Formulation, Development, and In-Vitro Evaluation of a Film-Coated Tablet Containing a Flavonoid Diosmin and Hesperidin Combination

Abstract

In this study combination of diosmin and hesperidin was used for the treatment of a condition called chronic venous insufficiency. diosmin and hesperidin are citrus bioflavonoids that act as a vascular-protecting agents used to treat chronic venous insufficiency, hemorrhoids, lymphedema, and varicose veins. A preformulation study was carried out for the formulation of the tablet of the selected drug. A compatibility study was carried out between diosmin and hesperidin along with excipients like Avicel pH 101, Klucel EXF, Sodium Starch Glycolate, and Magnesium stearate. Formulation of tablets was carried out in various trials. Trial 1 consists of two batches, F1 and F2 but due to disintegration issues, the formula was modified and trial 2 of batch F3 and F4 was carried out. Batch F2 and F3 were found to be of low hardness and high disintegration time. Trial 3 was conducted for batches F5, F6, and F7 where binders like polyvinyl pyrrolidone, Ac-Di-Sol, and Klucel EF were used. Batch F8 and F9 were formulated as trial 4 with Klucel EXF. Batch F8 produced a satisfactory result and hence coated with agent Wincoat WT-QCAQ-1261 Brown. Batch 8-V has shown acceptable results of disintegration time and was subjected to a stability study. Finally, a concluding manufacturing process was formulated depending on the obtained results.