Formulation and Evaluation of Aqueous Enteric Coated Delayed Release Omeprazole Pellets

The main objective of the present study was to develop and optimize enteric coated pellets of Omeprazole using enteric polymers like hydroxyl propylmethylcellulose phthalate. Characterization of the drug was carried out by performing the melting point, identification test by FTIR, solubility, loss on drying and assay parameteres. Then drug-excipient interaction studies were carried out using FTIR. Six formulations of pellets were prepared, from which F5 was chosen for further coating process. Then F5 formulation was sub-coated with HPMC E5 and enteric coated using HPMCP-55. All the formulations were evaluated for their physico-chemical parameters like assay, drug content and dissolution, etc. The in vitro drug release study was performed for the prepared formulations. From the in vitro drug release study, it was found that all the formulations demonstrated excellent physical resistance to the acid medium after 2 hour and the drug release was found to be within specified limits. Formulation subjected to stability studies were checked for physical appearance, drug content and dissolution for 3 months.