Pharmacokinetic evaluation in mice of amorphous itraconazole-based dry powder formulations for inhalation with high bioavailability and extended lung retention

European Journal of Pharmaceutics and Biopharmaceutics

Volumn 86, Issue 1, 2014, Pages 46-54

  Duret, Christophe ^a   Merlos, Romain ^a   Wauthoz, Nathalie ^a   Sebti, Thami ^b   Vanderbist, Francis ^b   Amighi, Karim ^a  

^a UNIVERSITÉ LIBRE DE BRUXELLES   (Belgium)

^b SMB SA   (Belgium)

Author keywords

Amorphous; Antifungal; Aspergillosis; Dry powder; Inhalation; Insufflation; Pharmacokinetic; Poorly water soluble; Solid dispersion

Indexed keywords

ITRACONAZOLE; MANNITOL; PHOSPHOLIPID;

AERATION; ANIMAL EXPERIMENT; ANIMAL TISSUE; AREA UNDER THE CURVE; ARTICLE; ASPERGILLUS FUMIGATUS; CD-1 MOUSE; CONTROLLED STUDY; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG DOSAGE FORM COMPARISON; DRUG ELIMINATION; DRUG FORMULATION; DRUG HALF LIFE; DRUG RETENTION; DRUG SOLUBILITY; DRUG TISSUE LEVEL; DRY POWDER; IN VITRO STUDY; IN VIVO STUDY; INHALATION; MALE; MINIMUM INHIBITORY CONCENTRATION; MOUSE; NONHUMAN; SPRAY DRYING; SUSPENSION; SYNTHESIS;

AMORPHOUS; ANTIFUNGAL; ASPERGILLOSIS; DRY POWDER; INHALATION; INSUFFLATION; PHARMACOKINETIC; POORLY WATER-SOLUBLE; SOLID DISPERSION;

ANIMALS; ANTIFUNGAL AGENTS; ASPERGILLUS FUMIGATUS; BIOLOGICAL AVAILABILITY; CHEMISTRY, PHARMACEUTICAL; CRYSTALLIZATION; DRUG COMPOUNDING; DRY POWDER INHALERS; HALF-LIFE; ITRACONAZOLE; LUNG; MALE; MICE; MICE, INBRED ICR; MICROBIAL SENSITIVITY TESTS; PARTICLE SIZE; POWDERS; SOLUBILITY; SURFACE PROPERTIES; TISSUE DISTRIBUTION;

EID: 84896738432     PISSN: 09396411     EISSN: 18733441     Source Type: Journal    
DOI: 10.1016/j.ejpb.2013.03.005     Document Type: Article

References (27)

1. Thomas J. Walsh, Elias J. Anaissie, David W. Denning, R. Herbrecht, Dimitrios P. Kontoyiannis, Kieren A. Marr, Vicki A. Morrison, Brahm H. Segal, William J. Steinbach, David A. Stevens, J. Anne v. Burik, John R. Wingard, and Thomas F. Patterson Treatment of aspergillosis: clinical practice guidelines of the infectious diseases society of America Clin. Infect. Dis. 46 2008 327 360
2. C. Lass-Florl Triazole antifungal agents in invasive fungal infections: a comparative review Drugs 71 2011 2405 2419
3. J. Le, and D.S. Schiller Aerosolized delivery of antifungal agents Curr. Fungal Infect. Rep. 4 2010 96 102
4. W. Yang, K.P. Johnston, and R.O. Williams 3rd Comparison of bioavailability of amorphous versus crystalline itraconazole nanoparticles via pulmonary administration in rats Eur. J. Pharm. Biopharm. 75 2010 33 41
5. C. Duret, N. Wauthoz, T. Sebti, F. Vanderbist, and K. Amighi New respirable and fast dissolving itraconazole dry powder composition for the treatment of invasive pulmonary aspergillosis Pharm. Res. 2012
6. C. Duret, N. Wauthoz, T. Sebti, F. Vanderbist, and K. Amighi Solid dispersions of itraconazole for inhalation with enhanced dissolution, solubility and dispersion properties Int. J. Pharm. 428 2012 103 113
7. V. Codrons, F. Vanderbist, B. Ucakar, V. Preat, and R. Vanbever Impact of formulation and methods of pulmonary delivery on absorption of parathyroid hormone (1-34) from rat lungs J. Pharm. Sci. 93 2004 1241 1252
8. C. Duret, N. Wauthoz, R. Merlos, J. Goole, C. Maris, I. Roland, T. Sebti, F. Vanderbist, and K. Amighi In vitro and in vivo evaluation of a dry powder endotracheal insufflator device for use in dose-dependent preclinical studies in mice Eur. J. Pharm. Biopharm. 81 2012 627 634
9. F.O. Costa, J.J. Sousa, A.A. Pais, and S.J. Formosinho Comparison of dissolution profiles of Ibuprofen pellets J. Control. Release 89 2003 199 212
10. C. Duret, N. Wauthoz, T. Sebti, F. Vanderbist, and K. Amighi New inhalation-optimized itraconazole nanoparticle-based dry powders for the treatment of invasive pulmonary aspergillosis Int. J. Nanomed. 7 2012 5475 5489
11. W.L. Hulse, R.T. Forbes, M.C. Bonner, and M. Getrost The characterization and comparison of spray-dried mannitol samples Drug Dev. Ind. Pharm. 35 2009 712 718
12. B. Shah, V.K. Kakumanu, and A.K. Bansal Analytical techniques for quantification of amorphous/crystalline phases in pharmaceutical solids J. Pharm. Sci. 95 2006 1641 1665
13. M.J. Telko, and A.J. Hickey Dry powder inhaler formulation Respir. Care 50 2005 1209 1227
14. R.J. Bruggemann, J.W. Alffenaar, N.M. Blijlevens, E.M. Billaud, J.G. Kosterink, P.E. Verweij, and D.M. Burger Clinical relevance of the pharmacokinetic interactions of azole antifungal drugs with other coadministered agents Clin. Infect. Dis. 48 2009 1441 1458
15. S. Anttila, J. Hukkanen, J. Hakkola, T. Stjernvall, P. Beaune, R.J. Edwards, A.R. Boobis, O. Pelkonen, and H. Raunio Expression and localization of CYP3A4 and CYP3A5 in human lung Am. J. Respir. Cell Mol. Biol. 16 1997 242 249
16. J.A. Tolman, and R.O. Williams 3rd Advances in the pulmonary delivery of poorly water-soluble drugs: influence of solubilization on pharmacokinetic properties Drug Dev. Ind. Pharm. 36 2010 1 30
17. C.A. Alvarez, N.P. Wiederhold, J.T. McConville, J.I. Peters, L.K. Najvar, J.R. Graybill, J.J. Coalson, R.L. Talbert, D.S. Burgess, R. Bocanegra, K.P. Johnston, and R.O. Williams 3rd Aerosolized nanostructured itraconazole as prophylaxis against invasive pulmonary aspergillosis J. Infect. 55 2007 68 74
18. B.J. Hoeben, D.S. Burgess, J.T. McConville, L.K. Najvar, R.L. Talbert, J.I. Peters, N.P. Wiederhold, B.L. Frei, J.R. Graybill, R. Bocanegra, K.A. Overhoff, P. Sinswat, K.P. Johnston, and R.O. Williams 3rd In vivo efficacy of aerosolized nanostructured itraconazole formulations for prevention of invasive pulmonary aspergillosis Antimicrob. Agents Chemother. 50 2006 1552 1554
19. T. Osaki, T. Hanagiri, R. Nakanishi, I. Yoshino, S. Taga, and K. Yasumoto Bronchial arterial infusion is an effective therapeutic modality for centrally located early-stage lung cancer: results of a pilot study Chest 115 1999 1424 1428
20. A.T. Serajuddin Solid dispersion of poorly water-soluble drugs: early promises, subsequent problems, and recent breakthroughs J. Pharm. Sci. 88 1999 1058 1066
21. B.C. Hancock, and M. Parks What is the true solubility advantage for amorphous pharmaceuticals? Pharm. Res. 17 2000 397 404
22. S. Ozaki, I. Kushida, T. Yamashita, T. Hasebe, O. Shirai, and K. Kano Evaluation of drug supersaturation by thermodynamic and kinetic approaches for the prediction of oral absorbability in amorphous pharmaceuticals J. Pharm. Sci. 101 2012 4220 4230
23. G.L. Amidon, H. Lennernas, V.P. Shah, and J.R. Crison A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability Pharm. Res. 12 1995 413 420
24. P. Ott, M.J. Hope, A.J. Verkleij, B. Roelofsen, U. Brodbeck, and L.L. van Deenen Effect of dimyristoyl phosphatidylcholine on intact erythrocytes. Release of spectrin-free vesicles without ATP depletion Biochim. Biophys. Acta 641 1981 79 87
25. T. Lindmark, Y. Kimura, and P. Artursson Absorption enhancement through intracellular regulation of tight junction permeability by medium chain fatty acids in Caco-2 cells J. Pharmacol. Exp. Ther. 284 1998 362 369
26. N.A. Beinborn, J. Du, N.P. Wiederhold, H.D. Smyth, and R.O. Williams 3rd Dry powder insufflation of crystalline and amorphous voriconazole formulations produced by thin film freezing to mice Eur. J. Pharm. Biopharm. 81 2012 600 608
27. H. Zhou, Y. Zhang, D.L. Biggs, M.C. Manning, T.W. Randolph, U. Christians, B.M. Hybertson, and K.Y. Ng Microparticle-based lung delivery of INH decreases INH metabolism and targets alveolar macrophages J. Control. Release 107 2005 288 299