Phytopharmaceutical Development, Standardization, and Evaluation of an Ehretia Laevis Roxb. Tincture Ointment for Topical Wound Healing

Background: Ehretia laevis Roxb. (Boraginaceae) is widely used in traditional Indian medicine, particularly by tribal communities, for the treatment of wounds and skin ailments. However, despite its ethnomedicinal importance, no standardized topical formulation has been developed to ensure consistent quality, safety, and efficacy. Objective: This study aimed to formulate and evaluate a standardized topical ointment incorporating E. laevis hydroalcoholic tincture with detailed physicochemical characterization, microbial safety assessment, and stability profiling. Methods: A hydroalcoholic tincture (70% ethanol) was prepared from shade-dried leaves of E. laevis by maceration (yield 22.6% w/w). A 2% w/w ointment was formulated using a petroleum jelly base by the fusion method. The formulation was evaluated for organoleptic characteristics, physicochemical parameters (pH, viscosity, spreadability, loss on drying, iodine value, peroxide value), microbial contamination (total viable count and specific pathogens, detection limit 10 CFU/g), accelerated stability (40±2°C/75±5% RH for 3 months), and in vitro skin permeation using Franz diffusion cells with Strat-M® membranes (thickness 300±50 μm). Results: The ointment exhibited a green color, characteristic herbal odor, smooth texture, and absence of phase separation. Physicochemical parameters were within acceptable limits (pH 4.9, viscosity 9.5 Poise, loss on drying 0.48%). No microbial contamination or pathogens were detected. Stability studies showed minimal variations, maintaining acceptable quality. In vitro permeation demonstrated biphasic release with an initial burst followed by sustained diffusion, fitting the Higuchi kinetic model (R² = 0.989). Conclusion: The developed ointment is stable, microbiologically safe, and exhibits desirable release characteristics, providing a promising standardized phytopharmaceutical approach for wound management. Further in vivo studies are warranted.