Pharmacokinetics and tissue distribution of amphotericin B following oral administration of three lipid-based formulations to rats

References

• Oura M, Sternberg TH, Wright ET. (1955). A new antifungal antibiotic, amphotericin B. Antibiot Annu, 3:566–573.
   PubMedGoogle Scholar
• Kim J, Sudbery P. (2011). Candida albicans, a major human fungal pathogen. J Microbiol, 49:171–177.
   PubMed Web of Science ®Google Scholar
• Ménez C, Legrand P, Rosilio V, Lesieur S, Barratt G. (2007). Physicochemical characterization of molecular assemblies of miltefosine and amphotericin B. Mol Pharm, 4:281–288.
   PubMed Web of Science ®Google Scholar
• Ouellette M, Drummelsmith J, Papadopoulou B. (2004). Leishmaniasis: drugs in the clinic, resistance and new developments. Drug Resist Updat, 7:257–266.
   PubMed Web of Science ®Google Scholar
• Thornton SJ, Wasan KM. (2009). The reformulation of amphotericin B for oral administration to treat systemic fungal infections and visceral leishmaniasis. Expert Opin Drug Deliv, 6:271–284.
   PubMed Web of Science ®Google Scholar
• Ostrosky-Zeichner L, Marr KA, Rex JH, Cohen SH. (2003). Amphotericin B: time for a new “gold standard”. Clin Infect Dis, 37:415–425.
   PubMed Web of Science ®Google Scholar
• Italia JL, Sharp A, Carter KC, Warn P, Kumar MN. (2011). Peroral amphotericin B polymer nanoparticles lead to comparable or superior in vivo antifungal activity to that of intravenous Ambisome® or Fungizone™. PLoS ONE, 6:e25744.
   PubMed Web of Science ®Google Scholar
• Patel PA, Patravale VB. (2011). AmbiOnp: solid lipid nanoparticles of amphotericin B for oral administration. J Biomed Nanotechnol, 7:632–639.
   PubMed Web of Science ®Google Scholar
• Prajapati VK, Awasthi K, Yadav TP, Rai M, Srivastava ON, Sundar S. (2012). An oral formulation of amphotericin B attached to functionalized carbon nanotubes is an effective treatment for experimental visceral leishmaniasis. J Infect Dis, 205:333–336.
   PubMed Web of Science ®Google Scholar
• Wasan EK, Gershkovich P, Zhao J, Zhu X, Werbovetz K, Tidwell RR et al. (2010). A novel tropically stable oral amphotericin B formulation (iCo-010) exhibits efficacy against visceral Leishmaniasis in a murine model. PLoS Negl Trop Dis, 4:e913.
   PubMed Web of Science ®Google Scholar
• Sivak O, Gershkovich P, Lin M, Wasan EK, Zhao J, Owen D et al. (2011). Tropically stable novel oral lipid formulation of amphotericin B (iCo-010): biodistribution and toxicity in a mouse model. Lipids Health Dis, 10:135.
   PubMed Web of Science ®Google Scholar
• Leon CG, Lee J, Bartlett K, Gershkovich P, Wasan EK, Zhao J et al. (2011). In vitro cytotoxicity of two novel oral formulations of Amphotericin B (iCo-009 and iCo-010) against Candida albicans, human monocytic and kidney cell lines. Lipids Health Dis, 10:144.
   PubMed Web of Science ®Google Scholar
• Wasan KM, Wasan EK, Gershkovich P, Zhu X, Tidwell RR, Werbovetz KA et al. (2009). Highly effective oral amphotericin B formulation against murine visceral leishmaniasis. J Infect Dis, 200:357–360.
   PubMed Web of Science ®Google Scholar
• Wasan EK, Bartlett K, Gershkovich P, Sivak O, Banno B, Wong Z et al. (2009). Development and characterization of oral lipid-based amphotericin B formulations with enhanced drug solubility, stability and antifungal activity in rats infected with Aspergillus fumigatus or Candida albicans. Int J Pharm, 372:76–84.
   PubMed Web of Science ®Google Scholar
• Ibrahim F, Gershkovich P, Sivak O, Wasan EK, Wasan KM. (2012). Assessment of novel oral lipid-based formulations of amphotericin B using an in vitro lipolysis model. Eur J Pharm Sci, 46:323–328.
   PubMed Web of Science ®Google Scholar
• Mori S, Matsuura A, Rama Prasad YV, Takada K. (2004). Studies on the intestinal absorption of low molecular weight heparin using saturated fatty acids and their derivatives as an absorption enhancer in rats. Biol Pharm Bull, 27:418–421.
   PubMed Web of Science ®Google Scholar
• Sachs-Barrable K, Thamboo A, Lee SD, Wasan KM. (2007). Lipid excipients Peceol and Gelucire 44/14 decrease P-glycoprotein mediated efflux of rhodamine 123 partially due to modifying P-glycoprotein protein expression within Caco-2 cells. J Pharm Pharm Sci, 10:319–331.
   PubMed Web of Science ®Google Scholar
• Gershkovich P, Sivak O, Wasan EK, Magil AB, Owen D, Clement JG et al. (2010). Biodistribution and tissue toxicity of amphotericin B in mice following multiple dose administration of a novel oral lipid-based formulation (iCo-009). J Antimicrob Chemother, 65:2610–2613.
   PubMed Web of Science ®Google Scholar
• Gershkovich P, Wasan EK, Lin M, Sivak O, Leon CG, Clement JG et al. (2009). Pharmacokinetics and biodistribution of amphotericin B in rats following oral administration in a novel lipid-based formulation. J Antimicrob Chemother, 64:101–108.
   PubMed Web of Science ®Google Scholar
• Ching MS, Raymond K, Bury RW, Mashford ML, Morgan DJ. (1983). Absorption of orally administered amphotericin B lozenges. Br J Clin Pharmacol, 16:106–108.
   PubMed Web of Science ®Google Scholar
• Constantinides PP. (1995). Lipid microemulsions for improving drug dissolution and oral absorption: physical and biopharmaceutical aspects. Pharm Res, 12:1561–1572.
   PubMed Web of Science ®Google Scholar
• Khoo SM, Shackleford DM, Porter CJ, Edwards GA, Charman WN. (2003). Intestinal lymphatic transport of halofantrine occurs after oral administration of a unit-dose lipid-based formulation to fasted dogs. Pharm Res, 20:1460–1465.
   PubMed Web of Science ®Google Scholar
• Porter CJ, Trevaskis NL, Charman WN. (2007). Lipids and lipid-based formulations: optimizing the oral delivery of lipophilic drugs. Nat Rev Drug Discov, 6:231–248.
   PubMed Web of Science ®Google Scholar
• Qi J, Zhuang J, Wu W, Lu Y, Song Y, Zhang Z et al. (2011). Enhanced effect and mechanism of water-in-oil microemulsion as an oral delivery system of hydroxysafflor yellow A. Int J Nanomedicine, 6:985–991.
   PubMed Web of Science ®Google Scholar
• Dixit RP, Nagarsenker MS. (2008). Formulation and in vivo evaluation of self-nanoemulsifying granules for oral delivery of a combination of ezetimibe and simvastatin. Drug Dev Ind Pharm, 34:1285–1296.
   PubMed Web of Science ®Google Scholar
• Miller JM, Beig A, Krieg BJ, Carr RA, Borchardt TB, Amidon GE et al. (2011). The solubility-permeability interplay: mechanistic modeling and predictive application of the impact of micellar solubilization on intestinal permeation. Mol Pharm, 8:1848–1856.
   PubMed Web of Science ®Google Scholar
• Mudra DR, Borchardt RT. (2010). Absorption barriers in the rat intestinal mucosa. 3: Effects of polyethoxylated solubilizing agents on drug permeation and metabolism. J Pharm Sci, 99:1016–1027.
   PubMed Web of Science ®Google Scholar
• Tan BJ, Liu Y, Chang KL, Lim BK, Chiu GN. (2012). Perorally active nanomicellar formulation of quercetin in the treatment of lung cancer. Int J Nanomedicine, 7:651–661.
   PubMed Web of Science ®Google Scholar
• Dahan A, Hoffman A. (2007). The effect of different lipid based formulations on the oral absorption of lipophilic drugs: the ability of in vitro lipolysis and consecutive ex vivo intestinal permeability data to predict in vivo bioavailability in rats. Eur J Pharm Biopharm, 67:96–105.
   PubMed Web of Science ®Google Scholar
• Larsen A, Holm R, Pedersen ML, Müllertz A. (2008). Lipid-based formulations for danazol containing a digestible surfactant, Labrafil M2125CS: in vivo bioavailability and dynamic in vitro lipolysis. Pharm Res, 25:2769–2777.
   PubMed Web of Science ®Google Scholar
• Kagan L, Gershkovich P, Wasan KM, Mager DE. (2011). Physiologically based pharmacokinetic model of amphotericin B disposition in rats following administration of deoxycholate formulation (Fungizone®): pooled analysis of published data. AAPS J, 13:255–264.
   PubMed Web of Science ®Google Scholar
• Smith PJ, Olson JA, Constable D, Schwartz J, Proffitt RT, Adler-Moore JP. (2007). Effects of dosing regimen on accumulation, retention and prophylactic efficacy of liposomal amphotericin B. J Antimicrob Chemother, 59:941–951.
   PubMed Web of Science ®Google Scholar
• Bellmann R. (2007). Clinical pharmacokinetics of systemically administered antimycotics. Curr Clin Pharmacol, 2:37–58.
   PubMedGoogle Scholar
• Walsh TJ, Goodman JL, Pappas P, Bekersky I, Buell DN, Roden M et al. (2001). Safety, tolerance, and pharmacokinetics of high-dose liposomal amphotericin B (AmBisome) in patients infected with Aspergillus species and other filamentous fungi: maximum tolerated dose study. Antimicrob Agents Chemother, 45:3487–3496.
   PubMed Web of Science ®Google Scholar
• Heinemann V, Bosse D, Jehn U, Debus A, Wachholz K, Forst H et al. (1997). Enhanced pulmonary accumulation of liposomal amphotericin B (AmBisome) in acute liver transplant failure. J Antimicrob Chemother, 40:295–297.
   PubMed Web of Science ®Google Scholar
• Vogelsinger H, Weiler S, Djanani A, Kountchev J, Bellmann-Weiler R, Wiedermann CJ et al. (2006). Amphotericin B tissue distribution in autopsy material after treatment with liposomal amphotericin B and amphotericin B colloidal dispersion. J Antimicrob Chemother, 57:1153–1160.
   PubMed Web of Science ®Google Scholar
• Atkinson AJ Jr, Bennett JE. (1978). Amphotericin B pharmacokinetics in humans. Antimicrob Agents Chemother, 13:271–276.
   PubMed Web of Science ®Google Scholar
• Bekersky I, Fielding RM, Dressler DE, Lee JW, Buell DN, Walsh TJ. (2002). Plasma protein binding of amphotericin B and pharmacokinetics of bound versus unbound amphotericin B after administration of intravenous liposomal amphotericin B (AmBisome) and amphotericin B deoxycholate. Antimicrob Agents Chemother, 46:834–840.
   PubMed Web of Science ®Google Scholar
• Fielding RM, Smith PC, Wang LH, Porter J, Guo LS. (1991). Comparative pharmacokinetics of amphotericin B after administration of a novel colloidal delivery system, ABCD, and a conventional formulation to rats. Antimicrob Agents Chemother, 35:1208–1213.
   PubMed Web of Science ®Google Scholar
• Gershkovich P, Wasan EK, Sivak O, Li R, Zhu X, Werbovetz KA et al. (2010). Visceral leishmaniasis affects liver and spleen concentrations of amphotericin B following administration to mice. J Antimicrob Chemother, 65:535–537.
   PubMed Web of Science ®Google Scholar
• Kontoyiannis DP, Luna MA, Samuels BI, Bodey GP. (2000). Hepatosplenic candidiasis. A manifestation of chronic disseminated candidiasis. Infect Dis Clin North Am, 14:721–739.
   PubMed Web of Science ®Google Scholar
• Sacks D, Noben-Trauth N. (2002). The immunology of susceptibility and resistance to Leishmania major in mice. Nat Rev Immunol, 2:845–858.
   PubMed Web of Science ®Google Scholar
• Vijayan VK. (2009). Parasitic lung infections. Curr Opin Pulm Med, 15:274–282.
   PubMed Web of Science ®Google Scholar
• Semis R, Mendlovic S, Polacheck I, Segal E. (2011). Activity of an Intralipid formulation of nystatin in murine systemic candidiasis. Int J Antimicrob Agents, 38:336–340.
   PubMed Web of Science ®Google Scholar