Chewable Tablets of Acacia catechu Extract, an Alternative to Betel (Paan) for Mouth Ulcers: Formulation and In vitro Evaluation

Abstract

Objective: The objective of the current research work was to prepare chewable tablets having Acacia catechu extract useful for mouth ulcers using a 32 factorial design. Methods: Acacia catechu heartwood extract was prepared using a reported method with some modifications. The extract was characterized using TLC against the catechin marker. Then, drug-excipient interaction studies were carried out. The mixture of drug and excipients was evaluated for pre-compression parameters. With the application of 32 factorial design, chewable tablets were prepared using direct compression technique. Prepared tablets were evaluated for post-compression parameters. Results: In vitrodrug release study of the developed formulations was investigated both in intact and crushed form of tablets. Based on in vitroperformance, the best formulations were selected (F6, F7 & F8 from intact and F1, F5 & F9 from the crushed group) and subjected to various kinetic models and evaluated for chewing difficulty index (CDI). Conclusion: The overall results revealed that the formulated chewable tablets complied with the standards and exhibited a satisfactory performance in terms of drug release, chewing difficulty index and other related parameters.