Análisis de la estabilidad de cuatro formulaciones magistrales con omeprazol en suspensión oral pediátrica, elaboradas con diferentes vehículos

Abstract

The aim of this research was to analyze the stability of four magistral formulations of omeprazole in pediatric oral suspensions made with different vehicles. The study is explanatory, experimental, longitudinal, with qualitative and quantitative data, it means, a mixed methods research. With the data obtained, a one-factor ANOVA test was performed to identify significant differences, rejecting or accepting hypotheses. A Standard Operating Procedure (SOP) was established for the samples. In the preparation of the omeprazole suspensions 20 mg capsules were used, where purified water (Formulation 1), aqua conservans (Formulation 2), Ora Plus (Formulation 3) and Ora Sweet (Formulation 4) were used as vehicles; Sodium bicarbonate, xanthan gum and sodium saccharin were used as excipients. The physical parameters were analyzed: color, smell, taste, presence of foreign particles and pH; in chemicals, the content of active ingredient and microbiological tests, the count of aerobic microorganisms, filamentous fungi and yeasts, additionally, the absence of Escherichia coli, all these parameters were evaluated in 96 samples packaged in 60 mL amber glass bottles and stored at 2-8 degrees Celsius and less than 30 degrees Celsius, from day 0 to 30. The results obtained showed changes in the physical characteristics of the magistral preparations, in accordance with the storage conditions to which they were exposed; In the chemical and microbiological analysis, all the samples were found within the established ranges. It was concluded that the stability of these depends on the storage conditions, vehicle and active principle used, in this sense the F3 elaborated with Ora plus, complies with the limits established by USP 38. It is recommended to evaluate the acceptability offered by the magistral formulations, analyzing the route of administration and aspects related to safety.