Design and optimization of polyherbal tablets for anti-inflammatory therapy: A design of experiment approach with in vitro and in vivo evaluation

Abstract

Objective

To develop and optimize polyherbal tablets containing Terminalia chebula, Moringa oleifera, and Ocimum sanctum as a multi-targeted therapeutic approach for the management of chronic inflammatory disorders.

Methods

Polyherbal tablets were formulated and optimized using a 3² central composite design within a Quality by Design framework. The optimized formulation (F-11) was evaluated for physicomechanical properties, stability under ambient and accelerated conditions for 60 days, in vitro drug release of key phytoconstituents (gallic acid, stigmasterol, and rosmarinic acid), in vitro anti-inflammatory activity using the human red blood cell (HRBC) membrane stabilization assay, and in vivo anti-inflammatory efficacy using the carrageenan-induced paw edema model in Wistar rats.

Results

The optimized formulation (F-11) exhibited acceptable physicomechanical characteristics and remained stable over 60 days under both storage conditions. Sustained in vitro release was observed, with cumulative releases of gallic acid (72.47%), stigmasterol (81.20%), and rosmarinic acid (76.21%) within 180 min. The formulation demonstrated strong in vitro anti-inflammatory activity, achieving 83.63% inhibition of hemolysis at 500 μg/mL, exceeding that of diclofenac sodium. In vivo studies revealed a significant, dose-dependent reduction in paw edema comparable to the standard drug.

Conclusion

The developed polyherbal tablets demonstrated promising anti-inflammatory efficacy, sustained phytoconstituent release, and short-term stability, supporting their potential for further development as an alternative therapeutic option for inflammatory conditions.