Einstein International Journal Organization(EIJO)

Abstract

The present study aimed to develop and evaluate a Ketoconazole-loaded bigel formulation for effective topical antifungal treatment with enhanced drug release and improved patient compliance. Bigels were prepared by combining hydrogels (Carbopol-934, HPMC, and Guar Gum) with organogels containing coconut oil, lemon oil, and almond oil in a 1:1 ratio. A total of nine formulations (BG1–BG9) were developed and characterized for physicochemical properties, drug compatibility, spreadability, extrudability, in vitro drug release, stability, and antifungal activity. Preformulation studies including melting point, solubility, UV spectroscopy, FTIR, and DSC analysis confirmed the identity and compatibility of Ketoconazole with selected excipients. The prepared formulations exhibited acceptable pH (7.0–7.6), good homogeneity, and satisfactory rheological properties. Among all formulations, BG1 containing Carbopol-934 hydrogel and coconut oil organogel demonstrated superior spreadability (8 cm), excellent extrudability, and the highest cumulative drug release (25.78% within 180 minutes). Drug release kinetics indicated a diffusion-controlled mechanism following first-order release behavior. Stability studies conducted under different storage conditions for three months revealed no significant changes in physical appearance, pH, viscosity, or drug content, confirming formulation stability. The antifungal sensitivity study demonstrated effective activity against fungal strains associated with Tinea versicolor. The results suggest that Ketoconazole-loaded bigel, particularly formulation BG1, is a promising carrier system for topical antifungal therapy, offering improved drug delivery, stability, and therapeutic efficacy.

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