Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Radical -xh acid – or anhydride – acid halide or salt thereof...
Reexamination Certificate
1999-07-02
2002-07-16
Criares, Theodore J. (Department: 1617)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Radical -xh acid, or anhydride, acid halide or salt thereof...
C424S659000, C514S967000
Reexamination Certificate
active
06420425
ABSTRACT:
FIELD OF INVENTION
This invention relates generally to a method for the treatment of infections, fungal, bacterial, parasitic, insecticidal and actinomycotic in origin, especially infections of organs such as the vagina and skin. This invention further relates to a composition in a form suitable for treating vaginal infections and skin conditions and in the prevention of such infections and conditions.
BACKGROUND OF THE INVENTION
Vaginitis is a frequent cause of distress and discomfort in adult women accounting for about 10 million physician office visits per year in the U.S. The three major causes of this inflammation and the corresponding symptoms of abnormal discharge, itching, burning, dyspareunia and dysuria, include vaginal candidiasis, bacterial vaginosis and trichomonas.
Traditionally the treatment for vaginal and ear candidiasis has been the imidazole/triazole related antifungal compounds. These compounds are primarily effective against
Candida albicans
and provide little to no relief from
Torulopsis glabrata
and
Candida tropicalis
. While terconazole is effective against non-albicans yeast as well as albicans, its use is limited to infections caused by the genus Candida, for example, vulvovaginitis. The recent introduction of over the counter imidazole/triazole compounds such as miconazole, clotrimizole and butconazole is therefore problematic. These compounds are limited in their application being only efficacious against particular types of infection, for example, infection caused by the genus Candida, as in vaginal candidiasis. Without proper testing it is not possible for a patient to know whether they suffer from, for example, vaginal candidiasis or bacterial vaginosis, the symptoms being similar. In other words, what the nature and origin of the infection is.
Additional active ingredients used in the treatment of vaginal candidiasis include sulfanilamide and nystatin. These compounds again are only effective against the genus Candida and prior to their use the diagnosis of vaginal candidiasis should be confirmed by laboratory analysis, such as, cytology including KOH smears, giemsa, Wrights and other stains and/or cultures and/or biopsy. Such diagnosis can mean that proper treatment is delayed. Common treatments for bacterial vaginosis include oral metronidazole and clindamycin vaginal cream or oral. Metronidazole taken orally causes gastrointestinal distress, creates a metallic taste for the course of treatment and has been shown to be carcinogenic in mice and rats. Clindamycin therapy has been associated with severe colitis which may end fatally. Additionally, while these compositions are effective in eliminating the bacterial vaginosis, their use, as with any antibiotic use, may cause yeast propagation and resulting vaginal candidiasis.
Trichomonas and related parasites are treated with antibiotics such as metronidazole.
There is currently no product available, either over the counter or by prescription, that may be used to safely and effectively treat, for example, vaginal infections of both bacterial and fungal origin. It would therefore be extremely advantageous to provide such a product that can be used for the treatment of vaginal infection such as symptomatic vaginal discharge, vaginitis and the like in which the cause, based on the symptoms alone, may be indeterminable without specific medical diagnosis. Furthermore it would be advantageous to provide a product which may be used as an interim treatment, or first choice treatment, while actual diagnosis is being determined and to provide an alternative to existing treatment products which may be toxic, expensive and environmentally unfriendly and which may also cause side effects, such as, in the case of antibiotics which can ironically cause vaginal candidiasis.
Acetic acid is known to have antimicrobial capacities and is effective at various percentages against Pseudomonas, Staphylococcus, Streptococcus and various yeasts. The fungitoxic effects of acetic acid on fungi causing otomycosis has been examined in
Mycoses
37: 299-301 (1994). In this study various volatile compounds, including acetic acid, were tested, in vitro, for their fungitoxic effects against five fungi. Some antifungal effect was illustrated for acetic acid.
Candida albicans
was shown to be the most resistant to the volatiles. Boric acid is known to be an effective antibacterial and antifungal agent and has been prepared in the form of a suppository for the treatment of fungal infection alone (see
The Annals of Pharmacotherapy
1993, Volume 27,pp.1355-1357). Boric acid has been shown to be fungistatic against
Candida albicans
in vitro and effective in treating vulvovaginal candidiasis (see
Obstet. Gynecol.
, (1974) 43:893-895, “Boric Acid Treatment of Vulvovaginitis”).
Acetic acid and boric acid have been used separately in vivo for the treatment of otomycosis (see
Revista Iberoamericana de Micologia
(1993):10: pp. 33-35). In this study two groups of patients were tested. Group A patients were treated with a combination of acetic acid (2%), hydrocortisone (1%) and sterile water (to 100%). Group B patients were treated with boric acid (4%) saturated in absolute alcohol (25%) and sterile water (to 100%). A composition comprising both acetic acid and boric acid was not used.
A solution comprising, as active ingredients, both acetic acid and boric acid is disclosed in U.S. Pat. No. 5,480,658, the disclosure of which is expressly incorporated herein by reference. The composition as described in this patent is useful in cleaning the ears of pets.
A composition comprising acetic acid and boric acid, in particular amounts, has now surprisingly been found to be synergistically effective in the broad based treatment of bacterial, fungal, insecticidal, parasitic and actinomycotic infection and in the treatment of keratinization disorders, i.e., the composition has been found to have bacteriostatic, bacteriocidal, anti-fungal, fungicidal, fungistatic and keratolytic properties and is particularly useful in the treatment of skin and vaginal infections. The composition is also effective in the prevention of such infections and provides a safe, effective, economical and environmentally friendly alternative to existing forms of treatment and prevention of such infections.
SUMMARY OF INVENTION
In accordance with one embodiment of the present invention, a method for the broad based treatment of vaginal infection is provided comprising administering to a patient in need thereof an effective amount of a composition which comprises both acetic acid and boric acid, and a pharmaceutically acceptable carrier.
In accordance with a further aspect of the present invention, a method for the interim treatment of vaginal infection is provided comprising, prior to determining the origin of the infection, administering an effective amount of a composition comprising acetic acid and boric acid and a pharmaceutically acceptable carrier to a patient in need thereof.
In accordance with another embodiment of the present invention, the composition may be used for the broad based treatment of skin conditions, particularly skin conditions associated with bacterial, fungal, insecticidal, parasitic and actinomycotic infection and keratinization disorders comprising topically applying to affected areas of the skin an effective amount of a composition comprising acetic acid and boric acid and a pharmaceutically acceptable carrier.
In accordance with a further embodiment of the present invention, the use of a composition comprising acetic acid and boric acid in the preparation of a keratolytic agent in the treatment of parasites such as mites and the likes, is provided.
In accordance with a further embodiment of the present invention, the use of a composition comprising acetic acid and boric acid in the preparation of an insecticidal agent is provided.
According to a further embodiment of the present invention the use of a composition comprising acetic acid and boric acid for the prevention of vaginal infections and skin conditions of bacterial, fungal, parasiti
Criares Theodore J.
Katten Muchin Zavis Rosenmam
Kim Jennifer
Pouliquen Corinne
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