Carvedilol stability in paediatric oral liquid formulations

Abstract

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.