| Non-absorbent articles containing additives for inhibiting the production of tsst-1 -> Monitor Keywords |
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Non-absorbent articles containing additives for inhibiting the production of tsst-1Related Patent Categories: Drug, Bio-affecting And Body Treating Compositions, Preparations Characterized By Special Physical Form, Web, Sheet Or Filament Bases; Compositions Of Bandages; Or Dressings With Incorporated MedicamentsNon-absorbent articles containing additives for inhibiting the production of tsst-1 description/claimsThe Patent Description & Claims data below is from USPTO Patent Application 20070190121, Non-absorbent articles containing additives for inhibiting the production of tsst-1. Brief Patent Description - Full Patent Description - Patent Application Claims
REFERENCE TO RELATED APPLICATIONS [0001] This application is a divisional application of U.S. patent application Ser. No. 10/271,457, filed Oct. 16, 2002, which is a patent application claiming the benefit of U.S. Provisional Application Ser. No. 60/331,971 and Ser. No. 60/331,937, both of which were filed Nov. 21, 2001. The entire contents of these applications are incorporated herein by reference. BACKGROUND OF THE INVENTION [0002] The present invention generally relates to inhibiting the production of toxic shock syndrome toxin one (TSST-1) by Staphylococcus aureus. More particularly, the present invention relates to inhibiting the production of TSST-1 in the presence of non-absorbent articles by incorporating certain compounds into the absorbent articles having an inhibitory effect on Gram positive bacteria and the production of TSST-1. [0003] 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.sup.9 bacteria per gram of vaginal fluid. The bacterial flora of the vagina is comprised of 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. [0004] Physiological, social, and idiosyncratic factors affect 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, corynebacteria, ureaplasma, and mycoplasma. Social and idiosyncratic factors include method of birth control, sexual practices, systemic disease (e.g., diabetes), and medications. [0005] Bacterial proteins and metabolic products produced in the vagina can affect 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 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. [0006] Some microbial products produced in the vagina may negatively affect the human host. For example, S. aureus is a bacteria that commonly colonizes human skin and mucous membranes. It causes disease in humans through invasion or through the production of toxic proteins. One such disease is toxic shock syndrome (TSS), caused by toxic shock syndrome toxin-1 (TSST-1) and other similar toxins. When absorbed into the blood stream, TSST-1 produces TSS in non-immune humans. [0007] 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 has been identified as causing TSS in humans. [0008] Symptoms of TSS 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 TSS 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 TSS. [0009] 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. [0010] 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 bacteria 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 catamenial products 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 eradication is technology designed to prevent or substantially reduce the bacteria's ability to produce toxins. [0011] There have been numerous attempts to reduce or eliminate pathogenic microorganisms and menstrually occurring TSS by incorporating into vaginal products one or more biostatic, biocidal, and/or detoxifying compounds. 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). [0012] Despite the aforementioned attempts, there continues to be a need for compounds that will effectively inhibit the production of 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 detoxifying compounds useful in the inhibition of the production of TSST-1 be substantially non-harmful to the natural flora found in the vaginal area. It is also desirable that the detoxifying compound be coated or otherwise introduced onto a non-absorbent substrate prior to use. SUMMARY OF THE INVENTION [0013] The present invention relates to non-absorbent substrates or articles which inhibit the production of TSST-1 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 can have the inhibitory compounds described herein 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 one or more of the inhibitory compounds described herein coated on an outer surface, such that when the applicator is used to introduce a tampon into a women's vagina the inhibiting 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. [0014] It is a general object of the present invention to provide a non-absorbent article which inhibits the production of TSST-1 from Gram positive bacteria. A more specific object of the present invention is to provide a non-absorbent incontinence device, a barrier birth control device, a contraceptive sponge, tampon applicator, or a douche incorporating one or more of the inhibitory compounds described herein which act to substantially inhibit the production of TSST-1 by S. aureus. [0015] Another object of the present invention is to provide a non-absorbent substrate incorporating one or more inhibitory compounds described herein in combination with one or more other inhibitory ingredients such as, but not limited to, for example, aromatic compounds, isoprenoid compounds, laureth-4, PPG-5 lauryl ether, 1-0-dodecyl-rac-glycerol, disodium laureth sulfosuccinate, glycerol monolaurate, alkylpolyglycosides, polyethylene oxide (2) sorbital ether or myreth-3-myristate which in combination act to substantially inhibit the production of TSST-1 by S. aureus. [0016] A further object of the present invention is to provide a non-absorbent substrate that has incorporated thereon one or more compounds that will inhibit the production of TSST-1 from Gram positive bacteria without significantly imbalancing the natural flora present in the vaginal tract. [0017] Therefore, the present invention is based on the discovery that when one or more inhibitory compounds are incorporated into or onto a non-absorbent article, the production of TSST-1 in Gram positive bacteria is substantially inhibited. In one embodiment, a first inhibitory compound has the Structure (I): wherein: R.sub.300 is, when present, selected from hydrogen and substituted or unsubstituted alkyl; R.sub.301 is selected from the group consisting of hydrogen, a monovalent, saturated or unsaturated, substituted or unsubstituted hydrocarbyl moiety, and when R.sub.300 is not present, a substituted or unsubstituted hydrocarbenyl moiety; R.sub.302 is selected from hydrogen, substituted or unsubstituted alkyl, and, R.sub.303 is selected from hydrogen, hydroxyl, and alkoxy. [0018] One preferred compound of Structure (I) includes thiolactomycin. [0019] As such, the present invention is directed to a tampon applicator comprising a non-absorbent substrate, an effective amount of a first active ingredient and an effective amount of a second active ingredient. The first active ingredient has a general formula: wherein: R.sub.300 is, when present, selected from hydrogen and substituted or unsubstituted alkyl; R.sub.301 is selected from the group consisting of hydrogen, a monovalent, saturated or unsaturated, substituted or unsubstituted hydrocarbyl moiety, and when R.sub.300 is not present, a substituted or unsubstituted hydrocarbenyl moiety; R.sub.302 is selected from hydrogen, substituted or unsubstituted alkyl; and, R.sub.303 is selected from hydrogen, hydroxy, and alkoxy. The second active ingredient has a general formula:R.sup.10--O--R.sup.11 (IV) wherein R.sup.10 is a straight or branched alkyl or straight or branched alkenyl having from 8 to about 18 carbon atoms and R.sup.11 is selected from the group consisting of an alcohol, a polyalkoxylated sulfate salt and a polyalkoxylated sulfosuccinate salt. The first active ingredient and the second active ingredient are effective in substantially inhibiting the production of TSST-1 from Gram positive bacteria. [0020] The present invention is further directed to a non-absorbent article comprising a non-absorbent substrate, an effective amount of a first active ingredient, and an effective amount of a second active ingredient. The first active ingredient has a general formula: wherein: R.sub.300 is, when present, selected from hydrogen and substituted or unsubstituted alkyl; R.sub.301 is selected from the group consisting of hydrogen, a monovalent, saturated or unsaturated, substituted or unsubstituted hydrocarbyl moiety, and when R.sub.300 is not present, a substituted or unsubstituted hydrocarbenyl moiety; R.sub.302 is selected from hydrogen, substituted or unsubstituted alkyl; and, R.sub.303 is selected from hydrogen, hydroxy, and alkoxy. The second active ingredient has a general formula:R.sup.10--O--R.sup.11 (IV) wherein R.sup.10 is a straight or branched alkyl or straight or branched alkenyl having from 8 to about 18 carbon atoms and R.sup.11 is selected from the group consisting of an alcohol, a polyalkoxylated sulfate salt and a polyalkoxylated sulfosuccinate salt. The first active ingredient and the second active ingredient are effective in substantially inhibiting the production of TSST-1 from Gram positive bacteria. The non-absorbent article is selected from the group consisting of non-absorbent incontinence devices, barrier birth control devices, and douches. [0021] Other objects and advantages of the present invention, and modifications thereof, will become apparent to persons skilled in the art without departure from the inventive concepts defined in the claims. Continue reading about Non-absorbent articles containing additives for inhibiting the production of tsst-1... 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