Targeted Oral Fixed-Dose Combination of Amphotericin B-Miltefosine for Visceral Leishmaniasis

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Autor(es): dc.contributorUniversidad Complutense de Madrid-
Autor(es): dc.contributorTrinity College Dublin-
Autor(es): dc.contributorUniversidade Estadual Paulista (UNESP)-
Autor(es): dc.contributorUniversidade de São Paulo (USP)-
Autor(es): dc.contributorUniversidad Cardenal Herrera-CEU-
Autor(es): dc.contributorUniversity of Strathclyde-
Autor(es): dc.creatorFernández-García, Raquel-
Autor(es): dc.creatorWalsh, David-
Autor(es): dc.creatorO’Connell, Peter-
Autor(es): dc.creatorPassero, Luiz Felipe D.-
Autor(es): dc.creatorde Jesus, Jéssica A.-
Autor(es): dc.creatorLaurenti, Marcia Dalastra-
Autor(es): dc.creatorDea-Ayuela, María Auxiliadora-
Autor(es): dc.creatorBallesteros, M. Paloma-
Autor(es): dc.creatorLalatsa, Aikaterini-
Autor(es): dc.creatorBolás-Fernández, Francisco-
Autor(es): dc.creatorHealy, Anne Marie-
Autor(es): dc.creatorSerrano, Dolores R.-
Data de aceite: dc.date.accessioned2025-08-21T18:55:56Z-
Data de disponibilização: dc.date.available2025-08-21T18:55:56Z-
Data de envio: dc.date.issued2025-04-29-
Data de envio: dc.date.issued2025-03-03-
Fonte completa do material: dc.identifierhttp://dx.doi.org/10.1021/acs.molpharmaceut.4c01133-
Fonte completa do material: dc.identifierhttps://hdl.handle.net/11449/297001-
Fonte: dc.identifier.urihttp://educapes.capes.gov.br/handle/11449/297001-
Descrição: dc.descriptionThe incidence of visceral leishmaniasis (VL) remains a significant health threat in endemic countries. Fixed-dose combination (FDC) of amphotericin B (AmB) and miltefosine (MLT) is a promising strategy for treating VL, but the parenteral administration of AmB leads to severe side effects, limiting its use in clinical practice. Here, we developed novel FDC granules combining AmB in the core with a MLT coating using wet granulation followed by the fluidized bed technology. The granules maintained the crystalline structure of AmB throughout manufacturing, achieving an AmB loading of ∼20%. The MLT coating layer effectively sustained AmB release from 3 to 24 h following Korsmeyer-Peppas kinetics. The formulation demonstrated remarkable stability, maintaining >90% drug content for over a year at both 4 °C and room temperature under desiccated conditions. In vivo efficacy studies in Leishmania infantum-infected hamsters showed 65-80% reduction in parasite burden in spleen and liver, respectively, suggesting potential as an oral alternative to current VL treatments. Uncoated and coated granules demonstrated comparable performance in key aspects, including in vivo efficacy and long-term stability.-
Descrição: dc.descriptionEuropean Regional Development Fund-
Descrição: dc.descriptionScience Foundation Ireland-
Descrição: dc.descriptionDepartamento de Farmacia Galénica y Tecnología Alimentaria Facultad de Farmacia Universidad Complutense de Madrid, Plaza de Ramón y Cajal, s/n-
Descrição: dc.descriptionSchool of Pharmacy and Pharmaceutical Sciences Trinity College Dublin-
Descrição: dc.descriptionInstitute of Biosciences São Paulo State University (UNESP), Praça Infante Dom Henrique, s/n, São Vicente-
Descrição: dc.descriptionInstitute for Advanced Studies of Ocean (IEAMAR) São Paulo State University (UNESP), Rua João Francisco Bensdorp, 1178. São Vicente-
Descrição: dc.descriptionLaboratório de Patologia das Moléstias Infecciosas (LIM/50) Faculdade de Medicina Universidade de São Paulo, Avenida Dr. Arnaldo-
Descrição: dc.descriptionDepartamento de Farmacia Facultad de Ciencias de la Salud Universidad Cardenal Herrera-CEU, Carrer Santiago Ramón y Cajal, s/n.-
Descrição: dc.descriptionInstituto Universitario de Farmacia Industrial Facultad de Farmacia Universidad Complutense de Madrid, Plaza de Ramón y Cajal, s/n.-
Descrição: dc.descriptionCRUK Formulation Unit School of Pharmacy and Biomedical Sciences University of Strathclyde, John Arbuthnot Building, Robertson Wing, 161 Cathedral-
Descrição: dc.descriptionDepartamento de Microbiología y Parasitología Facultad de Farmacia Universidad Complutense de Madrid, Plaza de Ramón y Cajal, s/n.-
Descrição: dc.descriptionInstitute of Biosciences São Paulo State University (UNESP), Praça Infante Dom Henrique, s/n, São Vicente-
Descrição: dc.descriptionInstitute for Advanced Studies of Ocean (IEAMAR) São Paulo State University (UNESP), Rua João Francisco Bensdorp, 1178. São Vicente-
Formato: dc.format1437-1448-
Idioma: dc.languageen-
Relação: dc.relationMolecular Pharmaceutics-
???dc.source???: dc.sourceScopus-
Palavras-chave: dc.subjectamphotericin B-
Palavras-chave: dc.subjectcoating-
Palavras-chave: dc.subjectfixed-dose combination-
Palavras-chave: dc.subjectmiltefosine-
Palavras-chave: dc.subjectoral delivery-
Palavras-chave: dc.subjectvisceral leishmaniasis-
Título: dc.titleTargeted Oral Fixed-Dose Combination of Amphotericin B-Miltefosine for Visceral Leishmaniasis-
Tipo de arquivo: dc.typelivro digital-
Aparece nas coleções:Repositório Institucional - Unesp

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