Design and Performance Evaluation of Unidirectional Buccal Patches Loaded with Carbamazepine: A Comprehensive Formulation Study

Abstract

Carbamazepine (CBZ) is used for epilepsy but has also been reported to have effect in treating bipolar disorder. The absorption is 75% because of first pass hepatic metabolism, Its half-life is 10-20hrs and it is a BCS – class II drug. Thus formulating an immediate release CBZ fast dissolving buccal films formulation for the speedy release of the drug was planned. FTIR analysis was done to know the compatibility of the drug with the excipients which are used in formulation of the drug. Preparation of fast dissolving buccal films by selecting various concentration of Sodium Saccharin Gel (SSG), croscarmellose and crospovidone. Coating solvent method was employed for the preparation of films. Various characteristics such as weight, thickness, surface pH, tensile strength, diffusion studies and its release kinetics were determined for the prepared film formulations. It was observed that all the films were within surface approximate, close to the neutral pH level and all of them were found to have content uniformity. The result shown here also clearly depict that the F4 formulation has higher release profile as compared to other all formulations. From the above data, it was perceived that increase in concentration of crospovidone will enhance the release profile of the formulation. It was seen that release kinetics depends on higuchi equation. Due to good tensile strength and the ability to get more than % drug release, more concentration crospovidone used film formulations was selected for the study.