The stability of azithromycin in a reconstituted oral suspension under various in-home storage conditions

Abstract

The stability tests of an active compound or pharmaceutical product provide information about the degradation of the active compound or the deterioration of the pharmaceutical product, which may occur due to various storage conditions—such as high temperature, light and humidity—to which these products may be exposed. The study aimed to investigate the stability of azithromycin in a reconstituted oral suspension under various in-home storage conditions over 10 days. Azithromycin oral suspension was reconstituted by boiled tap water (200 mg/5 ml) and stored under various in-home storage conditions (exposure to sunlight, refrigerated (4°C), stored at room (20°C) and higher temperatures (30°C, 40°C and 50°C). Azithromycin concentrations in the samples of the suspension were analysed daily for 10 days using an HPLC method. The results revealed that the reconstituted azithromycin stored under various in-home storage conditions is stable for 10 days. The active molecule of azithromycin showed good stability after reconstitution with boiled tap water. However, it is necessary to carry out further studies in which the reconstituted oral suspension will be evaluated in terms of the physicochemical and aesthetic appeal (odour, taste, colour and texture) properties of the formulation.