Nurturing Wellness: Development and Evaluation of a Novel Herbal Formulation with Immunomodulatory Activity

Abstract

Background: Disease prevention prevailed in the post-COVID world. The global trends are trailing toward prevention and immunity enhancement with alternative therapies and herbal drugs.Objectives: The current research was performed to prepare and standardize a herbal formulation reported to have multiple health benefits including immunomodulation.Materials and Methods: Ethanolic extracts of Asparagus racemosus, Tinospora cordifolia, and Trigonella foenum-graecum were prepared and used in the proportion of 1:1:1. The extracts were analyzed for phytochemicals and further standardized by high-performance thin layer chromatography (HPTLC) with analytical standards for all three drugs, that is, shatavarin IV, trigonelline, and berberine. The A. racemosus, T. cordifolia, and T. foenum-graecum extract blend (ATTEB) was tested for neutrophil adhesion and carbon clearance to check for overall immunomodulatory activity. The effervescent tablets were formulated and evaluated for various pharmacopoeial parameters. Accelerated stability studies of the formulations were done for 6 months duration as per the International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) guidelines.Results: The phytochemical and HPTLC results confirmed the presence of bioactive constituents in extracts and formulation. The blend of extract ATTEB (neutrophil adhesion: 52.17 ± 0.79, phagocytic index: 0.0292 ± 0.002) enhanced neutrophil adhesion by approximately 35% from the control group (16.91 ± 1.94), with almost five-fold higher phagocytic index compared to the control group (0.0056 ± 0.004) and even higher compared to the standard drug group (0.022 ± 0.001). A readyto-use formulation of effervescent tablets was prepared and evaluated. The B7 batch showed a suitable formulation based on the various evaluation parameters. The formulation was found to be stable under 6-month accelerated stability studies.Conclusion: The research study successfully developed a novel formulation of the blend with immunomodulatory activity.

Keywords: Herbal drug; immunomodulatory activity; high-performance thin layer chromatography; neutrophil activation; phagocytosis