Design and Optimization of Novel Anti-Tubercular Polyherbal Chewable Tablet Using Design Expert

Abstract

Introduction: Scientific and Ayurvedic literature provides strong evidence that plants, their phytoconstituents, and extracts have significant anti-tubercular activity. However, developing effective herbal formulations is a complex process due to the presence of multiple bioactive compounds with diverse chemical properties. This complexity requires a systematic and scientifically driven approach in formulation development. Implementing a Quality by Design (QbD) framework is therefore essential, as it allows for a deeper understanding of critical material attributes and process parameters involved in manufacturing. By adopting QbD principles, the formulation process becomes more robust, predictable, and efficient, reducing dependence on traditional trial-and-error methods and ensuring consistent quality, safety, and efficacy of the final herbal product for therapeutic use. Objectives: The study aims to design and develop anti-tubercular polyherbal chewable tablets using a 32 factorial design, with standardization achieved through HPLC. Materials and Methods: The formulation was developed systematically using Design-Expert Software (version 11) to ensure a scientific and optimized approach. Based on extensive evidence from scientific research and Ayurvedic literature, four medicinal plant extracts were selected for their proven anti-tubercular potential. These included Glycyrrhiza glabra (Yastimadhu), known for its anti-inflammatory and immunomodulatory properties; Piper longum (Pippali), recognized for its bio-enhancing and respiratory benefits; Curcuma longa (Haridra), valued for its potent anti-inflammatory and antimicrobial effects; and Adhatoda vasica (Vasaka), traditionally used for respiratory disorders. These extracts formed the core active components for the optimized polyherbal chewable tablet formulation. Results: Pre-compression, post-compression, and organoleptic evaluations indicated that formulation F5 exhibited superior taste and overall performance compared to all other formulations. The optimized batch demonstrated desirable hardness, disintegration time, and acceptable mouthfeel, making it the most suitable for patient compliance. Quantitative analysis using HPLC confirmed the presence of key active constituents, with the formulation containing 1.035% Glycyrrhin, 0.44% Piperine, 1.37% Curcumin, and 0.086% Vasicine. These results validated the consistency and standardization of the tablet. Additionally, accelerated stability studies were conducted, which showed that the formulation retained its physicochemical properties and active content throughout the study period, confirming its stability and suitability for long-term storage under recommended conditions. Conclusion: This factorial design approach can help to develop and optimize polyherbal chewable tablets and lead to the development of precious and cost-effective products in a minimal period of time. Quantification of active phytoconstituents in polyherbal chewable tablets by HPLC showed the product quality and through this, we can fluently control the batch- to- batch variations in the finished product which will also help to deliver consistent efficacy. Therefore, by adopting newer techniques of formulation development and manufacturing process, we can minimize the trials and improve the product quality, efficacy and shelf life. Moreover, this polyherbal formulation may offer therapeutic potential in the early stages of tuberculosis due to the anti-tubercular properties of the selected plants.