Development and evaluation of novel miltefosine-polyphenol co-loaded second generation nano-transfersomes for the topical treatment of cutaneous leishmaniasis

References

• Dar MJ, Din FU, Khan GM. Sodium stibogluconate loaded nano-deformable liposomes for topical treatment of leishmaniasis: macrophage as a target cell. Drug Deliv. 2018;25(1):1595–1606.
   PubMed Web of Science ®Google Scholar
• Navarro M, Gabbiani C, Messori L, et al. Metal-based drugs for malaria, trypanosomiasis and leishmaniasis: recent achievements and perspectives. Drug Discov Today. 2010;15(23–24):1070–1078.
   PubMed Web of Science ®Google Scholar
• Clive S, Leonard RC. Miltefosine in recurrent cutaneous breast cancer. Lancet. 1997;349(9052):621–622.
   PubMed Web of Science ®Google Scholar
• Garnier T, Croft SL. Topical treatment for cutaneous leishmaniasis. Curr Opin Invest Drugs. 2002;3(4):538–544.
   PubMedGoogle Scholar
• Van Bocxlaer K, Yardley V, Murdan S, et al. Topical formulations of miltefosine for cutaneous leishmaniasis in a BALB/c mouse model. J Pharm Pharmacol. 2016;68(7):862–872.
   PubMed Web of Science ®Google Scholar
• Wong IL, Chan K-F, Burkett BA, et al. Flavonoid dimers as bivalent modulators for pentamidine and sodium stiboglucanate resistance in Leishmania. Antimicrob Agents Chemother. 2007;51(3):930–940.
   PubMed Web of Science ®Google Scholar
• Fonseca-Silva F, Canto-Cavalheiro MM, Menna-Barreto RF, et al. Effect of apigenin on Leishmania amazonensis is associated with reactive oxygen species production followed by mitochondrial dysfunction. J Nat Prod. 2015;78(4):880–884.
   PubMed Web of Science ®Google Scholar
• Emiliano YS, Almeida-Amaral EE. Efficacy of apigenin and miltefosine combination therapy against experimental cutaneous leishmaniasis. J Nat Prod. 2018;81(8):1910–1913.
   PubMed Web of Science ®Google Scholar
• Tiwari B, Pahuja R, Kumar P, et al. Nanotized curcumin and miltefosine, a potential combination for treatment of experimental visceral leishmaniasis. Antimicrob Agents Chemother. 2017;61(3): 1169–16.
   Web of Science ®Google Scholar
• Espuelas S. Conventional formulations and emerging delivery systems for the topical treatment of cutaneous leishmaniasis. Ther Deliv. 2015;6(2):101–103.
   PubMed Web of Science ®Google Scholar
• Trinconi CT, Reimão JQ, Coelho AC, et al. Efficacy of tamoxifen and miltefosine combined therapy for cutaneous leishmaniasis in the murine model of infection with Leishmania amazonensis. J Antimicrob Chemother. 2016;71(5):1314–1322.
   PubMed Web of Science ®Google Scholar
• Romero EL, Morilla MJ. Highly deformable and highly fluid vesicles as potential drug delivery systems: theoretical and practical considerations. Int J Nanomedicine. 2013;8(2013):3171–3186.
   PubMedGoogle Scholar
• Lindner LH, Hossann M, Vogeser M, et al. Dual role of hexadecylphosphocholine (miltefosine) in thermosensitive liposomes: active ingredient and mediator of drug release. J Control Release. 2008;125(2):112–120.
   PubMed Web of Science ®Google Scholar
• Terrazas C, Oghumu S, Varikuti S, et al. Uncovering Leishmania–macrophage interplay using imaging flow cytometry. J Immunol Methods. 2015;423:93–98.
   PubMed Web of Science ®Google Scholar
• Celia C, Trapasso E, Cosco D, et al. Turbiscan Lab® Expert analysis of the stability of ethosomes® and ultradeformable liposomes containing a bilayer fluidizing agent. Colloids Surf B Biointerfaces. 2009;72(1):155–160.
   PubMed Web of Science ®Google Scholar
• Kasetvatin C, Rujivipat S, Tiyaboonchai W. Combination of elastic liposomes and low frequency ultrasound for skin permeation enhancement of hyaluronic acid. Colloids Surf B Biointerfaces. 2015;135(1):458–464.
   PubMedGoogle Scholar
• Cosco D, Paolino D, Maiuolo J, et al. Ultradeformable liposomes as multidrug carrier of resveratrol and 5-fluorouracil for their topical delivery. Int J Pharm. 2015;489(1–2):1–10.
   PubMedGoogle Scholar
• Firdessa R, Oelschlaeger TA, Moll H. Identification of multiple cellular uptake pathways of polystyrene nanoparticles and factors affecting the uptake: relevance for drug delivery systems. Eur J Cell Biol. 2014;93(8–9):323–337.
   PubMed Web of Science ®Google Scholar
• Reis LES, RCF DB, de Oliveira Cardoso JM, et al. Mixed formulation of conventional and pegylated meglumine antimoniate-containing liposomes reduces inflammatory process and parasite burden in Leishmania infantum-infected BALB/c mice. Antimicrob Agents Chemother. 2017;61(11): 962–17.
   Web of Science ®Google Scholar
• Mikus J, Steverding D. A simple colorimetric method to screen drug cytotoxicity against Leishmania using the dye Alamar Blue®. Parasitol Int. 2000;48(3):265–269.
   PubMedGoogle Scholar
• Abamor ES, Allahverdiyev AM, Bagirova M, et al. Meglumine antımoniate-TiO2@ Ag nanoparticle combinations reduce toxicity of the drug while enhancing its antileishmanial effect. Acta Trop. 2017;169(1):30–42.
   PubMedGoogle Scholar
• Rosas LE, Keiser T, Barbi J, et al. Genetic background influences immune responses and disease outcome of cutaneous L. mexicana infection in mice. Int Immunol. 2005;17(10):1347–1357.
   PubMed Web of Science ®Google Scholar
• Oghumu S, Varikuti S, Saljoughian N, et al. Pentalinonsterol, a constituent of pentalinon andrieuxii, possesses potent immunomodulatory activity and primes t cell immune responses. J Nat Prod. 2017;80(9):2515–2523.
   PubMed Web of Science ®Google Scholar
• Costa-Silva TA, Grecco SS, De Sousa FS, et al. Immunomodulatory and antileishmanial activity of phenylpropanoid dimers isolated from Nectandra leucantha. J Nat Prod. 2015;78(4):653–657.
   PubMed Web of Science ®Google Scholar
• Shaw C, Carter K. Drug delivery: lessons to be learnt from Leishmania studies. Nanomedicine. 2014;9(10):1531–1544.
   PubMed Web of Science ®Google Scholar
• Dar MJ, Ali H, Khan A, et al. Polymer-based drug delivery: the quest for local targeting of inflamed intestinal mucosa. J Drug Target. 2017;25(7):582–596.
   PubMed Web of Science ®Google Scholar
• Jain S, Jain P, Umamaheshwari R, et al. Transfersomes—a novel vesicular carrier for enhanced transdermal delivery: development, characterization, and performance evaluation. Drug Dev Ind Pharm. 2003;29(9):1013–1026.
   PubMed Web of Science ®Google Scholar
• Cevc G. Transfersomes, liposomes and other lipid suspensions on the skin: permeation enhancement, vesicle penetration, and transdermal drug delivery. Crit Rev Ther Drug Carrier Syst. 1996;13(3–4):257–388.
   PubMed Web of Science ®Google Scholar
• Chaudhary H, Kohli K, Kumar V. Nano-transfersomes as a novel carrier for transdermal delivery. Int J Pharm. 2013;454(1):367–380.
   PubMed Web of Science ®Google Scholar
• da Silva SM, Amorim IF, Ribeiro RR, et al. Efficacy of combined therapy with liposome-encapsulated meglumine antimoniate and allopurinol in treatment of canine visceral leishmaniasis. Antimicrob Agents Chemother. 2012;56(6):2858–2867.
   PubMed Web of Science ®Google Scholar
• Al-mahallawi AM, Khowessah OM, Shoukri RA. Nano-transfersomal ciprofloxacin loaded vesicles for non-invasive trans-tympanic ototopical delivery: in-vitro optimization, ex-vivo permeation studies, and in-vivo assessment. Int J Pharm. 2014;472(1–2):304–314.
   PubMed Web of Science ®Google Scholar
• Cevc G, Schätzlein A, Blume G. Transdermal drug carriers: basic properties, optimization and transfer efficiency in the case of epicutaneously applied peptides. J Control Release. 1995;36(1–2):3–16.
   Web of Science ®Google Scholar
• El Zaafarany GM, Awad GA, Holayel SM, et al. Role of edge activators and surface charge in developing ultradeformable vesicles with enhanced skin delivery. Int J Pharm. 2010;397(1–2):164–172.
   PubMed Web of Science ®Google Scholar
• Berman J. Development of miltefosine for the leishmaniases. Mini-Rev Med Chem. 2006;6(2):145–151.
   PubMed Web of Science ®Google Scholar
• Van Griensven J, Balasegaram M, Meheus F, et al. Combination therapy for visceral leishmaniasis. Lancet Infect Dis. 2010;10(3):184–194.
   PubMed Web of Science ®Google Scholar
• Croft SL, Engel J. Miltefosine—discovery of the antileishmanial activity of phospholipid derivatives. Trans R Soc Trop Med Hyg. 2006;100(Suppl 1):S4–S8.
   PubMedGoogle Scholar
• Gupta A, Aggarwal G, Singla S, et al. Transfersomes: a novel vesicular carrier for enhanced transdermal delivery of sertraline: development, characterization, and performance evaluation. Sci Pharm. 2012;80(4):1061–1080.
   PubMedGoogle Scholar
• Ghyczy M, Gareiss J, Kovats T. Liposomes from vegetable phosphatidylcholine: their production and effects on the skin. Cosmet Toiletries. 1994;109(7):75–80.
   Google Scholar
• El Maghraby GM, Barry BW, Williams AC. Liposomes and skin: from drug delivery to model membranes. Eur J Pharm Sci. 2008;34(4–5):203–222.
   PubMed Web of Science ®Google Scholar
• Kelly C, Jefferies C, Cryan SA. Targeted liposomal drug delivery to monocytes and macrophages. J Drug Deliv. 2011;2011(2011):727241.
   PubMedGoogle Scholar
• Bavarsad N, Bazzaz BSF, Khamesipour A, et al. Colloidal, in vitro and in vivo anti-leishmanial properties of transfersomes containing paromomycin sulfate in susceptible BALB/c mice. Acta Trop. 2012;124(1):33–41.
   PubMed Web of Science ®Google Scholar
• Barratt G. Colloidal drug carriers: achievements and perspectives. Cell Mol Life Sci. 2003;60(1):21–37.
   PubMed Web of Science ®Google Scholar
• Casa D, Scariot D, Khalil N, et al. Bovine serum albumin nanoparticles containing amphotericin B were effective in treating murine cutaneous leishmaniasis and reduced the drug toxicity. Exp Parasitol. 2018;192:12–18.
   PubMed Web of Science ®Google Scholar
• Tasdemir D, Kaiser M, Brun R, et al. Antitrypanosomal and antileishmanial activities of flavonoids and their analogues: in vitro, in vivo, structure-activity relationship, and quantitative structure-activity relationship studies. Antimicrob Agents Chemother. 2006;50(4):1352–1364.
   PubMed Web of Science ®Google Scholar
• Fonseca-Silva F, Inacio JD, Canto-Cavalheiro MM, et al. Oral efficacy of apigenin against cutaneous leishmaniasis: involvement of reactive oxygen species and autophagy as a mechanism of action. PLoS Negl Trop Dis. 2016;10(2):e0004442.
   PubMed Web of Science ®Google Scholar
• Alvar J, Canavate C, Gutierrez-Solar B, et al. Leishmania and human immunodeficiency virus coinfection: the first 10 years. Clin Microbiol Rev. 1997;10(2):298–319.
   PubMed Web of Science ®Google Scholar
• Berhe N, Wolday D, Hailu A, et al. HIV viral load and response to antileishmanial chemotherapy in co-infected patients. Aids. 1999;13(14):1921–1925.
   PubMed Web of Science ®Google Scholar
• Barros NB, Migliaccio V, Facundo VA, et al. Liposomal-lupane system as alternative chemotherapy against cutaneous leishmaniasis: macrophage as target cell. Exp Parasitol. 2013;135(2):337–343.
   PubMed Web of Science ®Google Scholar
• Gollob KJ, Viana AG, Dutra WO. Immunoregulation in human American leishmaniasis: balancing pathology and protection. Parasite Immunol. 2014;36(8):367–376.
   PubMed Web of Science ®Google Scholar
• Kane MM, Mosser DM. The role of IL-10 in promoting disease progression in leishmaniasis. J Immunol. 2001;166(2):1141–1147.
   PubMed Web of Science ®Google Scholar
• Mukherjee AK, Gupta G, Adhikari A, et al. Miltefosine triggers a strong proinflammatory cytokine response during visceral leishmaniasis: role of TLR4 and TLR9. Int Immunopharmacol. 2012;12(4):565–572.
   PubMed Web of Science ®Google Scholar
• Li -R-R, Pang -L-L, Du Q, et al. Apigenin inhibits allergen-induced airway inflammation and switches immune response in a murine model of asthma. Immunopharmacol Immunotoxicol. 2010;32(3):364–370.
   PubMed Web of Science ®Google Scholar
• Yotsumoto S, Kakiuchi T, Aramaki Y. Enhancement of IFN-γ production for Th1-cell therapy using negatively charged liposomes containing phosphatidylserine. Vaccine. 2007;25(29):5256–5262.
   PubMed Web of Science ®Google Scholar
• Horta MF, Mendes BP, Roma EH, et al. Reactive oxygen species and nitric oxide in cutaneous leishmaniasis. J Parasitol Res. 2012;2012(2012):203818.
   PubMedGoogle Scholar