Composition and method of use thereof

Abstract

A pharmaceutical composition comprises (a) metronidazole in an antibacterially effective amount; and (b) an antifungal agent in an antifungally effective amount, illustratively comprising butoconazole or a pharmaceutically acceptable salt or ester thereof. The composition is adapted for application in a unit dose amount to a vulvovaginal surface and has at least one nonlipoidal internal phase and at least one lipoidal external phase that is bioadhesive to the vulvovaginal surface. The composition is useful for administration to a vulvovaginal surface to treat a mixed bacterial vaginosis and vulvovaginal candidiasis infection.

Description

field of invention [0001] The present invention relates to pharmaceutical compositions suitable for vaginal delivery of antifungal and antibacterial agents. The invention further relates to methods of treatment using such compositions in women with mixed fungal and bacterial infections of the vulvovaginal system. Background of the invention [0002] Infectious vaginitis covers a range of disorders involving microbial infection of the vagina and associated inflammation that sometimes extends to the vulva. It accounts for an estimated 15 million annual clinician office visits in the United States, and with over-the-counter therapies especially for Candida infections, many additional cases are treated without professional diagnosis. [0003] Infectious pathogens involved in vaginitis include: [0004] (a) Fungi, more specifically yeasts, especially species of the genus Candida (Candidas pp.), including Candida albicans (C. albicans), Candida dubliniensis (C. dubliniensis), Ca...

AI Technical Summary

Problems solved by technology

The involvement of such misdiagnosis is likely to be non-minor, especially in view of the serious illness that can result in BV if left untreated