Development and Optimization of Ruellia tuberosa loaded Shatdhaut Ghrita-based herbal Antifungal Cream

Objectives: To develop and optimize a novel antifungal cream formulation containing Ruellia tuberosa extract using Shatadhaut Ghrita as a base through quality-by-design principles for enhanced therapeutic efficacy against common fungal pathogens. Methods: The cream formulation was optimized using 3² full factorial design with Shatadhaut Ghrita concentration (3-5%) and emulsifier blend ratio (4-6%) as independent variables. Formulations were characterized using FTIR, DSC, physicochemical parameters, in vitro release studies, and stability testing. Antifungal activity was evaluated against Candida albicans and Aspergillus niger. Results: The optimized formulation (MF5) exhibited ideal physicochemical properties with pH 6.2±0.12, viscosity 12358±245 cP, and spreadability 18.2±0.42g.cm/sec. FTIR and DSC analyses confirmed drug-excipient compatibility. MF5 demonstrated controlled release with 95.8% drug release over 12 hours and maintained stability for 3 months under accelerated conditions (40°C±2°C/75%±5% RH). The formulation showed significant antifungal activity with zones of inhibition of 21.4±0.8mm and 18.6±0.7mm against C. albicans and A. niger respectively, achieving approximately 88% efficacy compared to standard fluconazole. Conclusion: The optimized Ruellia tuberosa loaded Shatadhaut Ghrita cream formulation demonstrates promising potential as a stable, effective alternative to synthetic antifungal agents for topical applications. The enhanced therapeutic efficacy and controlled release profile suggest favourable clinical applications, warranting further in vivo investigations.