Relative precision of inhaler aerodynamic particle size distribution (APSD) metrics by full resolution and abbreviated Andersen cascade impactors (ACIs): Part 1

AAPS PharmSciTech

Volumn 11, Issue 2, 2010, Pages 843-851

  Mitchell, Jolyon P ^a   Nagel, Mark W ^a   Doyle, Cathy C ^a   Ali, Rubina S ^a   Avvakoumova, Valentina I ^a   Christopher, J David ^b   Quiroz, Jorge ^b   Strickland, Helen ^c   Tougas, Terrence ^d   Lyapustina, Svetlana ^e  

^a TRUDELL MEDICAL INTERNATIONAL   (Canada)

^b MERCK RESEARCH LABORATORIES   (United States)

^c GLAXOSMITHKLINE   (United States)

^d BOEHRINGER INGELHEIM PHARMACEUTICALS INC   (United States)

^e Drinker Biddle and Reath   (United States)

Author keywords

AIM; APSD; Impactor; Inhaler; Simplified

Indexed keywords

FLUORINATED HYDROCARBON; SALBUTAMOL; SURFACTANT; AEROSOL; RESPIRATORY TRACT AGENT;

ABBREVIATED ANDERSEN CASCADE IMPACTOR; ACCURACY; AERODYNAMIC PARTICLE SIZE DISTRIBUTION; AEROSOL; ARTICLE; DRUG DETERMINATION; DRUG DISTRIBUTION; EXPERIMENTAL DESIGN; FORCE; FULL RESOLUTION CASCADE IMPACTOR; INHALATION; MEASUREMENT; METERED DOSE INHALER; PARTICLE SIZE; PRIORITY JOURNAL; RESPIRATORY SYSTEM; SHEAR STRENGTH; SYSTEMATIC ERROR; ADMINISTRATION AND DOSAGE; CHEMISTRY; DEVICES; EQUIPMENT DESIGN; INHALATIONAL DRUG ADMINISTRATION; MATERIALS TESTING; PHARMACEUTICS; PRESSURE; REPRODUCIBILITY;

ADMINISTRATION, INHALATION; AEROSOLS; EQUIPMENT DESIGN; MATERIALS TESTING; METERED DOSE INHALERS; PARTICLE SIZE; PRESSURE; REPRODUCIBILITY OF RESULTS; RESPIRATORY SYSTEM AGENTS; TECHNOLOGY, PHARMACEUTICAL;

EID: 77954816252     PISSN: None     EISSN: 15309932     Source Type: Journal    
DOI: 10.1208/s12249-010-9452-6     Document Type: Article

References (13)

1. 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.
2. Bonam M, Christopher D, Cipolla D, Donovan B, Goodwin D, Holmes S, et al. Minimizing variability of cascade impaction measurements in inhalers and nebulizers. AAPS PharmSciTech. 2008;9(2):404-13.
3. Van Oort M, Roberts W. Variable flow-variable stage-variable volume strategy for cascade impaction testing of inhalation aerosols. In: Dalby RN, Byron PR, Farr SJ, editors. Respiratory drug delivery-V. Buffalo Grove: Interpharm Press Inc; 1996. p. 418-21.
4. Christopher D, Curry P, Doub B, Furnkranz K, Lavery M, Lin K, et al. Considerations for the development and practice of cascade impaction testing including a mass balance failure investigation tree. J Aerosol Med. 2003;16:235-47.
5. Mitchell JP. The role of aerosol measurement for aerodynamic particle size distribution (APSD) in a quality-by-design (QbD) environment. In: Dalby RN, Byron PR, Peart J, Suman JD, Farr SJ, Young PM, editors. Respiratory drug delivery 2008. River Grove: Davis Healthcare International Publishing LLC; 2008. p. 779-83.
6. Mitchell JP. The abbreviated impactor measurement (AIM) concept for aerodynamic particle size distribution (APSD) in a quality-by-design (QbD) environment. Proc. Biennial IPAC-RS Conference, Bethesda, MD, USA. 2008. http://www.ipacrs.com/ipac2008.html. Accessed 10 Sept 2009.
7. Tougas TP, Christopher D, Mitchell JP, Strickland H, Wyka B, Van Oort M, et al. Improved quality control metrics for cascade impaction measurements of orally inhaled drug products (OIPs). AAPS PharmSciTech. 2009;10(4):1276-85. doi:10.1208/s12249-009-9312-4.
8. 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.
9. USP33-NF28. Chapter <601> Aerosols, nasal sprays, metereddose inhalers, and dry powder inhalers. US Pharmacopeial Convention, Rockville, MD, USA. 2009.
10. European Pharmacopeia 6.03. Monograph 2.9.18. Preparations for inhalations: aerodynamic assessment of fine particles. European directorate for the quality of medicines (EDQM), Council of Europe, 67075 Strasbourg, France. 2009.
11. Dolovich MB, Mitchell JP. Canadian Standards Association standard CAN/CSA/Z264.1-02:2002: a new voluntary standard for spacers and holding chambers used with pressurized metereddose inhalers. Can Respir J. 2004;11(7):489-95.
12. Trudell Medical International, analytical laboratory procedure (ALP) 025: HPLC drug assay-method for Albuterol, Rev. G, July 2009.
13. Marple VA, Olson BA, Miller NC. The role of inertial collectors in evaluating pharmaceutical aerosol delivery systems. J Aerosol Med. 1998;11(S1):139-53.