Formulation and Optimization of a Polyherbal Gel Using Quality by Design Approach for Enhanced Wound Healing and AntiInflammatory Activity

The process of wound repair represents an intricate biological mechanism encompassing hemostatic responses, inflammatory reactions, cellular proliferation, and tissue remodeling phases. Persistent inflammatory conditions and impaired healing processes require efficacious topical therapeutic interventions. This investigation sought to formulate and enhance a multi-botanical gel incorporating Curcuma longa (curcuminoids), Azadirachta indica (nimbin), Aloe vera (acemannan), Centella asiatica (asiaticoside), and Tridax procumbens (flavonoids) through Quality by Design (QbD) methodology. The botanical extract preparation utilized Soxhlet extraction methodology (70% ethanol) with standardization via HPTLC/HPLC techniques. Carbopol-based gel optimization employed Box-Behnken experimental design, examining pH levels, viscosity parameters, active compound concentration, and in vitro release characteristics. The refined gel formulation underwent evaluation for anti-inflammatory properties (protein denaturation prevention, membrane stabilization, carrageenan-induced paw inflammation) and wound repair efficacy (excision and incision protocols in Wistar rats) through biochemical, histopathological, and cytokine assessments. Extract recovery achieved 12.4% w/w containing curcumin 3.21%, nimbin 1.87%, asiaticoside 2.45%, and total flavonoids 5.63%. The refined gel formulation (pH 6.0, viscosity 18,400 cP) demonstrated notable protein denaturation prevention (IC₅₀ 42.6 μg/mL) and 58.4% inflammation reduction at 4 h. Within the excision wound protocol, the gel accomplished complete wound closure by day 18 and epithelialization within 12.8 days, outperforming povidone-iodine treatment. Histopathological examination demonstrated thorough re-epithelialization, concentrated collagen formation, and neovascularization. Biochemical evaluations indicated increased hydroxyproline, SOD, catalase levels, and decreased MDA concentrations. Cytokine assessment verified reduced IL-6/TNF-α expression and enhanced IL-10 production. Stability evaluation (6 months accelerated conditions) validated formulation integrity. The QbD-enhanced multibotanical gel represents a secure, efficacious, and stable topical preparation for enhanced wound repair and inflammatory control.

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