Amphotericin B colloidal dispersion

Chemotherapy

Volumn 45, Issue , 1999, Pages 15-26

  Working, P K ^a  

^a ALZA CORPORATION   (United States)

Author keywords

ABCD; Amphocil; Amphotericin B; Efficacy; Preclinical; Safety

Indexed keywords

AMPHOTERICIN B; AMPHOTERICIN B CHOLESTEROL SULFATE; ANTIFUNGAL AGENT;

ANTIFUNGAL ACTIVITY; DRUG CLEARANCE; DRUG EFFICACY; DRUG ELIMINATION; DRUG SAFETY; DRUG TOLERABILITY; KIDNEY TUBULE DAMAGE; NEPHROTOXICITY; PRIORITY JOURNAL; REVIEW;

AMPHOTERICIN B; ANIMALS; ANTIBIOTICS, ANTIFUNGAL; DRUG EVALUATION, PRECLINICAL; HUMANS;

EID: 0032988726     PISSN: 00093157     EISSN: 14219794     Source Type: Journal    
DOI: 10.1159/000048466     Document Type: Article

References (72)

1. Hammond SM: Biological activity of polyene antibiotics. Prog Med Chem 1977;14:105-179.
2. Bolard J: How do the polyene ma-crolide antibiotics affect the cellular membrane properties? Biochim Bio-phys Acta 1986;864:257-304.
3. Cohen J: Good antimicrobial prescribing: antifungal chemotherapy. Lancet 1982;ii:532-537.
4. Warnock DW: Amphotericin B: an introduction. J Antimicrob Che-mother 1991;28(suppl B):27-38.
5. Maddux MS, Barriere SL: A review of the complications of amphotericin B therapy: Recommendations for prevention and management. Drug Intell Clin Pharm 1980; 14: 177-181.
6. Graybill JR, Craven PC: Antifungal agents used in systemic mycoses. Activity and therapeutic use. Drugs 1983;25:41-62.
7. Hay RJ: Overview of the treatment of desseminated fungal infections. J Antimicrob Chemother 1991;30: 17-25.
8. Bennett WM, Porter GA: Nephrotoxicity of common drugs used by urologists. Urol Clin NA 1990; 17: 145-156.
9. Bodey GR: Fungal infections in cancer patients. Ann NY Acad Sci 1988;544:431-442.
10. Gallis HA, Drew RH, Pickard WW: Amphotericin B: 30 years of clinical experience. Rev Infec Dis 1990; 12: 308-329.
11. Hermans PE, Keys TF: Antifungal agents used for deep-seated mycotic infections. Mayo Clin Proc 1983;58: 223-231.
12. Texter JH, Coffey DS: The effects of amphotericin B on prostatic and testicular function in the dog. Invest Urol 1969;7:90-98.
13. Hoeprich PD, Huston AC, Wolfe BM: Toxicity of amphotericins on chronic administration to mongrel dogs. Diag Microbiol Infect Dis 1985;3:47-58.
14. Gaeta GB, Utili R, Adinolfi LE, Tripodi MF, Esposito V: Effects of amphotericin B on the excretory function and the colloidal clearance capacity of the perfused rat liver. J Hepatol 1989;8:344-350.
15. Newman MS, Guo L, McCalden TA, Levy M: A colloidal dispersion of amphotericin B with reduced lethality and non lethal toxicity. Amer Assoc Pharmac Sci 1989, Abstract 36.
16. Keim GR Jr, Poutsiaka JW, Kirpan J, Keysser CH: Amphotericin B methyl ester hydrochloride and amphotericin B: Comparative acute toxicity. Science 1973; 179:584- 585.
17. Guo LSS, Fielding RM, Gantz DL, Steiner J, Small DM: Novel antifungal drug delivery: Stable amphotericin B-cholesteryl sulfate discs. Int J Pharm 1991;75:45-54.
18. Guo LSS, Working PK: Complexes of amphotericin B and cholesteryl sulfate. J Liposome Res 1993;3: 473-491.
19. LTI-07-89-07: Antifungal Activity of ABCD In Vitro.
20. a) and Fungizone.
21. Hanson HL, Stevens DA: Comparison of antifungal activity of amphotericin B deoxycholate suspension with that of amphotericin B choles-teryl sulfate colloidal dispersion. Antimicrob Agents Chemother 1992;36:486-488.
22. a (Amphotericin B Colloidal Dispersion), conventional amphotericin B (Fungizone®), Fluconazole (Diflucan®) and Itraconazole (Spora-nox®).
23. LTI-07-89-08: Antifungal Activity of ABCD in Infected Mice.
24. LTI-07-90-08: Comparison of ABCD with Fungizone in the Treatment of Coccidioides immitis Infected Mice.
25. Clemons KV, Stevens DA: Comparative efficacy of amphotericin B colloidal dispersion compared with those of amphotericin B deoxycho-late suspension in treatment of murine coccidioidomycosis. Antimi-crob Agents Chemother 1991;35: 1829-1833.
26. LTI-07-91-01: Comparison of ABCD with Fungizone in the Treatment of Cryptococcus neoformans Infected Mice.
27. Hostetler JS, Clemons KV, Hanson LH, Stevens DA: Efficacy and safety of amphotericin B colloidal dispersion compared with those of amphotericin B deoxycholate suspension for treatment of disseminated murine cryptococcosis. Antimicrob Agents Chemother 1992;36:2656-2660.
28. Allende MC, Lee JW, Francis P, Garrett K, Bacher J, Berenguer J, Lyman CA, Pizzo PA, Walsh, TJ: Dose-dependent antifungal activity and nephrotoxicity of Amphotericin B Colloidal Dispersion (ABCD) in experimental pulmonary aspergillosis. Antimicrob Agents Chemother 1994;38:518-522.
29. LTI-07-92-12: Activity of ABCD in the Treatment of Experimental Visceral Leishmaniasis in Hamsters.
30. Edmonds LC, Davidson L, Bertino JS: Solubility and stability of amphotericin B in human serum. Ther Drug Monit 1989;11:323-326.
31. Brajtburg J, Elberg S, Bolard J, Ko-bayshi GS, Levy RA, Ostlund RE, Schlessinger D, Medoff G: Interaction of plasma proteins and lipoproteins with amphotericin B. J Infect Dis 1984;149:986-997.
32. Koldin MH, Kobayashi GS, Brajt-burg J, Medoff G: Effects of elevation of serum cholesterol and administration of amphotericin B complexed to lipoproteins on amphotericin B-induced toxicity in rabbits. Antimicrob Agents Che-mother 1985;28:144-145.
33. Barwicz J, Gareau R, Audet A, Morisset A, Villiard J, Gruda I: Inhibition of the interaction between lipoproteins and amphotericin B in some delivery systems. Clin Endocrinol Metab 1991;1:515-550.
34. Wasan KM, Brazeau GA, Keyhani A, Hayman AC, Lopez-Berestein G: Roles of liposome composition and temperature in distribution of amphotericin B in serum lipoproteins. Antimicrob Agents Chemother 1993;37:246-250.
35. LTI-07-95-10: Dissociation of ABCD and Conventional Amphotericin B (Fungizone®) in Human Plasma.
36. LTI-07-90-05: Incubation of Human Plasma with Amphotericin B Colloidal Dispersion or Fungizone: Incorporation into Plasma Lipoproteins.
37. Guo LSS, Fielding RM, Lasic DD, Hamilton RL, Mufson D: Novel antifungal drug delivery: Stable amphotericin B-cholesteryl sulfate discs. Int J Pharm 1991;75:45-54.
38. LTI-07-95-08: Separation and Quantification of Protein/Lipoprotein-Bound Amphotericin B from Amphotericin B/Sodium Choleste-ryl Sulfate Complex in Rat Plasma.
39. LTI-07-90-04: Pharmacokinetics and Tissue Distribution of Amphotericin B after Injection of Single Doses of Amphotericin B Colloidal Dispersion (ABCD) and Fungizone in Sprague Dawley Rats.
40. Fielding RM, Smith PC, Wang LH, Porter J, Guo LSS: Comparative pharmacokinetics of amphotericin B after administration of a novel colloidal delivery system, ABCD, and a conventional formulation in the rat. Antimicrob Agents Che-mother 1991;35:1208-1211.
41. LTI-07-95-01: ABCD Pharmacokinetics in Rats: Measurement of Free and Cholesteryl Sulfate-Complexed Amphotericin B.
42. a) in the Liver after a Single Intravenous Dose in Rats.
43. a) after Repeat Dosing in Rats.
44. a) after Repeat Dosing in Rats.
45. a) and Fungizone® after repeated dosing in rats. Pharm Res 1995;12:275-283.
46. a for 13 Weeks.
47. a) after Repeat Dosing in Dogs.
48. Fielding RM, Singer AW, Wang LH, Babbar S, Guo LSS: Relationship of pharmacokinetics and drug distribution in tissue to increased safety of amphotericin B colloidal dispersion in dogs. Antimicrob Agents Chemother 1992;36:1208-1211.
49. LTI-07-92-05: Plasma Concentrations of Amphotericin B in Dogs Exposed to ABCD for 13 Weeks.
50. Bindschadler DD and Bennet JE: A pharmacologic guide to the clinical use of amphotericin B. J Infect Dis 1969;120:427-436.
51. a) and Fungizone® in Rats.
52. LTI-07-89-11: Single Dose Intravenous Toxicity Study of Amphotericin B Colloidal Dispersion (ABCD) in the Beagle Dog.
53. LTI-07-89-13: Multiple Dose Comparison of Kinetics and Distribution of Amphotericin B Formulations in Rats.
54. LTI-07-90-11: 28-Day Intravenous Toxicity Study of Amphotericin B Colloidal Dispersion in the Sprague Dawley Rat.
55. LTI-07-91-04: Amphotericin B Colloidal Dispersion. 13-Week Intravenous Toxicity Study in Rats.
56. LTI-07-89-10: Fourteen-Day Range-Finding Intravenous Toxicity Study of Amphotericin B Colloidal Dispersion in the Beagle Dog.
57. LTI-07-90-10: Thirteen-Week Repeated Dose Intravenous Toxicity Study of Amphotericin B Colloidal Dispersion in the Beagle Dog.
58. LTI-07-93-04: Developmental Toxicity (Embryo-Fetal Toxicity and Teratogenic Potential) Study of ABCD Administered Intravenously to Sprague Dawley Rats.
59. LTI-07-93-05: Developmental Toxicity (Embryo-Fetal Toxicity and Teratogenic Potential) Study of ABCD Administered Intravenously to New Zealand White Rabbits.
60. Physicians’ Desk Reference, 46th Edition. Montvale, Medical Economics Data, 1992, pp 2262-2263.
61. Ismail MA, Lerner SA: Disseminated blastomycosis in a pregnant woman: Review of amphotericin B usage during pregnancy. Amer Rev Resp Dis 1982;126:350-353.
62. LTI-07-92-14: Salmonella/Mamma-lian-Microsome Reverse Mutation Assay (Ames Test) with ABCD.
63. LTI-07-92-15: In Vivo Mammalian Micronucleus Assay with ABCD.
64. Loveday KS, Anderson BE, Resnick MA, Zeiger E: Chromosome aberration and sister chromatid exchange tests in Chinese hamster ovary cell in vitro. V. Results with 46 chemicals. Environ Molec Mutagen 1990; 16:272-303.
65. Zeiger E, Anderson B, Haworth S, Lawlor T, Mortelmans K: Salmonella mutagenicity tests. V. Results from the testing of 311 chemicals. Environ Molec Mutagen 1992;19 (suppl 21):2-141.
66. LTI-21-93-02: Mutagenicity Test of Amphotericin B in the L5178Y TK+/- Mouse Lymphoma Forward Mutation Assay with an Independent Repeat.
67. LTI-07-92-11: Intravenous Irritation Study of Amphocil in Rabbits.
68. LTI-07-92-10: Intra-arterial Irritation Study of Amphocil in Rabbits.
69. LTI-07-92-16: Potential of Ampho-cil (Amphotericin B Colloidal Dispersion) to Induce Hemolysis in Human Blood.
70. LTI-07-92-17: Compatibility of Amphocil (Amphotericin B Colloidal Dispersion) with Human Blood.
71. Iwamori M, Moser HW, Kishimoto Y: Cholesterol sulfate in rat tissues. Tissue distribution, developmental changes and brain subcellular localization. Biochim Biophys Acta 1976;441:268-279.
72. Lalumiere G, Longpre J, Trudel J, Chapdelain A, Roberts KD: Cholesterol sulfate. II. Studies on its metabolism and possible function in canine blood. Biochim Biophys Acta 1975;394:120-128.