Inhalable highly concentrated itraconazole nanosuspension for the treatment of bronchopulmonary aspergillosis

European Journal of Pharmaceutics and Biopharmaceutics

Volumn 83, Issue 1, 2013, Pages 44-53

  Rundfeldt, Chris ^a   Steckel, Hartwig ^b   Scherliess, Holger ^b   Wyska, Elzbieta ^c   Wlaź, Piotr ^d  

^a Drug ConsultNet   (Germany)

^b UNIVERSITY OF KIEL   (Germany)

^c JAGIELLONIAN UNIVERSITY MEDICAL COLLEGE   (Poland)

^d MARIA CURIE SK ODOWSKA UNIVERSITY   (Poland)

Author keywords

Inhalation; Itraconazole; Nanosuspension; Nebulizer; Rat pharmacokinetics; Rat tolerability; Wet milling

Indexed keywords

ITRACONAZOLE; POLYSORBATE 80;

ALLERGIC BRONCHOPULMONARY ASPERGILLOSIS; ANIMAL EXPERIMENT; ARTICLE; CONTROLLED STUDY; DRUG BLOOD LEVEL; DRUG HALF LIFE; DRUG MEGADOSE; LUNG PARENCHYMA; MALE; NEBULIZER; NONHUMAN; PARTICLE SIZE; RAT; REPEATED DRUG DOSE; SINGLE DRUG DOSE; SUSPENSION;

ADMINISTRATION, INHALATION; ANIMALS; ANTIFUNGAL AGENTS; ASPERGILLOSIS, ALLERGIC BRONCHOPULMONARY; CYSTIC FIBROSIS; DRUG STABILITY; DRUG STORAGE; HALF-LIFE; ITRACONAZOLE; MALE; NANOPARTICLES; PARTICLE SIZE; RATS; RATS, WISTAR; SUSPENSIONS; TEMPERATURE; TISSUE DISTRIBUTION;

EID: 84871918459     PISSN: 09396411     EISSN: 18733441     Source Type: Journal    
DOI: 10.1016/j.ejpb.2012.09.018     Document Type: Article

References (44)

1. J.R. Yankaskas, B.C. Marshall, B. Sufian, R.H. Simon, and D. Rodman Cystic fibrosis adult care: consensus conference report Chest 125 2004 1S 39S
2. C.A. O'Malley Infection control in cystic fibrosis: cohorting, cross-contamination, and the respiratory therapist Respir. Care 54 2009 641 657
3. S.B. Fiel Aerosol delivery of antibiotics to the lower airways of patients with cystic fibrosis Chest 107 1995 61S 64S
4. A. Chuchalin, E. Amelina, and F. Bianco Tobramycin for inhalation in cystic fibrosis: beyond respiratory improvements Pulm. Pharmacol. Ther. 22 2009 526 532
5. M. Bothra, R. Lodha, and S.K. Kabra Tobramycin for the treatment of bacterial pneumonia in children Expert Opin. Pharmacother. 13 2012 565 571
6. E.J. Bardana Jr. The clinical spectrum of aspergillosis-part 1: epidemiology, pathogenicity, infection in animals and immunology of Aspergillus Crit. Rev. Clin. Lab. Sci. 13 1981 21 83
7. D.M. Geiser, M.A. Klich, J.C. Frisvad, S.W. Peterson, J. Varga, and R.A. Samson The current status of species recognition and identification in Aspergillus Stud. Mycol. 59 2007 1 10
8. D.W. Denning Invasive aspergillosis Clin. Infect. Dis. 26 1998 781 803
9. D.H. Griffin Spore dormancy and germination D.H. Griffin, Fungal Physiology 1994 Wiley New York 375 398
10. A.O. Soubani, and P.H. Chandrasekar The clinical spectrum of pulmonary aspergillosis Chest 121 2002 1988 1999
11. L.A. Nelson, M.L. Callerame, and R.H. Schwartz Aspergillosis and atopy in cystic fibrosis Am. Rev. Respir. Dis. 120 1979 863 873
12. R. Agarwal Allergic bronchopulmonary aspergillosis Chest 135 2009 805 826
13. E.E. Leon, and T.J. Craig Antifungals in the treatment of allergic bronchopulmonary aspergillosis Ann. Allergy Asthma Immunol. 82 1999 511 516
14. A.P. Knutsen, and R.G. Slavin Allergic bronchopulmonary aspergillosis in asthma and cystic fibrosis Clin. Dev. Immunol. 2011 10.1155/2011/843763
15. M. Skov, N. Hoiby, and C. Koch Itraconazole treatment of allergic bronchopulmonary aspergillosis in patients with cystic fibrosis Allergy 57 2002 723 728
16. J. Peeters, P. Neeskens, J.P. Tollenaere, P. Van Remoortere, and M.E. Brewster Characterization of the interaction of 2-hydroxypropyl-β- cyclodextrin with itraconazole at pH 2, 4, and 7 J. Pharm. Sci. 91 2002 1414 1422
17. J.D. Sobel Practice guidelines for the treatment of fungal infections. For the Mycoses study group. Infectious diseases society of America Clin. Infect. Dis. 30 2000 652
18. J.A. Barone, J.G. Koh, R.H. Bierman, J.L. Colaizzi, K.A. Swanson, M.C. Gaffar, B.L. Moskovitz, W. Mechlinski, and V. van de Velde Food interaction and steady-state pharmacokinetics of itraconazole capsules in healthy male volunteers Antimicrob. Agents Chemother. 37 1993 778 784
19. J.M. Poirier, S. Hardy, F. Isnard, P. Tilleul, J. Weissenburger, and G. Cheymol Plasma itraconazole concentrations in patients with neutropenia: advantages of a divided daily dosage regimen Ther. Drug Monit. 19 1997 525 529
20. D. Smith, V. van de Velde, R. Woestenborghs, and B.G. Gazzard The pharmacokinetics of oral itraconazole in AIDS patients J. Pharm. Pharmacol. 44 1992 618 619
21. A.B. Watts, J.T. McConville, and R.O. Williams III Current therapies and technological advances in aqueous aerosol drug delivery Drug Dev. Ind. Pharm. 34 2008 913 922
22. L.Y. Yeo, J.R. Friend, M.P. McIntosh, E.N. Meeusen, and D.A. Morton Ultrasonic nebulization platforms for pulmonary drug delivery Expert Opin. Drug Deliv. 7 2010 663 679
23. C.F. Pegues, E.S. Daar, and A.R. Murthy The epidemiology of invasive pulmonary aspergillosis at a large teaching hospital Infect. Control Hosp. Epidemiol. 22 2001 370 374
24. P. Vaideeswar, S. Prasad, J.R. Deshpande, and S.P. Pandit Invasive pulmonary aspergillosis: a study of 39 cases at autopsy J. Postgrad. Med. 50 2004 21 26
25. D.E. Geller, W.H. Pitlick, P.A. Nardella, W.G. Tracewell, and B.W. Ramsey Pharmacokinetics and bioavailability of aerosolized tobramycin in cystic fibrosis Chest 122 2002 219 226
26. W. Yang, J. Tam, D.A. Miller, J. Zhou, J.T. McConville, K.P. Johnston, and R.O. Williams III High bioavailability from nebulized itraconazole nanoparticle dispersions with biocompatible stabilizers Int. J. Pharm. 361 2008 177 188
27. W. Yang, K.P. Johnston, and R.O. Williams III Comparison of bioavailability of amorphous versus crystalline itraconazole nanoparticles via pulmonary administration in rats Eur. J. Pharm. Biopharm. 75 2010 33 41
28. S. Bakand, A. Hayes, and F. Dechsakulthorn Nanoparticles: a review of particle toxicology following inhalation exposure Inhal. Toxicol. 24 2012 125 135
29. P. Borm, F.C. Klaessig, T.D. Landry, B. Moudgil, J. Pauluhn, K. Thomas, R. Trottier, and S. Wood Research strategies for safety evaluation of nanomaterials, part V: role of dissolution in biological fate and effects of nanoscale particles Toxicol. Sci. 90 2006 23 32
30. D.J.W. Grant, and H.G. Brittain Physical Characterization of Pharmaceutical Solids 1995 Marcel Dekker New York
31. R.J. Hintz, and K.C. Johnson The effect of particle size distribution on dissolution rate and oral absorption Int. J. Pharm. 51 1989 9 17
32. L. Lindfors, P. Skantze, U. Skantze, M. Rasmusson, A. Zackrisson, and U. Olsson Amorphous drug nanosuspensions. 1. Inhibition of Ostwald ripening Langmuir 22 2006 906 910
33. J.M. Vaughn, J.T. McConville, D. Burgess, J.I. Peters, K.P. Johnston, R.L. Talbert, and R.O. Williams III Single dose and multiple dose studies of itraconazole nanoparticles Eur. J. Pharm. Biopharm. 63 2006 95 102
34. J.M. Vaughn, N.P. Wiederhold, J.T. McConville, J.J. Coalson, R.L. Talbert, D.S. Burgess, K.P. Johnston, R.O. Williams III, and J.I. Peters Murine airway histology and intracellular uptake of inhaled amorphous itraconazole Int. J. Pharm. 338 2007 219 224
35. H.M. Miyazaki, S. Kohno, Y. Miyazaki, K. Mitsutake, K. Tomono, M. Kaku, H. Koga, and K. Hara Efficacy of intravenous itraconazole against experimental pulmonary aspergillosis Antimicrob. Agents Chemother. 37 1993 2762 2765
36. C.M. Buchanan, N.L. Buchanan, K.J. Edgar, S. Klein, J.L. Little, M.G. Ramsey, K.M. Ruble, V.J. Wacher, and M.F. Wempe Pharmacokinetics of itraconazole after intravenous and oral dosing of itraconazole-cyclodextrin formulations J. Pharm. Sci. 96 2007 3100 3116
37. A.G. Prentice, and A. Glasmacher Making sense of itraconazole pharmacokinetics J. Antimicrob. Chemother. 56 Suppl. 1 2005 i17 i22
38. S.A. Balajee, M. Weaver, A. Imhof, J. Gribskov, and K.A. Marr Aspergillus fumigatus variant with decreased susceptibility to multiple antifungals Antimicrob. Agents Chemother. 48 2004 1197 1203
39. P.R. Burgel, M.T. Baixench, M. Amsellem, E. Audureau, J. Chapron, R. Kanaan, I. Honore, J. Dupouy-Camet, D. Dusser, C.H. Klaassen, J.F. Meis, D. Hubert, and A. Paugam High prevalence of azole-resistant Aspergillus fumigatus in adults with cystic fibrosis exposed to itraconazole Antimicrob. Agents Chemother. 56 2012 869 874
40. R. Allendoerfer, D. Loebenberg, M.G. Rinaldi, and J.R. Graybill Evaluation of SCH51048 in an experimental model of pulmonary aspergillosis Antimicrob. Agents Chemother. 39 1995 1345 1348
41. N.S. Ryder, and I. Leitner Synergistic interaction of terbinafine with triazoles or amphotericin B against Aspergillus species Med. Mycol. 39 2001 91 95
42. R. Pandey, and G.K. Khuller Antitubercular inhaled therapy: opportunities, progress and challenges J. Antimicrob. Chemother. 55 2005 430 435
43. S.J. Lin, J. Schranz, and S.M. Teutsch Aspergillosis case-fatality rate: systematic review of the literature Clin. Infect. Dis. 32 2001 358 366
44. B. Mehrad, G. Paciocco, F.J. Martinez, T.C. Ojo, M.D. Iannettoni, and J.P. Lynch III Spectrum of Aspergillus infection in lung transplant recipients: case series and review of the literature Chest 119 2001 169 175