Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Wearing apparel – fabric – or cloth
Reexamination Certificate
2001-10-02
2003-07-22
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Wearing apparel, fabric, or cloth
C424S402000, C424S443000, C604S360000
Reexamination Certificate
active
06596290
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to the inhibition of exoprotein production in association with a non-absorbent article. More particularly, the present invention relates to the coating or treatment of certain isoprenoid compounds onto non-absorbent articles and the effects of these compounds on Gram positive bacteria.
There exists in the female body a complex process which maintains the vagina and physiologically related areas in a healthy state. In a female between the age of menarche and menopause, the normal vagina provides an ecosystem for a variety of microorganisms. Bacteria are the predominant type of microorganism present in the vagina; most women harbor about 10
9
bacteria per gram of vaginal fluid. The bacterial flora of the vagina comprises both aerobic and anaerobic bacteria. The more commonly isolated bacteria are Lactobacillus species, Corynebacteria,
Gardnerella vaginalis
, Staphylococcus species, Peptococcus species, aerobic and anaerobic Streptococcus species, and Bacteroides species. Other microorganisms that have been isolated from the vagina on occasion include yeast (
Candida albicans
), protozoa (
Trichomonas vaginalis
), mycoplasma (
Mycoplasma hominis
), chlamydia (
Chlamydia trachomatis
), and viruses (Herpes simplex). These latter organisms are generally associated with vaginitis or venereal disease, although they may be present in low numbers without causing symptoms.
Physiological, social, and idiosyncratic factors effect the quantity and species of bacteria present in the vagina. Physiological factors include age, day of the menstrual cycle, and pregnancy. For example, vaginal flora present in the vagina throughout the menstrual cycle can include lactobacilli, corynebacterium, ureaplasma, and mycoplasma. Social and idiosyncratic factors include method of birth control, sexual practices, systemic disease (e.g., diabetes), and medications.
Bacterial proteins and metabolic products produced in the vagina can effect other microorganisms and the human host. For example, the vagina between menstrual periods is mildly acidic having a pH ranging from about 3.8 to about 4.5. This pH range is generally considered the most favorable condition for the maintenance of normal flora. At that pH, the vagina normally harbors the numerous species of microorganisms in a balanced ecology, playing a beneficial role in providing protection and resistance to infection and makes the vagina inhospitable to some species of bacteria such as
Staphylococcus aureus
(
S. aureus
). The low pH is a consequence of the growth of lactobacilli and their production of acidic products. Microorganisms in the vagina can also produce antimicrobial compounds such as hydrogen peroxide and bactericides directed at other bacterial species. One example is the lactocins, bacteriocin-like products of lactobacilli directed against other species of lactobacilli.
Some microbial products produced in the vagina may negatively affect the human host. For example,
S. aureus
can produce and excrete into its environment a variety of exoproteins including enterotoxins, Toxic Shock Syndrome Toxin-1 (TSST-1), and enzymes such as proteases and lipase. When absorbed into the bloodstream of the host, TSST-1 may produce Toxic Shock Syndrome (TSS) in non-immune humans.
S. aureus
is found in the vagina of approximately 16% of healthy women of menstrual age. Approximately 25% of the
S. aureus
isolated from the vagina are found to produce TSST-1. TSST-1 and some of the staphylococcal enterotoxins have been identified as causing TSS in humans.
Symptoms of Toxic Shock Syndrome generally include fever, diarrhea, vomiting and a rash followed by a rapid drop in blood pressure. Multiple organ failure occurs in approximately 6% of those who contract the disease.
S. aureus
does not initiate Toxic Shock Syndrome as a result of the invasion of the microorganism into the vaginal cavity. Instead as
S. aureus
grows and multiplies, it can produce TSST-1. Only after entering the bloodstream does TSST-1 toxin act systemically and produce the symptoms attributed to Toxic Shock Syndrome.
Menstrual fluid has a pH of about 7.3. During menses, the pH of the vagina moves toward neutral and can become slightly alkaline. This change permits microorganisms whose growth is inhibited by an acidic environment the opportunity to proliferate. For example,
S. aureus
is more frequently isolated from vaginal swabs during menstruation than from swabs collected between menstrual periods.
When
S. aureus
is present in an area of the human body that harbors a normal microbial population such as the vagina, it may be difficult to eradicate the
S. aureus
bacterium without harming members of the normal microbial flora required for a healthy vagina. Typically, antibiotics that kill
S. aureus
are not an option for use in products inserted into the vagina because of their effect on the normal vaginal microbial flora and their propensity to stimulate toxin production if all of the
S. aureus
are not killed. An alternative to complete eradication is technology designed to prevent or substantially reduce the bacterium's ability to produce toxins.
There have been numerous attempts to reduce or eliminate pathogenic microorganisms and menstrually occurring Toxic Shock Syndrome by incorporating one or more biostatic, biocidal, and/or detoxifying compounds into vaginal products. For example, L-ascorbic acid has been applied to a menstrual tampon to detoxify toxin found in the vagina. Others have incorporated monoesters and diesters of polyhydric aliphatic alcohols, such as glycerol monolaurate, as biocidal compounds (see, e.g., U.S. Pat. No. 5,679,369). Still others have introduced other non-ionic surfactants, such as alkyl ethers, alkyl amines, and alkyl amides as detoxifying compounds (see, e.g., U.S. Pat. Nos. 5,685,872, 5,618,554, and 5,612,045).
Despite the aforementioned art, there continues to be a need for compounds that will effectively inhibit the production of exoproteins, such as TSST-1, from Gram positive bacteria, and maintain activity even in the presence of the enzymes lipase and esterase which can have adverse effects on potency and which may also be present in the vagina. Further, it is desirable that the compounds useful in the inhibition of the production of exoproteins be substantially non-harmful to the natural flora found in the vaginal area. It is also desirable that the inhibitory compound be coated or otherwise introduced onto a non-absorbent substrate prior to use.
SUMMARY OF THE INVENTION
The present invention is based on the discovery that when one or more isoprenoid compounds, such as a terpene compound or terpenoid compound, are incorporated onto a non-absorbent substrate, the production of exoprotein in Gram positive bacterium is substantially inhibited.
The present invention relates to non-absorbent substrates or articles for use in inhibiting the production of exoproteins from Gram-positive bacteria. The substrates are particularly useful for inhibiting the production of TSST-1 from
S. aureus
bacteria in the vaginal area. Examples of suitable non-absorbent substrates which may have the isoprenoid compounds of the present invention incorporated thereon include non-absorbent incontinence devices, barrier birth control devices, douches, contraceptive sponges, and tampon applicators. One specific example of a non-absorbent incontinence device is a female barrier incontinence device, such as an incontinence pledget formed from a resilient material like rubber. Another suitable non-absorbent substrate is the applicator used with a tampon. For example, the tampon applicator may have the isoprenoid compound coated on an outer surface, such that when the applicator is used to introduce a tampon into a women's vagina the isoprenoid compound (typically in the form of a cream, wax, gel or other suitable form) is transferred from the applicator onto the wall of the vagina.
It is a general object of the present invention to provide a non-absorbent article which inhibits the production of ex
Proctor Richard A.
Syverson Rae Ellen
Ghali Isis
Senniger Powers Leavitt & Roedel
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