Measurement of drug in small particles from aqueous nasal sprays by andersen cascade impactor

Pharmaceutical Research

Volumn 29, Issue 11, 2012, Pages 3122-3130

  Doub, William H ^a   Adams, Wallace P ^a   Wokovich, Anna M ^a   Black, John C ^a   Shen, Meiyu ^a   Buhse, Lucinda F ^a  

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

Author keywords

analytical chemistry; cascade impaction; drug delivery system; nasal spray

Indexed keywords

BECLOMETASONE DIPROPIONATE;

AEROSOL; ANALYTICAL EQUIPMENT; ANALYTICAL PARAMETERS; ANDERSEN CASCADE IMPACTOR; AQUEOUS SOLUTION; ARTICLE; AUTOANALYZER; AUTOMATIC ACTUATOR; AUTOMATION; BIOEQUIVALENCE; CONTROLLED STUDY; DRUG DETERMINATION; DRUG SOLUTION; EQUIPMENT DESIGN; FLOW RATE; MEASUREMENT; MOLECULAR WEIGHT; PARTICLE SIZE; PRIORITY JOURNAL; VARIANCE;

ADMINISTRATION, INHALATION; AEROSOLS; BIOLOGICAL AVAILABILITY; CHEMISTRY, PHARMACEUTICAL; EQUIPMENT DESIGN; METERED DOSE INHALERS; NASAL SPRAYS; PARTICLE SIZE; PHARMACEUTICAL SOLUTIONS; RESPIRATORY SYSTEM AGENTS;

EID: 84867845322     PISSN: 07248741     EISSN: 1573904X     Source Type: Journal    
DOI: 10.1007/s11095-012-0804-7     Document Type: Article

References (26)

1. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, June 1999, Draft Guidance for Industry, Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action. (Superseded by April 2003 Draft Guidance with same name.) [cited 6/20/2011]. Available from http://www.fda.gov/ downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070111.pdf.
2. USP 35/NF 30. Rockville: United States Pharmacopeial Convention, Inc.; 2012. <601>, Aerosols, Nasal Sprays, Metered-Dose Inhalers, and Dry Powder Inhalers; p. 232-52.
3. Newman SP, Steed KP, Hooper G, Brickwell J. Scintigraphic assessment of the oropharyngeal and nasal depositions of fusafungine from a pressurized inhaler and from a novel pump spray device. J Pharm Pharmacol. 1995;47:818-21.
4. Yu CD, Jones RE, Henesian M. Cascade impactor method for the droplet size characterization of a metered-dose nasal spray. J Pharm Sci. 1984;73:344-8.
5. Task Group on Lung Dynamics. Deposition and retention models for internal dosimetry of the human respiratory tract. Health Phys. 1966;12:173-207.
6. Suman JD, Laube BL, Dalby R. Comparison of nasal deposition and clearance of aerosol generated by a nebulizer and an aqueous spray pump. Pharm Res. 1999;16:1648-52.
7. Newman SP, Steed KP, Hardy JG, Wilding IR, Hooper G, Sparrow RA. The distribution of an intranasal insulin formulation in healthy volunteers: Effect of different administration techniques. J Pharm Pharmacol. 1994;46:657-60.
8. Newman SP, Moren F, Clarke SW. Deposition pattern of nasal sprays in man. Rhinology. 1987;26:111-20.
9. Zanen P, Laube BL. Drug delivery to the lungs. 1st ed. NY: Marcel Dekker; 2002. Chapter 7, Targeting the Lungs with Therapeutic Aerosols; p. 211-268.
10. Thorsson L, Newman SP, Weisz A, Trofast E, Morén F. Nasal distribution of budesonide inhaled via a powder inhaler. Rhinology. 1993;31:7-10.
11. Cohen B. Introduction: The first 40 years. In: Lodge Jr JP, Chen TL, editors. Cascade impactor sampling & data analysis, Chapter 1. 1st ed. Akron: American Industrial Hygiene Association; 1986.
12. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, October 1998, Draft Guidance for Industry, Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products, Chemistry, Manufacturing, and Controls Documentation. [cited 5/4/2012]. Available from http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM070573.pdf.
13. 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;9:404-13.
14. Shen X, Campbell KA, Maynard JA, Burki AR, Pilewski S. The development of an Andersen cascade impactor (ACI) method for testing of drug in small particles/droplets of nasal spray products. Poster session presented at Annual Meeting of the American Association of Pharmaceutical Scientists; Nov. 9, 2005; Nashville, TN.
15. Garmise RJ, Hickey AJ. Calibration of the Andersen cascade impactor for the characterization of nasal products. J Pharm Sci. 2008;97:3462-6.
16. See, for example: Quality Solutions for Inhaler Testing, 2010 ed., Copley Scientific; [cited 5/31/2012]. Available from: http://www.copleyscientific.com/ documents/ww/Inhaler%20Brochure%202010%20(High%20Res).pdf.
17. Hinds WC. Aerosol technology. 2nd ed. New York: Wiley; 1999. p. 125.
18. Valvo L, Paris A, Savella AL, Gallinella B, Signoretti EC. General high-performance liquid chromatographic procedures for the rapid screening of natural and synthetic corticosteroids. J Pharm Biomed Anal. 1994;12:805-10.
19. Hinds WC. Data Analysis. In: Lodge Jr JP, Chan TL, editors. Cascade impactor sampling & data analysis, Chapter 3. 1st ed. Akron: American Industrial Hygiene Association; 1986.
20. Doub WH, Adams WP. Measurement of drug in small particles/droplets from aqueous nasal spray by casade impaction. Poster session T3415 presented at Annual Meeting of the American Association of Pharmaceutical Scientists; Nov. 12, 2002; Toronto, Ontario.
21. Ziegler J, Wachtel H. Comparison of cascade impaction and laser diffraction for particle size distribution measurements. J Aerosol Med. 2005;18:311-24.
22. 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.
23. Mitchell JP. The Abbreviated Impactor Measurement (AIM) Concept for Aerodynamic Particle Size Distribution (APSD) in a Quality-by-Design (QbD) Environment. Presented at IPAC-RS conference: Doing the Right Thing in the Changing Culture of Design and Development of Inhalation and Nasal Drug Products: Science, Quality, and Patient-Focus; Sep 22-24, 2008; Bethesda, MD.
24. Mitchell JP, Nagel MW, Doyle CC, Ali RS, Avvakoumova VI, 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;11:843-51.
25. 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.
26. Dolovich MB. Assessing nebulizer performance. Respir Care. 2002;47:1290-301.