High dosage mucoadhesive metronidazole aqueous-based gel formulations and their use to treat bacterial vaginosis

A method of treating a subject suffering from and/or diagnosed with bacterial vaginosis (BV), comprising applying intravaginally to the subject an amount of an aqueousbased gel for a number of applications sufficient to achieve a clinical cure, wherein the aqueous-based gel comprises one or more mucoadhesive polymers, about 1.3 wt % metronidazole (MTZ), and water, and has one or more features or characteristics selected from the following group:

• the levels of MTZ from the aqueous-based gel measured in the stratum corneum and receiver fluid in an in vitro Franz cell skin permeation experiment carried out with human cadaver skin are at least about 25-55-fold higher and at least about 1-20-fold lower, respectively, when normalized for concentration, than the MTZ levels measured from MGV;
• a viscocity ranging from about 200,000 mPa to about 400,000 mPa, measured at 25° C. using the controlled shear rate method, a Bohlin CVO 100 rheometer and the rheometer settings of Table 11;
• a degree of mucoadhesion ranging within about ±10% of that of MG33PB;
• comprises about 30 wt % to about 60 wt % water;
• is stable for a period of at least 6 months at 25° C.;
• and
• includes about 1 wt % to about 3 wt % total mucoadhesive polymers and about 40 wt % to 45 wt % of a solvent system for the MTZ;
• wherein the amount of the aqueous-based gel applied in a single application contains about 65 mg MTZ, and the aqueous-based gel is free of dextrins, cyclodextrins, niacin, niacinamide and surfactants.