Formulation and stability evaluation of hydrogels with ketoconazole

Abstract

This study is focused on designing hydrogels with ketoconazole (KET) based on two polymers - Carbopol 980 or hydroxyethyl cellulose (HEC). Hydrogels were stored for 6 months at different temperature and relative humidity conditions (4ºC ± 2ºC, 25ºC ± 2ºC and 60% ± 5% RH, 40ºC ± 2ºC and 75% ± 5% RH). It was found that hydrogels made of Carbopol 980 exhibited more favourable physicochemical properties and better stability . In HEC hydrogels stored at 40ºC ± 2ºC and 75% ± 5% RH a decrease of pH, differences in the content and sedimentation of KET were observed. In vitro release study showed that amount of released KET from designed hydrogels was definitely higher than from registered product.