Standardization of techniques for using planar (2D) imaging for aerosol deposition assessment of orally inhaled products

Journal of Aerosol Medicine and Pulmonary Drug Delivery

Volumn 25, Issue SUPPL.1, 2012, Pages

  Newman, Stephen ^a   Bennett, William D ^b   Biddiscombe, Martyn ^c   Devadason, Sunalene G ^d   Dolovich, Myrna B ^e   Fleming, John ^f   Haeussermann, Sabine ^g   Kietzig, Claudius ^g   Kuehl, Philip J ^h   Laube, Beth L ⁱ   Sommerer, Knut ^g   Taylor, Glyn ^j   Usmani, Omar S ^k   Zeman, Kirby L ^b  

^a Scientific Consultant   (United Kingdom)

^b UNIVERSITY OF NORTH CAROLINA SCHOOL OF MEDICINE   (United States)

^c ROYAL BROMPTON HOSPITAL   (United Kingdom)

^d UNIVERSITY OF WESTERN AUSTRALIA   (Australia)

^e MCMASTER UNIVERSITY   (Canada)

^f UNIVERSITY HOSPITAL SOUTHAMPTON NHS FOUNDATION TRUST   (United Kingdom)

^g Inamed GmbH   (Germany)

^h LOVELACE RESPIRATORY RESEARCH INSTITUTE   (United States)

ⁱ JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^j CARDIFF UNIVERSITY   (United Kingdom)

^k NATIONAL HEART AND LUNG INSTITUTE   (United Kingdom)

more..

Author keywords

gamma scintigraphy; lung deposition; orally inhaled products; planar imaging

Indexed keywords

COBALT 57; KRYPTON 81M; MACROSALB TC 99M; PENTETATE TECHNETIUM TC 99M; TECHNEGAS; TECHNETIUM 99M; TECHNETIUM SULFUR COLLOID TC 99M; XENON 133;

AEROSOL; ARTICLE; COMPUTER ASSISTED TOMOGRAPHY; DRUG CLEARANCE; DRUG FORMULATION; DRUG HALF LIFE; GAMMA CAMERA; GAMMA RADIATION; GAMMA SCINTIGRAPHY; HUMAN; IMAGE ANALYSIS; IMAGING AND DISPLAY; INHALATION; ISOTOPE LABELING; LUNG; LUNG DEPOSIT; LUNG FUNCTION TEST; LUNG VOLUME; METERED DOSE INHALER; NEBULIZER; POWDER INHALER; PULMONARY VENTILATOR; RADIATION DOSE; RADIOACTIVITY; SINGLE PHOTON EMISSION COMPUTER TOMOGRAPHY; TWO DIMENSIONAL IMAGING;

ADMINISTRATION, INHALATION; AEROSOLS; DRUG DELIVERY SYSTEMS; HUMANS; LUNG; PHARMACEUTICAL PREPARATIONS; RADIONUCLIDE IMAGING; RADIOPHARMACEUTICALS; TECHNETIUM; TISSUE DISTRIBUTION;

EID: 84870834612     PISSN: 19412711     EISSN: 19412703     Source Type: Journal    
DOI: 10.1089/jamp.2012.1Su4     Document Type: Article

References (73)

1. Gerrity TR: Aerosol deposition using new radioaerosol imaging techniques. In: P Byron, RN Dalby, and SJ Farr, (eds). Respiratory Drug Delivery IV. Interpharm Press, Buffalo Grove, IL; pp. 179-186, 1994.
2. Lee Z, Ljungberg M, Muzic RF, and Berridge MS: Usefulness and pitfalls of planar gamma scintigraphy for measuring aerosol deposition in the lungs: a Monte Carlo investigation. J Nucl Med. 2001;42:1077-1083. (Pubitemid 32595308)
3. International Commission on Radiological Protection. Radiation Doses to Patients from Radiopharmaceuticals, ICRP Publication 80, 1998.
4. Administration of Radioactive Substance Advisory Committee: Notes for guidance on the clinical administration of radiopharmaceuticals and use of sealed radioactive sources. Health Protection Agency 2011 revision. Available at: http://www.arsac.org.uk/notes-for-guidance/documents/ ARSACNFG2006Corrected2011.pdf. Accessed October 9, 2012.
5. Law M, Cheng K-C, Wu PM, Ho WY, and Chow LWC: Patient effective dose from sentinel lymph node lymphoscintigraphy in breast cancer: a study using a female humanoid phantom and thermoluminescent dosemeters. Br J Radiol. 2003;76:818-823. (Pubitemid 37479341)
6. Stanford Dosimetry, LLC: RADAR Medical Procedure Radiation Dose Calculator and Consent Language Generator. Available at http://www.doseinfo- radar.com/RADARDose RiskCalc.html. Accessed October 9, 2012.
7. Newman SP, Pavia D, and Clarke SW: How should a pressurized beta-adrenergic bronchodilator be inhaled? Eur J Respir Dis. 1981;62:3-20. (Pubitemid 11141949)
8. Warren S, Taylor G, Smith J, Buck H, and Parry-Billings M: Gamma scintigraphic evaluation of a novel budesonide dry powder inhaler using a validated radiolabeling technique. J Aerosol Med. 2002;15:15-25. (Pubitemid 34327052)
9. Brand P, Hederer B, Austen G, Dewberry H, and Meyer T: Higher lung deposition with Respimat Soft Mist Inhaler than HFA-MDI in COPD patients with poor technique. Int J Chron Obstruct Pulmon Dis. 2008;3:763-770.
10. Coates AL, Green M, Leung K, Louca E, Tservistas M, Chan J, Ribeiro NM, and Charron M: The challenges of quantitative measurement of lung deposition using 99mTc-DTPA from delivery systems with very different delivery times. J Aerosol Med. 2007;20:320-330. (Pubitemid 47463185)
11. Dolovich MB: Practical aspects of imaging techniques employed to study aerosol deposition and clearance. In: AJ Hickey (ed). Pharmaceutical Inhalation Aerosol Technology, 2nd edit. Marcel Dekker, New York, NY; pp. 171-213, 2003.
12. Everard ML, and Dolovich MB: In vivo measurement of lung dose. In: H Bisgaard, C O'Callaghan, GC Smaldone, (eds). Drug Delivery to the Lung. Marcel Dekker, New York, NY; pp. 173-209, 2002.
13. Baskin MI, Abd AG, and Ilowite JS: Regional deposition of aerosolized pentamidine: effects of body position and breathing pattern. Ann Intern Med. 1990;113:677-683. (Pubitemid 20363640)
14. Hasani A, Agnew JE, Toms N, Black CM, Creer D, and Dilworth JP: Scintigraphic assessment of lung drug deposition distribution using a radiolabelled drug surrogate: significance of radiolabel transport post deposition as a source of error. Proceedings of Drug Delivery to the Lungs X. The Aerosol Society; pp. 96-99, 1999.
15. Walker PS, Conway JH, Fleming JS, Bondesson E, and Borgstrom L: Pulmonary clearance rate of two chemically different forms of inhaled pertechnetate. J Aerosol Med. 2001;14:209-215. (Pubitemid 32744352)
16. Bradvik I, Wollmer P, Evander E, Lárusdóttir H, Blom-Bulow B, and Jonson B: Kinetics of lung clearance of 99mTc- DTPA in smoking patients with sarcoidosis compared to healthy smokers. Respir Med. 2002;96:317-321.
17. Newman SP, Pitcairn GR, Hirst PH, and Rankin L: Radionuclide imaging technologies and their use in evaluating asthma drug deposition in the lungs. Adv Drug Deliv Rev. 2003;55:851-867. (Pubitemid 36776797)
18. Fleming JS, Conway JH, Holgate ST, Moore EA, Hashish AH, Bailey AG, and Martonen TB: Evaluation of the accuracy and precision of lung aerosol deposition measurements from planar radionuclide imaging using simulation. Phys Med Biol. 1998;43:2423-2429. (Pubitemid 28372636)
19. Bennett WD, Daviskas E, Hasani A, Mortensen J, Fleming J, and Scheuch G: Mucociliary and cough clearance as a biomarker for therapeutic development. J Aerosol Med Pulm Drug Deliv. 2010;23:261-272.
20. Sanchis J, Dolovich M, Chalmers R, and Newhouse M: Quantitation of regional aerosol clearance in the normal human lung. J Appl Physiol. 1972;33:757-762.
21. Hasani A, Pavia D, Spiteri MA, Yeo CT, Agnew JE, Clarke SW, and Chung KF: Inhaled frusemide does not affect lung mucociliary clearance in healthy and asthmatic subjects. Eur Respir J. 1994;7:1497-1500. (Pubitemid 24268338)
22. Bennett WD, Almond MA, Zeman KL, Johnson JG, and Donohue JF: Effect of salmeterol on mucociliary and cough clearance in chronic bronchitis. Pulm Pharmacol Ther. 2006;19:96-100. (Pubitemid 43052996)
23. Cross CE, Hornhof WJ, Koblik PD, and Fisher PE: Aerosol deposition: practical considerations of methodology for the direct measurement of aerosol delivery to the lung bronchiolar- alveolar surfaces. J Aerosol Med. 1992;5:39-45.
24. Burch WM, Sullivan PJ, and McLaren CJ: Technegas - a new ventilation agent for lung scanning. Nucl Med Commun. 1986;7:865-871. (Pubitemid 17221297)
25. Daviskas E, Anderson SD, Eberl S, Chan H-K, and Bautovich G: Inhalation of dry powder mannitol improves clearance of mucus in patients with bronchiectasis. Am J Respir Crit Care Med. 1999;159:1843-1848. (Pubitemid 29275053)
26. Daviskas E, Anderson SD, Eberl S, and Young IH: Effect of increasing doses of mannitol on mucus clearance in patients with bronchiectasis. Eur Respir J. 2008;31:765-772.
27. Fleming JS, Conway J, Majoral C, Tossici-Bolt L, Katz I, Caillibotte G, Perchet D, Pichelin M, Mullinger B, Martonen T, Kroneberg P, and Apiou-Sbirlea G: The use of combined single photon emission computed tomography and X-ray computed tomography to assess the fate of inhaled aerosol. J Aerosol Med Pulm Drug Deliv. 2011;24:49-60.
28. Zeman KL, Wu J, Donaldson SH, and Bennett WD: Comparison of 133Xenon ventilation equilibrium scan (XV) and 99mTechnetium transmission (TT) scan for use in regional lung analysis by 2D gamma scintigraphy in healthy and cystic fibrosis lungs. J Aerosol Med Pulm Drug Deliv. 2012; in press.
29. Brown JS, Zeman KL, and Bennett WD: Regional deposition of coarse particles and ventilation distribution in healthy subjects and patients with cystic fibrosis. J Aerosol Med. 2001;14:443-454. (Pubitemid 34008101)
30. Haeussermann S, Acerbi D, Brand P, Herpich C, Poli G, Sommerer K, and Meyer T: Lung deposition of formoterol HFA (Atimos/Forair) in healthy volunteers, asthmatics and COPD patients. J Aerosol Med. 2007;20:331-341. (Pubitemid 47463186)
31. Mo? ller W, Felten K, Meyer G, Meyer P, Seitz J, and Kreyling WG: Corrections in dose assessment of 99mTc radiolabeled aerosol particles targeted to central human airways using planar gamma camera imaging. J Aerosol Med Pulm Drug Deliv. 2009;22:45-54.
32. Coates AL, Dinh L, MacNeish CF, Rollin T, Gagnon S, Ho SL, and Lands LC: Accounting for radioactivity before and after nebulization of tobramycin to ensure accuracy of quantification of lung deposition. J Aerosol Med. 2000;13: 169-178.
33. Tothill P, and Galt JM: Quantitative profile scanning for the measurement of organ radioactivity. Phys Med Biol. 1971;16: 625-634.
34. Gonda I: Absolute and relative quantitation of deposition and clearance by scintigraphy. J Biopharm Sci. 1992;3: 191-197.
35. Fleming JS: Technique for use of standard outlines for attenuation correction and quantification in SPECT. Nucl Med Commun. 1990;11:685-696. (Pubitemid 20325113)
36. Lee Z, Berridge MS, Nelson AD, and Heald DL: The effect of scatter and attenuation on aerosol deposition as determined by gamma scintigraphy. J Aerosol Med. 2001;14: 167-183. (Pubitemid 32744349)
37. Fleming JS, Conway JH, Bolt L, and Holgate ST: A comparison of planar scintigraphy and SPECT measurement of total lung deposition of inhaled aerosol. J Aerosol Med. 2003; 16:9-19. (Pubitemid 36457649)
38. Messina MS, and Smaldone GC: Evaluation of quantitative aerosol techniques for use in bronchoprovocation studies. J Allergy Clin Immunol. 1985;75:252-257. (Pubitemid 15239078)
39. Newman SP, Woodman G, and Clarke SW: Deposition of carbenicillin aerosols in cystic fibrosis: effects of nebuliser system and breathing pattern. Thorax. 1988;43:318-322.
40. Forge NI, Mountford PJ, and O'Doherty MJ: Quantification of technetium-99m lung radioactivity from planar images. Eur J Nucl Med. 1993;20:10-15. (Pubitemid 23015330)
41. Fok TF, Al-Essa M, Kirpalnai H, Monkman S, Bowen B, Coates G, and Dolovich M: Estimation of pulmonary deposition of aerosol using gamma scintigraphy. J Aerosol Med. 1999;12:9-15. (Pubitemid 29109295)
42. Fleming JS: A technique for the absolute measurement of activity using a gamma camera and computer. Phys Med Biol. 1979;24:176-180. (Pubitemid 9097158)
43. Fleming JS, Hashish AH, Conway JH, Hartley-Davies R, Nassim MA, Guy MJ, Coupe J, Holgate ST, Moore E, Bailey AG, and Martonen TB: A technique for simulating radionuclide images from the aerosol deposition pattern in the airway tree. J Aerosol Med. 1997;10:199-212. (Pubitemid 27415414)
44. De Backer W, Devolder A, Poli G, Acerbi D, Monno R, Herpich C, Sommerer K, Meyer T, and Mariotti F: Lung deposition of BDP-formoterol HFA pMDI in healthy volunteers, asthmatic, and COPD patients. J Aerosol Med Pulm Drug Deliv. 2010;23:137-148.
45. Macey DJ, and Marshall R: Absolute quantitation of radiotracer uptake in the lungs using a gamma camera. J Nucl Med. 1982;23:731-735.
46. Pitcairn GR, and Newman SP: Tissue attenuation corrections in gamma scintigraphy. J Aerosol Med. 1997;10:187-198. (Pubitemid 27415413)
47. Biddiscombe MF, Melchor R, Mak VHF, Marriott RJ, Taylor AJ, Short MD, and Spiro SG: The lung deposition of salbutamol, directly labelled with technetium-99m, delivered by pressurised metered dose and dry powder inhalers. Int J Pharm. 1993;91:111-121. (Pubitemid 23159814)
48. Taylor G, and Warren SJ: Methods for tissue attenuation correction in inhalation pharmaceutical scintigraphy studies. In: RN Dalby, PR Byron, J Peart, JD Suman, SJ Farr, and PM Young, (eds). Respiratory Drug Delivery 2010. Davis Healthcare International, River Grove, IL; pp. 929-933, 2010.
49. Pitcairn GR, Lankinen T, Seppala O-P, and Newman SP: Pulmonary drug delivery from the Taifun dry powder inhaler is relatively independent of the patient's inspiratory effort. J Aerosol Med. 2000;13:97-104. (Pubitemid 30421868)
50. Hirst PH, Pitcairn GR, Weers JG, Tarara TE, Clark AR, Dellamary LA, Hall G, Shorr J, and Newman SP: In vivo lung deposition of hollow porous particles from a pressurized metered dose inhaler. Pharm Res. 2002;19:258-264. (Pubitemid 34211841)
51. Laube BL, Edwards AM, Dalby RN, Creticos PS, and Norman PS: The efficacy of slow versus faster inhalation of cromolyn sodium in protecting against allergen challenge in patients with asthma. J Allergy Clin Immunol. 1998;101: 475-483. (Pubitemid 28208251)
52. Laube BL, Geller DE, Lin TC, Dalby RN, Diener-West M, and Zeitlin PL: Positive expiratory pressure changes aerosol distribution in patients with cystic fibrosis. Respir Care. 2005;50:1438-1444. (Pubitemid 46888431)
53. Scheuch G, Bennett WD, Borgstrom L, Clark AR, Dalby RN, Dolovich MB, Fleming JS, Gehr P, Gonda I, O'Callaghan C, Taylor G, and Newman SP: Deposition, imaging and clearance: what remains to be done? J Aerosol Med Pulm Drug Deliv. 2010;23(Supplement 2):S39-S57.
54. Biddiscombe MF, Meah SN, Underwood SR, and Usmani OS: Comparing lung regions of interest in gamma scintigraphy for assessing inhaled therapeutic aerosol deposition. J Aerosol Med Pulm Drug Deliv. 2011;24:165-173.
55. Smaldone GC, Walser L, Perry RJ, Ilowite JS, Bennett WD, and Greco M: Generation and administration of aerosols for medical and physiological research studies. J Aerosol Med. 1989;2:81-87.
56. Short MD, Dowsett DJ, Heaf PJD, Pavia D, and Thomson ML: A comparison between monodisperse Tc-99m-labeled aerosol particles and krypton-81m for the assessment of lung function. J Nucl Med. 1979;20:194-200. (Pubitemid 9137210)
57. Agnew JE, Bateman JRM, Pavia D, and Clarke SW: A model for assessing bronchial mucus transport. J Nucl Med. 1984; 24:170-176. (Pubitemid 14187474)
58. Agnew JE, Pavia D, and Clarke SW: Airways penetration of inhaled aerosol: an index to small airways function? Eur J Respir Dis. 1981;62:239-245.
59. Usmani OS, Biddiscombe MF, and Barnes PJ: Regional lung deposition and bronchodilator response as a function of b2- agonist particle size. Am J Respir Crit Care Med. 2005;172: 1497-1504. (Pubitemid 43076536)
60. Pitcairn G, Joyson A, Hirst P, Prior D, and Newman S: Lung penetration profiles: a new method for analyzing regional lung deposition data in scintigraphic studies. In: RN Dalby, PR Byron, J Peart, and SJ Farr, (eds). Respiratory Drug Delivery VIII. Davis Horwood, Raleigh, NC; pp. 549-552, 2002.
61. Tossici-Bolt L, Fleming JS, Conway JH, and Martonen TB: Analytical technique to recover the third dimension in planar imaging of inhaled aerosols: (1) Impact on spatial quantification. J Aerosol Med. 2006;19:565-579. (Pubitemid 46067774)
62. Bennett WD, Brown JS, Zeman KL, Hu SC, Scheuch G, and Sommerer K: Targeting delivery of aerosols to different lung regions. J Aerosol Med. 2002;15:179-188. (Pubitemid 34827531)
63. Ilowite JS, Smaldone GC, Perry RJ, Bennett WD, and Foster WM: Relationship between tracheobronchial particle clearance rates and sites of initial deposition in man. Arch Environ Health. 1989;44:267-273. (Pubitemid 19232186)
64. Hasani A, Toms N, Agnew JE, Lloyd J, and Dilworth JP: Mucociliary clearance in COPD can be increased by both a D2/b2 and a standard b2 agonist. Respir Med. 2005;99: 145-151.
65. Newman SP, Hirst PH, Pitcairn GR, and Clark AR: Understanding regional lung deposition in gamma scintigraphy. In: RN Dalby, PR Byron, and SJ Farr, (eds). Respiratory Drug Delivery VI. Interpharm Press, Buffalo Grove, IL; pp. 9-15, 1998.
66. Clark AR: Understanding penetration index measurements and regional lung targeting. J Aerosol Med Pulm Drug Deliv. 2012;25:179-187.
67. Smaldone GC, Perry RJ, Bennett WD, Messina MS, Zwang J, and Ilowite L: Interpretation of ''24 hour lung retention'' in studies of mucociliary clearance. J Aerosol Med. 1988;1: 11-20.
68. Dolovich MB, Sanchis J, Rossman C, and Newhouse MT: Aerosol penetrance: a sensitive index of peripheral airways obstruction. J Appl Physiol. 1976;40:468-471.
69. Schroeter JD, Pritchard JN, Hwang D, and Martonen TB: Airway identification within planar gamma camera images using computer models of lung morphology. Pharm Res. 2005;22:1692-1699. (Pubitemid 41355909)
70. Zeman KL, Wu J, and Bennett WD: Targeting aerosolized drugs to the conducting airways using very large particles and extremely slow inhalations. J Aerosol Med Pulm Drug Deliv. 2010;23:363-369.
71. Fleming JS, and Alamaar AS: A rule based method for context sensitive threshold segmentation in SPECT using simulation. Phys Med Biol. 1998;43:2309-2323. (Pubitemid 28372625)
72. Biddiscombe MF, Barnes PJ, and Usmani OS: Generating monodisperse pharmacological aerosols using the spinningtop aerosol generator. J Aerosol Med. 2006;19:245-253. (Pubitemid 44735382)
73. Laube BL, Norman PS, Wagner HN Jr, Adams GK III: The effect of aerosol distribution on airway responsiveness to inhaled methacholine in patients with asthma. J Allergy Clin Immunol. 1992;89:510-518.