The development of oral tablet formulation for herbal medicines has been restricted by large\ndrug loadings and the poor physicochemical and mechanical properties of dry herbal extracts (DHEs).\nHerein, statistical experimental designs were applied to herbal tablet formulation development and\noptimization usingWuzi Yanzong dry extract (WYE). The tablet disintegration time and hardness\nwere identified as the critical quality attributes (CQAs) of the product. The tablet formulation was\ndesigned to achieve a high drug loading (50% or higher of WYE), shorter tablet disintegration time\n(less than 30 minutes), and suitable hardness (6.0 to 7.5 kp). A D-optimal mixture design was used\nto evaluate the effects of excipients on CQAs to minimize the risk compression failure and improve\nthe tabletability in formulations containing WYE at 50% and 65% by weight. A partial least squares\nmodel was used to elucidate the multivariate relationships between a large number of formulation\nvariables and product CQAs, and determine the maximum possible WYE loading. From overlaid\nplots of the effects of formulation variables on CQAs, it was found that a maximum WYE loading of\n67% in tablet formulation satisfied the acceptance criteria of CQAs. In conclusion, this study shows\nthat multivariate statistical tools are useful for developing tablet formulations containing high doses\nof herbal extracts and establishing control strategies that ensure product quality.
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