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<p>The objective of this study is to develop and optimize a temperature-sensitive in situ gel formulation of ozenoxacin for enhanced treatment of impetigo through systematic formulation design and characterization. Thermosensitive in situ gels were prepared using Kolliphor P407 (18–22% w/v) and HPMC K4M (0.4–1.2% w/v) through 3<sup>2</sup> factorial design. Formulations were characterized for physicochemical properties, gelation characteristics, and drug release. Response surface methodology was employed to optimize polymer concentrations based on gelation temperature and drug release. The optimized formulation was evaluated for antimicrobial activity against <i>S. aureus</i> and <i>S. pyogenes</i> and subjected to 6-month stability studies. The optimized formulation (VF2) exhibited ideal gelation temperature (32.4 ± 0.3&#xa0;°C), pH (6.7 ± 0.1), and viscosity (3124 ± 178 cps before gelation, 16,580 ± 412 cps after gelation). Drug content remained high (97.8 ± 1.4%) with sustained release (93.8 ± 1.2% at 12&#xa0;h). Enhanced antimicrobial activity was demonstrated through larger zones of inhibition (26.8 ± 1.4&#xa0;mm for <i>S. aureus</i>, 28.5 ± 1.5&#xa0;mm for <i>S. pyogenes</i>) compared to pure drug (24.6 ± 1.2&#xa0;mm, 26.2 ± 1.3&#xa0;mm) and standard antibiotic (22.4 ± 1.1&#xa0;mm, 23.8 ± 1.2&#xa0;mm). The formulation maintained stability at room temperature for 6&#xa0;months with minimal changes in critical attributes. The developed thermosensitive in situ gel offers a promising platform for enhanced impetigo treatment through improved drug delivery and antimicrobial efficacy, warranting further clinical investigation.</p> Graphical Abstract <p></p>

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Development and Fabrication of Ozenoxacin Loaded Thermosensitive In-Situ Gel for Impetigo

  • 期刊论文

  • 发表日期：

    2025年9月4日

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  • Suhas Shivaji Siddheshwar,
  • Varsha Ramnath Kale,
  • Someshwar Dattatraya Mankar,
  • Arti Changdev Ghorpade,
  • Payal Sopan Gawali

摘要

The objective of this study is to develop and optimize a temperature-sensitive in situ gel formulation of ozenoxacin for enhanced treatment of impetigo through systematic formulation design and characterization. Thermosensitive in situ gels were prepared using Kolliphor P407 (18–22% w/v) and HPMC K4M (0.4–1.2% w/v) through 32 factorial design. Formulations were characterized for physicochemical properties, gelation characteristics, and drug release. Response surface methodology was employed to optimize polymer concentrations based on gelation temperature and drug release. The optimized formulation was evaluated for antimicrobial activity against S. aureus and S. pyogenes and subjected to 6-month stability studies. The optimized formulation (VF2) exhibited ideal gelation temperature (32.4 ± 0.3 °C), pH (6.7 ± 0.1), and viscosity (3124 ± 178 cps before gelation, 16,580 ± 412 cps after gelation). Drug content remained high (97.8 ± 1.4%) with sustained release (93.8 ± 1.2% at 12 h). Enhanced antimicrobial activity was demonstrated through larger zones of inhibition (26.8 ± 1.4 mm for S. aureus, 28.5 ± 1.5 mm for S. pyogenes) compared to pure drug (24.6 ± 1.2 mm, 26.2 ± 1.3 mm) and standard antibiotic (22.4 ± 1.1 mm, 23.8 ± 1.2 mm). The formulation maintained stability at room temperature for 6 months with minimal changes in critical attributes. The developed thermosensitive in situ gel offers a promising platform for enhanced impetigo treatment through improved drug delivery and antimicrobial efficacy, warranting further clinical investigation.

Graphical Abstract