Development and characterization of thermosensitive pluronic-based metronidazolein situgelling formulations for vaginal applicationThe purpose of this study was to develop pluronic-basedin situgelling formulations of metronidazole (MTZ) for treatment of bacterial vaginosis, aimed at prolonging the residence time, controlling drug release, enhancing efficacy, decreasing recurrence, and increasing patient compliance. Thein situgel formulations were prepared using different concentrations of pluronic F-127 (PF-127) alone and in combination with pluronic F-68 (PF-68). The prepared formulations were evaluated for their gelation temperature (Tgel),in vitrodrug release, rheological properties, mucoadhesion properties and tolerability by vaginal mucosa in tissue levels. TheTgeldecreased with increasing PF-127 concentration. TheTgelwas modulated by addition of PF-68 to be within the acceptable range of 25-37 °C. With increasing pluronic concentration, thein vitrodrug release decreased, viscosity and mucoadhesive force increased. Histopathological examination of rabbit vaginas from the control and treated groups revealed normal histology of the vagina and cervix. Based on thein vitroevaluation of prepared formulations, thein situgelling liquid formulated with PF-127/PF-68 (20/10 %,m/m) was selected for further clinical evaluation.

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Pilot testing showed that in situ MTZ vaginal gel is more effective than the conventional vaginal gel for long-term cure of BV. These findings suggest a novel and efficient long-term treatment of BV.

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