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Pesquisa do Estado de S??o Paulo","doi-asserted-by":"publisher","award":["2016\/0048-0"],"award-info":[{"award-number":["2016\/0048-0"]}],"id":[{"id":"10.13039\/501100001807","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2020,10,9]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>Cutaneous fungal and parasitic diseases remain challenging to treat, as available therapies are unable to permeate the skin barrier. Thus, treatment options rely on systemic therapy, which fail to produce high local drug concentrations but can lead to significant systemic toxicity. Amphotericin B (AmB) is highly efficacious in the treatment of both fungal and parasitic diseases such as cutaneous leishmaniasis but is reserved for parenteral administration in patients with severe pathophysiology. Here, we have designed and optimized AmB-transfersomes [93.5% encapsulation efficiency, 150 nm size, and good colloidal stability (\u221235.02 mV)] that can remain physicochemically stable (&amp;gt;90% drug content) at room temperature and 4 \u00b0C over 6 months when lyophilized and stored under desiccated conditions. AmB-transfersomes possessed good permeability across mouse skin (4.91 \u00b1 0.41 \u03bcg\/cm2\/h) and 10-fold higher permeability across synthetic Strat-M membranes. In vivo studies after a single topical application in mice showed permeability and accumulation within the dermis (&amp;gt;25 \u03bcg AmB\/g skin 6 h postadministration), indicating the delivery of therapeutic amounts of AmB for mycoses and cutaneous leishmaniasis, while a single daily administration in Leishmania (Leishmania) amazonensis infected mice over 10 days, resulted in excellent efficacy (98% reduction in Leishmania parasites). Combining the application of AmB-transfersomes with metallic microneedles in vivo increased the levels in the SC and dermis but was unlikely to elicit transdermal levels. In conclusion, AmB-transfersomes are promising and stable topical nanomedicines that can be readily translated for parasitic and fungal infectious diseases.<\/jats:p>","DOI":"10.1021\/acsinfecdis.0c00293","type":"journal-article","created":{"date-parts":[[2020,8,18]],"date-time":"2020-08-18T18:07:56Z","timestamp":1597774076000},"page":"2647-2660","source":"Crossref","is-referenced-by-count":40,"title":["Ultradeformable Lipid Vesicles Localize Amphotericin\nB in the Dermis for the Treatment of Infectious Skin Diseases"],"prefix":"10.1021","volume":"6","author":[{"given":"Raquel","family":"Ferna\u0301ndez-Garci\u0301a","sequence":"first","affiliation":[{"name":"Universidad Complutense de Madrid , , Plaza Ramo\u0301n y Cajal s\/n , ,","place":["Madrid, Spain, 28040"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Larry","family":"Statts","sequence":"additional","affiliation":[{"name":"University of Portsmouth , , St. Michael\u2019s Building, White Swan Road , ,","place":["Portsmouth, United\nKingdom"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Je\u0301ssica\nA.","family":"de Jesus","sequence":"additional","affiliation":[{"name":"University of Sa\u0303o Paulo , , Avenida Dr. Arnaldo 455 , , SP ,","place":["Cerqueira Ce\u0301sar, Brazil, 01246903"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria Auxiliadora","family":"Dea-Ayuela","sequence":"additional","affiliation":[{"name":"Facultad de Ciencias de la Salud, Universidad CEU Cardenal Herrera , , Carrer Santiago Ramo\u0301n y Cajal s\/n , ,","place":["Valencia, Spain, 46113"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Liliana","family":"Bautista","sequence":"additional","affiliation":[{"name":"University of Portsmouth , , St. Michael\u2019s Building, White Swan Road , ,","place":["Portsmouth, United\nKingdom"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ru\u0301ben","family":"Sima\u0303o","sequence":"additional","affiliation":[{"name":"Universidad Complutense de Madrid , , Plaza Ramo\u0301n y Cajal s\/n , ,","place":["Madrid, Spain, 28040"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francisco","family":"Bola\u0301s-Ferna\u0301ndez","sequence":"additional","affiliation":[{"name":"Universidad Complutense de Madrid , , Plaza Ramo\u0301n y Cajal s\/n , ,","place":["Madrid, Spain, 28040"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria Paloma","family":"Ballesteros","sequence":"additional","affiliation":[{"name":"Universidad Complutense de Madrid , , Plaza Ramo\u0301n y Cajal s\/n , ,","place":["Madrid, Spain, 28040"]},{"name":"Universidad Complutense de Madrid , , Plaza Ramo\u0301n y Cajal s\/n , ,","place":["Madrid, Spain, 28040"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marcia Dalastra","family":"Laurenti","sequence":"additional","affiliation":[{"name":"University of Sa\u0303o Paulo , , Avenida Dr. Arnaldo 455 , , SP ,","place":["Cerqueira Ce\u0301sar, Brazil, 01246903"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Luiz F. D.","family":"Passero","sequence":"additional","affiliation":[{"name":"Sa\u0303o Paulo State University (UNESP), Institute of Biosciences , Sa\u0303o Vicente Prac\u0327a Infante Dom Henrique s\/n , , ,","place":["Sa\u0303o Vicente, SP, Brazil, 11330-900"]},{"name":"Sa\u0303o Paulo State University (UNESP), Institute for Advanced Studies of Ocean , Sa\u0303o Vicente Av. Joa\u0303o Francisco Bensdorp 1178 , , ( )","place":["Sa\u0303o Vicente, SP, Brazil, 11350-011"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4791-7468","authenticated-orcid":true,"given":"Aikaterini","family":"Lalatsa","sequence":"additional","affiliation":[{"name":"University of Portsmouth , , St. Michael\u2019s Building, White Swan Road , ,","place":["Portsmouth, United\nKingdom"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0475-8420","authenticated-orcid":true,"given":"Dolores R.","family":"Serrano","sequence":"additional","affiliation":[{"name":"Universidad Complutense de Madrid , , Plaza Ramo\u0301n y Cajal s\/n , ,","place":["Madrid, Spain, 28040"]},{"name":"Universidad Complutense de Madrid , , Plaza Ramo\u0301n y Cajal s\/n , ,","place":["Madrid, Spain, 28040"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"316","published-online":{"date-parts":[[2020,8,18]]},"reference":[{"issue":"1","key":"2026081722120702900_cit1","doi-asserted-by":"publisher","first-page":"139","DOI":"10.1016\/j.ijpharm.2017.04.013","article-title":"Unmet clinical needs\nin the treatment of systemic fungal infections: The role of amphotericin\nB and drug targeting","volume":"525","author":"Fernandez-Garcia","year":"2017","journal-title":"Int. J. Pharm."},{"issue":"1\u20132","key":"2026081722120702900_cit2","doi-asserted-by":"publisher","first-page":"38","DOI":"10.1016\/j.ijpharm.2013.02.038","article-title":"Hemolytic and pharmacokinetic\nstudies of liposomal and particulate amphotericin B formulations","volume":"447","author":"Serrano","year":"2013","journal-title":"Int. J. Pharm."},{"issue":"7","key":"2026081722120702900_cit3","doi-asserted-by":"publisher","first-page":"2405","DOI":"10.1002\/jps.21179","article-title":"Amphotericin\nB Formulations and Drug Targeting","volume":"97","author":"Torrado","year":"2008","journal-title":"J. Pharm.\nSci."},{"issue":"3","key":"2026081722120702900_cit4","doi-asserted-by":"publisher","first-page":"173","DOI":"10.1080\/08982104.2017.1380664","article-title":"The care\nand feeding of a commercial liposomal product: liposomal amphotericin\nB (AmBisome\u00ae)","volume":"27","author":"Jensen","year":"2017","journal-title":"J. Liposome Res."},{"issue":"7","key":"2026081722120702900_cit5","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pntd.0006653","article-title":"A phase II study to evaluate the\nsafety and efficacy of topical 3% amphotericin B cream (Anfoleish)\nfor the treatment of uncomplicated cutaneous leishmaniasis in Colombia","volume":"12","author":"Lo\u0301pez","year":"2018","journal-title":"PLoS Neglected Trop. Dis."},{"issue":"4","key":"2026081722120702900_cit6","doi-asserted-by":"publisher","first-page":"369","DOI":"10.4103\/0019-5154.135489","article-title":"Delivery of Amphotericin\nB for Effective Treatment of Candida Albicans\nInduced Dermal Mycosis in Rats via Emulgel System: Formulation and\nEvaluation","volume":"59","author":"Ganeshpurkar","year":"2014","journal-title":"Indian J. Dermatol"},{"issue":"22","key":"2026081722120702900_cit7","doi-asserted-by":"publisher","first-page":"2327","DOI":"10.2174\/1568026615666150605122917","article-title":"Emerging Nanonisation Technologies:\nTailoring Crystalline Versus Amorphous Nanomaterials","volume":"15","author":"Serrano","year":"2015","journal-title":"Curr. Top. Med. Chem."},{"key":"2026081722120702900_cit8","doi-asserted-by":"publisher","first-page":"118817","DOI":"10.1016\/j.ijpharm.2019.118817","article-title":"Transferosomes as nanocarriers for\ndrugs across the skin: Quality by design from lab to industrial scale","volume":"573","author":"Ferna\u0301ndez-Garci\u0301a","year":"2020","journal-title":"Int. J. Pharm."},{"issue":"1","key":"2026081722120702900_cit9","doi-asserted-by":"publisher","first-page":"226","DOI":"10.1016\/0005-2736(92)90154-E","article-title":"Lipid vesicles\npenetrate into intact skin owing to the transdermal\nosmotic gradients and hydration force","volume":"1104","author":"Cevc","year":"1992","journal-title":"Biochim.\nBiophys. Acta, Biomembr."},{"issue":"3","key":"2026081722120702900_cit10","doi-asserted-by":"publisher","first-page":"138","DOI":"10.4103\/2231-4040.85524","article-title":"Transferosomes\n- A vesicular transdermal delivery system for enhanced drug permeation","volume":"2","author":"Rajan","year":"2011","journal-title":"J. Adv. Pharm. Technol. Res."},{"key":"2026081722120702900_cit11","doi-asserted-by":"publisher","first-page":"293","DOI":"10.1166\/jbn.2010.1121","article-title":"Development\nand Performance Evaluation of Amphotericin B Transfersomes Against\nResistant and Sensitive Clinical Isolates of Visceral Leishmaniasis","volume":"6","author":"Singodia","year":"2010","journal-title":"J. Biomed. Nanotechnol."},{"issue":"1\u20132","key":"2026081722120702900_cit12","doi-asserted-by":"publisher","first-page":"148","DOI":"10.1016\/j.ijpharm.2014.07.004","article-title":"New amphotericin B-gamma\ncyclodextrin formulation for topical use with synergistic activity\nagainst diverse fungal species and Leishmania spp","volume":"473","author":"Ruiz","year":"2014","journal-title":"Int. J. Pharm."},{"issue":"8","key":"2026081722120702900_cit13","doi-asserted-by":"publisher","first-page":"423","DOI":"10.1111\/j.1365-3024.2009.01116.x","article-title":"Immunopathogenic\ncompetences of Leishmania (V.) braziliensis and L. (L.) amazonensis\nin American cutaneous leishmaniasis","volume":"31","author":"Silveira","year":"2009","journal-title":"Parasite\nImmunol."},{"key":"2026081722120702900_cit14","doi-asserted-by":"publisher","first-page":"119003","DOI":"10.1016\/j.ijpharm.2019.119003","article-title":"Transcutaneous Anaesthetic\nNano-enabled Hydrogels for Eyelid Surgery","volume":"577","author":"Lalatsa","year":"2020","journal-title":"Int.\nJ. Pharm."},{"issue":"4","key":"2026081722120702900_cit15","doi-asserted-by":"publisher","first-page":"321","DOI":"10.1258\/002367790780865921","article-title":"The mouse\nepidermis as a model in\nskin pharmacology: influence of age and sex on epidermal metabolic\nreactions and their circadian rhythms","volume":"24","author":"Kietzmann","year":"1990","journal-title":"Lab.\nAnim."},{"issue":"4","key":"2026081722120702900_cit16","doi-asserted-by":"publisher","first-page":"802","DOI":"10.1093\/jac\/dkm303","article-title":"In vivo studies on\nthe antileishmanial activity of buparvaquone and its prodrugs","volume":"60","author":"Garnier","year":"2007","journal-title":"J. Antimicrob. Chemother."},{"issue":"3","key":"2026081722120702900_cit17","doi-asserted-by":"publisher","first-page":"292","DOI":"10.1023\/A:1014443001802","article-title":"Determining Dermal\nAbsorption Parameters in Vivo From Tape Strip Data","volume":"19","author":"Reddy","year":"2002","journal-title":"Pharm. Res."},{"issue":"23","key":"2026081722120702900_cit18","doi-asserted-by":"publisher","first-page":"4879","DOI":"10.1002\/adfm.201200864","article-title":"Hydrogel-Forming Microneedle Arrays for Enhanced Transdermal\nDrug Delivery","volume":"22","author":"Donnelly","year":"2012","journal-title":"Adv. Funct. Mater."},{"issue":"3","key":"2026081722120702900_cit19","doi-asserted-by":"publisher","first-page":"473","DOI":"10.1208\/s12248-011-9288-3","article-title":"Characterization of microchannels\ncreated by metal microneedles: formation and closure","volume":"13","author":"Kalluri","year":"2011","journal-title":"AAPS J."},{"issue":"14","key":"2026081722120702900_cit20","doi-asserted-by":"publisher","first-page":"1547","DOI":"10.1016\/j.addr.2012.04.005","article-title":"Microneedles\nfor drug and vaccine\ndelivery","volume":"64","author":"Kim","year":"2012","journal-title":"Adv. Drug Delivery Rev."},{"issue":"10","key":"2026081722120702900_cit21","doi-asserted-by":"publisher","first-page":"1221","DOI":"10.1111\/j.1365-4632.2012.05460.x","article-title":"Adverse effects of intralesional meglumine antimoniate\nand its influence on clinical laboratory parameters in the treatment\nof cutaneous leishmaniasis","volume":"51","author":"Esfandiarpour","year":"2012","journal-title":"Int. J. Dermatol."},{"issue":"6","key":"2026081722120702900_cit22","doi-asserted-by":"publisher","first-page":"524","DOI":"10.1056\/NEJMoa1202657","article-title":"Topical Paromomycin with or without\nGentamicin for Cutaneous Leishmaniasis","volume":"368","author":"Ben\nSalah","year":"2013","journal-title":"N. Engl.\nJ. Med."},{"issue":"3","key":"2026081722120702900_cit23","doi-asserted-by":"publisher","first-page":"557","DOI":"10.4269\/ajtmh.12-0736","article-title":"Randomized, double-blinded, phase\n2 trial of WR 279,396 (paromomycin and gentamicin) for cutaneous leishmaniasis\nin Panama","volume":"89","author":"Sosa","year":"2013","journal-title":"Am. J. Trop. Med. Hyg."},{"issue":"2","key":"2026081722120702900_cit24","doi-asserted-by":"publisher","first-page":"255","DOI":"10.1208\/s12248-011-9267-8","article-title":"Physiologically\nbased pharmacokinetic model of amphotericin B disposition in rats\nfollowing administration of deoxycholate formulation (Fungizone\u00ae):\npooled analysis of published data","volume":"13","author":"Kagan","year":"2011","journal-title":"AAPS J."},{"issue":"10","key":"2026081722120702900_cit25","doi-asserted-by":"publisher","first-page":"9693","DOI":"10.1021\/acsnano.8b03800","article-title":"Enhanced Transdermal Drug Delivery by Transfersome-Embedded\nOligopeptide Hydrogel for Topical Chemotherapy of Melanoma","volume":"12","author":"Jiang","year":"2018","journal-title":"ACS Nano"},{"issue":"7","key":"2026081722120702900_cit26","doi-asserted-by":"publisher","first-page":"1452","DOI":"10.1080\/21691401.2016.1247850","article-title":"Development and optimization\nof apigenin-loaded transfersomal system for skin cancer delivery:\nin vitro evaluation","volume":"45","author":"Jangdey","year":"2017","journal-title":"Artif. Cells, Nanomed.,\nBiotechnol."},{"key":"2026081722120702900_cit27","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1080\/08982104.2017.1295989","article-title":"Enhancement of\nthe bioavailability\nof an antihypertensive drug by transdermal protransfersomal system:\nformulation and in vivo study","volume":"28","author":"Morsi","year":"2018","journal-title":"J. Liposome Res."},{"key":"2026081722120702900_cit28","unstructured":"AEMPS\nAmBisome\n          , data sheet. https:\/\/cima.aemps.es\/cima\/dochtml\/ft\/61117\/FT_61117.html (accessed Dec 29, 2019)."},{"issue":"4","key":"2026081722120702900_cit29","doi-asserted-by":"publisher","first-page":"1606","DOI":"10.1208\/s12249-018-0959-6","article-title":"A Mechanistic Study\nto Determine the Structural Similarities\nBetween Artificial Membrane Strat-M and Biological Membranes and Its\nApplication to Carry Out Skin Permeation Study of Amphotericin B Nanoformulations","volume":"19","author":"Kaur","year":"2018","journal-title":"AAPS PharmSciTech"},{"key":"2026081722120702900_cit30","first-page":"40","article-title":"In vitro diffusion\nstudies in transdermal\nresearch: A synthetic membrane model in place of human skin","volume":"12","author":"Joshi","year":"2012","journal-title":"Drug Dev. Deliv."},{"key":"2026081722120702900_cit31","doi-asserted-by":"publisher","first-page":"113","DOI":"10.1016\/j.ejps.2014.11.002","article-title":"Prediction of skin permeation by chemical compounds\nusing the artificial membrane, Strat-M","volume":"67","author":"Uchida","year":"2015","journal-title":"Eur.\nJ. Pharm. Sci."},{"issue":"10","key":"2026081722120702900_cit32","doi-asserted-by":"publisher","first-page":"4755","DOI":"10.1128\/AAC.00671-11","article-title":"In vitro and in\nvivo studies of the utility of dimethyl\nand diethyl carbaporphyrin ketals in treatment of cutaneous leishmaniasis","volume":"55","author":"Taylor","year":"2011","journal-title":"Antimicrob. Agents Chemother."},{"issue":"5","key":"2026081722120702900_cit33","doi-asserted-by":"publisher","first-page":"1057","DOI":"10.1128\/AAC.42.5.1057","article-title":"In vitro activities\nof terbinafine\nagainst cutaneous isolates of Candida albicans and other pathogenic\nyeasts","volume":"42","author":"Ryder","year":"1998","journal-title":"Antimicrob. Agents Chemother."},{"issue":"1","key":"2026081722120702900_cit34","doi-asserted-by":"publisher","first-page":"150","DOI":"10.1093\/jac\/dkt318","article-title":"In vitro interaction between paromomycin\nsulphate and four drugs with leishmanicidal activity against three\nNew World Leishmania species","volume":"69","author":"de\nMorais-Teixeira","year":"2014","journal-title":"J. Antimicrob.\nChemother."},{"issue":"12","key":"2026081722120702900_cit35","doi-asserted-by":"publisher","first-page":"445","DOI":"10.1016\/S0165-6147(96)01012-7","article-title":"Amphotericin B: new life for an old drug","volume":"17","author":"Hartsel","year":"1996","journal-title":"Trends Pharmacol. Sci."},{"issue":"4","key":"2026081722120702900_cit36","doi-asserted-by":"publisher","first-page":"243","DOI":"10.1016\/S0924-8579(99)00133-8","article-title":"A comparison of\nthe activities of three amphotericin\nB lipid formulations against experimental visceral and cutaneous leishmaniasis","volume":"13","author":"Yardley","year":"2000","journal-title":"Int. J. Antimicrob. Agents"},{"issue":"2","key":"2026081722120702900_cit37","doi-asserted-by":"publisher","first-page":"165","DOI":"10.1007\/s00228-006-0240-x","article-title":"Plasma\nprotein distribution and its\nimpact on pharmacokinetics of liposomal amphotericin B in paediatric\npatients with malignant diseases","volume":"63","author":"Hong","year":"2007","journal-title":"Eur. J. Clin.\nPharmacol."},{"issue":"4","key":"2026081722120702900_cit38","doi-asserted-by":"publisher","first-page":"325","DOI":"10.1016\/j.ijantimicag.2007.05.013","article-title":"In vitro\neffect of new formulations of amphotericin B on amastigote and promastigote\nforms of Leishmania infantum","volume":"30","author":"Ordo\u0301n\u0303ez-Gutie\u0301rrez","year":"2007","journal-title":"Int. J. Antimicrob.\nAgents"},{"issue":"1","key":"2026081722120702900_cit39","doi-asserted-by":"publisher","first-page":"97","DOI":"10.1080\/17425247.2020.1700227","article-title":"Development\nand evaluation of novel miltefosine- polyphenol co-loaded second generation\nnano- transfersomes for the topical treatment of cutaneous leishmaniasis","volume":"17","author":"Dar","year":"2020","journal-title":"Expert Opin. Drug Delivery"},{"key":"2026081722120702900_cit40","doi-asserted-by":"publisher","DOI":"10.1590\/s1678-9946201860008","article-title":"Histopathological\ncharacteristics of cutaneous lesions caused by Leishmania Viannia\npanamensis in Panama","volume":"60","author":"Gonza\u0301lez","year":"2018","journal-title":"Rev. Inst Med. Trop SP"},{"issue":"2","key":"2026081722120702900_cit41","doi-asserted-by":"publisher","first-page":"148","DOI":"10.1016\/j.jconrel.2011.05.021","article-title":"Kinetics\nof skin resealing after insertion of microneedles in human subjects","volume":"154","author":"Gupta","year":"2011","journal-title":"J. Controlled Release"},{"issue":"3","key":"2026081722120702900_cit42","doi-asserted-by":"publisher","first-page":"473","DOI":"10.1208\/s12248-011-9288-3","article-title":"Characterization\nof Microchannels\nCreated by Metal Microneedles: Formation and Closure","volume":"13","author":"Kalluri","year":"2011","journal-title":"AAPS J."},{"issue":"6","key":"2026081722120702900_cit43","doi-asserted-by":"publisher","first-page":"1578","DOI":"10.1093\/jac\/dkw012","article-title":"Drug permeation\nand barrier damage in Leishmania-infected mouse skin","volume":"71","author":"Van\nBocxlaer","year":"2016","journal-title":"J. Antimicrob. Chemother."},{"issue":"3","key":"2026081722120702900_cit44","doi-asserted-by":"publisher","first-page":"517","DOI":"10.1046\/j.1523-1747.1998.00318.x","article-title":"Expression of epidermal keratins and the cornified\nenvelope protein involucrin is influenced by permeability barrier\ndisruption","volume":"111","author":"Ekanayake-Mudiyanselage","year":"1998","journal-title":"J. Invest. Dermatol."},{"key":"2026081722120702900_cit45","unstructured":"ShinEtsu Metolose\n          , data sheet. http:\/\/www.metolose.jp\/en\/pharmaceutical\/metolose.html (accessed Jan 14, 2020)."},{"key":"2026081722120702900_cit46","doi-asserted-by":"publisher","first-page":"859","DOI":"10.1590\/S1984-82502014000400021","article-title":"Determination of amphotericin B in\nPLA-PEG blend nanoparticles by HPLC-PDA","volume":"50","author":"Rodrigues","year":"2014","journal-title":"Braz\nJ. Pharm. 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