Osmotic Release Oral Tablet Formulation, Development, and Evaluation of an Anti-epileptic Drug

Abstract

Eff orts were attempted to create a bioequivalent Osmatic release tablet formulation of carbamazepine, with a drug release profi le comparable to that of the innovator product. Tablets were formulated using the wet granulation technique based on literature data and the innovative product’s characterization. It was discovered that the pioneer tablet had a fi lm coating. After reviewing the existing literature and patents, it was determined to use a non-infringing approach and create a fi lm-coated tablet with an equivalent bioavailability and dissolution profi le. Based of justifi cation, the optimized formulation has an F9 value of 90, which is excellent. The intention was to keep the same composition and only increase the size. Trial formulation 9’s formula and procedure fulfi lled the specifi ed physicochemical properties and dissolution profi le, which is equivalent to the reference product in various media, based on the results of several laboratory trials and evaluations. The extended-release was achieved by combining the rate-controlling polymer Natrosol 250L/Natrosol 250 H, a pH-dependent polymer, and Hypromellose. Compared to the innovator sample, the extended-release tablets were found to comply with the USP specifi cation. Stability tests on the optimised batch showed no major deviations, which is a positive result.