Formulation and statistical analysis of an herbal medicine tablet containing Morus alba leaf extracts

It has reported that Morus alba has properties to treat fever, protect liver damage, improve eyesight, strengthen the joint, facilitate discharge of urine, and prevent high blood pressure. Extracts from herbal plants, have hygroscopic and low flowability characteristics. Due to these properties, it is difficult to develop the formulation using herbal extracts in pharmaceutics. In this study, Morus alba leaf extract (MLE) was fermented by Viscozyme ® (MLE-V) and Pectinex ® (MLE-P) as well as non-fermented MLE (MLE-C). Physicochemical properties of MLEs were evaluated for optimization of formulation. As a result, cell viability was higher MLE-V than MLE-P, although there was no difference in flowability depending on the enzyme type. Based on the pre-formulation study, MLE-V was selected. Wet granulation method was used to overcome the poor flowability of MLE and MLE tablet was developed by statistical-based experimental design method. A Box-Behnken design, one of the models of experimental design, was constructed using lactose content in lactose plus microcrystalline cellulose (X1), disintegration agent (X2), and binding agent (X3). The dependent variables were hardness (Y1), friability (Y2), and disintegration time (Y3). Finally, MLE tablet with hardness (11.83 ± 0.36 Kp), friability (0.26 ± 0.01%) and disintegration time (1395.56 ± 49.84 s) were optimized. This is the first work to report the formulation design using herbal extracts fermented with enzyme through quality by design.