Formulation And Evaluation Of Ozenoxacin-Loaded Hydrogel For The Treatment Of Impetigo

Objectives: The objective of this study was to develop and optimize a stable Ozenoxacin-loaded hydrogel for effective topical treatment of impetigo, aiming to enhance localized delivery, sustain drug release, and overcome current limitations such as antibiotic resistance. Methods: A 3² full factorial design was employed to study the effects of Carbopol 934P and PEG-8000 concentrations on hydrogel viscosity (R₁) and in-vitro drug release at 12 hours (R₂). Physicochemical characterization, differential scanning calorimetry (DSC), Fourier-transform infrared spectroscopy (FTIR), and in-vitro release studies were conducted. Accelerated stability studies were performed as per ICH Q1A(R2) guidelines. Results: The optimized formulation (TF7) exhibited a pH of 7.04 ± 0.07, viscosity of 4893 ± 147 cP, spreadability of 29.67 ± 1.08 g·cm/sec, drug content of 97.89 ± 1.31%, and cumulative drug release of 94.21 ± 3.24% at 12 hours. Release kinetics followed a Zero-order model (R² = 0.9871), indicating constant drug release. Accelerated stability studies confirmed physical and chemical stability over 6 months. The optimization approach using factorial design enabled precise selection of the ideal batch based on desirability value (1.000). Conclusion: The developed Ozenoxacin-loaded hydrogel demonstrated promising physicochemical and release properties, suggesting potential clinical benefits for impetigo management. Future in-vivo studies are warranted to validate therapeutic efficacy and support clinical translation.