QbD Optimized Nanoemulsion Based Topical Formulation of Jatyadi Taila: Unveiling its In Vitro and In Vivo Efficacy for Enhanced Wound Healing.

Abstract

<h4>Background</h4>Jatyadi Taila (JT) is an Ayurvedic herbal formulation traditionally used for wound healing. However, its oily nature restricts clinical use due to greasy texture, slower absorption, occlusiveness, and application difficulties, resulting in poor patient compliance.<h4>Objectives</h4>To develop and optimize a JT containing nanoemulsion (JT-NE) and incorporate it into a Carbopol-based hydrogel for enhanced wound healing efficacy.<h4>Methods</h4>JT-NE was developed using a Quality by Design (QbD) approach and incorporated into a Carbopol-based hydrogel. The formulations were characterized for physicochemical properties, rheology, and morphology. In vitro fibroblast proliferation and migration assays, along with in vivo wound healing studies in full-thickness wound-bearing Wistar rats, were performed to evaluate therapeutic efficacy.<h4>Results</h4>The optimized JT-NE formulations exhibited a globule size range of 220-300 nm, polydispersity index (0.245-0.380), and zeta potential values of -25.94 ± 1.01 mV, 18.14 ± 1.20 mV, and -26.10 ± 1.25 mV. Hydrogels containing JT-NE demonstrated thixotropic behavior with an average viscosity of 88748 mPa, pH 4.5-5.5, a porous mesh-like morphology with entrapped JT-NE, and ~70% water loss within 4 h. In vitro, JT-NE significantly promoted fibroblast proliferation and migration. In vivo, the formulation enhanced wound closure, increased collagen biosynthesis, downregulated TNF-α, and upregulated KI-67 expression compared to untreated and JT treated groups.<h4>Conclusion</h4>The JT-NE hydrogel significantly improved the therapeutic efficacy of JT, offering a novel, patient-compliant delivery system for effective wound management.