Extemporaneous clobazam suspensions for paediatric use prepared from commercially available tablets and pure drug.

OBJECTIVE: Two clobazam aqueous suspensions for paediatric oral usage (5 mg/ml) were investigated to determinate its physicochemical stability under different storage conditions. METHOD: Formulations were stored at 4 and 25 °C and the clobazam content was determined by High Performance Liquid Chromatography. Each sample was analyzed by triplicate at different time points (0, 7, 14, 28 and 56 days). RESULTS: Liquid suspensions were successfully formulated from pure drug and commercially available tablets. In both cases, samples showed suitable physical stability. Clobazam was chemically stable in aqueous suspension during the 56 days of the study at the two storage temperatures. CONCLUSIONS: All the tried oral liquid formulations can be conserved at 4 and 25 °C at least 56-day period.

Objetivo: Dos suspensiones orales acuosas de clobazam para uso pediátrico (5 mg/ml) fueron evaluadas para determinar su estabilidad fisicoquimica bajo diferentes condiciones de almacenamiento. Métodos: Las formulaciones fueron conservadas a 4 y 25 °C y el contenido de clobazam fue determinado mediante Cromatografía Líquida de Alta Performance. Cada una de las muestras fue analizada por triplicado a diferentes tiempos (0, 7, 14, 28 y 56 días). Resultados: Las suspensiones fueron formuladas satisfactoriamente a partir del principio activo puro y de comprimidos disponibles comercialmente. En ambos casos, las muestras presentaron una adecuada estabilidad física. El clobazam fue químicamente estable en las suspensiones acuosas durante los 56 días de duración del estudio a las dos temperaturas elegidas para su conservación. Conclusiones: Todas las formulaciones orales líquidas formuladas y evaluadas en este estudio pueden ser conservadas a 4 y 25 °C por al menos 56 días.

Carvedilol stability in paediatric oral liquid formulations

Objective Two carvedilol aqueous solutions and one carvedilol aqueous suspension for paediatric oral use (1mg/ml) were studied to determine their stability. Method All samples were stored at 4, 25 and 40°C. Carvedilol content of each of the three formulations was tested using high performance liquid chromatography (HPLC). Each sample was analysed in triplicate at 0, 3, 7, 14, 28 and 56 days. Results Carvedilol stayed stable in the acidic aqueous solution at the three different temperatures during the 56 days of the study. In the alkaline solution, carvedilol was stable during 56 days at 25°C, but only 28 days at 4 and 40°C. In the aqueous suspension, carvedilol was stable during 56 days at 4 and 25°C, but only 28 days at 40°C.ConclusionsAll the formulations that were tested can be stored at 25°C for at least 56 days(AU)

Objetivo Se estudió la estabilidad de carvedilol (1mg/ml) en 2 soluciones acuosas y una suspensión acuosa para uso pediátrico. Método Las formulaciones fueron almacenadas a 4, 25 y 40°C. El contenido de carvedilol de cada una de las 3 formulaciones fue analizado por cromatografía líquida de alta eficacia (HPLC). Cada muestra fue analizada por triplicado a tiempos 0, 3, 7, 14, 28 y 56 días. Resultados Carvedilol se mantuvo estable en la solución acuosa de pH ácido durante los 56 días del ensayo a las 3 temperaturas estudiadas. En la solución alcalina fue estable 56 días a 25°C, pero sólo 28 días a 4 y 40°C. En la suspensión acuosa carvedilol fue estable 56 días a 4 y 25°C, y sólo 28 días a 40°C.ConclusionesTodas las formulaciones ensayadas pueden ser conservadas a 25°C al menos por un período de 56 días (AU)

Carvedilol stability in paediatric oral liquid formulations.

OBJECTIVE: Two carvedilol aqueous solutions and one carvedilol aqueous suspension for paediatric oral use (1mg/ml) were studied to determine their stability. METHOD: All samples were stored at 4, 25 and 40°C. Carvedilol content of each of the three formulations was tested using high performance liquid chromatography (HPLC). Each sample was analysed in triplicate at 0, 3, 7, 14, 28 and 56 days. RESULTS: Carvedilol stayed stable in the acidic aqueous solution at the three different temperatures during the 56 days of the study. In the alkaline solution, carvedilol was stable during 56 days at 25°C, but only 28 days at 4 and 40°C. In the aqueous suspension, carvedilol was stable during 56 days at 4 and 25°C, but only 28 days at 40°C. CONCLUSIONS: All the formulations that were tested can be stored at 25°C for at least 56 days.