The present invention provides methods, products, and compositions for selectively inhibiting the growth of Staphylococcus aureus without preventing the growth of Lactobacillus species. Specifically, the present invention discloses the use of tetrahydroiso alpha acid or hexahydro beta acid at a concentration effective to inhibit the growth of S. aureus without preventing the growth of Lactobacillus. The inhibition of S. aureus in accordance with the present invention thus provides useful methods, compositions and products such as feminine hygiene products for treating the diseases associated with S. aureus infections and infestations, i.e., toxic shock syndrome, without disrupting the normal bacterial flora in the area of its application.

BRIEF SUMMARY OF THE INVENTION

The present invention is summarized in that certain compounds are disclosed which are capable of affecting the growth of Staphylococcus aureus without preventing the growth of Lactobacillus when applied in certain concentrations. These compounds are selected from the group consisting of tetrahydroiso alpha acids, hexahydro beta acids, and salts, mixtures or combinations thereof, and are applied in an amount effective to kill, inhibit, or otherwise control the growth or proliferation of S. aureus without preventing the growth of Lactobacillus. An effective amount of such compounds, for example, includes a concentration in the range of from about 0.2 ppm to about 25 ppm, or more preferably in the range of from about 0.5 ppm to about 12.5 ppm.

In addition, the present invention includes a product comprising an absorbent material and a compound selected from the group consisting of tetrahydroiso alpha acids, hexahydro beta acids, salts thereof, and mixtures thereof in an amount effective to kill, inhibit, or otherwise control the growth or proliferation of S. aureus without preventing the growth of Lactobacillus. The material may include, for example, cellulosic fiber material such as those typically used in feminine hygiene products (i.e., feminine napkins, tampons, etc.), or used to absorb bodily fluids or apply compounds employed in preventing or treating bacterial infections.

The present invention also includes a composition comprising a pharmaceutically acceptable carrier, and a compound selected from the group consisting of tetrahydroiso alpha acids, hexahydro beta acids, salts thereof, and mixtures thereof in an amount effective to kill, inhibit, or otherwise control the growth or proliferation of S. aureus without preventing the growth of Lactobacillus. The carrier may include, for example, topical ointments or washes formulated to facilitate effective administration of the compound.

It is an object of the present invention to provide a compound having inhibitory activity against S. aureus and minimal to no inhibitory activity against Lactobacillus when applied at certain concentrations.

It is also an object of the present invention to provide products and compositions for contacting S. aureus with such a compound.

It is yet another object of the invention to provide a method for preventing or treating S. aureus infection or infestation.
 

DETAILED DESCRIPTION OF THE INVENTION

The present invention discloses compounds which, when applied at certain concentrations, affect the growth of Staphylococcus aureus without preventing the growth of Lactobacillus. The compounds are selected from the group consisting of tetrahydroiso alpha acids, hexahydro beta acids, salts thereof, and mixtures thereof, and may be combined with various materials or carriers to form products and compositions suitable for facilitating effective administration. The present invention also discloses methods for using the compounds to prevent or treat S. aureus infection or infestation without disrupting the normal flora of Lactobacillus in its area of application.

We have discovered that the hop acids tetrahydroiso alpha and hexahydro beta have unexpectedly different bacteriocidal or bacteriostatic effects against Lactobacillus as compared to S. aureus. Specifically. Lactobacillus and S. aureus exhibit a differing level of sensitivity to tetrahydroiso alpha and hexahydro beta acids, with S. aureus being more sensitive than Lactobacillus. As a result, it is now possible to selectively inhibit S. aureus without preventing the growth of Lactobacillus by contacting the S. aureus with an amount of tetrahydroiso alpha acid or hexahydro beta acid which effectively inhibits S. aureus while allowing Lactobacillus to continue to grow.

The primary embodiment of the present invention is to provide a method for inhibiting S. aureus infection or infestation by contacting the S. aureus environment with an effective concentration of a compound which kills, inhibits, or otherwise controls the growth or proliferation of S. aureus without preventing the growth of Lactobacillus. In the preferred embodiment, the S. aureus environment is exposed to an effective concentration of the compound in a range of from about 0.2 ppm to about 25 ppm, and more preferably, in a range of from about 0.5 ppm to about 12.5 ppm.

As used herein, the term "compound" is intended to include hexahydro beta acids, hexahydro beta salts, tetrahydroiso alpha acids, tetrahydroiso alpha salts, and mixtures or combinations thereof.

To affect the growth of S. aureus the compound may be placed in contact with a S. aureus environment either independently or as part of a composition or product wherein the composition or product contains an effective amount of the compound in accordance with the present invention. In another embodiment, the compound may be layered or coated onto a barrier type contraceptive such as a diaphragm or contraceptive sponge that is placed in the S. aureus environment. The S. aureus environment may include, for example, any environment having a population of the S. aureus bacterium or an environment capable of allowing S. aureus to grow and proliferate. For instance, the environment may include, without limitation, wounds, lesions, tampons, the vagina, sanitary napkins, gauze, diapers, suppositories, or any other possible areas susceptible to S. aureus infection or infestation.

As used herein, the term "product" includes those products capable of, either inherently or by virtue of the manner in which they are assembled, absorbing liquids such as water, urine, menstrual fluids, blood, wound exudates and the like. Such products include, for example, catemenial products (e.g. tampons), wound dressings, suppositories, disposable diapers, and sanitary napkins, in addition to other kinds of tampons intended for medical, surgical, dental and/or nasal use. Products according to the present invention may be prepared according to known methods for manufacturing such products. In general, the products should be prepared to allow an effective amount of the compound utilized to be placed in contact with the S. aureus environment.

In one embodiment, the product comprises of an absorbent material and an amount of compound which effectively kills, inhibits, or otherwise controls the growth or proliferation of S. aureus without preventing the growth of Lactobacillus when said product is exposed to the S. aureus environment. A used herein, the term "absorbent material" includes, without limitation, natural fibers or synthetic fibers, films, foams, wood, pulp, peat moss, superabsorbent polymers and the like which are capable of, either inherently or by virtue of the manner in which they are assembled, absorbing liquids such as water, urine, menstrual fluids, blood, wound exudates and the like.

The term "composition" includes those compositions capable of, either inherently or by virtue of their formulation, use as a topical ointment or wash applied to a wound, infection, or the like. Compositions may be formulated according to known methods for preparing pharmaceutically useful compositions. Formulations are described in detail in a number of sources which are well known and readily available to those skilled in the art. For example, Remington's Pharmaceutical Science, by E. W. Martin describes formulations which can be used in connection with the subject invention. In general, the compositions should be formulated such that an effective amount of the compound utilized is combined with the suitable carrier in order to facilitate effective administration.

In one embodiment, the composition consists of a douche for killing, inhibiting, or otherwise controlling the growth or proliferation of S. aureus in the vagina. This is particularly useful for providing a treatment to a woman to help fight against S. aureus infection or infestation that can cause toxic shock syndrome. Alternatively, the composition may be formulated as a topical ointment or wash for application to wounds or infections in other parts of the body.

It should be understood that the examples and embodiments described herein are for illustrative purposes only and that various modifications or changes in light thereof are to be included within the spirit and purview of this application and the scope of the appended claims. Following are examples which are intended to be purely illustrative, and should not be construed as limiting but merely exemplary.

 

Claim 1 of 9 Claims

1. A method for affecting the growth of Staphylococcus aureus in the vaginal area, said method comprising the step of:

contacting the vaginal area with a compound selected from the group consisting of hexahydro beta acids, hexahydro beta salts, tetrahydroiso alpha acids, and tetrahydroiso alpha salts, in an amount effective to kill, inhibit, or otherwise control the growth or proliferation of S. aureus in the vaginal area while allowing the growth of Lactobacillus in the vaginal area wherein the concentration of the compound is in the range of from about 0.2 ppm to about 25 ppm.

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