Aqueous-based metronidazole gel formulations

A mucoadhesive aqueous-based gel comprising one or more mucoadhesive gelling polymers, about 1.3 wt % of MTZ, and water, and has one or more features or characteristics selected from the following group:

• a) 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 25-55 fold higher and at least 1-20 fold lower, respectively, when normalized for concentration, than the MTZ levels measured from MGV;
• b) a viscosity 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;
• c) a degree of mucoadhesion ranging within about +10% of that of MG33PB;
• d) comprises about 30 wt % to about 60 wt % water;
• e) is stable for a period of at least 6 months at 25° C.;
• and
• f) includes about 1 wt % to about 3 wt % total mucoadhesive gelling polymers and about 40 wt % to about 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 substantially free of dextrins, cyclodextrins, niacin, niacinamide and surfactants.