Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Implant or insert
Reexamination Certificate
2000-11-28
2003-07-29
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Implant or insert
C424S422000, C424S443000, C424S078080, C424S402000, C424S406000
Reexamination Certificate
active
06599521
ABSTRACT:
BACKGROUND
Disposable absorbent devices for the absorption of human exudates are widely used. These disposable absorbent devices typically have a mass of absorbent formed into a desired shape, which is typically dictated by the intended consumer use. In the area of a catamenial tampon, the disposable absorbent article is intended to be inserted in a body cavity for absorption of the body fluids generally discharged during a woman's menstrual period.
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 exudate. 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 Streptococcal species and Bacteroides species. Other microorganisms that have been isolated from the vagina on occasion include yeasts (e.g.,
Candida albicans
), protozoas (e.g.,
Trichomonas vaginalis
), mycoplasmas (e.g.,
Mycoplasma hominis
), chlamydias (e.g.,
Chlamydia trachomatis
) and viruses (e.g.,
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 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 Lactobacillus species, corynebacterium and mycoplasma. Social and idiosyncratic factors include method of birth control, sexual practices, systemic disease (e.g., diabetes) and medication.
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 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, products of lactobacilli directed against other species of lactobacilli.
Some microbial products may 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 protease and lipase.
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 capable of producing TSST-1.
Menstrually occurring Toxic Shock Syndrome (TSS), a severe and sometimes fatal multi-system disease, is associated with colonization by
S. aureus
. This disease has been associated with the use of tampons during menstruation. The disease is caused by TSST-1 and other staphylococcal enterotoxins.
Symptoms of TSS generally include fever, diarrhea, vomiting and a rapid drop in blood pressure. A characteristic rash is usually present. Systemic vital organ failure occurs in approximately 6% of those who contact 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 act systemically and produce the symptoms attributed to TSS.
There have been numerous attempts to reduce or eliminate pathogenic microorganisms and menstrually occurring TSS by incorporating into a tampon one or more biostatic, biocidal, and/or detoxifying compounds. For example, L-ascorbic acid has been applied to a catamenial tampon to detoxify toxin found in the vagina of the human female during menstruation. Others have incorporated monoesters and diesters of polyhydric aliphatic alcohols, such as glycerol monolaurate, as detoxifying compounds. The use of other non-ionic surfactants, such as alkyl ethers, alkyl amines and alkyl amides, has also been reported as a means of avoiding the problem of degradation by esterase (see, e.g., U.S. Pat. Nos. 5,685,872; 5,618,554; and 5,612,045).
In addition to the use of certain surfactants as detoxifying compounds, surfactants have been used to treat nonwovens for many applications involving body fluids, such as menses, to enhance wicking or the ability to rapidly distribute menses in use, so as to take advantage of the absorbency of the disposable absorbent article. Prior surfactant treatments such as ethoxylated hydrocarbons, siloxanes, and ionic surfactants have been shown to aid wicking. Although such conventional surfactants may increase wettability, they often fail to effectively reduce the viscoelasticity of menses in a manner that enhances wicking to the degree of the present invention.
It has been reported that use of specific surfactants, including alkyl polyglycosides, can not only reduce the viscoelastic properties of an insult fluid, such as menses, but also can provide surfactant properties to aid in rapidly distributing the fluid. Results were reported with alkyl polyglycosides having 8-10 carbons in the alkyl chain deposited onto the fibers of the absorbent distribution layer of an absorbent product, such as a sanitary napkin. The report suggested the use of about 0.2% to about 5% of the alkyl polyglycoside based on the total weight of absorbent material.
There continues to exist a need for agents that will effectively inhibit the production of exoproteins, such as TSST-1, from Gram positive bacteria. For such agents to become widely accepted, in addition to being effective in suppressing exoprotein production, the agent(s) should desirably also be an effective aid with regard to the distribution and/or uptake of a complex fluid on the surface of a disposable absorbent article. Such agents desirably would be substantially unaffected by the enzymes lipase and esterase and would have additional desirable properties with respect to enhancement of the wetting properties of hydrophobic polymeric materials, such as, for example, nonwoven materials commonly used as covers for absorbent articles. The selection of compounds to inhibit the production of exoproteins is not so readily apparent as some compounds, such as block copolymers of propylene oxide and ethylene oxide, can stimulate toxin production by Gram positive bacteria.
SUMMARY
It has been found that alkyl polyglycoside compounds can inhibit the production of exoprotein(s) of Gram positive bacteria. Exposure to effective amounts of the alkyl polyglycoside(s) can inhibit the production of potentially harmful toxins, such as those produced by Staphylococcus and/or Streptococcal species. For example, the alkyl polyglycoside(s) can be utilized to inhibit the production of TSST-1, alpha toxin and/or enterotoxins A, B and C from
S. aureus
. The alkyl polyglycoside typically has a hydrophilic/lipophilic balance (HLB) of at least about 10 and/or an average number of carbon atoms in the alkyl chain of 8 to 12. The alkyl polyglycoside may be used alone or in combination with one or more other surfactants (e.g., myreth-3-myristate, glycerol monolaurate and/or laureth-4) and/or other additives (e.g., reducing agent(s) such as
Potts David C.
Resheski-Wedepohl Kim L.
Syverson Rae Ellen
Yahiaoui Ali
Young Matthew D.
Di Nola-Baron Liliana
Page Thurman K.
Senniger Powers Leavitt & Roedel
LandOfFree
Absorbent articles for the inhibition of exoprotein... does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Absorbent articles for the inhibition of exoprotein..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Absorbent articles for the inhibition of exoprotein... will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-3105208