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Artículo

Development and in vitro/in vivo evaluation of a novel benznidazole liquid dosage form using a quality-by-design approach

Santos Souza, Higo Fernando; Real, Daniel AndresIcon ; Leonardi, DaríoIcon ; Rocha, Sandra Carla; Alonso, Victoria LuciaIcon ; Serra, Esteban CarlosIcon ; Silber, Ariel Mariano; Salomon, Claudio JavierIcon
Fecha de publicación: 12/2017
Editorial: Wiley Blackwell Publishing, Inc
Revista: Tropical Medicine And International Health
ISSN: 1360-2276
Idioma: Inglés
Tipo de recurso: Artículo publicado
Clasificación temática:
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Resumen

Objectives: To develop an alcohol-free solution suitable for children of benznidazole, the drug of choice for treatment of Chagas disease. Methods: In a quality-by-design approach, a systematic optimisation procedure was carried out to estimate the values of the factors leading to the maximum drug concentration. The formulations were analysed in terms of chemical and physical stability and drug content. The final preparation was subjected to an in vivo palatability assay. Mice were infected and treated orally in a murine model. Results: The results showed that benznidazole solubility increased up to 18.38 mg/ml in the optimised co-solvent system. The final formulation remained stable at all three temperatures tested, with suitable drug content and no significant variability. Palatability of the preparation was improved by taste masking of BZL. In vivo studies showed that both parasitaemia and mortality diminished, particularly at a dose of 40 mg/kg/day. Conclusion: Quality by design was a suitable approach to formulate a co-solvent system of benznidazole. The in vivo studies confirmed the suitability of the optimised such solutions to diminish both parasitaemia and mortality. Thus, this novel alternative should be taken into account for further clinical evaluation in all age ranges.
Palabras clave: Benznidazole , Chagas Disease , Co-Solvency , In Vivo Study , Solubility
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info:eu-repo/semantics/openAccess Excepto donde se diga explícitamente, este item se publica bajo la siguiente descripción: Creative Commons Attribution-NonCommercial-ShareAlike 2.5 Unported (CC BY-NC-SA 2.5)
Identificadores
URI: http://hdl.handle.net/11336/50459
DOI: https://dx.doi.org/10.1111/tmi.12980
URL: https://onlinelibrary.wiley.com/doi/abs/10.1111/tmi.12980
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Articulos(IQUIR)
Articulos de INST.DE QUIMICA ROSARIO
Citación
Santos Souza, Higo Fernando; Real, Daniel Andres; Leonardi, Darío; Rocha, Sandra Carla; Alonso, Victoria Lucia; et al.; Development and in vitro/in vivo evaluation of a novel benznidazole liquid dosage form using a quality-by-design approach; Wiley Blackwell Publishing, Inc; Tropical Medicine And International Health; 22; 12; 12-2017; 1514-1522
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