DEVELOPMENT AND STANDARDIZATION OF POLYHERBAL ANTIDIABETIC FORMULATION

Type 2 Diabetes Mellitus (T2DM) is a complex metabolic disorder of global epidemic proportions, characterised by chronic hyperglycaemia. Current pharmacological agents, despite their efficacy, has some disadvantages. The present study was designed to develop, optimise, and standardise a polyherbal antidiabetic tablet formulation comprising five scientifically validated medicinal plants Gymnema sylvestre, Momordica charantia, Trigonella foenum graecum, Moringa oleifera, and Azadirachta indica. Standardised dry extracts characterised for yield, total phenolic content, total flavonoid content, and HPLC marker compound content. In-vitro antidiabetic activity was evaluated by alpha-amylase and alpha-glucosidase inhibition assays. Isobolographic analysis identified the pentaherbal combination at a 3:1:1:1:1 ratio (Gymnema:Momordica:Trigonella:Moringa:Azadirachta) as the optimal synergistic combination, with a combination index (CI) of 0.38, indicating strong synergism. Polyherbal antidiabetic tablets were prepared by wet granulation and optimised using a Box-Behnken Design. The optimised tablets met all IP 2022 specifications. HPTLC fingerprinting confirmed the identity of all five plant components. A validated HPLC method for simultaneous quantification of gymnemic acid, charantin, and quercetin meeting ICH Q2(R1) requirements. The formulation exhibited superior in-vitro antidiabetic activity compared to the reference drug acarbose for both alpha-amylase (IC50 31.2 vs. 48.6 µg/mL) and alpha glucosidase inhibition (IC50 26.8 vs. 49.2 µg/mL). Good accelerated stability studies achieved. The developed formulation represents an affordable, quality-controlled, multi-target therapeutic alternative for the management of T2DM.