Skip to main content
SpringerLink
Log in

Evaluation of an Abbreviated Impactor for Fine Particle Fraction (FPF) Determination of Metered Dose Inhalers (MDI)

  • Research Article
  • Published:
AAPS PharmSciTech Aims and scope Submit manuscript

Abstract

Abbreviated impactors have been developed recently to allow more rapid evaluation of inhalation products as alternates to the eight-stage Andersen Cascade Impactor (ACI) which has been widely used in the pharmaceutical industry for assessing aerodynamic particle size distribution. In this paper, a two-stage abbreviated impactor, Westech Fine Particle Dose Impactor (WFPD), was used to characterize the aerodynamic particle size of metered dose inhaler (MDI) products, and the results were compared with those obtained using the standard eight-stage ACI. Seven commercial MDI products, with different propellants (chlorofluorocarbon/hydrofluoroalkane) and formulation types (suspension/solution, dry/normal/wet), were tested in this study by both WFPD and ACI. Substantially equivalent measures of fine particle fraction were obtained for most of the tested MDI products, but larger coarse particle fraction and extra-fine particle fraction values were measured from WFPD relative to those measured using the ACI. Use of the WFPD also produced more wall loss than the ACI. Therefore, it is recommended that the system suitability be evaluated on a product-by-product basis to establish substantial equivalency before implementing an abbreviated impactor measurement methodology for routine use in inhaler product characterization.

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
Fig. 2
Fig. 3
Fig. 4
Fig. 5

Similar content being viewed by others

References

  1. US Food and Drug Administration. Draft guidance for industry: metered dose inhaler (MDI) and dry powder inhaler (DPI) drug products. 1998.

  2. European Medicines Agency. Guideline on the pharmaceutical quality of inhalation and nasal products. 2006.

  3. European Pharmacopeia. Section 2.9.18—preparations for inhalation: aerodynamic assessment of fine particles. European Pharmacopeia. 5 ed. 67075 Strasbourg, France: Council of Europe; 2005. p. 2799–811.

  4. United States Pharmacopeia. USP 30-NF 25; chapter 601—physical tests and determinations: aerosols. Rockville, MD, USA: United States Pharmacopeia; 2007. p. 220–40.

  5. Mitchell JP, Nagel MW, Avvakoumova V, MacKay H, Ali R. The abbreviated impactor measurement (AIM) concept: part 1—influence of particle bounce and re-entrainment—evaluation with a “dry” pressurized metered dose inhaler (pMDI)-based formulation. AAPS PharmSciTech. 2009;10(1):243–51.

    Article  PubMed  CAS  Google Scholar 

  6. Mitchell JP, Nagel MW, Avvakoumova V, MacKay H, Ali R. The abbreviated impactor measurement (AIM) concept: part II—influence of evaporation of a volatile component—evaluation with a “droplet-producing” pressurized metered dose inhaler (pMDI)-based formulation containing ethanol as cosolvent. AAPS PharmSciTech. 2009;10(1):252–7.

    Article  PubMed  CAS  Google Scholar 

  7. Mitchell JP, Nagel MW, Doyle CC, Ali RS, Avvakoumova V, Christopher JD, et al. Relative precision of inhaler aerodynamic particle size distribution (APSD) metrics by full resolution and abbreviated Andersen cascade impactors (ACIs): part 1. AAPS PharmSciTech. 2010;11(2):843–51.

    Article  PubMed  CAS  Google Scholar 

  8. Mitchell JP, Nagel MW, Doyle CC, Ali RS, Avvakoumova V, Christopher JD, et al. Relative precision of inhaler aerodynamic particle size distribution (APSD) metrics by full resolution and abbreviated Andersen cascade impactors (ACIs): part 2—investigation of bias in extra-fine mass fraction with AIM-HRT impactor. AAPS PharmSciTech. 2010;11(3):1115–8.

    Article  PubMed  CAS  Google Scholar 

  9. Keegan G, Lewis D. Rapid prototype screening with the Copley Fast Screening Andersen (FSA). In: Dalby R, Byron P, Peart J, Suman J, Young P, editors. Respiratory drug delivery 2012. River Grove: Davis HealthCare Int. Publishing; 2012. p. 469–72.

    Google Scholar 

  10. Keegan G, Lewis D. Formulation-dependent effects on aerodynamic particle size measurements using the Fast Screening Andersen (FSA). In: Dalby R, Byron P, Peart J, Suman J, Young P, editors. Respiratory drug delivery 2012. River Grove: Davis HealthCare Int. Publishing; 2012. p. 465–8.

    Google Scholar 

  11. Chambers F, Smurthwaite M. Comparative performance evaluation of the Westech Fine Particle Dose (FPD) impactor. In: Dalby R, Byron P, Peart J, Suman J, Young P, editors. Respiratory drug delivery 2012. River Grove: Davis HealthCare Int. Publishing; 2012. p. 553–7.

    Google Scholar 

  12. Andersen AA. A sampler for respiratory health assessment. Am Ind Hyg Assoc J. 1966;27(2):160–5.

    Article  PubMed  CAS  Google Scholar 

  13. Berg E, Lamb P, Ali A, Dennis J, Tservistas M, Mitchell J. Assessment of the need to coat particle collection cups of the NGI to mitigate droplet bounce when evaluating nebuliser produced droplets. PharmEuropa Sci Notes. 2008;1:21–6.

    Google Scholar 

  14. Mitchell JP, Nagel MW. Cascade impactors for the size characterization of aerosols from medical inhalers: their uses and limitations. J Aerosol Med. 2003;16:341–77.

    Article  PubMed  CAS  Google Scholar 

Download references

Disclaimer

The findings and conclusions in this article have not been formally disseminated by the Food and Drug Administration and should not be construed to represent any agency determination or policy.

Author information

Author notes

  1. Shafiq Ahadi

    Present address: Office of Regulatory Affairs, US Food and Drug Administration, 15 Sunnen Drive, Suite 113, Saint Louis, Missouri, 63143, USA

Authors and Affiliations

  1. Division of Pharmaceutical Analysis, US Food and Drug Administration, 1114 Market Street, Room 1002, St. Louis, Missouri, 63101, USA

    Changning Guo, Diem Ngo, Shafiq Ahadi & William H. Doub

Authors
  1. Changning Guo
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Diem Ngo
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Shafiq Ahadi
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. William H. Doub
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Changning Guo.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Guo, C., Ngo, D., Ahadi, S. et al. Evaluation of an Abbreviated Impactor for Fine Particle Fraction (FPF) Determination of Metered Dose Inhalers (MDI). AAPS PharmSciTech 14, 1004–1011 (2013). https://doi.org/10.1208/s12249-013-9984-7

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1208/s12249-013-9984-7

KEY WORDS

Search

Navigation