Stability studies of compression coated ornidazole tablets for colon specific drug delivery
Makaleler > Tam Makale · 2018
Yazarlar: Seda Rençber, Zeynep Şenyiğit, Mine Özyazıcı
Journal of Research in Pharmacy, Uluslararası, Scopus, 2018, cilt 23, ss 34-43
Özet
In our previous study, colon targeted tablets of ornidazole were prepared with compression coating technique.Pectin was used as the coating layer and different ethyl cellulose (EC) types (EC N7, N 10 and N 100) were added to Pectin to enhance mechanical and release properties.The object of the present study was performed stability testing of these coated tablets of ornidazole in a high density polyethylene plastic bottle with/without silica gel as per ICH guidelines.For this aim, several quality-control parameters such as uniformity of weight, diameter and thickness of tablets, tablet hardness, friability, content uniformity and tablet dissolution rate are determined in stability conditions (25±2°C / 60±5% relative humidity and 40±2°C / 75±5% relative humidity).These parameters were evaluated at 0 month, 3 month, 6 month and 12 month intervals.It was concluded that the coated ornidazole tablets should be stored in a high density polyethylene plastic bottle with silica gel at controlled room temperature (25°C) or below their relative humidities and the presence of desiccant in the market package was essential.