Intravaginal treatment of vaginal infections with buffered metronidazole compositions

DETAILED DESCRIPTION The present invention provides a safe and effective, relatively low-dose treatment of a human vagina which is afflicted with BV.
The invention also obviates the need for oral administration of metronidazole for BV, which administration can lead to undesirable side effects, as above reviewed.
A method aspect of this invention comprises introducing into such an afflicted vagina a therapeutically effective amount of metronidazole in a buffered, non-flowing pharmaceutical composition having a low, acidic pH value, preferably in the range of about 3.
75 to about 4.
25.
The present method not only provides an effective relatively low-dose treatment of BV, but also promotes the beneficial and effective reestablishment of the normal vaginal microflora, such as Lactobacilli, especially the hydrogen peroxide producing species.
Thus, for example, the inventive method provides not only an effective BV treatment, but also a safe treatment since it leaves the treated vagina in a substantially normal condition able to cope with, and resist, future microorganism infections.
So far as now known, no other existing BV treatment offers such an advantage.
The present treatment contemplates administration of the composition at least once a day for a time period of at least one day and up to ten days, preferably three to ten days.
In accordance with another aspect of the present invention, a class of buffered metronidazole compositions is provided which is particularly well suited for the practice of such method.
Buffered formulations of this class not only have the ability to control and eliminate, at surprisingly low dosages, the anaerobic bacteria population causing BV, but also have the ability to adjust and maintain the vaginal environment at about the normal physiological pH.
Thus, such compositions provide the necessary environment for the restoration of favorable bacterial flora while delivering a relatively low, but therapeutic amount of metronidazole.
Yet another aspect of the present invention entails the prevention of bacterial vaginosis in susceptible patients by the intravaginal administration of a prophylactic amount of the buffered metronidazole compositions described in greater detail hereinbelow