Evaluación de la actividad antifúngica del ketoconazol para su uso en preparación oficinal

Abstract

The objective of this research was to evaluate the antifungal activity of ketoconazole for its use in officinal preparation. With this purpose, the minimum inhibitory and minimum fungicidal concentration of ketoconazole in-vitro against a laboratory strain of Candida albicans was determined with the microdilution method for yeasts, which was described by Clinical & Laboratory Standards Institute in the document M27 A. The result was that the microorganism is moderately sensitive to ketoconazole, being feasible for the elaboration of an officinal or magistral preparation. For the formula, the necessary characteristics that the preparation must have for a mycotic infection in the skin were taken into account. Therefore, carbopol 940 was chosen as the base of the gel, propylene glycol as cosolvent, EDTA as an antioxidant agent, and a 2% concentration of ketoconazole. Finally, quality control was performed following the techniques described by the USP (2010); where the organoleptic characteristics such as color, odor, presence of lumps, consistency, and physicochemical characteristics such as pH, density, and extensibility were analyzed. It obtained positive results in each analysis. For the microbiological parameters, petrifilm plates were used for Staphylococcus aureus, mesophilic aerobes, fungi, and yeasts. For Pseudomona auroginosa, incubation in blood agar was performed. In all microbiological analyses, there was no bacterial or fungal growth, concluding that the official formula carried out in this experimental work, complies with all the safety and efficacy parameters for its use.