Preformulation and long-term stability studies of an optimized palatable praziquantel Ethanol-free Solution for pediatric delivery

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dc.citation.titlePharmaceutics
dc.contributor.orcidhttps://orcid.org/0000-0001-6302-7073
dc.creatorBedogni, Giselle
dc.creatorGarcía , Paula
dc.creatorSeremeta, Katia
dc.creatorOkulik , Nora
dc.creatorSalomon, Claudio
dc.date.accessioned2024-07-03T19:22:49Z
dc.date.available2024-07-03T19:22:49Z
dc.date.issued30-07-23
dc.description.abstractTo date, the treatment for cysticercosis and neurocysticercosis consists of a single oral intake of praziquantel (5–10 mg/kg), which since it is only available as tablets, hinders its administration to pediatric patients. Praziquantel is a poorly water-soluble drug which represents a challenge for its formulation in solution, particularly for the pediatric population. Thus, this study aimed to develop a palatable solution for praziquantel using pharmaceutical-accepted co-solvent systems. A design of experiments approach was applied to identify the optimal conditions for achieving a suitable amount of praziquantel in solution using co-solvent mixtures. Thus, praziquantel solubility increased from 0.38 up to 43.50 mg/mL in the optimized system. A taste masking assay in healthy human volunteers confirmed a successful reduction of drug bitterness after the addition of selected flavors and a sweetener. Stability studies were also conducted at different temperatures (4, 25, and 40 °C) for 12 months Even though the presence of the three known impurities of praziquantel was observed, their amounts never exceeded the acceptance criteria of the USP. Thus, this novel approach should be considered a valuable alternative for further preclinical studies considering the high prevalence of this infection worldwide.
dc.description.filFil: Bedogni, Giselle. Universidad Nacional de Rosario. Facultad de Ciencias Bioquímicas y Farmacéuticas. Instituto de Química Rosario (IQUR-CONICET); Argentina.
dc.description.filFil: García, Paula. Universidad Nacional de Rosario. Facultad de Ciencias Bioquímicas y Farmacéuticas. Planta Piloto de Producción de Medicamentos; Argentina.
dc.description.filFil: Seremeta, Katia. Universidad Nacional del Chaco Austral. Instituto de Investigaciones en Procesos Tecnológicos Avanzados. (INIPTA-CONICET); Argentina.
dc.description.filFil: Okulik, Nora. Universidad Nacional del Chaco Austral. Instituto de Investigaciones en Procesos Tecnológicos Avanzados. (INIPTA-CONICET); Argentina.
dc.description.filFil: Salomon, Claudio. Universidad Nacional de Rosario. Facultad de Ciencias Bioquímicas y Farmacéuticas. Instituto de Química Rosario (IQUR-CONICET); Argentina.
dc.description.filFil: Salomon, Claudio. Universidad Nacional de Rosario. Facultad de Ciencias Bioquímicas y Farmacéuticas. Departamento de Farmacia; Argentina.
dc.description.sponsorshipConsejo Nacional de Investigaciones Científicas y Técnicas (CONICET)
dc.description.versionpeerreviewed
dc.format.extent1-16
dc.identifier.issn1999-4923
dc.identifier.urihttps://hdl.handle.net/2133/27410
dc.language.isoen
dc.publisherMDPI
dc.relation.publisherversionhttps://www.mdpi.com/1999-4923/15/8/2050
dc.relation.publisherversionhttps://doi.org/10.3390/pharmaceutics15082050
dc.rightsopenAccess
dc.rights.holderBedogni, Giselle
dc.rights.holderGarcía, Paula
dc.rights.holderSeremeta, Katia
dc.rights.holderOkulik, Nora
dc.rights.holderSalomon, Claudio
dc.rights.holderUniversidad Nacional de Rosario. Facultad de Ciencias Bioquímicas y Farmacéuticas
dc.rights.textATTRIBUTION 4.0 INTERNATIONAL
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/
dc.subjectParasitic diseases
dc.subjectHelminthiasis
dc.subjectPraziquantel
dc.subjectCo-solvency
dc.subjectSolubility
dc.subjectFlavoring agents
dc.subjectInfant
dc.subjectChild
dc.titlePreformulation and long-term stability studies of an optimized palatable praziquantel Ethanol-free Solution for pediatric delivery
dc.typearticulo
dc.type.collectionarticulo
dc.type.versionpublishedVersion

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