AU2016200825B2 — High dosage mucoadhesive metronidazole aqueous-based gel formulations their use to treat bacterial vaginosis

USPTO Abstract

The present disclosure relates to mucoadhesive aqueous-based homogenous gel formulations of metronidazole (MTZ) for intravaginal application and their uses, for example to treat bacterial vaginosis. Particular compositions comprise high concentration, high dosage, 1% to 2% by weight formulations providing 60mg-Omg MTZ in a single application. These compositions also reduce the incidence of vulvovaginal candidiasis, which is a common occurrence following treatment for bacterial vaginosis. Compositions also comprise mucoadhesive gelling polymers and a solvent system comprising lower aromatic alcohols, lower alkylene diols and polyoxyalkeylenes, wherein the formulation can be free from solubility enhancers such as dextrins, cyclodextrins, niacin, niacinamide and surfactants.