Aiming for a moving target: Challenges with impactor measurements of MDI aerosols

International Journal of Pharmaceutics

Volumn 355, Issue 1-2, 2008, Pages 53-61

  Stein, Stephen W ^a  

^a 3M COMPANY   (United States)

Author keywords

Aerodynamic particle size; Cascade impactor testing; Evaporation; Variability

Indexed keywords

ALCOHOL; BECLOMETASONE DIPROPIONATE;

AEROSOL; ARTICLE; DRY POWDER; EVAPORATION; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; MEDICAL LITERATURE; METERED DOSE INHALER; PARTICLE SIZE; PRIORITY JOURNAL;

AEROSOLS; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; EQUIPMENT DESIGN; ETHANOL; METERED DOSE INHALERS; PAPER; PARTICLE SIZE;

EID: 41349119146     PISSN: 03785173     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ijpharm.2007.11.047     Document Type: Article

References (35)

1. Berg, E., Asking, L., 2004. Nebulizer droplet size distribution-refrigerated NGI at 15 l/min. In: Dalby, R.N., Byron, P.R., Farr, S.J., Suman, J.D., Peart, J. (Eds.), Respiratory Drug Delivery IX. Palm Desert, CA (Amy David Biggs, River Grove, IL), pp. 361-363.
2. Clark, A., 1991. Metered atomization for respiratory drug delivery. Ph.D. Thesis. Loughborough University, Loughborough, UK.
3. Christopher D., Curry P., Doub B., Furnkranz K., Lavery M., Lin K., Lyapustina S., Mitchell J., Rogers B., Strickland H., Tougas T., Tsong Y., and Wyka B. Considerations for the development and practice of cascade impaction testing, including a mass balance failure investigation tree. J. Aerosol Med. 16 (2003) 235-247
4. Dolovich M., and Rhem R. Impact of oropharyngeal deposition on inhaled dose. J. Aerosol Med. 11 (1998) S112-S115
5. Finlay W.H., and Stapleton K.W. Undersizing of droplets from a vented nebulizer caused by aerosol heating during transit through an Andersen impactor. J. Aerosol Sci. 30 (1999) 105-109
6. Gabrio B.J., Stein S.W., and Velasquez D.J. A new method to evaluate plume characteristics of HFA and CFC metered dose inhalers. Int. J. Pharm. 186 (1999) 3-12
7. Gupta A., Stein S.W., and Myrdal P.B. Balancing ethanol cosolvent concentration with product performance in 134a-based pressurized metered dose inhalers. J. Aerosol Med. 16 (2003) 167-174
8. Harrison L., Leach C., Machacek J., Vanden Burgt J., and Vogel J. Beneficial effects with reduced particle size and CFC-free extrafine aerosol steroid on lung deposition, absorption, efficacy and safety. Am. J. Respir. Crit. Care Med. 155 (1997) A666
9. Hickey A.J., Martonen T.B., and Yang Y. Theoretical relationship of lung deposition to the fine particle fraction of inhalation aerosols. Pharmaceutica Acta Helvetiae 71 (1996) 185-190
10. Hinds W.C. Aerosol Technology: Properties, Behavior, and Measurement of Airborne Particles (1999), John Wiley and Sons, New York
11. Howarth P.H. Why particle size should affect clinical response to inhaled therapy. J. Aerosol Med. 14 (2001) S27-S34
12. Jauernig, J., Ohl, S., Knoch, M., Keller, M., 2004. Effects of the test set-up, formulation, and nebulizer type on aerodynamic droplet characteristics. In: Dalby, R.N., Byron, P.R., Farr, S.J., Suman, J.D., Peart, J. (Eds.), Respiratory Drug Delivery IX. Palm Desert, CA (Amy David Biggs, River Grove, IL), pp. 609-612.
13. Lange C.F., and Finlay W.H. Overcoming the adverse effect of humidity in aerosol delivery via pressurized metered dose inhalers during mechanical ventilation. Am. J. Respir. Crit. Care Med. 161 (2000) 1614-1618
14. Marple V.A. History of impactors-the first 110 years. Aerosol Sci. Technol. 38 (2004) 247-292
15. May K.R. The cascade impactor: an instrument for sampling coarse aerosols. J. Sci. Instrum. 22 (1945) 187-195
16. Meakin, B.J., Lewis, D.A., Ganderton, D., Brambilla, G., 2000. Countering challenges posed by mimicry of CFC performance using HFA systems. In: Dalby, R.N., Byron, P.R., Farr, S.J., Peart, J. (Eds.), Respiratory Drug Delivery VII. Tarpon Springs, FL (Serentec Press, Raleigh, NC), pp. 99-107.
17. Mitchell J.P., Nagel M.W., Wiersema K.J., Doyle C.C., and Migounov V.A. The delivery of chlorofluorocarbon-propelled versus hydrofluoroalkane-propelled beclomethasone dipropionate aersosol to the mechanically ventilated patient: a laboratory study. Respir. Care 48 (2003) 1025-1032
18. Mitchell J.P., and Nagel M.W. Cascade impactors for the size characterization of aerosols from medical inhalers: their uses and limitations. J. Aerosol Med. 16 (2003) 341-377
19. Morrow P.E. Deposition and retention models for internasal dosimetry of the human respiratory tract. Health Phys. 12 (1966) 173-207
20. Myrdal P., Stein S., Mogalian E., Hoye W., and Gupta A. Comparison of the TSI model 3306 impactor inlet with the andersen cascade impactor: solution metered dose inhalers. Drug Deliv. Ind. Pharm. 30 (2004) 859-868
21. Myrdal P., Mogalian E., Mitchell J., Nagel M., Wright C., Kiser B., Prell M., Woessner M., and Stein S. Application of heated inlet extensions to the TSI 3306/3321 system: comparison with the andersen cascade impactor and next generation impactor. J. Aerosol Med. 19 (2006) 543-554
22. Naini V., Chaudhry S., Berry J., Sharpe S., Hart J., and Sequeira J. Entry port selection for detecting particle size differences in metered dose inhaler formulations using cascade impaction. Drug Deliv. Ind. Pharm. 30 (2004) 75-82
23. Smyth, H.D.C., Hickey, A.J., 2003. Multimodal particle size distributions emitted from HFA-134a solution pressurized metered-dose inhalers. AAPS PharmSciTech [http://www.aapspharmscitech.org], 4(3) Article 38.
24. Stein S.W. Size distribution measurements of metered dose inhalers using Andersen Mark II cascade impactors. Int. J. Pharm. 186 (1999) 43-52
25. Stein S.W., and Olson B.A. Variability in size distribution measurements obtained using multiple Andersen Mark II cascade impactors. Pharm. Res. 14 (1997) 1718-1725
26. Stein, S.W., Gabrio, B.J., Beck, T.J., 2000. Evaluation of a new aerodynamic particle sizer spectrometer for MDI size distribution measurements. In: Dalby, R.N., Byron, P.R., Farr, S.J., Peart, J. (Eds.), Respiratory Drug Delivery VII. Tarpon Springs, FL (Serentec Press, Raleigh, NC), pp. 283-286.
27. Stein, S.W., Gabrio, B.J., 2000. Understanding throat deposition during cascade impactor testing in respiratory drug delivery VII. In: Dalby, R.N., Byron, P.R., Farr, S.J., Peart, J. (Eds.), Respiratory Drug Delivery VII. Tarpon Springs, FL (Serentec Press, Raleigh, NC), pp. 287-290.
28. Stein S.W., Gabrio B.J., Oberreit D., Hairston P., Myrdal P.B., and Beck T.J. An evaluation of mass-weighted size distribution measurements with the Model 3320 aerodynamic particle sizer. Aerosol Sci. Technol. 36 (2002) 1-10
29. Stein S.W., and Stefely J.S. Reinventing metered dose inhalers: from poorly efficient CFC MDIs to highly efficient HFA MDIs. Drug Deliv. Technol. 3 (2003) 46-51
30. Stein S.W., Myrdal P.B., Gabrio B.J., Obereit D., and Beck T.J. Evaluation of a new aerodynamic particle sizer spectrometer for size distribution measurements of solution metered dose inhalers. J. Aerosol Med. 16 (2003) 107-119
31. Stein S., and Myrdal P. A theoretical and experimental analysis of formulation and device parameters affecting solution MDI size distributions. J. Pharm. Sci. 93 (2004) 2158-2175
32. Stein S., and Myrdal P. The relative influence of evaporation and atomization on metered dose inhaler drug delivery efficiency. Aerosol Sci. Technol. 40 (2006) 335-347
33. United States Pharmacopeia, 1996. Physical tests and determinations <601> aerosols, metered dose inhalers, and dry powders. Pharmacopeial Forum 22, pp. 3065-3095.
34. Van Oort M., Gollmar R.O., and Bohinski R.J. Effects of sampling chamber volume and geometry on aerodynamic size distribution of metered-dose inhalation aerosols measured with the Andersen cascade impactor. Pharm. Res. 11 (1994) 604-607
35. Zhang Y., Finlay W.H., and Matida E.A. Particle deposition measurements and numerical simulations in a highly idealized mouth-throat. Aerosol Sci. 35 (2004) 789-803