Diseño experimental y evaluación técnica de la estabilidad en uso del producto Nitazoxanida 100 mg/5 mL en polvo para reconstituir suspensión oral

Abstract

CONDITION FOR PROJECT PUBLICATION. Oral powder suspensions for reconstitution are formulations frequently used in pediatrics. However, as this type of product is a multi-dose medicine for reconstitution, its stability after opening may be compromised due to incorrect reconstitution, repeated handling, and exposure to the environment, highlighting the importance of studies that demonstrate its quality during its period of use. The objective of this study was to design and evaluate the stability in use of the product Nitazoxanide 100mg/5mL powder for reconstitution as an oral suspension, demonstrating that during the period of use (once opened, reconstituted, and stored under the recommended storage conditions) the product maintains its physicochemical and microbiological quality. The study was carried out by identifying regional technical guidelines and regulations applicable to in-use stability studies, followed by the design and execution of the experimental study, which evaluated parameters such as appearance, pH, density, active ingredient and preservative assessment, impurities, total aerobic microorganism count, filamentous fungi and yeasts, and investigation of the pathogen Escherichia coli, over a period of 7 days at room temperature and 14 days under refrigeration. The results showed that despite certain fluctuations during the study, these are attributable to the nature of the product (continuous agitation and exposure to temperature changes during daily handling influence homogeneity) and the drug maintains its physicochemical and microbiological properties under controlled handling and storage conditions. Keywords: Powder for oral suspension, stability in use, multi-dose medications, forms of handling, forms of storage, nitazoxanide