FORMULATION AND EVALUATION OF RAPIDLY DIS INTEGRATING FILM OF AMLODIPINE BES YLATE

Abstract

Fast-dissolving drug-delivery systems were first developed in the late 1970s as an alternative to tablets, capsules, and syrups. Fast dissolving oral films (FDOFs) are the most advanced form of  oral solid dosage form due to more flexibility and comfort. It improve the efficacy of APIs by dissolving within minute in oral cavity after the contact with less saliva as compared to fast dissolving tablets, without chewing and no need of water for admin istration. The FDOFs place as an alternative in the market due to the consumer’s preference for a fast dissolving product over conventional tablets / capsules. The oral thin-film technology is still in the beginning stages and has bright future ahead because it fulfils all the need of patients. Eventually, film formulations having drug/s will be commercially launched using the oral film technology. In the present study fast dissolving film of  Amlodipine Besylate was prepared using sodium alginate as film forming polymer. To decrease the disintegration time of formulationssodium starch glycolate was used as disintegrating agent. A full 32factorial design was applied using concentration of polymer and disintegrant as independent variable and disintegration time and % cumulative drug release as dependent variable. Response surface curves were plotted. Batch F6 was found to be the optimized batch as its disintegration was completed within the minimum time as compared to all other batches. The formulation (F6) was also showing sufficient drug release after 6 min. All the nine formulation was showing approximately 70-85% drug release after 6 min