Preparation and optimization of a pediatric palatable praziquantel alcohol-free solution

BEDOGNI, GISELLE ROCIO; SEREMETA, KATIA PAMELA; OKULIK, NORA BEATRIZ; SALOMON, CLAUDIO JAVIER

Conferencia; 3rd Edition of Euro-Global Conference on Pediatrics and Neonatology; 2021

To date, praziquantel is only available as solid formulations, hindering its administration to paediatric patients. Therefore, the purpose of this work was to develop an alcohol-free oral liquid formulation of praziquantel. A design of experiment approach was applied in order to optimize a cosolvent mixture based on 2-N-methyl pyrrolidone, polyethylene glycol 400 and water and a stability assay was performed at different temperatures (4, 25 and 40 °C, with and without light exposure). The obtained formulation showed good stability in terms of praziquantel concentration, maintaining its initial value of 40 mg/ml at 25 and 40 °C, with and without light exposure, over 4 months. Contrarily, samples that were kept at 4 °C showed praziquantel precipitation, decreasing its concentration down to 35 mg/ml. Additionally, they all passed the USP microbiological examination of nonsterile products test and kept a pH of 7.0 during the evaluated period. The developed formulation allowed to increase praziquantel solubilization up to a 200-fold, using solvents at quantities considered as safe. Furthermore, the bitter and metallic taste of praziquantel was masked with a cheery flavoured essence and sucralose, making it more tasteful for children, which could help with paediatric patients’ compliance in different treatments, such as intestinal taeniasis.