Preclinical evaluation of tacrolimus colloidal dispersion for inhalation

European Journal of Pharmaceutics and Biopharmaceutics

Volumn 77, Issue 2, 2011, Pages 207-215

  Watts, Alan B ^a   Peters, Jay I ^b   Talbert, Robert L ^b   O'Donnell, Kevin P ^a   Coalson, Jacqueline J ^c   Williams III, Robert O ^a  

^a UNIVERSITY OF TEXAS AT AUSTIN   (United States)

^b UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT SAN ANTONIO   (United States)

^c University of Texas Health Science Center   (United States)

Author keywords

Amorphous; Colloidal; Inhalation; Preclinical; Safety; Tacrolimus

Indexed keywords

TACROLIMUS;

ANIMAL CELL; ANIMAL EXPERIMENT; ANIMAL MODEL; ANIMAL TISSUE; ARTICLE; BLOOD CHEMISTRY; CHRONIC GRAFT REJECTION; CLINICAL EVALUATION; CONTROLLED STUDY; DRUG ELIMINATION; DRUG POTENCY; HISTOPATHOLOGY; KIDNEY FUNCTION; LIVER FUNCTION; LUNG GRAFT REJECTION; LUNG INJURY; LUNG PARENCHYMA; LUNG TRANSPLANTATION; MACROPHAGE; NONHUMAN; RAT;

ADMINISTRATION, INHALATION; ANIMALS; BLOOD CELL COUNT; CLINICAL CHEMISTRY TESTS; COLLOIDS; DRUG EVALUATION, PRECLINICAL; DRUG STABILITY; FEMALE; GRAFT REJECTION; IMMUNOSUPPRESSIVE AGENTS; LACTOSE; LUNG; LUNG TRANSPLANTATION; MALE; NEBULIZERS AND VAPORIZERS; POWDER DIFFRACTION; RATS; SOLUBILITY; TACROLIMUS; TRANSPLANTATION, HOMOLOGOUS;

EID: 79551540883     PISSN: 09396411     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ejpb.2010.11.013     Document Type: Article

References (51)

1. J.D. Christie, L.B. Edwards, P. Aurora, F. Dobbels, R. Kirk, A.O. Rahmel, D.O. Taylor, A.Y. Kucheryavaya, and M.I. Hertz Registry of the international society for heart and lung transplantation: twenty-fifth official adult lung and heart/lung transplantation report-2008 J. Heart Lung Transplant. 27 9 2008 957 969
2. J.D. Crapo, A.G. Harmsen, M.P. Sherman, and R.A. Musson Pulmonary immunobiology and inflammation in pulmonary diseases Am. J. Respir. Crit. Care Med. 162 5 2000 1983 1986
3. C. Knoop, A. Haverich, and S. Fisher Immunosuppressive therapy after human lung transplantation Eur. Respir. J. 23 2004 159 171
4. T. Wang, S. Noonberg, R. Steigerwalt, M. Lynch, R.A. Kovelesky, C.A. Rodriguez, K. Sprugel, and N. Turner Preclincial safety evaluation of inhaled cyclosporine in propylene glycol J. Aerosol Med. 20 4 2007 417 428
5. R.J. Keenan, A.T. Iacono, J.H. Dauber, A. Zeevi, S.A. Yousem, N.P. Ohori, G.J. Burckart, A. Kawai, G.C. Smaldone, and B.P. Griffith Treatment of refractory acute allograft rejection with aerosolized cyclosporine in lung transplant recipients J. Thorac. Cardiovasc. Surg. 113 2 1997 335 341
6. A.T. Iacono, T.E. Corcoran, B.P. Griffith, W.F. Grgurich, D.A. Smith, A. Zeevi, G.C. Smaldone, K.R. McCurry, B.A. Johnson, and J.H. Dauber Aerosol cyclosporin therapy in lung transplant recipients with bronchiolitis obliterans Eur. Respir. J. 23 2004 384 390
7. A.T. Iacono, B.A. Johnson, W.F. Grgurich, J.G. Youssef, T.E. Corcoran, D.A. Seiler, J.H. Dauber, G.C. Smaldone, A. Zeevi, S.A. Yousem, J.J. Fung, G.J. Burckart, K.R. McCurry, and B.P. Griffith A randomized trial of inhaled cyclosporine in lung-transplant recipients New Engl. J. Med. 354 2 2006 141 150
8. T.E. Corcoran Inhaled delivery of aerosolized cyclosporine Adv. Drug Deliv. Rev. 58 9-10 2006 1119 1127
9. W.H. Finlay, C.F. Lange, M. King, and D.P. Speert Lung delivery of aerosolized dextran Am. J. Respir. Crit. Care Med. 161 2000 91 97
10. T. Kino, H. Hatanaka, S. Miyata, N. Inamura, M. Nishiyama, T. Yajima, T. Goto, M. Okuhara, M. Kohsaka, and H. Aoki FK-506, a novel immunosuppressant isolated from a Streptomyces. II. Immunosuppressive effect of FK-506 in vitro J. Antibiot. (Tokyo) 40 6 1987 1256 1265 (Pubitemid 17138110)
11. R.J. Keenan, H. Konishi, A. Kawai, I.L. Paradis, D.R. Nunley, A.T. Iacono, R.L. Hardesty, R.J. Weyant, and B.P. Griffith Clinical trial of tacrolimus versus cyclosporine in lung transplantation Ann. Thorac. Surg. 60 3 1995 580 584
12. S. Hariharan, V.R. Peddi, R. Munda, A.M. Demmy, T.J. Schroeder, J.W. Alexander, and M.R. First Long-term renal and pancreas function with tacrolimus rescue therapy following kidney/pancreas transplantation Transplant. Proc. 29 1997 652 653
13. J.G. O'Grady, A. Burroughs, P. Hardy, D. Elboume, and A. Truesdale Tacrolimus versus microemulsified ciclosproin in liver transplantation: the TMC randomised controlled trial Lancet 360 2002 1119 1125
14. A.M. Craig, T. McKechnie, M. McKenna, W. Klein, and T.M. Schindler A cost-effectiveness analysis of tacrolimus versus cyclosporine microemulsion following kidney transplantation Transplant. Proc. 34 2002 1646 1648
15. N. Matsuo, T. Shimoda, K. Mitsuta, C. Fukushima, H. Matsuse, Y. Obase, and S. Kohno Tacrolimus inhibits cytokine production and chemical mediator release following antigen stimulation of passively sensitized human lung tissues Ann. Allergy Asthma Immunol. 86 2001 671 678
16. H.U. Meier-Kriesche, S. Li, R.W.G. Gruessner, J.J. Fung, R.T. Bustami, M.L. Barr, and A.B. Leichtman Immunosuppression: evolution in practice and trends, 1994-2004 Am. J. Transplant. 6 5p2 2006 1111 1131
17. A. Yamauchi, I. Ieiri, Y. Kataoka, M. Tanabe, T. Nishizaki, R. Oishi, S. Higuchi, K. Otsubo, and K. Sugimach Neurotoxicity induced by tacrolimus after liver transplantation: relation to genetic polymorphisms of the ABCB1 (MDR1) gene Transplantation 74 4 2002 571 578
18. O. Heisel, R. Heisel, R. Balshaw, and P. Keown New onset diabetes mellitus in patients receiving calcineurin inhibitors: a systematic review and meta-analysis Am. J. Transplant. 4 4 2004 583 595
19. L. Scott, K. McKeage, S. Keam, and G. Plosker Tacrolimus: a further update of its use in the management of organ transplantation Drugs 63 12 2003 1247 1297
20. P. Sinswat, K.A. Overhoff, J.T. McConville, K.P. Johnston, and R.O. Williams III Nebulization of nanoparticulate amorphous or crystalline tacrolimus - single-dose pharmacokinetics study in mice Eur. J. Pharm. Biopharm. 69 3 2008 1057 1066
21. K.A. Overhoff, J.D. Engstrom, B. Chen, B.D. Scherzer, T.E. Milner, K.P. Johnston, and R.O. Williams III Novel ultra-rapid freezing particle engineering process for enhancement of dissolution rates of poorly water-soluble drugs Eur. J. Pharm. Biopharm. 65 1 2007 57 67
22. N.M. Davies, and M.R. Feddah A novel method for assessing dissolution of aerosol inhaler products Int. J. Pharm. 255 1-2 2003 175 187
23. R.O. Cook, R.K. Pannu, and I.W. Kellaway Novel sustained release microspheres for pulmonary drug delivery J. Control. Release 104 1 2005 79 90
24. T. Akashi, T. Nefuji, M. Yoshida, and J. Hosoda Quantitative determination of tautomeric FK506 by reversed-phase liquid chromatography J. Pharm. Biomed. Anal. 14 1996 339 346
25. A.B. Watts, A.M. Cline, A.R. Saad, S.B. Johnson, J.I. Peters, and R.O. Williams Characterization and pharmacokinetic analysis of tacrolimus dispersion for nebulization in a transplanted rodent model Int. J. Pharm. 384 1-2 2010 46 52
26. N. Cimolai, G.P. Taylor, D. Mah, and B.J. Morrison Definition and application of a histopathological scoring scheme for an animal model of acute mycoplasma pneumoniae pulmonary infection Microbiol. Immunol. 36 5 1992 465 478
27. K. Yamashita, T. Nakate, K. Okimoto, A. Ohike, Y. Tokunaga, R. Ibuki, K. Higaki, and T. Kimura Establishment of new preparation method for solid dispersion formulation of tacrolimus Int. J. Pharm. 267 2003 79 91
28. E.C. Gryparis, G. Mattheolabakis, D. Bikiaris, and K. Avgoustakis Effect of conditions of preparation on the size and encapsulation properties of PLGA-mPEG nanoparticles of cisplatin Drug Deliv. 14 6 2007 371 380
29. ICH, International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, Impurities in New Drug Products: Q3B(R2), Geneva, Switzerland, 2006. < http://www.ich.org/LOB/media/ MEDIA421.pdf >.
30. ICH, International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, Impurities: Guidelines for Residual Solvents Q3B(R3), Geneva, Switzerland, 2006. < http://www.ich.org/ LOB/media/MEDIA423.pdf >.
31. S.E. Lucangioli, E. Kenndler, A. Carlucci, V.P. Tripodi, S.L. Scioscia, and C.N. Carducci Relation between retention factors of immunosuppressive drugs in microemulsion electrokinetic chromatography with biosurfactants and octanol-water partition coefficients J. Pharm. Biomed. Anal. 33 5 2003 871 878
32. G.J. Burckart, G.C. Smaldone, M.A. Eldon, R. Venkataramanan, J. Dauber, A. Zeevi, K.R. McCurry, T. McKaveney, T.E. Corcoran, B.P. Griffith, and A.T. Iacono Lung deposition and pharmacokinetics of cyclosporine after aerosolization in lung transplant patients Pharm. Res. 20 2 2003 252 256
33. S.M. McAllister, H.O. Alpar, Z. Teitelbaum, and D.B. Bennett Do interactions with phospholipids contribute to the prolonged retention of polypeptides within the lung? Adv. Drug Deliv. Rev. 19 1 1996 89 110
34. O. Canadas, R. Guerrero, R. Garcia-Canero, G. Orellana, M. Menendez, and C. Casals Characterization of liposomal tacrolimus in lung surfactant-like phospholipids and evaluation of its immunosuppressive activity Biochemistry 43 30 2004 9926 9938
35. R. Kawai, K. Ochiai, A. de Fraissinette, K. Hoshiko, A. Nakashima, and N. Masuda Pharmacokinetic assessment of pulmonary absorption and accumulation after inhalation of a cyclosporine derivative, IMM 125 Xenobio. Metabol. Dispos. 12 1997 S104 S105
36. 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 1-2 2007 219 224
37. S. Endter, U. Becker, N. Daum, H. Huwer, C.-M. Lehr, M. Gumbleton, and C. Ehrhardt P-glycoprotein (MDR1) functional activity in human alveolar epithelial cell monolayers Cell Tissue Res. 328 1 2007 77 84
38. D. Anglicheau, C. Verstuyft, P. Laurent-Puig, L. Becquemont, M.-H. Schlageter, B. Cassinat, P. Beaune, C. Legendre, and E. Thervet Association of the multidrug resistance-1 gene single-nucleotide polymorphisms with the tacrolimus dose requirements in renal transplant recipients J. Am. Soc. Nephrol. 14 7 2003 1889 1896
39. C. Knoop, P. Thiry, F. Saint-Marcoux, A. Rousseau, P. Marquet, and M. Estenne Tacrolimus pharmacokinetics and dose monitoring after lung transplantation for cystic fibrosis and other conditions Am. J. Transplant. 5 6 2005 1477 1482
40. T.P. Pretlow, E.F. Keith, A.K. Cryar, A.A. Bartolucci, A.M. Pitts, T.G. Pretlow II, P.M. Kimball, and E.A. Boohaker Eosinophil infiltration of human colonic carcinomas as a prognostic indicator Cancer Res. 43 6 1983 2997 3000
41. J.G. Pegels, E.C.E. Bruynes, C.P. Engelfriet, and A.E.G.K. von dem Borne Pseudothrombocytopenia: an immunologic study on platelet antibodies dependent on ethylene diamine tetra-acetate Blood 59 1982 157 161
42. R. Lattermann, T. Schricker, U. Wachter, M. Georgieff, and A. Goertz Understanding the mechanisms by which isoflurane modifies the hyperglycemic response to surgery Anesth. Analg. 93 1 2001 121 127
43. F. Armutcu, Ö. Coskun, A. Gürel, S. Sahin, M. Kanter, A. Cihan, K.V. Numanoglu, and C. Altinyazar Vitamin E protects against acetone-induced oxidative stress in rat red blood cells Cell Biol. Toxicol. 21 1 2005 53 60
44. L.E. Johnson, T.P. Frye, A.R. Arnot, C. Marquette, L.A. Couture, A. Gendron-Fitzpatrick, and D.G. McNeel Safety and immunological efficacy of a prostate cancer plasmid DNA vaccine encoding prostatic acid phosphatase (PAP) Vaccine 24 3 2006 293 303
45. G.E. McLaughlin, and C.L. Abitbol Reversal of oliguric tacrolimus nephrotoxicity in children Nephrol. Dial. Transplant. 20 7 2005 1471 1475
46. C.C. Mok, K.H. Tong, C.H. To, Y.P. Siu, and T.C. Au Tacrolimus for induction therapy of diffuse proliferative lupus nephritis: an open-labeled pilot study Kidney Int. 68 2 2005 813 817
47. K.C. Tse, M.F. Lam, S.C. Tang, C.S. Tang, and T.M. Chan A pilot study on tacrolimus treatment in membranous or quiescent lupus nephritis with proteinuria resistant to angiotensin inhibition or blockade Lupus 16 1 2007 46 51
48. A. Jacquet, H. Francois, C. Frangie, L. Ahmad, B. Charpentier, and A. Durrbach Prevention of calcineurin inhibitor nephrotoxicity in renal transplantation Transplant. Immunol 20 1-2 2008 29 31
49. D. Ninova, M. Covarrubias, D. Rea, W. Park, J. Grande, and M. Stegall Acute nephrotoxicity of tacrolimus and sirolimus in renal isografts: differential intragraft expression of transforming growth factor-β1 and α-smooth muscle actin Transplantation 78 2004 338 344
50. B.J. Nankivell, R.J. Borrows, C.L.S. Fung, P.J. O'Connell, J.R. Chapman, and R.D.M. Allen Calcineurin inhibitor nephrotoxicity: longitudinal assessment by protocol histology Transplantation 78 4 2004 557 565
51. J.R. Johnson, B.M. Cohen, C. Crandall, and O. Sonio Aerosol-induced sputum: an effective inexpensive method for nebulization of a super-heated mixture of 40 per cent propylene glycol in isotonic saline Dis. Chest 42 1962 251 256