Considerations for the development and practice of cascade impaction testing, including a mass balance failure investigation tree

Journal of Aerosol Medicine: Deposition, Clearance, and Effects in the Lung

Volumn 16, Issue 3, 2003, Pages 235-247

  Christopher, Dave ^a   Strickland, Helen ^g   Tougas, Terrence ^b   Tsong, Yi ^c   Wyka, Bruce ^a   Curry, Paul ^b   Doub, Bill ^c   Furnkranz, Kenneth ^c   Lavery, Martin ^d   Lin, Karl ^c   Lyapustina, Svetlana ^e   Mitchell, Jolyon ^f   Rogers, Brian ^c  

^a MERCK RESEARCH LABORATORIES   (United States)

^b BOEHRINGER INGELHEIM PHARMACEUTICALS INC   (United States)

^c CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^d Aventis Pharma Ltd   (United Kingdom)

^e Gardner Carton and Douglas   (United States)

^f TRUDELL MEDICAL INTERNATIONAL   (Canada)

^g GLAXOSMITHKLINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AEROSOL; DEVICE; DRUG INDUSTRY; DRUG MANUFACTURE; MASS; METERED DOSE INHALER; PARTICLE SIZE; REVIEW;

AEROSOLS; CALIBRATION; EQUIPMENT DESIGN; EQUIPMENT FAILURE ANALYSIS; NEBULIZERS AND VAPORIZERS; PARTICLE SIZE;

EID: 0141540766     PISSN: 08942684     EISSN: None     Source Type: Journal    
DOI: 10.1089/089426803769017604     Document Type: Review

References (23)

1. FDA, CDER. 1998. Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products Chemistry, Manufacturing, and Controls Documentation (Docket No. 98D-0997) [On-line]. Available: www.fda.gov/cder/guidance/2180dft.pdf.
2. In July 2002, this draft Guidance was issued in final form: FDA, CDER. 2002. Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products Chemistry, Manufacturing, and Controls Documentation (Docket No. 99D-1454) [On-line]. Available: www.fda.gov/cder/guidance/4234fnl.pdf.
3. PQRI Particle Size Distribution Mass Balance Working Group. 2002. Work Plan for the Establishment of the Appropriate Use of the Particle Size Distribution Mass Balance Determined by Cascade Impactor for Orally Inhaled and Nasal Drug Products [On-line]. Available: http://pqri.org/minutes/pdfs/dptc/psdmbwg/ workplan02.pdf.
4. The ICH definition of "acceptance criteria" is used here, i.e., "numerical limits, ranges, or other suitable measures for acceptance of the results of analytical procedures." ICH. 1999. Guideline Q6A, Specifications: Test Procedures And Acceptance Criteria For New Drug Substances And New Drug Products: Chemical Substances [On-line]. Available: www.ich. org/pdfICH/q6a.pdf.
5. Other efforts undertaken by the PQRI MB Working Group will provide information related to specific acceptance criteria.
6. The ICH definition of "robustness" is understood here. ICH. 1994. Guideline Q2A, Text on Validation of Analytical Procedures [On-line]. Available: www. ich.org/pdfICH/Q2A.pdf.
7. Esmen, N.A., and Lee, T.C. 1980. Distortion of cascade impactor measured size distribution due to bounce and blow-off. Am. Industrial Hygiene Assoc. J. 41:410-419.
8. Rao, A.K., and Whitby K.T. 1977. Nonideal collection characteristics of single stage and cascade impactors. Am. Industrial Hygiene Assoc. J. 38:174-179.
9. Dolovich, M. 1991. Measurement of particle size characteristics of metered dose inhaler (MDI) aerosols. J. Aerosol Med. 4:251-263.
10. Nasr, M.M., Ross, D.L., and Miller, N.C. 1977. Effect of drug load and plate coating on the particle size distribution of a commercial albuterol metered dose inhaler (MDI) determined using the Andersen and Marple-Miller cascade impactors. Pharm. Res.14:1437-1443.
11. el-Araud, K.A., Clark, B.J., Kaahwa, C., et al. 1998. The effect of dose on the characterization of aerodynamic particle-size distributions of beclomethasone dipropionate metered-dose inhalers. J. Pharm. Pharmacol. 50:1081-1085.
12. Byron, P.R. 1994. Compendial dry powder testing: USP perspectives. In P.R. Byron, R.N. Dalby and S.J. Farr eds. Respiratory Drug Delivery IV. Interpharm Press, Buffalo Grove, IL, 153-162.
13. Podczeck, F. 1997. Optimization of the operation conditions of an Andersen cascade impactor and the relationship to centrifugal adhesion measurements to aid in the development of dry powder inhalations. Int. J. Pharm. 149:51-61.
14. This statement does not consider product-specific wall losses greater than 5% of the label claim.
15. Horton, K.D., and Mitchell. J.P. 1992. The calibration of a California measurements PC-2 quartz crystal cascade impactor. J. Aerosol Sci. 23:505-524.
16. Young, J.Y., ed. 1995. Particle Sampling Using Cascade Impactors: Some Practical Application Issues. AIHA Publications, Fairfax, VA.
17. Asking, L., and Olsson, B. 1997. Calibration at different flow rates of a multistage liquid impinger. Aerosol Sci. Technology. 27:39-49.
18. Olsson, B. 2002. Private communication.
19. Olsson, B., and Asking, L. 2003. Methods of setting and measuring flow rates in pharmaceutical impactor experiments. Pharmacopeial Forum 29:879-884.
20. Olsson, B., and Asking, L. 2002. Methods of setting and measuring flow rates in pharmaceutical impactor experiments. In Proceeding of the Drug Delivery to the Lung XIII. The Aerosol Society, London, UK, 168-171.
21. MSP Corporation. 2001. Next Generation Pharmaceutical Impactor User's Guide. Minneapolis, MN.
22. See references 1 and 2.
23. This order may be adjusted based on the results of the survey to be conducted by the PQRI PSD Mass Balance Working Group.