Compounding, stability evaluation, efficacy and safety of vancomycin syrup for the treatment of clostridioides difficile infection

• Autores: Josep Edo Peñarrocha, M. Dolores Bellés Medall, Sergio García Muñoz, Julia Bodega Azuara, Esther Vicente Escrig, Raúl Ferrando Piqueres
• Localización: European journal of clinical pharmacy: atención farmacéutica, ISSN 2385-409X, Vol. 23, Nº. 2, 2021, págs. 98-105
• Idioma: inglés
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• Resumen

  • Objective: The objective of this study is to validate a vancomycin syrup 50 mg/mL developed in a hospital pharmacy service by studying the physical, chemical and microbiological stability and checking the efficacy and safety of this compound.

    Method: The syrup contains a mixture of sorbitol-water, sodium ascorbate, strawberry essence and citric acid as vehicle and it is transferred into a topaz glass. The constancy of pH value, the absence of precipitate and the non-alteration of organoleptic properties were assessed for physical stability. Chemical stability was studied by the remaining concentration of vancomycin by a developed and validated method, HPLC-UV. Microbiological stability was defined as the absence of bacterial colonies in various growth medium. A prospective study of patients treated with the formula in our hospital for one year was designed to study the efficacy and safety. Data collection were done by demographic variables, resolution of the disease, recurrence episodes and adverse drug reaction.

    Results: The analytical method presented an acceptable lineal correlation (R2 >0.999), relative error (RE <10%) and coefficient of variation (CV <10%). The formula proved to be physically (absence of precipitation without change in organoleptic properties and stable pH values), chemically (concentration of vancomycin has been maintained above 90% of the initial concentration) and microbiologically (no colony of microorganisms was isolated in growth medium) stable for 30 days at 2-8ºC protected from light. Safety and efficacy were analyzed in 70 patients. In 95.7% of cases, the disease was resolved at the end of the treatment. Five patients (7.1%) presented recurrence episodes. One patient presented an adverse drug reaction (intestinal absorption of vancomycin).

    Conclusions: The formula has been shown to be effective and safe in the Clostridioides difficile infection treatment. From a galenic point of view it is stable for 30 days at 2-8ºC protected from light