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

OBJECTIVE: The objective of the current research work was to prepare chewable tablets having Acacia catechu extract useful for mouth ulcers using a 3(2) 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 3(2) factorial design, chewable tablets were prepared using direct compression technique. Prepared tablets were evaluated for post-compression parameters. RESULTS: In vitro drug release study of the developed formulations was investigated both in intact and crushed form of tablets. Based on the in vitro performance, 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 the satisfactory performance in terms of drug release, chewing difficulty index and other related parameters.