Evaluation of Film-Coated Tablets of Ethyl Acetate Fraction of Uncaria gambir (Hunter) Roxb

Gambir (Uncaria gambir [Hunter] Roxb) is a plant that can effectively treat hyperlipidemia. Its pharmacological effect is influenced by the high concentration of catechin, the major active compound, especially in the ethyl acetate fraction of gambier (EAFG). The EAFG can be utilized commercially, and it is produced into film-coated tablets to boost its stability because catechins are less stable when exposed to humidity and light. The present study was conducted to produce EAFG film-coated tablets and evaluate their physicochemical characteristics and stability during storage. Gambir leaf extract was prepared and fractionated with ethyl acetate as a solvent. The EAFG was granulated, followed by the tablet compacting and coating processes. The film-coated tablets of EAFG were subjected to physicochemical evaluation, dissolution, and accelerated stability tests. The physicochemical analysis revealed that the film-coated tablets met the standards for general appearance, hardness, friability, disintegration time, and catechin content. After 60 minutes, the dissolution profile of EAFG revealed that at least 75% of the catechin was dissolved in the media at pH 1.2, 4.5, and 6.8. Accelerated stability studies indicated good stability over six months. The formulation demonstrated no changes in the physicochemical properties of EAFG film-coated tablets. The development of film-coated tablets of EAFG showed good quality in terms of physicochemical, dissolution, and stability during storage. This is suitable for improving catechin's moisture and light protection.