Acetate-lactate buffering vaginal gel and for method of making same and treating bacterial vaginosis

A composition of matter comprising a pH buffering system comprising a combination of lactic acid and related base salt that occur naturally in the human female body that, when applied to the surface of the vagina, maintains the pH level thereon at approximately the pH level of a healthy vagina. The composition my include a gel form, and also contain acetic acid as well as polyethylene glycol, glycerol and oxyquinoline.

EXAMPLE I 1 Raw Materials % v/v Lactic acid, U.S.P. 2.0 Acetic acid, glacial, U.S.P. 0.9 Glycerol, U.S.P. 15.0 Polyethylene glycol 4500, U.S.P. 62.0 Oxyquinoline sulfate, U.S.P. 0.025 2N Potassium hydroxide solution 2.4 Water, U.S.P. q.s. 100% Place the polyethylene glycol, preferably 4500, in a suitable mixing container equipped with a mixer. Warm the ingredient to around 50° C. Add glycerol (and perhaps oxyquinoline sulfate), lactic acid, acetic acid and 2N Potassium hydroxide solution along with about one half of the q.s. water and stir at 40° C. until completely mixed. Cool to room temperature (about 21° C.) and bring to 100% (v/v) water. This medicament is placed in 50 gram tubes. The solution formulated in Example I remained as an uncolored gel when stored at room temperature for two years. Stability studies on said gel revealed lactic acid at 2%±0.2% content, for two years. 
 EXAMPLE II 2 Raw Materials % v/v Lactic acid, U.S.P. 2.0 Glycerol, U.S.P. 15.0 Polyethylene glycol 4500, U.S.P. 62.0 Oxyquinoline sulfate, U.S.P. 0.025 2N Potassium hydroxide solution 2.4 Water, U.S.P. q.s. 100% 
 Results of Clinical Trial with “Example 1 ” to Test Bacterial Vaginosis The clinical investigation of the vaginal gel according to Example 1 was carried out in the laboratory of Timothy J. Bell, D O, (PA), Fort Smith, AR using 18 patients. The criteria for bacterial vaginosis included at least three out of four of the following conditions: (a) gray homogenous discharge, (b) pH of the vaginal wall fluid 4.5 or greater, (c) positive clue cells on wet mount microscopic examination, (d) release of amine odor with addition of potassium hydroxide solution to the vaginal discharge fluid. In general there was additional vulva irritation associated with the diagnosis. Cure was the cessation of vaginal discharge for one month or longer as well as the disappearance of other symptoms. Four of the females met all four criteria for bacteria vaginosis out of the eighteen studied. Of the 18, seven had repeated symptoms after previous repeated treatment of metronidazole or clindamycin and one was refractory to all previous medications. Seventeen were cured including the refractory patient (vaginal pH 4) who also had less pelvic irritation. The one patient that remained uncured admittedly to continue the application treatment regime as directed. 
 Statistics of the Eighteen Patients Tested (a) age in years: eight, 21 to 27; eight, 31 to 38; one, 41; and one, 50; (b) 3 used oral contraceptives of which 2 had repeated infections; 1 used vaginal douche; (c) 2 complained that the gel of Example I was messy; and (d) 1 had a repeated infection 8 months later which was cured with Example I. The treatment of bacterial vaginosis with Example 1 was effective when used as directed. Many other patients using Example I did not return for follow up visits and were considered cured. To date, about 5000 patients have been treated with Example I. A physician questionnaire has revealed that there have been eight cases of minor vaginal irritation and burning. The therapy consisted of using Example 1 twice a day for seven days also the patients with repeated bacterial vaginosis were continued once a night for thirty days. 
 The pH Measurements with Example I Vaginal Gel Measurement of pH of the pure gel of Example I is not reliable because the gel has insufficient water for the measurement. With the addition of water to the gel 1:03 (water) the pH was 4.66, on the addition of more water 1:06, pH 4.22, and 1:1 (water) to 3.72 and the same for 1:2 (water). As the gel is further diluted the pH remains around pH 3.7. Those skilled in the art who have the benefit of this disclosure will appreciate that it may be used as the creative basis for designing devices or methods similar to those disclosed herein, or to design improvements to the invention disclosed herein; such new or improved creations should be recognized as dependant upon the invention disclosed herein, to the extent of such reliance upon this disclosure.