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Method and composition for prevention and treatment of female lower genital tract microbial infections
| Details |
Inventors: Kross, Robert D.;
Assignee: Alcide Corporation (Redmond, WA)
Primary Examiner: Pak; John
Assistant Examiner:
Attorney, Agent or Firm: Seed and Berry LLP
Methods for preventing and treating microbial infections in the mammalian female lower genital tract such as vulvitis, vaginitis, cervicitis, and endometritis involve the intra-vaginal and/or intra-uterine infusion of a solution containing a pharmacologically acceptable carrier and chlorine dioxide in an amount ranging from about 5 ppm to 1000 ppm, and having a chlorine dioxide to chlorite ratio of at least 5:1. Typical solutions exhibit a pH compatible with the lower genital tract, e.g., a pH from about 5 to about 7.5. In many embodiments, chlorine dioxide in the solution is produced by reacting a chlorite with a mineral acid and adjusting the pH, by reacting a chlorite with an organic acid having a pK of about 2.8 to 4.2, or by reacting a chlorite at a pH below about 5.5 with a heat-activated saccharide in the presence of an organic acid having a pK of about 2.8 to about 4.2. Sodium chlorite is employed in preferred embodiments. |
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DETAILED DESCRIPTION OF THE INVENTION This invention is based upon the finding that a solution containing chlorine dioxide having defined chlorine dioxide-to-chlorite molar ratios that limit tissue irritation are efficacious in the treatment and prevention of lower genital tract infections in female mammals.
In one embodiment, the present invention is directed to the use of chlorine dioxide for the prevention, mitigation or cure of endometritis, cervicitis, vaginitis, and vulvitis, and/or the alleviation of the associated inflammation, in such a manner as to overcome the rapid loss of antimicrobial activity of the agent which occurs in the presence of significant quantities of organic matter present in lower genital tract infections and in the postpartum birth canal.
The invention allows for such treatment without the disadvantage associated with antibiotics employed for such treatment such as gastrointestinal distress, and side effects elicited by the absorption of other drugs.
In contrast to antibiotics, systemic absorption of the compositions of the invention is minimized in treatments using them because of the inorganic nature of chlorine dioxide, and its reductive degradation to chloride as a result of its interaction with organic matter (including bacteria and yeast).
It is important to note that materials may be non-inflammatory (i.
e.
, not provoke inflammation) but not anti-inflammatory (i.
e.
, counter the effects of inflammation).
Chlorine dioxide has been found to be non-inflammatory, by virtue of being infusible into the birth canal and uterus without evoking the inflammatory response, as well as being anti-inflammatory; see the copending U.
S.
application Ser.
No.
07/930,088, filed Aug.
14, 1992, now abandoned, which is hereby incorporated in its entirety by reference.
In order to utilize the germ-killing and non-inflammatory qualities of chlorine dioxide, it is preferable to isolate it from chlorites and its acidic form, chlorous acid (which have detrimental cytotic effects).
To minimize the negative effects caused by chlorite (and chlorous acid in lower pH solutions), techniques are employed which preferably either a) deliver the soluble chlorine dioxide gas in a solution relatively free of harmful chlorite, or b) employ a pre-infusion chemical reaction whereby the chlorite species has substantially converted to chlorine dioxide leaving relatively little chlorite remaining
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