Formulation and In-vitro Characterization of Novasomes Containing In-situ Gel for the Topical Delivery of Ketoconazole and Hydrocortisone

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Background: Novasomes, modified liposomal vesicles, enable simultaneous encapsulation of hydrophilic and hydrophobic drugs, offering prolonged and targeted drug delivery. Objective: To develop and characterize a novasomal in-situ gel containing ketoconazole (antifungal) and hydrocortisone (anti-inflammatory) for sustained topical delivery. Methods: Novasomes were prepared by the ethanol injection method and incorporated into a thermosensitive in-situ gel of Pluronic F127 (17–25%) and Pluronic F68 (1–5%). The formulations were evaluated for pH, gelation temperature/time, viscosity, spreadability, DSC, TGA, SEM, and in-vitro release using Franz diffusion cells. Results: Formulations exhibited pH 5.5–6.6 and gelation temperatures 22–35℃, enabling sol–gel transition at skin temperature. DSC showed a sharp endothermic peak at 120℃, confirming thermal stability; TGA indicated 10–12 % weight loss between 40–150℃, suggesting low thermal degradation. SEM revealed spherical vesicles (200–400 nm) with uniform surface morphology. In-vitro release reached 89.78 % for ketoconazole and 90.02 % for hydrocortisone within 11 h. Drug release followed zero-order kinetics (R2 = 0.93–0.98) and non-Fickian diffusion (n = 0.75–0.89), confirming controlled release behavior. Conclusion: The optimized novasomal in-situ gel demonstrated stable, biocompatible, and controlled topical delivery, highlighting its potential for dual antifungal–anti-inflammatory therapy in dermatological applications.

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