Determination of lung deposition following inhalation of ciclesonide using different bioanalytical procedures

Bioanalysis

Volumn 2, Issue 4, 2010, Pages 807-814

  Nave, Rüdiger ^a  

^a Nycomed GmbH   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

CICLESONIDE; TECHNETIUM 99M; PREGNANE DERIVATIVE;

ASTHMA; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG DISTRIBUTION; DRUG DOSAGE FORM COMPARISON; DRUG EXCRETION; DRUG MEGADOSE; DRUG METABOLISM; DRUG TISSUE LEVEL; HUMAN; LUNG SCINTISCANNING; MASS SPECTROMETRY; REVERSED PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; REVIEW; SINGLE DRUG DOSE; SYSTEMIC CIRCULATION; ANIMAL; CHEMICAL ANALYSIS; INHALATIONAL DRUG ADMINISTRATION; LUNG; METABOLISM; METHODOLOGY;

ADMINISTRATION, INHALATION; ANIMALS; CHEMISTRY TECHNIQUES, ANALYTICAL; HUMANS; LUNG; PREGNENEDIONES;

EID: 79952457291     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.10.21     Document Type: Review

References (40)

1. US NIH. National Heart, Lung, and Blood Institute. National Asthma Education and Prevention Program. Expert panel report 3: guidelines for the diagnosis and management of asthma. Summary Report 2007. J. Allergy Clin. Immunol. 120, 94-138 (2007).
2. Levy ML, Thomas M, Small I, Pearce L, Pinnock H, Stephenson P. Summary of the 2008 BTS/SIGN British guideline on the management of asthma. Prim.Care Respir. J. 18(Suppl. 1), S1-S16 (2009).
3. Kelly HW. Establishing a therapeutic index for the inhaled corticosteroids: part I. Pharmacokinetic/pharmacodynamic comparison of the inhaled corticosteroids. J. Allergy Clin. Immunol. 102(4 Pt 2), 36-51 (1998).
4. Derendorf H. Pharmacokinetic and pharmacodynamic properties of inhaled corticosteroids in relation to efficacy and safety. Respir. Med. 91(Suppl. A), 22-28 (1997). (Pubitemid 27453647)
5. Allen DB, Bielory L, Derendorf H et al. Inhaled corticosteroids: past lessons and future issues. J. Allergy Clin. Immunol. 112(3 Suppl.), 1-40 (2003).
6. Pearlman DS, Berger WE, Kerwin E et al. Once-daily ciclesonide improves lung function and is well tolerated by patients with mild-to-moderate persistent asthma. J. Allergy Clin. Immunol. 116 (6), 1206-1212 (2005). (Pubitemid 41740924)
7. Langdon CG, Adler M, Mehra S et al. Once-daily ciclesonide 80 or 320 microg for 12 weeks is safe and effective in patients with persistent asthma. Respir. Med. 99(10), 1275-1285 (2005). (Pubitemid 41245314)
8. Buhl R, Vinkler I, Magyar P et al. Comparable efficacy of ciclesonide once daily versus fluticasone propionate twice daily in asthma. Pulm. Pharmacol. Ther. 19(6), 404-412 (2005). (Pubitemid 44234118)
9. Dietzel K, Engelstätter R, Keller A. Ciclesonide: an on-site-activated steroid. In: New Drugs for Asthma, Allergy and COPD. Hansel TT, Barnes PJ (Eds). Karger, Basel, Switzerland, 91-93 (2001). (Pubitemid 33253203)
10. Nave R. Clinical pharmacokinetic and pharmacodynamic profile of inhaled ciclesonide. Clin. Pharmacokinet. 48, 243-252 (2009).
11. Lipworth BJ. Systemic adverse effects of inhaled corticosteroid therapy: a systematic review and meta-analysis. Arch. Intern. Med. 159, 941-955 (1999). (Pubitemid 29222495)
12. Rohatagi S, Rhodes GR, Chaikin P. Absolute oral versus inhaled bioavailability: significance for inhaled drugs with special reference to inhaled glucocorticoids. J. Clin. Pharmacol. 39(7), 661-663 (1999).
13. Rohatagi S, Appajosyula S, Derendorf H et al. Risk-benefit value of inhaled glucocorticoids: a pharmacokinetic/ pharmacodynamic perspective. J. Clin. Pharmacol. 44(1), 37-47 (2004). (Pubitemid 38005092)
14. Leach CL, Davidson PJ, Hasselquist BE, Boudreau RJ. Lung deposition of hydrofluoroalkane-134a beclomethasone is greater than that of chlorofluorocarbon fluticasone and chlorofluorocarbon beclomethasone: a cross-over study in healthy volunteers. Chest 122, 510-516 (2002). (Pubitemid 35002128)
15. Warren S, Taylor G, Smith J, Buck H, Parry-Billings M. g-scintigraphic evaluation of a novel budesonide dry powder inhaler using a validated radiolabeling technique. J. Aerosol. Med. 15, 15-25 (2002). (Pubitemid 34327052)
16. Pickering H, Pitcairn GR, Hirst PH et al. Regional lung deposition of a technetium 99m-labeled formulation of mometasone furoate administered by hydrofluoroalkane 227 metered-dose inhaler. Clin Ther. 22, 1483-1493 (2000). (Pubitemid 32056086)
17. Minshall EM, Hogg JC, Hamid QA. Cytokine mRNA expression in asthma is not restricted to the large airways. J. Allergy Clin. Immunol. 101(3), 386-390 (1998). (Pubitemid 28146359)
18. Derendorf H, Nave R, Drollmann A, Cerasoli F, Wurst W. Relevance of pharmacokinetics and pharmacodynamics of inhaled corticosteroids to asthma. Eur. Respir. J. 28, 1042-1050 (2006). (Pubitemid 46335529)
19. Chalupa DC, Morrow PE, Oberdorster G et al. Ultrafine particle deposition in subjects with asthma. Environ. Health Perspect. 112(8), 879-882 (2004). (Pubitemid 38811931)
20. Thongngarm T, Silkoff PE, Kossack WS et al. Hydrofluoroalkane-134A beclomethasone or chlorofluorocarbon fluticasone: effect on small airways in poorly controlled asthma. J. Asthma 42(4), 257-263 (2005). (Pubitemid 40967717)
21. Leach C, Bethke T, Boudreau R et al. 2D and 3D imaging show ciclesonide has high lung deposition and peripheral distribution: a nonrandomized study in healthy volunteers. J. Aerosol. Med. 19(2), 117-126 (2006). (Pubitemid 43993378)
22. Newman S, Salmon A, Nave R et al. High lung deposition of (99m)Tc-labeled ciclesonide administered via HFA-MDI to patients with asthma. Respir. Med. 100(3), 375-384 (2006). (Pubitemid 43239871)
23. Newman SP, Pitcairn GR, Hirst PH, Rankin L. Radionuclide imaging technologies and their use in evaluating asthma drug deposition in the lungs. Adv. Drug Deliv. Rev. 55, 851-867 (2003). (Pubitemid 36776797)
24. Fleming JS, Conway JH. Three-dimensional imaging of aerosol deposition. J. Aerosol. Med. 14, 147-153 (2001). (Pubitemid 32744347)
25. Conway JH, Halson P, Moore E. Multimodality imaging: the use of single photon emission computed tomography and magnetic resonance imaging to assess regional intrapulmonary deposition of nebulised aerosols. J. Aerosol. Med. 8, 293-295 (1995).
26. Nave R, McCracken N. Metabolism of ciclesonide in the upper and lower airways. Review of available data. J. Asthma Allergy 1, 11-18 (2008).
27. Nave R, Hoffmann H, Watz H, Boss H, Magnussen H. Deposition and metabolism of inhaled cilclesonide in the human lung. Eur. Resp. J. (Ahead of press).
28. Chapman KR, Patel P, D"Urzo AD et al. Maintenance of asthma control by once-daily inhaled ciclesonide in adults with persistent asthma. Allergy 60, 330-337 (2005). (Pubitemid 40293349)
29. Mascher HJ, Zech K, Mascher DG. Sensitive simultaneous determination of ciclesonide, ciclesonide-M1-metabolite and fluticasone propionate in human serum by HPLC-MS/MS with APPI. J. Chromatogr. B 869, 84-92 (2008).
30. Nave R, Bethke TD, Seiberling M et al. Pharmacokinetics and pharmacodynamics of ciclesonide and its active principle after inhalative and intravenous administration in healthy subjects. Eur. Respir. J. 20(Suppl. 38), 749 (2002).
31. Nave R, Fisher R, Zech K. In vitro metabolism of ciclesonide in human lung and liver precision-cut tissue slices. Biopharm. Drug Dispos. 27, 197-207 (2006). (Pubitemid 43797116)
32. Mutch E, Nave R, McCracken N et al. The role of esterases in the metabolism of ciclesonide to desisobutyryl-ciclesonide in human tissue. Biochem. Pharmacol. 73(10), 1657-1664 (2007). (Pubitemid 46527549)
33. Nave R, Bethke TD, van Marle SP et al. Pharmacokinetics of 14C ciclesonide after oral and intravenous administration to healthy subjects. Clin. Pharmacokinet. 43(7), 479-486 (2004). (Pubitemid 38716505)
34. Drollmann A, Nave R, Steinijans VW et al. Equivalent pharmacokinetics of the active metabolite of ciclesonide with and without use of the AeroChamber Plus spacer for inhalation. Clin. Pharmacokinet. 45, 729-736 (2006). (Pubitemid 43990573)
35. Bethke TD, Drollmann A, Hauns B et al. Bioequivalence of two ciclesonide dosing regimen (4 puffs of 200 μg vs. 16 puffs of 50 μg using a MDI). Eur. Respir. J. 20(Suppl. 38), 1914 (2002).
36. Drollmann A, Bethke TD, Nave R et al. Bioequivalence of two ciclesonide dosing regimen (4 puffs of 200 μg vs. 8 puffs of 100 μg using a MDI). Eur. Respir. J. 20(Suppl. 38), 1914 (2002).
37. Pedersen S, Frost L, Arnfred T. Errors in inhalation technique and efficiency in inhaler use in asthmatic children. Allergy 41, 118-124 (1986). (Pubitemid 16044352)
38. Vella C, Grech V. Assessment of use of spacer devices for inhaled drug delivery to asthmatic children. Pediatr. Allergy Immunol. 16, 258-261 (2005). (Pubitemid 40638055)
39. Boss H, Minic P, Nave R. Similar results for steady state pharmacokinetic parameters of ciclesonide inhaled with or without the spacer in children with asthma. Clin. Med. Pediatrics (Ahead of press).
40. Nave R, Gunawardena KA, Zech K et al. Pharmacokinetic disposition of inhaled ciclesonide and its metabolite desisobutyryl-ciclesonide in healthy subjects and patients with asthma are similar. Int. J. Clin. Pharmacol. Ther. 44(1), 1-7 (2006). (Pubitemid 43085491)