Extended Release Gastro Retentive Mucoadhesive Bilayer Tablet of an Anti-Ulcer Drug

The present research work was concerned with the development of mucoadhesive gastroretentive bilayer tablets of Pantoprazole. Mucoadhesive bilayer tablets were prepared by direct compression method by using synthetic mucoadhesive polymers like Carbopol 934P, HPMC K100M, and Sodium CMC for ascertaining the best possible polymer with ethyl cellulose as backing layer. The prepared tablets were evaluated for their pre-compression and post-compression parameters. The formulations were optimised for percentage of drug release and its concentration using factorial design by taking Carbopol 934p, HPMC K100M, and Sodium CMC as independent variables and percentage of drug release as dependent variables respectively. Pre-compression and post-compression values of preliminary trials and initial optimised formulations were within the specified limits. The final optimised formulations showed mucoadhesion time 12 h, mucoadhesive strength 38 g and maximum drug release of 98.11% at the end of 12 h. The evaluation parameters of final optimised formulation OPF were found to be within the preferred limits. The possible order and drug release mechanisms for the optimised mucoadhesive bilayer tablets of pantopazole were observed to be peppas model with mechanism of drug release non-fickian diffusion. The accelerated stability studies of the final optimised formulations indicated no appreciable change in drug content and in vitro drug release rates of the formulations. Thus a stable and safe mucoadhesive bilayer tablet of pantoprazole can be formulated to achieve maximum bioavailability and therapeutic efficacy.