Oral administration of amphotericin B nanoparticles: antifungal activity, bioavailability and toxicity in rats

References

• Adams ML, Kwon GS. (2003). Relative aggregation state and hemolytic activity of amphotericin B encapsulated by poly (ethylene oxide)-block–poly (N-hexyl-l-aspartamide)-acyl conjugate micelles: effects of acyl chain length. J Control Release 87:23–32
   PubMed Web of Science ®Google Scholar
• Al-Quadeib BT, Radwan MA, Siller L, et al. (2015). Stealth amphotericin B nanoparticles for oral drug delivery: in vitro optimization. Saudi Pharm J 23:290–302
   PubMed Web of Science ®Google Scholar
• Al‐Quadeib BT, Radwan MA, Siller L, et al. (2014). Therapeutic monitoring of amphotericin B in Saudi ICU patients using UPLC MS/MS assay. Biomed Chromat. 28:1652–9
   PubMed Web of Science ®Google Scholar
• Allémann E, Leroux J, Gurny R. (1998). Biodegradable nanoparticles of poly (lactic acid) and poly (lactic-co-glycolic acid) for parenteral administration. Pharm Dosage Forms: Disperse Syst 3:163–93
   Google Scholar
• Amaral AC, Bocca AL, Ribeiro AM, et al. (2009). Amphotericin B in poly (lactic-co-glycolic acid)(PLGA) and dimercaptosuccinic acid (DMSA) nanoparticles against paracoccidioidomycosis. J Antimicrob Chemother 63:526–33
   PubMed Web of Science ®Google Scholar
• Anand P, Nair HB, Sung B, et al. (2010). Design of curcumin-loaded PLGA nanoparticles formulation with enhanced cellular uptake, and increased bioactivity in vitro and superior bioavailability in vivo. Biochem Pharmacol 79:330–8
   PubMed Web of Science ®Google Scholar
• Asghari H. (2011). Preparation and antifungal activity of spray-dried amphotericin B-loaded nanospheres. DARU J Pharm Sci 19:351–5
   Web of Science ®Google Scholar
• Bang JY, Song CE, Kim C, et al. (2008). Cytotoxicity of amphotericin B-incorporated polymeric micelles composed of poly (DL-lactide-co-glycolide)/dextran graft copolymer. Arch Pharm Res 31:1463–9
   PubMed Web of Science ®Google Scholar
• Barwicz J, Christian S, Gruda I. (1992). Effects of the aggregation state of amphotericin B on its toxicity to mice. Antimicrob Agents Chemother 36:2310–15
   PubMed Web of Science ®Google Scholar
• Bekersky II, Fielding RM, Buell D, Lawrence II. (1999). Lipid-based amphotericin B formulations: from animals to man. Pharm Sci Technol Today 2:230–6
   PubMedGoogle Scholar
• Belkherroubi-Sari L, Boucherit Z, Boucherit K, Belbraouet S. (2011). Study of renal toxicity in wistar rats following the action of amphotericin B solution prepared under extreme pH conditions. Food Nutri Sci 2:731–5
   Google Scholar
• Brajtburg J, Bolard J. (1996). Carrier effects on biological activity of amphotericin B. Clin Microbiol Rev 9:512–31
   PubMed Web of Science ®Google Scholar
• Chen LY, Davey AK, Chen YX, et al. (2009). Effects of diammonium glycyrrhizinate on the pharmacokinetics of aconitine in rats and the potential mechanism. Xenobiotica 39:955–63
   PubMed Web of Science ®Google Scholar
• Cheng J, Teply BA, Sherifi I, et al. (2007). Formulation of functionalized PLGA-PEG nanoparticles for in vivo targeted drug delivery. Biomaterials 28:869–76
   PubMed Web of Science ®Google Scholar
• Cho SW, Lee JS, Choi SH. (2004). Enhanced oral bioavailability of poorly absorbed drugs. I. Screening of absorption carrier for the ceftriaxone complex. J Pharm Sci 93:612–20
   PubMed Web of Science ®Google Scholar
• Chuealee R, Aramwit P, Noipha K, Srichana T. (2011). Bioactivity and toxicity studies of amphotericin B incorporated in liquid crystals. Eur J Pharm Sci 43:308–17
   PubMed Web of Science ®Google Scholar
• Cifani C, Costantino S, Massi M. (2012). Commercially available lipid formulations of amphotericin B: are they bioequivalent and therapeutically equivalent? Acta Bio Medica Atenei Parmensis 83:154–63
   PubMedGoogle Scholar
• Deray G. (2002). Amphotericin B nephrotoxicity. J Antimicrob Chemother 49:37–41
   PubMed Web of Science ®Google Scholar
• Drew RH. (2013). Pharmacology of amphotericin B [Online]. Wolter Kluwer. Available at: www.uptodate.com/contents/pharmacology-of-amphotericin-b [last accessed 26 Apr 2013]
   Google Scholar
• Egger P, Bellmann R, Wiedermann CJ. (2001). Determination of amphotericin B, liposomal amphotericin B, and amphotericin B colloidal dispersion in plasma by high-performance liquid chromatography. J Chromatogr B Biomed Sci Appl 760:307–13
   PubMed Web of Science ®Google Scholar
• Falamarzian A, Lavasanifar A. (2010). Chemical modification of hydrophobic block in poly(ethylene oxide) poly(caprolactone) based nanocarriers: effect on the solubilization and hemolytic activity of amphotericin B. Macromol Biosci 10:648–56
   PubMed Web of Science ®Google Scholar
• Fernandez-Carballido A, Pastoriza P, Barcia E, et al. (2008). PLGA/PEG-derivative polymeric matrix for drug delivery system applications: characterization and cell viability studies. Int J Pharm 352:50–7
   PubMed Web of Science ®Google Scholar
• Fukui H, Koike T, Saheki A, et al. (2003). Evaluation of the efficacy and toxicity of amphotericin B incorporated in lipid nano-sphere (LNS®). Int J Pharm 263:51–60
   PubMed Web of Science ®Google Scholar
• Garinot M, Fiévez V, Pourcelle V, et al. (2007). PEGylated PLGA-based nanoparticles targeting M cells for oral vaccination. J Control Release 120:195–204
   PubMed Web of Science ®Google Scholar
• Gershkovich P, Sivak O, Wasan EK, 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 65:2610–13
   PubMed Web of Science ®Google Scholar
• Gibaldi & Perrier. 1982. Pharmacokinetics, New York: Marcel Dekker
   Google Scholar
• Huh KM, Cho YW, Park K. (2003). PLGA-PEG block copolymers for drug formulations. Drug Deliv Technol 3:42–4
   Google Scholar
• Ibrahim F, Gershkovich P, Sivak O, et al. (2012). Assessment of novel oral lipid-based formulations of amphotericin B using an in vitro lipolysis model. Eur J Pharm Sci 46:323–8
   PubMed Web of Science ®Google Scholar
• Imai T, Sakai M, Ohtake H, et al. (1999). In vitro and in vivo evaluation of the enhancing activity of glycyrrhizin on the intestinal absorption of drugs. Pharm Res 16:80–6
   PubMed Web of Science ®Google Scholar
• Italia J, Yahya M, Singh D, Kumar MR. (2009). Biodegradable nanoparticles improve oral bioavailability of amphotericin B and show reduced nephrotoxicity compared to intravenous Fungizone®. Pharm Res 26:1324–31
   PubMed Web of Science ®Google Scholar
• Italia JL, Sharp A, Carter KC, et al. (2011). Peroral amphotericin B polymer nanoparticles lead to comparable or superior in vivo antifungal activity to that of intravenous Ambisome® or Fungizone™. PloS One 6:1–8
   Web of Science ®Google Scholar
• Jain JP, Kumar N. (2010). Development of amphotericin B loaded polymersomes based on (PEG) 3-PLA co-polymers: factors affecting size and in vitro evaluation. Eur J Pharm Sci 40:456–65
   PubMed Web of Science ®Google Scholar
• Jain S, Valvi PU, Swarnakar NK, Thanki K. (2012). Gelatin coated hybrid lipid nanoparticles for oral delivery of amphotericin B. Mol Pharm 9:2542–53
   PubMed Web of Science ®Google Scholar
• Kayser O, Olbrich C, Yardley V, et al. (2003). Formulation of amphotericin B as nanosuspension for oral administration. Int J Pharm 254:73–5
   PubMed Web of Science ®Google Scholar
• Khalil NM, Do Nascimento TCF, Casa DM, et al. (2013). Pharmacokinetics of curcumin-loaded PLGA and PLGA-PEG blend nanoparticles after oral administration in rats. Colloids Surf B Biointerfaces 101:353–60
   PubMed Web of Science ®Google Scholar
• Kumar R, Sahoo GC, Pandey K, et al. (2015). Study the effects of PLGA-PEG encapsulated Amphotericin B nanoparticle drug delivery system against Leishmania donovani. Drug Deliv 22:383–8
   PubMed Web of Science ®Google Scholar
• Laniado-Laborín R, Cabrales-Vargas MN. (2009). Amphotericin B: side effects and toxicity. Revista Iberoamericana De Micología 26:223–7
   PubMed Web of Science ®Google Scholar
• Legrand P, Romero EA, Cohen BE, Bolard J. (1992). Effects of aggregation and solvent on the toxicity of amphotericin B to human erythrocytes. Antimicrob Agents Chemother 36:2518–22
   PubMed Web of Science ®Google Scholar
• Miller C, Waller E, Klingemann H, et al. (2004). Lipid formulations of amphotericin B preserve and stabilize renal function in HSCT recipients. Bone Marrow Transplant 33:543–8
   PubMed Web of Science ®Google Scholar
• Motlekar NA, Srivenugopal KS, Wachtel MS, Youan BBC. (2006). Evaluation of the oral bioavailability of low molecular weight heparin formulated with glycyrrhetinic acid as permeation enhancer. Drug Develop Res 67:166–74
   PubMed Web of Science ®Google Scholar
• Mullen A, Carter K, Baillie A. (1997). Comparison of the efficacies of various formulations of amphotericin B against murine visceral leishmaniasis. Antimicrob Agents Chemother 41:2089–92
   PubMed Web of Science ®Google Scholar
• Nahar M, Jain NK. (2009). Preparation, characterization and evaluation of targeting potential of amphotericin B-loaded engineered PLGA nanoparticles. Pharm Res 26:2588–98
   PubMed Web of Science ®Google Scholar
• Nahar M, Mishra D, Dubey V, Jain NK. (2008). Development, characterization, and toxicity evaluation of amphotericin B–loaded gelatin nanoparticles. Nanomed Nanotechnol Biol Med 4:252–61
   PubMed Web of Science ®Google Scholar
• Nishi K, Antony M, Mohanan P, et al. (2007). Amphotericin B-gum arabic conjugates: synthesis, toxicity, bioavailability, and activities against Leishmania and fungi. Pharm Res 24:971–80
   PubMed Web of Science ®Google Scholar
• Packhaeuser C, Schnieders J, Oster C, Kissel T. (2004). In situ forming parenteral drug delivery systems: an overview. Eur J Pharm Biopharm 58:445–55
   PubMed Web of Science ®Google Scholar
• Pfaller M, Barry A. (1994). Evaluation of a novel colorimetric broth microdilution method for antifungal susceptibility testing of yeast isolates. J Clin Microbiol 32:1992–1996
   PubMed Web of Science ®Google Scholar
• Pompei R, Pani A, Flore O, et al. (1980). Antiviral activity of glycyrrhizic acid. Experientia 36:304
   PubMedGoogle Scholar
• Prajapati VK, Awasthi K, Yadav TP, et al. (2011). An oral formulation of amphotericin B attached to functionalized carbon nanotubes is an effective treatment for experimental visceral leishmaniasis. J Infect Dis 205:333–6
   PubMed Web of Science ®Google Scholar
• Radwan MA, Aboul-Enein HY. (2002). The effect of oral absorption enhancers on the in vivo performance of insulin-loaded poly (ethylcyanoacrylate) nanospheres in diabetic rats. J Microencapsul 19:225–235
   PubMed Web of Science ®Google Scholar
• Risovic V, Boyd M, Choo E, Wasan KM. (2003). Effects of lipid-based oral formulations on plasma and tissue amphotericin B concentrations and renal toxicity in male rats. Antimicrob Agents Chemother 47:3339–3342
   PubMed Web of Science ®Google Scholar
• Saadati R, Dadashzadeh S. (2014). Marked effects of combined TPGS and PVA emulsifiers in the fabrication of etoposide-loaded PLGA-PEG nanoparticles: in vitro and in vivo evaluation. Int J Pharm 464:135–144
   PubMed Web of Science ®Google Scholar
• Sabra R, Branch RA. (1990). Amphotericin B nephrotoxicity. Drug Safety 5:94–108
   PubMed Web of Science ®Google Scholar
• Sachs-Barrable K, Lee SD, Wasan EK, et al. (2008). Enhancing drug absorption using lipids: a case study presenting the development and pharmacological evaluation of a novel lipid-based oral amphotericin B formulation for the treatment of systemic fungal infections. Adv Drug Deliv Rev 60:692–701
   PubMed Web of Science ®Google Scholar
• Serrano DR, Lalatsa A, Dea-Ayuela MA, et al. (2015). Oral particle uptake and organ targeting drives the activity of amphotericin B nanoparticles. Mol Pharm 12:420–431
   PubMed Web of Science ®Google Scholar
• Shao K, Huang R, Li J, et al. (2010). Angiopep-2 modified PE-PEG based polymeric micelles for amphotericin B delivery targeted to the brain. J Control Release 147:118–126
   PubMed Web of Science ®Google Scholar
• Sheikh S, Ali SM, Ahmad MU, et al. (2010). Nanosomal amphotericin B is an efficacious alternative to Ambisome® for fungal therapy. Int J Pharm 397:103–108
   PubMed Web of Science ®Google Scholar
• Singh K, Tiwary A, Rana V. (2013). Spray dried chitosan–EDTA superior microparticles as solid substrate for the oral delivery of amphotericin B. Int J Biol Macromol 58:310–319
   PubMed Web of Science ®Google Scholar
• Sivak O, Gershkovich P, Lin M, 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
• Skiba-Lahiani M, Hallouard F, Mehenni L, et al. (2015). Development and characterization of oral liposomes of vegetal ceramide based amphotericin B having enhanced dry solubility and solubility. Mater Sci Eng C 48:145–149
   PubMed Web of Science ®Google Scholar
• Souza A, Nascimento A, De Vasconcelos N, et al. (2015). Activity and in vivo tracking of amphotericin B loaded PLGA nanoparticles. Eur J Med Chem 95:267–276
   PubMed Web of Science ®Google Scholar
• Standards (NCFCL). (2002). Reference methods for broth dilution antifungal susceptibility testing of yeast: Approved standard, National Committee for Clinical Laboratory Standards
   Google Scholar
• Sundar S, Chakravarty J, Agarwal D, et al. (2010). Single-dose liposomal amphotericin B for visceral leishmaniasis in India. N Engl J Med 362:504–512
   PubMed Web of Science ®Google Scholar
• Tanaka M, Takahashi M, Kuwahara E, et al. (1992). Effect of glycyrrhizinate on dissolution behavior and rectal absorption of amphotericin B in rabbits. Chem Pharm Bull 40:1559–1562
   PubMed Web of Science ®Google Scholar
• Tasset C, Preat V, Bernard A, Roland M. (1992). Comparison of nephrotoxicities of different polyoxyethyleneglycol formulations of amphotericin B in rats. Antimicrob Agents Chemother 36:1525–1531
   PubMed Web of Science ®Google Scholar
• Teekamp N, Duque LF, Frijlink HW, et al. (2015). Production methods and stabilization strategies for polymer-based nanoparticles and microparticles for parenteral delivery of peptides and proteins. Expert Opin Drug Deliv 12:1311–31
   PubMed Web of Science ®Google Scholar
• Tiyaboonchai W, Woiszwillo J, Middaugh CR. (2001). Formulation and characterization of amphotericin B-polyethylenimine-dextran sulfate nanoparticles. J Pharm Sci 90:902–914
   PubMed Web of Science ®Google Scholar
• Tonomura Y, Yamamoto E, Kondo C, et al. (2009). Amphotericin B-induced nephrotoxicity: characterization of blood and urinary biochemistry and renal morphology in mice. Hum Exp Toxicol 28:293–300
   PubMed Web of Science ®Google Scholar
• Torrado J, Espada R, Ballesteros M, Torrado‐Santiago S. (2008). Amphotericin B formulations and drug targeting. J Pharm Sci 97:2405–2425
   PubMed Web of Science ®Google Scholar
• Tozer TN, Rowland M. (2006). Introduction to pharmacokinetics and pharmacodynamics: the quantitative basis of drug therapy. Philadelphia, PA: Lippincott Williams & Wilkins
   Google Scholar
• Yan Q, Xiao LQ, Tan L, et al. (2015). Controlled release of simvastatin‐loaded thermo‐sensitive PLGA‐PEG‐PLGA hydrogel for bone tissue regeneration: in vitro and in vivo characteristics. J Biomed Mater Res Part A 103:3508–9
   Web of Science ®Google Scholar
• Yang FH, Zhang Q, Liang QY, et al. (2015). Bioavailability enhancement of paclitaxel via a novel oral drug delivery system: paclitaxel-loaded glycyrrhizic acid micelles. Molecules 20:4337–4356
   PubMed Web of Science ®Google Scholar
• Yang Z, Chen M, Yang M, et al. (2014). Evaluating the potential of cubosomal nanoparticles for oral delivery of amphotericin B in treating fungal infection. Int J Nanomed 9:327
   PubMed Web of Science ®Google Scholar
• Yang Z, Tan Y, Chen M, et al. (2012). Development of amphotericin B-loaded cubosomes through the solemuls technology for enhancing the oral bioavailability. AAPS PharmSciTech 13:1483–1491
   PubMed Web of Science ®Google Scholar
• Yoo HS, Park TG. (2001). Biodegradable polymeric micelles composed of doxorubicin conjugated PLGA-PEG block copolymer. J Control Release 70:63–70
   PubMed Web of Science ®Google Scholar
• Yu B, Okano T, Kataoka K, Kwon G. (1998). Polymeric micelles for drug delivery: solubilization and haemolytic activity of amphotericin B. J Control Release 53:131–136
   PubMed Web of Science ®Google Scholar
• Zu Y, Sun W, Zhao X, et al. (2014). Preparation and characterization of amorphous amphotericin B nanoparticles for oral administration through liquid antisolvent precipitation. Eur J Pharm Sci 53:109–117
   PubMed Web of Science ®Google Scholar