta L, Broeders M, et al. Effect of incorrect use of dry powder inhalers on management of patients with asthma and COPD. Respir Med. 2008;102(4):593–604.

    Article  PubMed  Google Scholar 

  8. Newman S, Busse W. Evolution of dry powder inhaler design, formulation, and performance. Respir Med. 2002;96(5):293–304.

    Article  CAS  PubMed  Google Scholar 

  9. Tarsin W, Assi KH, Chrystyn H. In-vitro intra- and inter-inhaler flow rate-dependent dosage emission from a combination of budesonide and eformoterol in a dry powder inhaler. J Aerosol Med. 2004;17(1):25–32.

    Article  CAS  PubMed  Google Scholar 

  10. von Schantz S, Katajavuori N, Antikainen O, Juppo A. Evaluation of dry powder inhalers with a focus on ease of use and user preference in inhaler-naïve individuals. Int J Pharm. 2016;509(1):50–8.

    Article  CAS  Google Scholar 

  11. Yun Kirby S, Zhu C-Q, Kerwin EM, Stanford RH, Georges G. A preference study of two placebo dry powder inhalers in adults with COPD: Ellipta® dry powder inhaler (DPI) versus DISKUS® DPI. COPD: J Chron Obstruct Pulmon Dis. 2016;13(2):167–75.

    Article  Google Scholar 

  12. Hamilton M, Leggett R, Pang C, Charles S, Gillett B, Prime D. 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;28(6):498–506.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  13. Komase Y, Asako A, Kobayashi A, Sharma R. Ease-of-use preference for the ELLIPTA® dry powder inhaler over a commonly used single-dose capsule dry powder inhaler by inhalation device-naïve Japanese volunteers aged 40 years or older. Int J Chron Obstruct Pulmon Dis. 2014;9:1365.

    Article  PubMed  PubMed Central  Google Scholar 

  14. Grant AC, Walker R, Hamilton M, Garrill K. 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;28(6):474–85.

    Article  PubMed  PubMed Central  Google Scholar 

  15. GSK. What makes the ELLIPTA inhaler easy to use? 2018 [cited 2018 10/08/2018]. Available from: https://www.gsksource.com/pharma/content/gsk/source/us/en/brands/breo-asthma/pi/ellipta-inhaler.html.

  16. Wieshammer S, Dreyhaupt J. Dry powder inhalers: which factors determine the frequency of handling errors? Respiration. 2008;75(1):18–25.

    Article  PubMed  Google Scholar 

  17. Nicola M, Elberry AA, Sayed OM, Hussein RRS, Abdelrahim MEA. Effect of DPI’s training-device on inhalation technique and clinical efficacy in asthmatics. BJBAS. 2018;7(2):178–83.

  18. Elgendy MO, Abdelrahim ME, Salah Eldin R. Potential benefit of repeated MDI inhalation technique counselling for patients with asthma. Eur J Hosp Pharm. 2015;22:318–22.

    Article  Google Scholar 

  19. Elgendy MO, Abdelrahim ME, Eldin RS. Potential benefit of repeated dry powder inhaler’s inhalation technique counseling on asthmatic patients. Pulm Ther. 2015;1(1):91–101.

    Article  Google Scholar 

  20. Masimukku SK, Chintala R. Development and validation of stability indicating RP-HPLC method for fluticasone furoate and vilanterol in pharmaceutical formulations. Indian Drugs. 2018;55(3):27–31.

    Google Scholar 

  21. Nicola M, Elberry A, Sayed O, Hussein R, Saeed H, Abdelrahim M. The impact of adding a training device to familiar counselling on inhalation technique and pulmonary function of asthmatics. Adv Ther. 2018;35:1049–58.

    Article  PubMed  Google Scholar 

  22. Chrystyn H. The Diskus Inhaler. Clin Drug Investig. 1999;18(4):287–96.

    Article  Google Scholar 

  23. Boshra MS, Almeldien AG, Salah Eldin R, Elberry AA, Abdelwahab NS, Salem MN, et al. Total emitted dose of salbutamol sulphate at different inhalation flows and inhalation volumes through different types of dry powder inhalers. Exp Lung Res. 2018; (in press).

  24. Al-Showair RA, Pearson SB, Chrystyn H. The potential of a 2Tone Trainer to help patients use their metered-dose inhalers. Chest. 2007;131(6):1776–82.

Download references

Author information

Authors and Affiliations

  1. Clinical Pharmacy Department, Faculty of Pharmacy, Beni-suef University, Beni-suef, Egypt

    Haitham Saeed, Hoda Rabea & Mohamed E. A. Abdelrahim

  2. Pharmaceutics and Industrial Pharmacy Department, University Beni-suef University, Beni-suef, Egypt

    Heba F. Salem

  3. Clinical Pharmacy Department, Faculty of Pharmacy, Modern University for Technology and information, Cairo, Egypt

    Mohamed E. A. Abdelrahim

Authors
  1. Haitham Saeed
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Heba F. Salem
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Hoda Rabea
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Mohamed E. A. Abdelrahim
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Mohamed E. A. Abdelrahim.

Electronic Supplementary Material

ESM 1

(JPEG 5 kb)

ESM 2

(JPEG 4 kb)

ESM 3

(JPEG 5.34 kb)

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Saeed, H., Salem, H.F., Rabea, H. et al. Effect of Human Error, Inhalation Flow, and Inhalation Volume on Dose Delivery from Ellipta® Dry-Powder Inhaler. J Pharm Innov 14, 239–244 (2019). https://doi.org/10.1007/s12247-018-9352-y

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s12247-018-9352-y

Keywords

Search

Navigation