Development, Optimization and Evaluation of Ozenoxacin Nanoemulgel for the Treatment of Impetigo
Abstract
Background- Impetigo, a highly infectious superficial epidermal infection caused by Streptococci and Staphylococcus aureus, is commonly treated with topical antibacterial agents. Ozenoxacin is the drug of choice, a potent quinolone antibiotic, recently approved by (USFDA) in December 2017 with reported antibacterial activity against Impetigo. It is the preferred drug due to its strong antibacterial activity and lipophilic nature, which improves patient compliance. Aim- This study aimed to develop and evaluate a nanoemulgel that combines nanotechnology and gel properties to improve drug penetration, provide targeted action and sustain therapeutic effects. Method- Preliminary studies such as drug identification, solubility testing, and FTIR analysis were performed. Eucalyptus oil, Tween-80, and Span-80 were selected using the solubility equilibrium method. Smix ratios were optimized through water titration and pseudo-ternary diagrams. 13 Nanoemulgel formulation batches were prepared using a homogenization method and optimized via the Box-Behnken design model. Result- The nanoemulgel formulations were characterised and evaluated for their physicochemical properties. Acceptable results were obtained from the optimized batch's evaluation parameters, globule size, PDI, and zetapotential. The optimized batch (F14) demonstrated 96.24% drug release over 12 hours in in-vitro studies using the Franz diffusion cell. The formulation exhibited a viscosity of 1430 cps at 100rpm, a pH range of 6.5–7.1, and excellent spreadability. Microbiological efficacy testing confirmed Ozenoxacin’s activity against Staphylococcus aureus. Stability analysis showed no significant changes in pH, viscosity, or drug content, confirming formulation stability. Compared to the marketed cream, the Nanoemulgel showed superior drug release, and the study successfully developed an optimized formulation that meets desired therapeutic and application requirements, ensuring satisfactory results. Keywords: Ozenoxacin, Impetigo, Nanoemulgel, Box-Behnken design , Nanotechnology, Homogenization.