Editor-in-Chief İlkay Küçükgüzel Associate Editor Esra Tatar Online ISSN 2630-6344 Publisher Marmara University Frequency Quarterly (January-April-July-October) Abbreviation J.Res.Pharm. Former Name Marmara Pharmaceutical Journal
Marmara Pharmaceutical Journal 2019 , Vol 23 , Issue 1
Stability studies of compression coated ornidazole tablets for colon specific drug delivery
Seda RENÇBER1,Zeynep ŞENYİĞİT2,Mine ÖZYAZICI1
1Department of Pharmaceutical Technology, Faculty of Pharmacy, Ege University, Bornova, İzmir, Turkey
2Department of Pharmaceutical Technology, Faculty of Pharmacy, İzmir Katip Çelebi University, Çiğli, İzmir, Turkey
DOI : 10.12991/jrp.2018.106 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. Keywords : Stability studies; compression coated ornidazole tablet; ethylcellulose; characterization of tablet; dissolution study
Marmara University