Abstract

MAYES CISNEROS, Selvin Yassir et al. Preparation of a powder for oral suspension of spironolactone: physicochemical and microbiological characterization. Universidad y Sociedad [online]. 2022, vol.14, n.6, pp. 658-669.  Epub Dec 30, 2022. ISSN 2218-3620.

The objective of this study was to formulate three suspensions of powdered spironolactone for reconstitution (5 mg/mL) for pediatric use. Methodology. The tests were carried out: sedimentation time, pH, rheology, particle size, polydispersity, and Z potential of the three formulations (F1, F2, and F3) to choose the suspension with the best results. The chosen formulation underwent: accelerated physical stability, dissolution test, drug quantification, and microbiological stability stored at 4, 25, and 40°C (days 0, 15, and 30). Results. Of the three formulations, F2 and F3 remained suspended for more than 24 h, but not F1. The pH values were suitable for F1, F2, and F3. The particle sizes, polydispersity, and Z potential were ideal for F2 (chosen formulation). Spironolactone content remained within the stipulated parameters at temperatures of 4 and 25 °C, not at 40 °C. The dissolution test showed that the F2 released the drug faster than the Aldactone® tablet. Regarding the microbiological tests, the F2 remained stable for 30 days, with counts lower than 10 CFU/mL. Conclusion. F2 is a suitable formulation for use in pediatrics.

Keywords : spironolactone; suspension; pediatric use; Physicochemical stability; microbiological stability.

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