Cyclosporin a liposome aerosol: Lack of acute toxicity in rats with a high incidence of underlying pneumonitis

Inhalation Toxicology

Volumn 9, Issue 8, 1997, Pages 717-730

  Gilbert, Brian E ^a   Black, Melanie B ^a   Waldrep, J Clifford ^a   Bennick, Jerry ^b   Montgomery, Charles ^a   Knight, Vernon ^a  

^a BAYLOR COLLEGE OF MEDICINE   (United States)

^b Stillmeadow Inc   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 0030931742     PISSN: 08958378     EISSN: None     Source Type: Journal    
DOI: 10.1080/089583797197962     Document Type: Article

References (40)

1. Alexander, A. G., Barnes, N. C., and Kay, A. B. 1992. Trial of cyclosporin in corticosteroid-dependent chronic severe asthma. Lancet 339:324-328.
2. Andersen, A. A. 1958. New sampler for the collection, sizing, and enumeration of viable airborne particles. J. Bacteriol. 76:471-484.
3. Anver, M. R., and Cohen, B. J. 1979. Lesions associated with aging. In The laboratory rat. Vol. 1, Biology and diseases, eds. H. J. Baker, J. R. Lindsey, and S. H. Weisbroth, pp. 378-399. New York: Academic Press.
4. Burek, J. D. 1978. Pathology of aging rats. West Palm Beach, FL: CRC Press.
5. Coleman, G. L., Barthold, S. W., Osbaldiston, G. W., Foster, S. J., and Jonas, A. M. 1977. Pathological changes during aging in barrier-reared Fischer 344 male rats. J. Gerontol. 32:258-278.
6. Crim, C., Keller, C. A., Dunphy, C. H., Maluf, H. M., and Ohar, J. A. 1996. Flow cytometric analysis of lung lymphocytes in lung transplant recipients. Am. J. Respir. Crit. Care Med. 153:1041-1046.
7. Dowling, R. D., Zenati, M., Burckart, G. J., Yousem, S. A., Schaper, M., Simmons, R. L., Hardesty, R. L., and Griffith, B. P. 1990. Aerosolized cyclosporine as single-agent immunotherapy in canine lung allografts. Surgery 108:198-205.
8. Eustis, S. L., and Boorman, G. A. 1990. The liver. In Pathology of the Fischer rat. Reference and atlas, eds. G. A. Boorman, S. L. Eustis, M. R. Elwell, C. A. Montgomery, and W. F. MacKenzie, pp. 71-94. New York: Academic Press.
9. Freise, C. E., Liu, T., Hong, K. L., Osorio, R. W., Papahadjopoulos, D., Ferrell, L., Ascher, N. L., and Roberts, J. P. 1994. The increased efficacy and decreased nephrotoxicity of a cyclosporine liposome. Transplantation 57:928-932.
10. Gilbert, B. E., Wilson, S. Z., Garcon, N. M., Wyde, P. R., and Knight, V. 1993. Characterization and administration of cyclosporine liposomes as a small-particle aerosol. Transplantation 56:974-977.
11. Gorecki, D. C., Jakobisiak, M., Kruszewski, A., and Lasek, W. 1991. Evidence that liposome incorporation of cyclosporine reduces its toxicity and potentiates its ability to prolong survival of cardiac allografts in mice. Transplantation 52:766-769.
12. Grit, M., Crommelin, D. J. A., and Lang, J. 1991. Determination of phosphatidylcholine, phosphatidylglycerol, and their lyso forms from liposome dispersions by high-performance liquid chromatography using high-sensitivity refractive index detection. J. Chromatogr. 585:239-246.
13. Hall, W. C., Ganaway, J. R., Rao, G. N., Peters, R. L., Allen, A. M., Luczak, J. W., Sandberg, E. M., and Quigley, B. H. 1992. Histopathologic observations in weanling B6C3F1 mice and F344/N rats and their adult parental strains. Toxicol. Pathol. 20:146-154.
14. Hammond, J. M., and Bateman, E. D. 1990. Successful treatment of life-threatening steroid-resistant pulmonary sarcoidosis with cyclosporin in a patient with systemic lupus erythematosus. Respir. Med. 84:77-80.
15. Heritier, F., Madden, B., Hodson, M. E., and Yacoub, M. 1992. Lung allograft transplantation-indications, preoperative assessment and postoperative management. Eur. Respir. J. 5:1262-1278.
16. Hoffman, R. M., Dauber, J. H., Paradis, I. L., Griffith, B. P., and Hardesty, R. L. 1991. Alveolar macrophage migration after lung transplantation. Am. Rev. Respir. Dis. 143:834-838.
17. Hoffman, R. M., Dauber, J. H., Paradis, I. L., and Griffith, B. P. 1993. Peripheral blood monocyte migration in lung transplant recipients. Transplantation 56:228-230.
18. Hossain, M. B., van der Helm, D., Antel, J., Sheldrick, G. M., Sanduja, S. K., and Weinheimer, A. J. 1988. Crystal and molecular structure of didemnin B, an antiviral and cytotoxic depsipeptide. Proc. Natl. Acad. Sci. USA 85:4118-4122.
19. Iacono, A. T., Keenan, R. J., Duncan, S. R., Smaldone, G. C., Dauber, J. H., Paradis, I. L., Ohori, N. P., Grgurich, W. F., Burckart, G. J., Zeevi, A., Delgado, E., Oriordan, T. G., Zendarsky, M. M., Yousem, S. A., and Griffith, B. P. 1996. Aerosolized cyclosporine in lung recipients with refractory chronic rejection. Am. J. Respir Crit. Care Med. 153:1451-1455.
20. Keenan, R. J., Duncan, A. J., Yousem, S. A., Zenati, M., Schaper, M., Dowling, R. D., Alarie, Y., Burckart, C. J., and Griffith, B. P. 1992. Improved immunosuppression with aerosolized cyclosporine in experimental pulmonary transplantation. Transplantation 53:20-25.
21. Keenan, R. J., Zeevi, A., Iacono, A. T., Spichty, K. J., Cai, J. Z. J., Yousem, S. A., Ohori, P., Paradis, I. L., Kawai, A., and Griffith, B. P. 1995. Efficacy of inhaled cyclosporine in lung transplant recipients with refractory rejection: Correlation of intragraft cytokine gene expression with pulmonary function and histologic characteristics. Surgery 118:385-391.
22. Kirby, J. A., Reader, J. A., and Pepper, J. R. 1986. Lung transplantation: Effect of cyclosporine A on the frequency of cytolytic lymphocytes recovered from blood and the bronchoalveolar space. J. Heart Transplant. 5:33-38.
23. Klein, R. M., Leschke, M., and Strauer, B. E. 1995. Cyclosporin in chronic severe corticosteroid-dependent bronchial asthma. Dtsch. Med Wochenschr. 120:1349-1355.
24. Knight, V., and Gilbert, B. 1988. Antiviral therapy with small particle aerosols. Eur. J. Clin. Microbiol. Infect. Dis. 7:721-731.
25. Knight, V., Black, M. T., and Waldrep, J. C. 1994. Development of cyclosporin-A liposome aerosol therapy for pulmonary diseases. Am. J. Respir. Crit. Care Med. 149:A-1095.
26. Koblinger, L., and Hofmann, W. 1995. Aerosol inhalation in the rat lung. Part II: Theoretical predictions of particle deposition patterns. J. Aerosol Med. 8:21-32.
27. Magnan, A., Mege, J. L., Reynaud, M., Thomas, P., Capo, C., Garbe, L., Meric, B., Badier, M., Bongrand, P., Viard, L., Metras, D., Giudicelli, R., and Noirclerc, M. 1994. Monitoring of alveolar macrophage production of tumor necrosis factor-alpha and interleukin-6 in lung transplant recipients. Am J. Respir. Crit. Care Med. 150:684-689.
28. Maronpot, R. R., Montgomery, C. A., Boorman, G. A., and McConnell, E. E. 1986. National toxicology program nomenclature for hepatoproliferative lesions of rats. Toxicol. Pathol. 14:263-273.
29. Martinet, Y., Pinkston, P., Saltini, C., Spurzem, J., Muller-Quernheim, J., and Crystal, R. G. 1988. Evaluation of the in vitro and in vivo effects of cyclosporine on the lung T-lymphocyte alveolitis of active pulmonary sarcoidosis. Am. Rev. Respir. Dis. 138:1242-1248.
30. Marionen, T. B. 1988. Surrogate experimental models for studying particle deposition in the human respiratory tract: An overview. In Aerosols: Research, risk assessment and control strategies, eds. S. D. Lee, T. Schneider, L. D. Grant, and P. J. Verkerk, pp. 547-568. Chelsea, MI: Lewis.
31. Montgomery, C. A., and Seely, J. C. 1990. The kidney. In Pathology of the Fischer rat. Reference and atlas, eds. G. A. Boorman, S. L. Eustis, M. R. Elwell, C. A. Montgomery, and W. F. MacKenzie, pp. 127-153. New York: Academic Press.
32. Nizankowska, E., Soja, J., Pinis, G., Bochenek, G., Sladek, K., Domagala, B., Pajak, A., and Szczeklik, A. 1995. Treatment of steroid-dependent bronchial asthma with cyclosporin. Eur. Respir. J. 8:1091-1099.
33. Phalen, R. F. 1984. Inhalation studies: Foundations and techniques. Boca Raton, FL: CRC Press.
34. Smeesters, C., Giroux, L., Vinet, B., Arnoux, R., Chaland, P., Corman, J., St-Louis, G., and Daloze, P. 1988. Reduced nephrotoxicity of cyclosporine A after incorporation into liposomes. Transplant. Proc. 20(suppl. 3):831-832.
35. Tanoue, L. T. 1992. Lung transplantation. Lung 170:187-200.
36. Vadiei, K., Lopezberestein, G., Perezsoler, R., and Luke, D. R. 1989. In vitro evaluation of liposomal cyclosporine. Int. J. Pharm. 57:133-138.
37. Waldrep, J. C., Scherer, P. W., Keyhani, K., and Knight, V. 1993. Cyclosporin-A liposome aerosol - Particle size and calculated respiratory deposition. Int. J. Pharm. 97:205-212.
38. Whitehead, B. F., Stoehr, C., Wu, C. J., Patterson, G., Burchard, E. G., Theodore, J., Clayberger, C., and Starnes, V. A. 1993. Cytokine gene expression in human lung transplant recipients. Transplantation 56:956-961.
39. Wiggins, N. A. 1991. The development of a mathematical approximation technique to determine the mass median aerodynamic diameter (MMAD) and geometric standard deviation (GSD) of drug particles in an inhalation aerosol spray. Drug Dev. Ind. Pharm. 17:1971-1986.
40. Yu, C. P., Zhang, L., Oberdoster, G., Mast, R. W., and Utell, M. J. 1995. Deposition of refractory ceramic fibers (RCF) in the human respiratory tract and comparison with rodent studies. Aerosol Sci. Technol. 23:291-300.