Development and Pharmacokinetic Evaluation of Two Parenteral Formulations of Albendazole Using Prodrug and Cosolvent Approaches


Por: Becerril-Vega, Jose, Hernandez-Campos, Alicia, Gonzalez-Hernandez, Iliana, Flores-Ramos, Miguel, Castillo, Rafael, Leyva-Gomez, Gerardo, Mayet-Cruz, Lourdes, Jung-Cook, Helgi

Publicada: 27 jul 2023
Resumen:
Albendazole is a broad-spectrum anthelmintic drug used for parasitic infections. In addition, due to its mechanism of action, it has been studied as an anticancer agent. However, poor and highly variable bioavailability are limiting factors for its use in systemic illnesses. The present study aimed to develop two parenteral formulations of albendazole and to compare its pharmacokinetic profile with the conventional oral administration. Parenteral formulations were developed using two different approaches: a phosphonooxymethylated prodrug and cosolvents. For the albendazole prodrug, once synthetized, its solubility and hydrolysis with alkaline phosphatase were evaluated. A factorial design of experiments was used for the cosolvent formulation. Stability and hemolytic activity were assessed. A pharmacokinetic study was performed on New Zealand rabbits. Both formulations were administered intravenously, and the prodrug was also administered intramuscularly. Results were compared with those obtained after the oral administration of albendazole. A 20,000-fold and 6000-fold increase in albendazole solubility was found with the prodrug and cosolvent formulations, respectively. Both parenteral formulations displayed higher albendazole plasma concentrations for the first 2 h compared with oral administration, even when the oral dose was doubled. The absolute bioavailability of oral albendazole was 15.5% while for the intramuscular administration of the prodrug was 102.6%. Both parenteral formulations showed a significant decrease in the formation of albendazole sulfoxide (ANOVA p<0.05) and allowed greater exposure to albendazole. Albendazole cosolvent parenteral formulation could be a promising option in systemic illnesses considering its ease of preparation and superb pharmacokinetic performance.

Filiaciones:
Becerril-Vega, Jose:
 Departamento de Farmacia, Facultad de Química, Universidad Nacional Autónoma de México, Mexico City, 04510, Mexico

 Univ Nacl Autonoma Mexico, Fac Quim, Dept Farm, Mexico City 04510, Mexico

Hernandez-Campos, Alicia:
 Departamento de Farmacia, Facultad de Química, Universidad Nacional Autónoma de México, Mexico City, 04510, Mexico

 Univ Nacl Autonoma Mexico, Fac Quim, Dept Farm, Mexico City 04510, Mexico

Gonzalez-Hernandez, Iliana:
 Laboratorio de Neuropsicofarmacología, Instituto Nacional de Neurología y Neurocirugía Manuel Velasco Suárez, Mexico City, Mexico

 Inst Nacl Neurol & Neurocirugia Manuel Velasco Sua, Lab Neuropsicofarmacol, Mexico City, Mexico

Flores-Ramos, Miguel:
 Escuela Nacional de Estudios Superiores, Unidad Mérida, Universidad Nacional Autónoma de México, Yucatán, Mexico

 Univ Nacl Autonoma Mexico, Escuela Nacl Estudios Super, Unidad Merida, Merida, Yucatan, Mexico

Castillo, Rafael:
 Departamento de Farmacia, Facultad de Química, Universidad Nacional Autónoma de México, Mexico City, 04510, Mexico

 Univ Nacl Autonoma Mexico, Fac Quim, Dept Farm, Mexico City 04510, Mexico

Leyva-Gomez, Gerardo:
 Departamento de Farmacia, Facultad de Química, Universidad Nacional Autónoma de México, Mexico City, 04510, Mexico

 Univ Nacl Autonoma Mexico, Fac Quim, Dept Farm, Mexico City 04510, Mexico

Mayet-Cruz, Lourdes:
 Departamento de Farmacia, Facultad de Química, Universidad Nacional Autónoma de México, Mexico City, 04510, Mexico

 Univ Nacl Autonoma Mexico, Fac Quim, Dept Farm, Mexico City 04510, Mexico

Jung-Cook, Helgi:
 Departamento de Farmacia, Facultad de Química, Universidad Nacional Autónoma de México, Mexico City, 04510, Mexico

 Univ Nacl Autonoma Mexico, Fac Quim, Dept Farm, Mexico City 04510, Mexico
ISSN: 15221059





AAPS PHARMSCITECH
Editorial
American Association of Pharmaceutical Scientists, ONE NEW YORK PLAZA, SUITE 4600, NEW YORK, NY, UNITED STATES, Estados Unidos America
Tipo de documento: Article
Volumen: 24 Número: 6
Páginas:
WOS Id: 001038668600003
ID de PubMed: 37498473
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