Formulation and Evaluation of Pantoprazole Delayed Release Tablets using Eudragit L30D55

Pantoprazole sodium is a proton pump-inhibitor which is used in the treatment of peptic ulcer. In this study Pantoprazole enteric coated tablets were prepared by using Methacrylate co-polymers (Eudragit L30D55).Eight formulations of enteric coated tablets of Pantoprazole were developed by preparing core tablets using Mannitol as diluent and Crospovidone as super disintegrant and Povidone (PVP K-30) as binder in different proportions and varying the compositions of sub coating and enteric coating using Sicovit yellow ,titanium dioxide and Eudragit (L30D55) .The core tablets were prepared by dry granulation method.F7 was found to be best of all the trials showing drug release matching the innovator product. The best formulation F7 was repeated again for reproducibility, and all the quality control tests were done for conformation. Stability study is carried out for 2 months at 25°C; 60% RH: and 40°C; 75%RH, according to ICH guidelines. The tablets were tested for acid release during the stability period and confirmed that results were found within the limits. The identified formula shall be utilized for the formulation development and other studies for successful launching of the product.