Drug – bio-affecting and body treating compositions – Topical body preparation containing solid synthetic organic... – Anti-infective
Reexamination Certificate
2000-12-18
2003-03-25
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Topical body preparation containing solid synthetic organic...
Anti-infective
C424S430000, C424S422000, C424S078080, C424S078020, C424S078050
Reexamination Certificate
active
06537538
ABSTRACT:
FIELD OF THE INVENTION
This invention generally provides a method for preventing, inhibiting, or treating vaginitis or bacterial vaginosis. More specifically, the present invention provides a method for preventing, inhibiting, or treating vaginitis and/or bacterial vaginosis using polystyrene sulfonate. The polystyrene sulfonate used in the present invention inhibits Trichomonas (a flagellate protozoon), Gardnerella, and other vaginitis/vaginosis-causing bacteria.
BACKGROUND OF THE INVENTION
The female vagina is colonized by a variety of bacteria. Under normal conditions, the vagina flora provides a protective mechanism, including the maintenance of a low pH, to guard against the invasion of pathogenic microbes. A normal vagina generally contains more than about 10
4
lactobacilli per milliliter of vaginal material.
Infectious vaginitis is a common clinical syndrome and is diagnosed in more that 25 percent of women visiting sexually transmitted disease clinics. Common symptoms of infectious vaginitis include, for example, disruption of the normal vagina flora, irritation, odor, and/or vaginal discharge. Infectious vaginitis or vulvovaginities includes Candidiasis, trichomoniasis, bacterial vaginosis, and other vaginal infections. Bacterial vaginosis is the most common form of infectious vaginitis, accounting for 45 percent of symptomatic cases and estimated to be present in 15 percent of asymptomatic sexually active women. See, e.g.,
The Gynecologist and the Older Patient
, Breen, J. (ed.), pp. 304-305 (1988);
Principles and Practice of Infectious Diseases,
Mandell, G. L., J. E, Bennett, & R. Dolin (eds.), vol. 1, ch. 95, pp. 1218-1235 (5
th
Edition, 2000);
The Merck Manual of Medical Information: Home Edition
, Berkow, R. (Editor-in-Chief, 1081-1083 (1997). Bacterial vaginosis is a polymicrobial vaginal infection believed to be caused by an increase in the number of anaerobic organisms with a concomitant decrease in lactobacilli in the vagina. The decrease in the number of lactobacilli in the vagina has a dual effect, i.e., (1) a decreased competition for nutrients and (2) a decrease in the amount of lactic acid present (i.e., increasing the pH), thus allowing for the multiplication of opportunistic pathogens in the vagina, whose growth is normally suppressed by the lactobacilli and the acidic pH of the vagina. The principal pathogens associated with bacterial vaginosis are believed to be
Gardnerella vaginitis
and other pathogenic anaerobes. Thus, bacterial vaginosis is considered a broad spectrum infection requiring a broad spectrum treatment.
Clinically, bacterial vaginosis presents itself as a superficial vaginal infection with no inflammatory response. Generally symptoms include an unpleasant smell, an elevated vaginal pH greater than about 5.0, a thin homogeneous discharge, and the presence of Gardnerella clue cells (i.e., vaginal epithelial cells coated with small Gram-variable rods). Generally, lowering the vaginal pH is an effective measure against the infection.
Generally, current treatment regimens for bacterial infection of the vagina, including vaginosis, involve the use of various broad spectrum antibiotics administered either topically or orally. The following table illustrates some of the current treatments for common vaginal/vulvar infections:
Infection Type
Common Treatment
Candidal (yeast)
miconazole, clotrimazole, butoconazole, or
terconazole (cream, vaginal tablets, vaginal
suppositories); fluconzole or ketoconazole (oral)
Bacterial
metronidazole (vaginal cream or oral), clindamycin
(vaginal cream), or rifaximin (vaginal foam or cream)
Trichomonal
metronidazole (oral)
Antibiotics are generally undesirable, however, because they may kill a broad range of the normal bacterial flora in the vagina, including the beneficial lactobacilli. This may cause secondary complications, since the lactobacilli keep various opportunistic pathogens in the vagina in check. The treatment might then necessitate a further treatment regimen, such as the ingestion of cultured dairy products to replace the lactobacilli in the body, as well as treatment by antifungal agents. Moreover, a rise in the level of anaerobes due to a lack of lactobacilli could further complicate the infection. Additionally, antibiotics, when used frequently within the vagina, can cause systemic toxicity through absorption from the vagina.
More recently developed treatment regimes include those provided in U.S. Pat. No. 5,536,743 (Jul. 16, 1996) and U.S. Pat. No. 5,840,744 (Nov. 24, 1998) which used metronidazole in a buffered composition (pH maintained at about 3.75 to about 4.25) for intravaginal treatment of bacterial vaginosis. U.S. Pat. No. 6,017,521 (Jan. 25, 2000) provided a bioadhesive aqueous composition to control vaginal pH and, therefore, alleviate microorganism growth and odor such as presented by bacterial vaginosis.
U.S. Pat. No. 5,308,612 (May 3, 1994) provides a method using polystyrene sulfonate to inhibit or antagonize the transactivating transcription factor (Tat) of HIV/AIDS; the polystyrene sulfonate was reported to bock HIV replication as well as HIV viral adhesion and infection. U.S. patent application Ser. No. 09/252,417, filed Feb. 18, 1999, provides a method using polystyrene sulfonate for preventing sexually transmitted diseases (STDs) and/or reducing the rate of transmission of such sexually transmitted diseases; this method is especially adapted for use by sexually active individuals not at risk for pregnancy. U.S. patent application Ser. No. 09/252,417 is hereby incorporated by reference.
It would still be desirable, however, to provide improved methods for preventing, inhibiting, or treating vaginitis or bacterial vaginosis. It also would be desirable if such improved methods for preventing, inhibiting, or treating vaginitis or bacterial vaginosis did not involve the use of antibiotics. It would also be desirable if such methods would assist in obtaining or maintaining the natural and protective vaginal mechanisms. It would also be desirable if such methods would be relatively easy to use and have relatively few side effects. It would also be desirable if such methods utilize an active ingredient that is not absorbed, or only minimally absorbed, through the vagina lining, thereby greatly decreasing or eliminating the chance for systemic toxicity. The present invention, as detailed in the present specification, provides such methods.
SUMMARY OF THE INVENTION
This invention generally provides a method for preventing, inhibiting, or treating vaginitis or bacterial vaginosis. More specifically, the present invention provides a method for preventing, inhibiting, or treating vaginitis and/or bacterial vaginosis using polystyrene sulfonate. The polystyrene sulfonate used in the present invention inhibits Trichomonas (a flagellate protozoon), Gardnerella, and other vaginitis/vaginosis-causing bacteria.
The method of this invention generally comprises the application of an effective amount of an inhibitory agent into the vagina of a female in need of inhibition and/or treatment of vaginitis and/or bacterial vaginosis. Preferably the polystyrene sulfonate is contained in an aqueous based composition, and more preferably in an aqueous based composition buffered to a pH of about 3.5 to about 7.5, and even more preferably buffered at a pH of about 3.5 to 5.
The polystyrene sulfonate compositions of this invention can be used for treatment of active cases of vaginitis and/or bacterial vaginosis. Since the compositions of the present invention cause few, if any side effects, the polystyrene sulfonate compositions of this invention can also be used for prophylactic purposes. The polystyrene sulfonate used in the present invention is generally not toxic (or only minimally toxic) to natural and beneficial vaginal flora and, thus, does not significantly upset the local microbiological balance or significantly disrupt the protective glycoprotein vaginal coating. Disruption of the natural vaginal flora and/or removal or disruption of the protective glycoprotein vaginal coating using conve
Anderson, Jr. Robert Anthony
Zaneveld Lourens Jan Dirk
Di Nola-Baron Liliana
Fitch Even Tabin & Flannery
Rush-Presbyterian-St. Luke's Medical Center
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