KR20030068154A - Inhibition of exoprotein production from grampositive bacteria - Google Patents

Abstract

Absorbent and nonabsorbable substrates are described. The absorption and non-absorption substrates described herein are effective in inhibiting the production of potentially harmful toxins such as TSST-1, alpha-toxin and / or enterotoxin A, B and C from Staphylococcus aureus. Seed. Absorbent substrates comprising the alkyl polyglycosides described herein can be tampons or sanitary napkins, and non-absorbable substrates can be incontinence devices.

Description

Inhibition of exoprotein production from Gram-positive bacteria {INHIBITION OF EXOPROTEIN PRODUCTION FROM GRAMPOSITIVE BACTERIA}

Disposable absorbent devices such as tampons, nonabsorbable substrates such as incontinence devices, and vaginal cleansing compositions are widely used. For example, disposable absorbent devices for the absorption of human secretions are widely used. Typically, such disposable absorbent devices typically have an absorbent body shaped into the desired shape, as specified by the intended consumer use. In the field of menstrual tampons, disposable absorbent articles are intended to be inserted into the body cavity for absorbing body fluids that are typically drained during a woman's menstrual period.

There is a complex process in the body of a woman that keeps the vaginal and physiologically relevant sites healthy. For women between menarche age and menopause age, normal vagina provides an ecosystem for a variety of microorganisms. Bacteria are the predominant species that represent microorganisms present in the vagina; Most women have about 10 ⁹ bacteria latent per gram of vaginal discharge. The bacterial flora of vagina consists of aerobic and anaerobic bacteria. More commonly isolated bacteria are Lactobacillus species, Corynebacteria, Gardnerella vaginalis, Staphylococcus spp., Peptokcoccus spp., Aerobic and anaerobic streptococci. Species and bacteroids. Other microorganisms that have been occasionally isolated from the vagina are yeasts (e.g. Candida albicans), protozoa (e.g. Trichomonas vaginalis), mycoplasma (e.g. Mycoplasma hominis), chlamydia (E.g. Chlamydia trachomatis) and viruses (e.g. Herpes simplex) These latter microorganisms may be present in small numbers without causing symptoms, but are generally associated with vaginitis or sexually transmitted diseases Related.

Physiological, social and idiopathic factors affect the amount and species of bacteria present in the vagina. Physiological factors include age, menstrual cycle days and pregnancy. For example, vaginal bacterial flora present in the vagina throughout the menstrual cycle may include Lactobacillus spp., Corynebacterium and Mycoplaza. Social and idiopathic factors include birth control methods, sexual practice, systemic diseases (eg diabetes) and drug use.

Bacterial proteins and metabolic products produced in the vagina can affect other microorganisms and human hosts. For example, the vagina between menstrual cycles is moderately acidic with a pH range of about 3.8 to about 4.5. This pH range is generally considered to be the most favorable condition for maintaining normal flora. At this pH, usually, the vagina lurks many species of microorganisms in a balanced ecology that plays a beneficial role in providing protection and resistance to infections, and the vagina is directed to several bacterial species, such as S. aureus. To be ruthless. Low pH is the result of the growth of Lactobacillus and the production of its acidic product. Microorganisms in the vagina can also produce antimicrobial compounds targeting other bacterial species, such as hydrogen peroxide and bactericides. One example is lactocin, a product of Lactobacillus targeting other species of Lactobacillus.

Some microbial products can affect human hosts. For example, S. aureus produces a variety of exoproteins, including enterotoxins, Toxic Shock Syndrome Toxin-1 (TSST-1), and enzymes such as proteases and lipases. Can secrete into his environment. Staphylococcus aureus is found in the vagina of about 16% of healthy menstrual age women. About 25% of Staphylococcus aureus isolated from the vagina can produce TSST-1.

Toxic Shock Syndrome (TSS), a multi-symptom disease that is serious and sometimes fatal, is associated with colonization of S. aureus. This disease was associated with the use of tampons during menstruation. This 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. Usually a characteristic rash exists. About 6% of people with this disease develop systemic critical organ failure. S. aureus does not initiate TSS just because the microbes have invaded the vaginal cavity. Instead, when Staphylococcus aureus grows and multiplies, it can produce TSST-1. Only after entering the bloodstream, TSST-1 acts systemically and develops symptoms due to TSS.

Many attempts have been made to reduce or eliminate pathogenic microorganisms and TSS occurring during menstruation by incorporating one or more biostatic, biocidal and / or detoxifying compounds into tampons. For example, L-ascorbic acid was applied to menstrual tampons to detoxify toxins found in women's vagina during menstruation. In other cases monoesters and diesters of polyhydric aliphatic alcohols such as glycerol monolaurate were incorporated into the detoxification compound. It has also been reported to use other nonionic surfactants such as alkyl esters, alkyl amines and alkyl amides as a means of avoiding degradation problems by esterases (see US Pat. Nos. 5,685,872 and 5,612,045).

In addition to the use of some surfactants as detoxification compounds, surfactants have the ability to rapidly distribute menstrual blood during wicking or use of nonwovens for many applications involving body fluids, such as menstrual blood, to promote absorbency of disposable absorbent articles. It was used to handle this enhancement. Conventional surfactant treatments such as ethoxylated hydrocarbons, siloxanes and ionic surfactants have been found to aid wicking. While such conventional surfactants can increase wettability, they often do not effectively reduce menstrual blood viscoelasticity in a way that enhances wicking to the extent of the present invention.

The use of certain surfactants, including alkyl polyglycosides, can reduce the viscoelastic properties of insult fluids such as menstrual blood, as well as provide surfactant properties that aid in the rapid distribution of fluids. Results have been reported when alkyl polyglycosides having 8-10 carbons in the alkyl chain are attached to the fibers of an absorbent distribution layer of an absorbent article such as a sanitary napkin. This report suggested using about 0.2% to about 5% of alkyl polyglycosides based on the total weight of absorbent material.

Women use many feminine hygiene and internal cleansing products, mainly in liquid form. Many vaginal douche agents are used to prevent vaginal infections, not only because of contraception, but also because the irrigation of the vagina keeps the vagina clean. Vaginal cleaning compositions can be prepared from a variety of materials. Vinegar is the most common substance used to clean the vaginal area. However, there is insufficient evidence to conclusively establish that vinegar-based compositions are effective at altering vaginal pH for a time sufficient to promote growth of normal vaginal flora and inhibit infection.

When daily use of acidic or alkaline solutions as vaginal cleaners, no overall change in vaginal pH or vaginal mucosa has been reported. It has also been reported that vaginal pH during the cleaning period indicates the pH of the cleaning solution. However, 30 minutes after washing with an acidic solution, the vaginal pH becomes substantially alkaline.

There is a continuing need for agents that effectively inhibit the production of exoproteins, such as TSST-1 from Gram-positive bacteria. In particular, it would be advantageous to develop new vaginal cleansing compositions incorporating agents that inhibit exoprotein production from Gram-positive bacteria. In order for such a medicament to be widely recognized, in addition to being effective in inhibiting exoprotein production, the medicament (s) should preferably be an effective adjuvant with regard to dispensing and / or absorbing complex fluids on the surface of disposable absorbent articles. It must be able to be coated onto a nonabsorbing substrate. Such agents will preferably not be substantially affected by lipase and esterase enzymes, and further desirable properties with regard to improving the wetting properties of hydrophobic materials, such as nonwovens commonly used as covers for absorbent articles, for example. Will have Since some compounds, such as block copolymers of propylene oxide and ethylene oxide, can stimulate toxin production by Gram-positive bacteria, the choice of compounds that inhibit exoprotein production is not so readily apparent. In addition, these agents should not alter the normal flora found in the vaginal area.

Summary of the Invention

The inventors have found that alkyl polyglycoside compounds can inhibit the production of exoprotein (s) of Gram-positive bacteria. Exposure to an effective amount of the alkyl polyglycoside (s) of the present invention may inhibit the production of potentially harmful toxins such as those produced by Staphylococcus and / or Streptococcus species. For example, alkyl polyglycoside (s) can be used to inhibit the production of TSST-1, alpha-toxin and / or enterotoxin A, B and C from Staphylococcus aureus. Typically, alkyl polyglycosides have a hydrophilic / lipophilic balance (HLB) of at least about 10 and / or an average number of carbon atoms of alkyl chains of 8 to 12. Alkyl polyglycosides may be used alone or in combination with one or more other surfactants such as mireth-3-myritate, glycerol monolaurate and / or laureth-4, and / or other additives such as ascorbic acid, sodium bisulfite , Reducing agent (s) such as vitamin E). Such reducing agents can act as oxygen inhibitors and enhance the ability of the combination to reduce toxin production.

The alkyl polyglycoside agents or compositions of the invention are substances that can reduce the production of exoproteins such as TSST-1 when exposed to Staphylococcus aureus or other Gram-positive bacteria in disposable absorbent articles. It is also believed that this compound in the disposable absorbent articles of the present invention is effective in inhibiting the production of other types of bacterial toxins, in particular alpha-toxin and Staphylococcal enterotoxins A, B and C. In particular, the alkyl polyglycosides described herein relate to the exoprotein when the compound is placed near or incorporated into or on a nonabsorbable substrate in the presence or absence of a pharmaceutically acceptable carrier. It is effective in suppressing production. Alkyl polyglycosides may be used with one or more other compounds, for example with compounds such as mireth-3-myritate, glycerol monolaurate and / or laureth-4.

The alkyl polyglycosides of the present invention are particularly useful for inhibiting exogenous production of bacteria when incorporated into or on disposable absorbent articles. In particular, it has been found that incorporating alkyl polyglycosides into at least an outer layer of a disposable article, such as tampons, may be effective. The outer layer may be a cover over the absorbent material or may simply be the outer part of the absorbent itself. For example, the alkyl polyglycoside can be impregnated into the outermost layer, for example a 1-2 mm thick outer layer of absorbent material. When alkyl polyglycosides are present as part of the cover, the cover is often formed from fibers of the hydrophobic polymer. It is formed from a liquid permeable material such as a porous nonwoven sheet. Of course, if desired, the absorbent article may also form alkyl polyglycosides to be distributed throughout the absorbent material.

The present invention also relates to a nonabsorbing substrate for use in inhibiting exoprotein production from Gram-positive bacteria. Substrates comprising alkyl polyglycoside agents are particularly useful for inhibiting TSST-1, alpha-toxin and / or enterotoxin A, B and C production from Staphylococcus aureus. Examples of suitable nonabsorbable substrates having alkyl polyglycosides incorporated into or on at least a portion of the device include nonabsorbable incontinence devices, barrier lived devices, and contraceptive sponges. Non-absorbent articles are typically exemplified herein in connection with incontinence or contraception, but one of ordinary skill in the art will understand that it may be applied to other disposable non-absorbent articles where it is beneficial to inhibit exoproteins from Gram-positive bacteria. One particular example of a nonabsorbable incontinence device is a female barrier incontinence device such as incontinence gauze formed from a resilient material such as rubber. Another suitable nonabsorbable substrate is an applicator used with tampons. For example, the applicator may be coated with an alkyl polyglycoside on its outer surface, thus, when the tampon is used to put the tampon into the female vagina, it is formulated with an alkyl polyglycoside (eg, formulated as a cream or wax). Is transferred from the applicator to the vaginal wall. The nonabsorbable substrate typically comprises at least about 3% by weight, preferably about 5 to about 10% by weight, of alkyl polyglycosides (in weight percent (additional amount)).

The present invention also relates to a composition for use in inhibiting exoprotein production from Gram-positive bacteria. This composition is particularly useful for inhibiting TSST-1 and / or Enterotoxin A, B and C production from Staphylococcus aureus. This composition comprising an alkyl polyglycoside and a pharmaceutically acceptable carrier includes, but is not limited to, aqueous solutions, lotions, balms, gels, plasters, ointments, bolus, suppositories, and the like. ) It can be manufactured and applied in various forms. For example, the active ingredients of the compositions of the present invention can be formulated into a variety of vaginal cleansing formulations, such as those used in currently available vaginal cleansing formulations or in vaginal cleansing agents having higher viscosity. Examples of suitable formulations for use in vaginal cleansing applications include formulations comprising from about 0.1 mmol to about 5.0 mmol of alkyl polyglycosides.

The alkyl polyglycoside compositions of the present invention may further comprise auxiliary ingredients conventionally found in pharmaceutical compositions in the manner established in the art and in amounts established in the art. For example, the composition may include additional compatible drugs, such as complementary antimicrobial, antiparasitic, antifogging, local anesthetics or anti-inflammatory agents, for combination treatment.

When the alkyl polyglycoside is used as part of an absorbent article, incontinence or contraceptive or as a vaginal cream or otherwise introduced into the area affecting the vagina, the alkyl polyglycoside preferably has an effect on the original vaginal flora It is used in a way and amount to minimize this. The alkyl polyglycoside compositions of the present invention can generally substantially inhibit exoprotein production from Gram-positive bacteria, for example by reducing the amount of protein produced by at least about 75%, preferably at least about 90%. .

It has been found that the use of alkyl polyglycosides can reduce the viscoelastic properties of complex body fluids as well as provide surfactant properties that aid in the rapid distribution of body fluids. Typically, alkyl polyglycosides have 8-14 carbons in the alkyl chain and are at least about 3% by weight, based on, for example, the weight of the material of the outer layer of the product, and / or on the outer surface of the disposable absorbent article. , Preferably in an amount of about 6% by weight or more. It is conveniently applicable to the material in the form of an aqueous solution, for example, an aqueous solution containing from about 40 to about 60% by weight of water.

When alkyl polyglycosides are used as part of menstrual tampons or otherwise introduced into areas affecting the vagina, the alkyl polyglycosides are preferably in a manner and in an amount so as to minimize their effect on the original vaginal flora. use. Alkyl polyglycoside compositions of the present invention generally substantially inhibit (eg, reduce the amount of exoprotein produced) from gram-positive bacteria without causing significant imbalances in the bacterial flora originally present in the vagina. 75% or more, preferably about 90% or more).

The term "nonwoven web or nonwoven" as used herein refers to a web having a structure of interlaced individual fibers or threads rather than in a regular or identifiable manner as in knitted fabrics. The term also encompasses individual filaments and strands, yarns, or tows, as well as foams and films that are fibrillated, perforated, or otherwise treated to impart fabric-like properties. Nonwoven or nonwoven webs have been formed from many methods, such as, for example, meltblowing methods, spunbonding methods, and bonded carded web methods. The basis weight of nonwovens is usually expressed in ounce per square yard (osy) or gram per square meter (gsm), and the useful fiber diameter is usually expressed in microns. Basis weight can be converted from osy to gsm by simply multiplying the value in osy by 33.91.

The term "microfiber" as used herein means a small diameter fiber having an average diameter of about 75 microns or less, for example having an average diameter of about 0.5 microns to about 50 microns, or more particularly, The microfibers may have an average diameter of about 2 microns to about 40 microns. Another commonly used expression for fiber diameter is denier, which is defined as g per 9000 m of fiber, which can be calculated by square the fiber diameter in microns and multiply it by density (g / cc) and multiply by 0.00707 Can be. Low denier refers to fine fibers, and high denier refers to thick or heavy fibers. For example, a polypropylene fiber diameter of 15 microns can be converted to denier by square it and multiply it by 0.89 g / cc and multiply by 0.00707. Thus, the 15 micron polypropylene fiber has a denier of about 1.42 (15 ² x 0.89 x 0.00707 = 1.415). Outside the United States, "tex" is the more common unit of measure, which is defined as g per kilometer of fiber. The text can be calculated with denier / 9.

The term "spunbonded fibers" as used herein refers to, for example, US Pat. Nos. 4,340,563, 3,692,618, 3,802,817, 3,338,992, 3,341,394, 3,502,763, 3,502,538, and 3,542,615. As described herein, a molten thermoplastic refers to a small diameter fiber formed by extruding a filament from a plurality of fine, usually circular capillaries of a spinneret, and then rapidly reducing the diameter of the extruded filament. Spunbond fibers are generally not tacky when deposited on a collecting surface. Spunbond fibers are generally continuous and have an average diameter frequently greater than about 7 microns, typically about 10 to about 20 microns.

As used herein, the term "meltblown fibers" refers to a molten thermoplastic material as a molten thread or filament through a plurality of fine, usually circular die capillaries into a convergent, normally heated, high velocity gas (e.g., air) stream. By extruded, this stream refers to fibers formed by attenuation of the filaments of molten thermoplastic to reduce their diameters (which may be up to fine fiber diameters). The molten fibers are then carried by the high velocity gas stream and are often still sticky deposited on the collecting surface to form a web of randomly dispersed meltblown fibers. Such a method is described, for example, in US Pat. No. 3,849,241. Meltblown fibers are fine fibers that may be continuous or discontinuous and have an average diameter of generally less than about 10 microns.

The term "bonded carded web" or "BCW" as used herein is known to those skilled in the art and further described, for example, in US Pat. No. 4,488,928, which is incorporated herein by reference. It refers to the nonwoven web formed by the method. In brief, the carding method starts with, for example, a binding fiber or other binding component in a bulky ball and a blend of staple fibers and processes it in a combing or other way to produce a uniform overall weight. It includes providing. The web is heated or otherwise treated to activate the adhesive component to form an integrated, usually lofty nonwoven material.

The term "polymer" as used herein generally includes, but is not limited to, homopolymers, copolymers such as blocks, grafts, random and alternating copolymers, terpolymers, and the like and blends thereof and variations thereof. Does not. In addition, unless specifically limited otherwise, the term "polymer" includes all possible geometrical arrangements of the material. Such arrangements include, but are not limited to, isotactic, syndiotactic, and random symmetry.

The term "hydrophilic" as used herein means that the polymeric material has a surface free energy that allows it to be wetted by an aqueous medium, ie a liquid medium whose main component is water. The term "hydrophobic" includes materials that are not hydrophilic as defined. The term “original hydrophobic” means a material that is hydrophobic in its chemical composition without an additive or treatment affecting the hydrophobic nature. The hydrophobic material can be made hydrophilic by treating it internally or externally with a surfactant or the like.

As used herein, the term "porous hydrophobic polymer material" is meant to include any shape of article as long as it is porous and consists entirely or in part of a hydrophobic polymer. For example, the substrate may be a sheet-like material such as a foam sheet. In addition, the sheet-like material may be a woven or nonwoven fabric or a fibrous web such as a woven or nonwoven web. The substrate may also include hydrophobic polymer fibers themselves or may comprise hydrophobic polymer fibers formed from fibrous webs. Preferably, the fibrous web will be a nonwoven web such as, but not limited to, a meltblown web or a spunbonded web. The substrate may also be a laminate of two or more sheets of sheet-like material. For example, the layers can be independently selected from the group consisting of meltblown webs and spunbonded webs. However, other sheet-like materials may be used in addition to or instead of meltblown and spunbonded webs. In addition, the layers of laminate can be made from the same hydrophobic polymer or different hydrophobic polymers.

The term "hydrophobic polymer" as used herein refers to any polymer that is resistant to wetting by water or that is not easily wetted by water, ie lacks affinity for water. Examples of hydrophobic polymers include polyolefins such as polyethylene, ethylene-propylene copolymers and ethylene-vinyl acetate copolymers; Styrene polymers such as poly (styrene), poly (2-methylstyrene), styrene-acrylonitrile copolymers having less than about 20 mole percent acrylonitrile; Halogenated hydrocarbon polymers such as poly (tetrafluoroethylene), tetrafluoroethylene-ethylene copolymers, poly (trifluoroethylene); Vinyl polymers such as poly (vinyl butyrate) and poly (methacrylonitrile); Acrylic polymers such as poly (n-butyl acetate), poly (ethyl acrylate); And polyesters such as poly (ethylene terephthalate) and poly (butylene terephthalate), but those listed here are for illustration only. The hydrophobic polymer may also contain trace amounts of additives commonly used in the art. For example, hydrophobic polymers can include pigments, delustrants, antioxidants, antistatic agents, stabilizers, oxygen scavengers, and the like.

As used herein, the term "polyolefin" refers to a polymer prepared by addition polymerization of one or more unsaturated monomers containing only carbon and hydrogen atoms. Examples of such polyolefins include polyethylene, polypropylene, poly (1-butene), poly (2-pentene), and the like. In addition, the term refers to random and block copolymers prepared from blends of two or more polyolefins and two or more other unsaturated monomers. Because of their commercial importance, the most preferred polyolefins are polyethylene and polypropylene.

As already mentioned, the coated porous substrate may comprise hydrophobic polymer fibers. Such fibers are coated substantially uniformly with a hydrophilic polymeric material. For example, the hydrophobic polymer fibers can be polyolefin fibers. For example, the polyolefin fibers can be polyethylene or polypropylene fibers. Hydrophobic polymer fibers can be made by any generally known means. In practice, however, the fibers will usually be produced by melt extrusion methods and formed into fibrous webs such as nonwoven webs. The term " melt extrusion method " applied to nonwoven webs refers to nonwoven webs produced by melt extrusion methods for forming nonwoven webs followed by web formation, typically on the porous support after melt extrusion to form fibers. It means to include. The term includes in particular well known methods such as meltblowing, conforming, spunbonding and the like.

As used herein, the term "pledget" is a compress used to apply pressure or compression to a body part.

As used herein, the term "surface" and its plural form generally refer to the outer or uppermost boundary of the object.

The term "durable" as used herein in connection with the coating of a hydrophilic polymeric material on a porous substrate refers to the wettability after the coated porous material has been exposed to water, saline, and aqueous media such as urine and other body fluids three or more times. I mean. One procedure for assessing durability when the porous substrate is a fibrous web is a modified run-off test followed by washing and drying (washing / drying cycles). The fibrous web will typically remain wet for at least five exposure, washing and drying cycles. Preferably, the coated porous substrate will maintain wettability even after 10 or more cycles. Run-off testing (exposure) and laundry / drying procedures are described in US Pat. No. 5,258,221, which is incorporated herein by reference.

As used herein, the term "hydrophilic polymeric material" means that the polymeric material has surface free energy that can be wetted by an aqueous medium. That is, the aqueous medium wets the hydrophilic polymeric material coated with the porous substrate. For example, the surface free energy of the hydrophilic polymer material may be at least 50 dyne / cm. As another example, the surface free energy of the hydrophilic polymeric material can range from about 50 to about 72 dyne / cm.

As used herein, the term "aqueous medium" means a liquid medium whose main component is water. Thus, the term includes water itself and aqueous solutions and aqueous dispersions. For example, the aqueous medium can be liquid intradermal secretions such as urine, menstrual blood and saliva.

As used herein, “wetability” and variations thereof mean that it can be wetted with an aqueous medium, ie, the aqueous medium is spread over the surface of the substrate. This term is used interchangeably with the term "which can be wetted by water" and variations thereof, and has the same meaning.

The phrase "complex body fluid" as used herein generally describes a fluid characterized by a viscoelastic mixture comprising special components having heterogeneous physical and / or chemical properties. It is the heterogeneous nature of the special ingredients that often challenges the effectiveness of absorbent articles that handle complex fluids such as, for example, blood, menstrual blood, diarrhea with bowel movements, and nasal secretions. In contrast to complex fluids, simple fluids, such as, for example, urine, physiological saline, water, and the like, are generally Newtonian fluids and are generally characterized by one or more components having homogeneous physical and / or chemical properties. Because of their homogeneous nature, one or more components of a simple fluid behave substantially similarly upon absorption or adsorption.

As used herein, the term "absorbent article" refers to an appliance that absorbs and contains body fluids, and more specifically, an appliance that is placed on or near the skin to absorb and contain various fluids that exit the body. do. The term "disposable" as used herein describes an absorbent article that is not intended to be washed after one use or otherwise restored or reused as an absorbent article. Examples of such disposable absorbent articles include health care related products including tampons and bandages, such as those intended for medical, dental, surgical and / or nasal use, where it would be beneficial to inhibit exoprotein production from Gram-positive bacteria; Feminine hygiene products (eg, sanitary napkins, panty liners and menstrual tampons), diapers, stool training panties, incontinence articles, and the like.

As used herein, the term "personal hygiene" refers to diapers, stool training panties, absorbent underpants, adult incontinence, sanitary wipes and feminine hygiene products, such as sanitary napkins and tampons. The term "absorbent medical article" is used to mean medical bandages, medical, dental and surgical, and / or tampons, surgical drapes, and the like, intended for nasal applications.

Brief description of the drawings

1 is a graph showing the expected percent stain area as a function of the amount (g) loaded for the internal stain pattern of a tampon prototype with covers coated with various surface treatment agents. The sign in the graph corresponds to the following treatment of the cover used to form the tampon prototype: L-7 wt% Laureth-4; P-18 wt% PPG-5 laureth-5; S-8 wt% steareth-2; And T-14 wt% glucophone 220.

FIG. 2 is a graph showing the expected percent stain area as a function of the amount (g) loaded for the external stain pattern of a tampon prototype with covers coated with various surface treatment agents. The sign in the graph corresponds to the following treatment of the cover used to form the tampon prototype: L-7 wt% Laureth-4; P-18 wt% PPG-5 laureth-5; S-8 wt% steareth-2; And T-14 wt% glucophone 220.

details

Disposable absorbent articles suitable for use in the present invention are particularly suited to containing simple and / or complex body fluids. For purposes of discussion, the absorbent articles specifically discussed herein are menstrual tampons. However, those skilled in the art will appreciate that the present invention can be applied to other disposable absorbent articles in which exoprotein inhibition from Gram-positive bacteria is beneficial.

Specifically, menstrual tampons suitable for use in the present invention include absorbers. This absorbent body can be formed from fibers assembled into an absorbent sheet or ribbon. Alternatively, the absorbent body may be formed from absorbent fibers that are assembled and compressed into generally elongated and / or cylindrical shapes. The absorbent body is preferably formed from cellulose fibers such as cotton and rayon. For example, the absorbent may be 100% cotton, 100% rayon, blends of cotton and rayon fibers, or other materials known to be suitable for tampons.

Absorbents formed from absorbent sheets or ribbons are often made from blends of cotton and rayon fibers. Two methods for forming such absorbent sheets are those known as "carding" and "airlaying". The basis weight of the absorbent sheet may vary depending on the desired absorbency desired for the final tampon. The US Food and Drug Administration (FDA) has set absorbency standards for "junior" size, "regular" size, "super" size, and "superplus size" tampons. In order to meet the FDA standards for these four sizes, the goal is to ensure that the absorbent sheet has a basis weight of about 100 gsm (gram per square), about 120 gsm, about 170 gsm and about 230 gsm, respectively. Typically, the carding method is adjusted to produce an absorbent sheet having a width of about 40 to about 60 mm, preferably about 50 mm. The basis weight and / or length of the absorbent body may also be adjusted to form tampons of different sizes.

The absorbent body may be partially or completely surrounded by the cover. Preferably, the cover is liquid permeable. The term "liquid permeable" means that liquids such as water or body fluids can pass through the cover. The cover can be hydrophilic or hydrophobic.

The term "hydrophilic" means that the cover has affinity that tends to absorb or bind water. The term "hydrophobic" means that the cover tends to be hostile to water or not to bind with water. The cover can also be treated with a surfactant or other material to make it hydrophilic or to make it more hydrophilic. The cover preferably comprises an alkyl polyglycoside disposed thereon to allow the absorbent article to be in contact with a body fluid intended to receive.

The liquid permeable cover may be formed from a woven or nonwoven material having a porous substrate. Woven materials include textile fabrics that can be made from rayon, cotton, or polyolefins. The polyolefin may be staples or continuous filaments. Nonwoven materials may include spunbond, bonded carded webs, and hydroentangled webs. Spunbond and bonded carded webs are commercially sold by Kimberly-Clark Corporation (Nina Lake Street 401N, 54957 Wisconsin). Another nonwoven material that can be used as a cover is formed from 100% polyester fibers bonded by a binder. This material is known as powder-bonded-carded web (PBCW). PBCW is commercially available from HDK Industries, Inc. (Greenville Arcadia Drive 304, South Carolina, 29609, USA). The cover may also be formed from a perforated thermoplastic film having a two or three dimensional thickness. Perforated thermoplastic films are available from some commercial sales agents. Two of these salespeople are Pantex SRL, Pantex Sud SL, and Buyer Terrasini SNC. (51031 Agliana, Pistioia, Italy) and Applied Exposure Technology (Applied). Extrusion Technology (Middleton P. Box 582, Delaware, USA 19709).

Although the cover may be formed from a porous nonwoven sheet primarily formed from hydrophobic polymer materials, such as hydrophobic polymer fibers, alkyl polyglycoside treatment of the cover surface may allow the surface to be wetted with an aqueous fluid. One example of a particularly suitable cover material is a spunbond formed from hydrophobic polymers such as polypropylene or polyethylene. Such cover materials typically have a basis weight of about 0.1 to about 0.8 osy and include sufficient alkyl polyglycosides to allow the cover surface to be wetted with an aqueous fluid. Alkyl polyglycosides are generally present as durable coatings on the fiber surface constituting the cover, ie the porous substrate remains wettable even after three or more exposures to an aqueous medium such as water, saline, urine or other body fluids. In addition, the alkyl polyglycosides are preferably selected in an amount sufficient to inhibit the production of exoproteins such as TSST-1 from Gram-positive bacteria. This can be accomplished, for example, by coating the porous polypropylene spunbond sheet with an alkyl polyglycoside having an HLB of about 12 to about 15.

The absorbent articles comprising the alkyl polyglycosides of the present invention can reduce the production of potentially harmful exoproteins when exposed to Staphylococcus aureus or other Gram-positive bacteria. In particular, exposure to alkyl polyglycoside (s) can inhibit the production of potentially harmful proteins by Staphylococcus and / or Streptococcus species.

Alkyl polyglycosides are generally present in an additional amount (based on the weight of the spunbond substrate) of at least about 3% by weight, more typically from about 6 to about 10% by weight. In some cases it may be useful to use higher levels of alkyl polyglycosides, for example up to about 20 weight percent (additional). As used herein, the term "weight percent (additional amount)" means the amount of alkyl polyglycoside used as a percentage of the dry weight of the uncoated substrate. Thus, 10 weight percent (additional amount) equals 9.1 weight percent (10/110 = 9.1) based on the total weight of the coated substrate. Unless explicitly stated otherwise herein, all amounts of alkyl polyglycosides on a substrate (absorbed or non-absorbed) are referred to as weight percent (additional amounts), although the amount may only be referred to as "weight percent." This is not the case for the amount of alkyl polyglycosides present as part of a fluid composition, referred to as% or% (w / v) of the total composition. The amount of alkyl polyglycoside used in a particular absorbent article will depend on the particular form and use of the absorbent article. The amount of alkyl polyglycoside used for a particular application will depend on the particular form and / or use of the composition or article. Actual amounts can be readily selected by those skilled in the art based on the teachings herein. For example, menstrual tampons designed to be in intimate contact with the vaginal epithelium after being inserted into the body cavity may require substantially less than absorbent articles that wear alkyl polyglycosides in vitro.

The alkyl polyglycoside compositions of the present invention can reduce the production of harmful exoproteins when exposed to Staphylococcus aureus or other Gram-positive bacteria in nonabsorbable articles. In particular, exposure to alkyl polyglycoside (s) can inhibit the production of harmful proteins by Staphylococcus and / or Streptococcus species.

The nonabsorbable substrates of the present invention are particularly suitable for use in contact with fluids such as menstrual blood, blood products and the like. The substrate usually includes an outer layer formed from a hydrophobic material comprising alkyl polyglycosides arranged to be in contact with a fluid intended for use with the product. For example, the nonabsorbent article may be a female incontinence device formed mainly from hydrophobic polymer material, for example having an impermeable outer layer formed from rubber or other hydrophobic polymer material.

Alkyl polyglycosides can generally be represented by the formula:

H-(Z) n-O-R

Wherein "Z" is a saccharide residue having 5 or 6 carbon atoms, "n" is a number having a value from about 1 to about 6, and "R" is an alkyl group, typically having 8 to 18 carbon atoms An alkyl group is shown. Commercially available examples of suitable alkyl polyglycosides include Glucopons 220, 225, 425, 600 and 625 (all of which are available from Henkel Corporation). These materials are all mixtures of alkyl mono- and oligoglucopyranosides with alkyl groups based on fatty alcohols derived from coconut and / or palm kernel oils. Glucophones 220, 225 and 425 are examples of particularly suitable alkyl polyglycosides. Glucophone 220 is an alkyl polyglycoside containing an average of 1.4 glucosyl residues per molecule and a mixture of alkyl groups having 8 to 10 carbon atoms (average 9.1 carbon atoms per alkyl chain). Glucophone 225 is a related alkyl polyglycoside having a straight chain alkyl group having an average of 8 or 10 carbon atoms in the alkyl chain (average number of carbon atoms of 9.1 per alkyl chain). Glucophone 425 comprises a mixture of alkyl polyglycosides comprising alkyl groups (average number of carbon atoms of 10.3 carbon atoms per alkyl chain) each having 8, 10, 12, 14 or 16 carbon atoms. Glucophone 600 comprises a mixture of alkyl polyglycosides each comprising an alkyl group having 12, 14 or 16 carbon atoms, with an average of 12.8 carbon atoms per alkyl chain. Glucophone 625 comprises a mixture of alkyl polyglycosides comprising alkyl groups each having 12, 14 or 18 carbon atoms, with an average of 12.8 carbon atoms per alkyl chain. Another example of a suitable commercially available alkyl polyglycoside is TL2141 (Glucophone 220 analog available from ICI).

As used herein, an "alkyl polyglycoside" may consist of a single kind of alkyl polyglycoside molecule, or as representative, may comprise a mixture of different alkyl polyglycoside molecules. The different alkyl polyglycoside molecules may be isomers and / or may be alkyl polyglycoside molecules having different alkyl groups and / or saccharide moieties. By using the term "alkyl polyglycoside isomer", one or more chiral centers of the molecule, as well as alkyl polyglycosides, which may include the same alkyl ether moiety, may differ in the position of the alkyl ether moiety in the alkyl polyglycoside. Isomers that differ in orientation of the functional groups relative to are mentioned. For example, alkyl polyglycosides are saccharides that are mono-, di- or oligosaccharides derived from more than one saccharide residue of 6 carbon atoms and etherified by reaction with a mixture of fatty alcohols of various carbon chain lengths. It may include a mixture of molecules having a portion. The alkyl polyglycosides of the present invention preferably comprise alkyl groups having an average number of carbon atoms of 9 to 11 in the alkyl chain. One example of a suitable alkyl polyglycoside is a mixture of alkyl polyglycosides with alkyl chains having 8 to 10 carbon atoms.

The alkyl polyglycosides used in the absorbent articles and other articles and compositions described herein may be characterized in terms of HLB. This can be calculated based on the chemical structure using techniques well known to those skilled in the art. The HLB of the alkyl polyglycosides used in the process of the present invention is in the range of about 10 to about 15. Preferably, the alkyl polyglycosides of the present invention have an HLB of at least about 12, more preferably from about 12 to about 14.

Alkyl polyglycosides are generally known to have good surface tension reduction, wetting and dispersibility properties. Alkyl polyglycosides can be produced using conventional methods. For example, US Pat. Nos. 5,527,892 and 5,770,543, the contents of which are incorporated herein by reference, describe alkyl polyglycosides and / or methods for their preparation. Since alkyl polyglycosides are derived from saccharides and fatty alcohols, these compounds can be readily biodegradable.

In one embodiment of the invention, the absorbent article typically comprises a liquid permeable cover comprising at least about 3% by weight, generally about 20% by weight or less, and more preferably about 6 to about 10% by weight of alkyl polyglycosides. Include. Suitable examples of such absorbent articles are menstrual tampons with a liquid permeable cover comprising alkyl polyglycosides. Typically, such tampons will have a cover formed from a spunbond fiber of a hydrophobic polymer material having an alkyl polyglycoside coated on the outside of the fiber, for example a spunbond polypropylene cover.

In other embodiments, the alkyl polyglycosides may be formulated as a composition comprising a pharmaceutically acceptable carrier. The composition typically comprises at least about 0.01% (w / v), preferably at least about 0.4% (w / v) alkyl polyglycoside (based on the total weight of the formulation). Generally, this composition comprises up to about 0.3% (w / v) alkyl polyglycosides. Particularly suitable formulations for use in applications for cleansing the vagina may comprise at least about 0.25 mmol, preferably at most about 5 mmol, more preferably about 0.5 to 3 mmol of alkyl polyglycosides. Agents comprising about 1 to 2 mmol of alkyl polyglycosides are typically used in the present invention.

The alkyl polyglycoside treatment composition may contain other additives suitable for the desired result as long as it does not have a major deleterious effect on the activity of the alkyl polyglycoside. Examples of such additives include additional conventional surfactants such as ethoxylated hydrocarbons or ionic surfactants, or wetting aids such as low molecular weight alcohols. As mentioned, the composition is preferably applied from a solvent or water with a high solids content, advantageously up to 80%, in order to minimize drying and the accompanying costs and deleterious effects. The treatment composition may be applied in various amounts depending on the desired result and application. For sanitary napkin distribution layer applications, for example, effective results are obtained within a solids addition amount range of about 5% to about 20% based on the dry weight of the fabric and from about 6% to about both cost and performance. A range of 10% is advantageous.

In another embodiment of the invention, the non-absorbent article typically comprises at least about 3% by weight, preferably at most about 16% by weight, more preferably at about 5 to about 10% by weight of alkyl polyglycoside (% by weight (parts) Cover sheet)). Suitable examples of such nonabsorbent articles are gauze having a coversheet comprising an alkyl polyglycoside. Typically, such gauze is a coversheet formed from spunbond fibers of a hydrophobic polymer material coated with an alkyl polyglycoside on the outside of the fiber. For example, a spunbond polypropylene cover layer. As used herein, the term "gauze" refers to a compression mechanism used to apply pressure or compression to a body part.

The fibers used to make the absorbent articles of the present invention can be prepared, for example, meltblowing or including those that make bicomponent, biconstituent or polymer blend fibers well known in the art. It can be produced by a spunbonding method. These methods generally use an extruder to feed the molten thermoplastic polymer to the spinneret, where the polymer is fiberized to produce fibers that can have a staple length or longer. The fibers are then stretched, usually by air, and deposited on a moving perforated mat or belt to form a nonwoven. The fibers produced by the spunbond and meltblown methods are typically microfibers as defined above. The manufacture of spunbond and meltblown webs is described generally above. As mentioned, the nonwoven can also be a bonded carded web. Bonded carded webs are made from staple fibers, usually purchased in bales. The bale is placed in the picker, which separates the fibers. The fibers are then sent through a coaming or carding unit, which further breaks down the staple fibers and aligns them in the machine direction to form a generally machine oriented fibrous nonwoven web. Once the web is formed, it is joined by one or more of several known bonding methods. One such bonding method is powder bonding in which the powdered adhesive is distributed through the web and then usually activated by heating the web and the adhesive with hot air. Another suitable joining method is pattern joining, which typically joins the fibers together in an ubiquitous bonding pattern, although a heated calender roll or ultrasonic bonding equipment can be used to bond the web across its entire surface if desired. Another suitable bonding method, in particular when using bicomponent staple fibers, is a through-air bonding.

Absorbent articles of the present invention comprise an effective amount of alkyl polyglycoside compound that substantially inhibits exoprotein formation, such as TSST-1, when an absorbent article, such as menstrual tampons or sanitary napkins, is exposed to Gram-positive bacteria. If alkyl polyglycosides are present as part of the absorbent of the absorbent article, at least about 0.005 mmol of alkyl polyglycoside compounds per gram of absorbent may be effective in reducing exoprotein production. Preferably, the alkyl polyglycoside compound comprises at least about 0.05 mmol per gram of absorber, more preferably about 0.1 mmole per gram of absorber to about 1.0 mmol per gram of absorber. Although the term "compound" is used in the singular, one skilled in the art will understand that it includes the plural. That is, the absorbent article may comprise more than one kind of alkyl polyglycoside compound.

Generally, it is not necessary to impregnate the inhibitor with the entire non-absorbent article. Optimal results, both economically and functionally, can often be achieved by concentrating on or near the outer surface where it is most effective when in use.

Suitable materials for use as absorbers in the absorbent articles described herein are nonwoven webs composed of about 3 denier polyethylene sheath / polypropylene core bicomponent staple fibers having a length of about 38 mm. Such bicomponent fibers are available from Chisso Corporation, and are typically provided with a fiber finish sold. Staple fibers are sent through an opener, mixed together uniformly and then carded into the web at a linear speed of about 15 m per minute (about 50 feet per minute). Once the web is formed, it can be sent through a through-air coupler (drum type) having an air temperature of about 131 ° C. Representative residence times in the combiner are from about 3 to about 4.5 seconds. The resulting web, which has a basis weight of about 100 gsm and a density of about 0.06 g / cm 3, can then be rolled up on a roll.

Other materials suitable for use as absorbers include materials comprising hydrophilic natural and / or synthetic fibers. For example, the material formed from a mixture of cotton and rayon fibers is an absorbent material that can be used to form all or part of the absorbent of absorbent articles such as menstrual tampons and sanitary napkins.

The alkyl polyglycoside treatment composition used to form the absorbent article of the present invention may include other additives suitable for the desired result so long as it does not have a major deleterious effect on the activity of the alkyl polyglycoside. Examples of such additives include additional conventional surfactants such as ethoxylated hydrocarbons or ionic surfactants, or wetting aids such as low molecular weight alcohols. As mentioned, the composition is applied from a solvent or water, preferably having a high solids content, advantageously up to about 80%, in order to minimize drying and the accompanying costs and deleterious effects. The treatment composition may be applied in various amounts depending on the desired result and application. For sanitary napkin distribution layer applications, for example, effective results are obtained in the range of about 5 to about 20% solids addition based on the dry weight of the fabric, and about 6 to about 10%, considering both cost and performance. Range is preferred. In addition, as will be appreciated by those skilled in the art, many substrate materials include nonwoven webs such as spunbond, meltblown, carded webs and the like, as well as woven webs and flat films, etc., in which improved fluid distribution is desired. Can be processed according to. Those skilled in the art will also recognize that some alkyl polyglycosides can be used as internal additives, that is, they can be added directly or in concentrated form to the polymer melt. After fiber formation, these additives can migrate to the fiber surface to give the desired effect. For further discussion of the internal addition of additives, see, for example, US Pat. No. 5,540,979, the contents of which are incorporated herein by reference.

Alkyl polyglycosides are generally present in an amount of at least about 3 weight percent (additional amount), more typically about 6 to 10 weight percent (additional amount) based on the weight of the outer layer of the nonabsorbable substrate. In some cases, it may be useful to use higher levels of alkyl polyglycosides, such as up to about 20 weight percent (additional amount) of the outer layer. For incontinence instrument applications, for example, effective results can be obtained within the range of about 5 to about 15 weight percent (addition) of alkyl polyglycoside solids based on the dry weight of the outer layer. As used herein, the term "weight percent (additional amount)" means the amount of alkyl polyglycoside used as a percentage of the dry weight of the uncoated substrate. Thus, 10 weight percent (additional amount) equals 9.1 weight percent (10/110 = 9.1) based on the total weight of the coated substrate. Unless stated otherwise clearly in the specification, all amounts of alkyl polyglycosides on a substrate refer to weight percent (additional), although sometimes referred to as "weight percent." This is not the case for the amount of alkyl polyglycosides present as part of a fluid composition, in which case the amount is referred to as weight percent, or mM, as a percentage of the total composition.

The composition can be applied to the absorbent article using conventional methods for applying the inhibitor to the desired absorbent article. For example, uncovered menstrual tampons can be directly immersed in the liquid bath with the composition and then air dried to remove volatile solvent if necessary. In the case of compression tampons, it is best to impregnate its elements before compression. The composition, when incorporated onto and / or in tampons, may be unfixed, loosely anchored, bonded or a combination thereof. As used herein, the term “unfixed” means that the composition can move through tampon material. For example, the alkyl polyglycosides can be blended with the polymeric material to be processed into one component of the absorbent article.

Alternatively, solutions comprising alkyl polyglycosides may be applied directly to each layer of material prior to incorporation into an article to be manufactured, such as an absorbent article. For example, an aqueous solution comprising an alkyl polyglycoside may be sprayed onto the surface of a liquid permeable cover or absorbent material that is intended to be incorporated into the absorbent article. This can be done during the manufacture of the material or during the processing of incorporating the material into the absorbent article to be produced.

Nonwoven webs coated with alkyl polyglycosides can be prepared by conventional methods. For example, alkyl polyglycosides can be applied to one or both sides of the moving web. Those skilled in the art will appreciate that this application may be performed inline processing or in a separate offline processing step. The web, such as a spunbond or meltblown nonwoven web, may be guided by a support roll to a processing station that includes a rotating spray head for application to one side of the web. Any processing station may include a rotating spray head for applying the alkyl polyglycoside to the opposite side of the web. Each processing station generally receives a processing liquid supply from the reservoir. The treated web may then be dried, if desired, by passing through a dryer can or other drying means, which may then be rolled up or converted to the intended use. Other drying devices such as ovens, through-air dryers, infrared dryers, air blowers and the like can also be used.

One example of an exemplary absorbent article is a menstrual tampon that includes an alkyl polyglycoside. Alkyl polyglycosides may be incorporated into the absorber of tampons and / or on or in the cover. Tampons with alkyl polyglycosides such as Glucophone 220 deposited on the cover are particularly suitable for inhibiting the production of bacterial exoproteins by Gram-positive bacteria, such as Staphylococcus aureus.

Inhibitory alkyl polyglycoside compositions may further employ one or more conventional pharmaceutically acceptable compatible carrier materials useful for the desired application. The carrier may covalently or suspend the material used in the composition. Accordingly, suitable carrier materials for use in the compositions of the present invention include those well known for use in the cosmetic and pharmaceutical industry as a basis for ointments, lotions, creams, plasters, aerosols, suppositories, gels and the like. Suitable carriers may consist of alcohols and surfactants.

The composition can be applied to a nonabsorbent article using conventional methods for applying the inhibitor to the desired article. For example, the apparatus can be directly immersed in a liquid bath with inhibitors and then air dried to remove volatile solvent if necessary. The composition may be immobilized, loosely anchored, bonded, or a combination thereof when incorporated onto and / or in tampon material. As used herein, the term “unfixed” means that the composition can move through tampon material. For example, the alkyl polyglycoside may be blended with the polymeric material to be processed into components of the absorbent or nonabsorbent article.

Alternatively, the solution comprising alkyl polyglycosides may be applied directly to each layer of material before incorporation into the article to be manufactured, such as a nonabsorbable article. For example, an aqueous solution comprising an alkyl polyglycoside may be sprayed onto the surface of one layer of material that is intended to be incorporated into a non-absorbent article. This can be done during the manufacture of each layer or during the processing of incorporating each layer into the article to be manufactured.

Examples of representative personal care products are incontinence or contraceptive devices that include alkyl polyglycosides. Alkyl polyglycosides may be incorporated into or on the outer layer of the device. Apparatus having alkyl polyglycosides such as Glucophone 220 deposited on the outer layer are particularly suitable for inhibiting bacterial exoprotein production by Gram-positive bacteria, such as Staphylococcus aureus.

The following examples are provided to illustrate the present invention and to assist those of ordinary skill in making and using the present invention. The examples are not intended to limit the scope of the invention.

Example A

The effect of Glucophone 220 on the growth of Staphylococcus aureus and TSST-1 production was measured in 100 mL of growth medium in sterile 500 mL Corning fleaker® (mmole / mL (mmolar, hereinafter referred to as mM). To be tested).

Growth medium was prepared as follows: Brain heart infusion broth (BHI) was dissolved in 880 mL of distilled water and sterilized. BHI liquid medium is available from Difco Laboratories, Becton Dickinson Microbiology Systems (Cockiesville, Midland, USA) 21030-0243. BHI was supplemented with 100 mL fetal bovine serum (FBS) (Sigma Chemical Company; US 63178-9916, St. Louis P. Box 14508, Missouri). 10 mL of a 0.021 M sterile solution (Sigma Chemical Company) of magnesium chloride hexahydrate was added to the BHI-FBS mixture. In addition, 10 mL of 0.027M sterile solution of S-glutamine (Sigma Chemical Company) was added to the BHI-FBS mixture.

Glucophone 220 was added directly to the growth medium, sterilized and diluted in sterile growth medium to obtain the desired final concentration.

When preparing for inoculation of the flicker of growth medium containing Glucophone 220, the inoculation liquid medium was prepared as follows: Staphylococcus aureus MN8 was prepared on a TSA plate (tryptic soy agar plate (TSA); Difco Laboratories). Streaked and incubated at 35 ° C. The test microorganism in this example was obtained from Dr. Pat Schlievert (Department of Microbiology, University of Minnesota Medical School, Minneapolis, MN). After 24 hours of incubation, three to five individual colonies were harvested with sterile inoculation loops and used to inoculate 10 mL of growth medium. Tubes of inoculated growth media were incubated at 35 ° C. in atmospheric air. After 24 hours of incubation, the cultures were removed from the incubator and mixed well with an S / P brand vortex mixer. 0.5 mL of the culture after 24 hours was inoculated into a second tube containing 10 mL of growth medium and incubated at 35 ° C. in atmospheric air. After 24 hours of incubation, the cultures were removed from the incubator and mixed well with an S / P brand vortex mixer. The optical density of the culture fluid was determined with a microplate reader (Bio-Tek Instruments, Model EL309; Winuskey Box 998, Ver., USA 05404-0998). The amount of inoculum required to provide 5 × 10 ⁶ CFU / mL was determined using standard curves prepared in advance.

This experiment included flickers of growth medium without glucophone 220 (control) or with varying concentrations of glucophone 220. Each flicker was inoculated with the amount of inoculum determined as described above. Flicker was covered with sterile aluminum foil and incubated at 35 ° C. in atmospheric air in a Lab-Line rotary shake bath at 180 rpm. Lab-line baths were obtained from VWR Scientific Products (VWR Scientific Products, McGow Park Waukegan Road 1430, 60085, USA). At the desired time point, samples were removed in 5 mL portions and the optical density of the culture fluid was determined. Culture fluids were evaluated for the number of colony forming units of Staphylococcus aureus using standard plate counting procedures.

24 hours after incubation, the experiment was repeated using fresh medium. However, in this case. Inoculum was obtained from 24 hours old flicker containing the same concentration of Glucophone 220. The method was used to determine the amount of fluid needed to obtain a 5 × 10 ⁶ CFU / mL inoculum. For example, Staphylococcus aureus grown in 2 mM Glucophone 220 was inoculated into fresh growth medium containing 2 mM Glucophone 220. Glucophone 220 was tested at 20, 10, 4, 2, 1 and 0.5 mM concentrations. Growth was not observed when present at 10 and 20 mM concentrations. In growth media containing 4 mM Glucophone 220, no growth was observed until 26 hours post inoculation and therefore did not reinoculate fresh media after the first 24 hours of incubation.

5 mL of remaining culture fluid was prepared for analysis on TSST-1 as follows: Culture fluid was centrifuged at 2500 rpm for 15 minutes at 2-10 ° C. The supernatant was filtered sterilized through an Autovial® 5 city filter (Whatman, Inc., Clifton, NJ) with a pore size of 0.2 μM. The resulting fluid was frozen at -70 ° C in a Fisherbrand® 12 x 75 polystyrene culture tube (Fisher Scientific, Pittsburgh Alpha Drive 585, Pa.).

The amount of TSST-1 per mL was determined by a noncompetitive sandwich enzyme-linked immunoabsorbent assay (ELISA). Culture fluid samples and TSST-1 comparison standards were analyzed in sets of three. The method used was as follows: rabbit polyclonal anti-TSST-1 IgG conjugated with four reagents, rabbit polyclonal anti-TSST-1 IgG (LTI-101), horseradish peroxidase. (# LTC-101), TSST-1 (# TT-606), and normal earthenware serum (NRS) (# NRS-10) that were found to be free of anti-TSST-1 were incubated with Toxin Technology, Inc. Inc .; Curtis Avenue 7165, Sarasota, Florida, USA. A 10 μg / mL solution of polyclonal rabbit anti-TSST-1 IgG was prepared in pH 7.4 phosphate buffered saline (PBS). PBS was prepared from 0.016M NaH ₂ PO ₄ , 0.004M NaH ₂ PO ₄ -H ₂ O, 0.003M KCl and 0.137M NaCl, all available from Sigma Chemical Company. 100 μl of polyclonal rabbit anti-TSST-1 IgG solution was pipetted into the wells inside the polystyrene microplates (catalog # 439454; obtained from Nunc-Denmark). The plate was covered and incubated overnight at room temperature. Unbound antitoxin was removed by draining until there was no.

TSST-1 is phosphate buffered saline containing 0.05% (v / v) Tween-20 (pH 7.4) (PBS-Twin) (available from Sigma Chemical Company) and PBS with 1% NRS (v / v) Diluted to 10 ng / mL incubated at 4 ° C. overnight. Test samples were combined with 1% NRS (v / v) and incubated overnight at 4 ° C.

100 μl of a 1% (w / v) solution of sodium salt in casein in PBS (Sigma Chemical Company) was pipetted into the wells inside the polystyrene microplates, covered with the plate and incubated at 35 ° C. for 1 hour. Unbound BSA was removed by washing three times with PBS-Twin. TSST-1 comparative standard (10 ng / mL) treated with NRS, test samples treated with NRS, and 200 μl volume of reagent control were pipetted into each well in the first and seventh rows of plates. To the remaining wells 100 μl of PBS-Tween was added. TSST-1 comparative standards and test samples were then serially diluted 5-fold in PBS-twin by transferring 100 μl from the wells to the wells. Samples were mixed before transfer by repeated aspiration and expression. This was then incubated at 35 ° C. for 1.5 hours, washed five times with PBS-T and three times with distilled water to remove unbound toxins.

Rabbit polyclonal anti-TSST-1 IgG conjugated with horseradish peroxidase was diluted according to the manufacturer's instructions and 50 μl was added to each microtiter well except well A-1, the conjugate control well. The plate was covered and incubated at 35 ° C. for 1 hour.

After incubation, the plates were washed five times in PBS-twin and three times with distilled water. After washing, the wells were 100 μl of horseradish peroxidase substrate buffer consisting of 5 mg o-phenylenediamine and 11 μl 30% hydrogen peroxide (both available from Sigma Chemical Company) in 11 mL citrate buffer (pH 5.5). Treated with. Citrate buffer was prepared from 0.012M citric anhydride and 0.026M dibasic sodium phosphate (both available from Sigma Chemical Company). Plates were incubated at 35 ° C. for 15 minutes. The reaction was stopped by adding 50 μl of 5% sulfuric acid solution. The intensity of the hue response of each well was evaluated using a Biotek model EL309 microplate reader (OD 490 nm). TSST-1 concentrations in the test samples were determined from the comparative toxin regression equation derived during each assay procedure.

The efficacy of Glucophone 220 in inhibiting TSST-1 production is shown in Table I below. The data not only showed the units of TSST-1 (ng / OD units) but also indicated TSST-1 levels as a percentage of untreated controls.

Glucophone 220 (mM) OD (10 hours) TSST-1 (ng / OD units) TSST-1 (% Of control) OD (24 hours) TSST-1 (ng / OD unit) TSST-1 (% Of control) First 24-hour incubation none 7.49 189 11.47 1471 4 mM 0.03 ND - 0.04 ND - 2 mM 7.95 23 12% 11.47 37 3% 1 mM 8.1 63 33% 11.21 168 11% 0.5 mM 7.45 143 76% 10.71 187 13% Second 24-Hour Incubation in Fresh Badges none 6.34 232 - 10.00 1141 - 2 mM 7.91 12 8% 11.93 37 3% 1 mM 7.95 41 17% 9.92 127 11%

Example B

Tampon prototypes with covers treated with various other nonionic surface treatments were tested in a laboratory microbial challenge test to determine the effect of the surface treatment on TSST-1 production by Staphylococcus aureus.

The cover material was prepared by coating a specific nonionic surface treatment agent on a commercially prepared 0.4 osy polypropylene spunbond cover material. Surface treatments were applied by diluting the surfactant to the desired concentration with clarified water and applying the solution to the nonwoven cover material with a Butterworth treatment equipment. The amount of solution applied was controlled by nip pressure and line speed.

The coated cover was used to make a tampon prototype comprising an absorbent layer consisting of a mixture of cotton and rayon fibers. The uncompressed absorbent gauze made from a combination of cotton and rayon fibers was covered with the treated spunbond cover material. A string hole was drilled through the uncompressed gauze. The string was knotted and looped through the absorbent gauze and cover, and the structure was compressed and placed in a tampon applicator.

Addition levels of various cover surface treatments were determined by the weight of the extract. Correction was made for extract levels obtained from untreated cover material, extraction efficiency of certain surfactants, and solids content of surfactants. Treated spunbond covers were sampled in triplicate and the recovery efficiency was calculated by triplicate tests on one addition level of each surfactant. As a control, spiked samples were prepared using comparative samples of untreated nonwoven cover material and various surfactants. The spiked sample was tested at the same extraction conditions as the corresponding coated cover material.

Tampon prototypes to be tested were randomly selected from each of the prototype groups with various types of cover coatings. The prototype was picked up with sterile tweezers. The string was cut with sterile scissors, and the end of the string was placed in a sterile polystyrene test tube capped with gauze.

Each gauze is inoculated with 10.5 mL of inoculation liquid medium containing 5 x 10 ⁶ CFU / mL of Staphylococcus aureus MN8 (obtained from the Department of Microbiology, University of Minnesota Medical School, Minneapolis, Minn.) It was. After incubation at 35 ° C. for 24 hours in a stoppered tube, the gauze was placed in a sterile stomacher bag and sterile fluid was added. The gauze and fluid were then stomaching. Fluid aliquots were removed from the stomamarker bags using sterilization techniques and placed into sterile tubes for testing.

Plate counting samples were prepared by vortexing the samples, recovering 5 mL samples, and placing the 5 mL into fresh sterile 50 mL centrifuge tubes. The samples were then sonicated for 15 seconds at 8% power in a Virtis Virsonic 475 sonicator. When all samples were sonicated, the number of colonization units per mL was determined using standard plate counting procedures.

Analysis of TSST-1 Concentration

5 mL of culture fluid was prepared for TSST-1 analysis as follows: The culture fluid was centrifuged at 9000 rpm for 5 minutes at 4 ° C. The supernatant was filtered sterilized through a 0.45 micron filter and aliquoted into two aliquots in a 1.5 mL polypropylene screw cap freezer vial and frozen at -70 ° C.

The amount of TSST-1 per mL was determined by noncompetitive sandwich enzyme-linked immunoabsorbent assay (ELISA). Samples of culture fluid and TSST-1 comparison standards were analyzed by triplicate. The method used was as follows: rabbit polyclonal anti-TSST-1 IgG conjugated with four reagents, rabbit polyclonal anti-TSST-1 IgG (LTI-101), horseradish peroxidase (# LTC- 101), TSST-1 (# TT-606), and normal Earthenware Serum (NRS) (# NRS-10) that were found to be free of anti-TSST-1 toxin technology, Inc. (Curtis, Sarasota, FL 34231, USA). Avenue 7165). 62 μl of polyclonal rabbit anti-TSST-1 IgG (# LTI-101) was appropriately diluted so that a 1: 100 dilution gave an absorbance of 0.4 at 205 nm. It was added to 6.5 mL of 0.5 M carbonate buffer, pH 9.6, and 100 μl of this solution was pipetted into the wells inside Polystyrene Microplate Catalog # 439454 (obtained from Nunc-Denmark). The plate was covered and incubated overnight at 37 ° C. Unbound antitoxin is phosphate buffered saline (pH 7.2) containing 0.5% (v / v) Tween 20 (0.016M NaH ₂ PO ₄ and 0.9% (w / v) NaCl (both of these are Sigma Chemical Company) in an autoplate washer Available from)) (PBS-Twin) (which is also available from Sigma Chemical Company). Plates were treated with 100 μl of a 1% (w / v) solution of bovine serum albumin (BSA) fraction V in the 0.5 M carbonate buffer. BSA Fraction V is available from Sigma Chemical Company. The plate was covered and incubated at 37 ° C. for 1 hour. Unbound BSA was removed by washing six times with 250 μl PBS-Tween. Test samples were treated with normal rabbit serum (10% (v / v) final concentration) for 15 minutes at room temperature. TSST-1 comparative standard and NRS treated test samples serially diluted from 1-20 ng / mL in PBS-Twin (serially diluted in PBS-Twin so that TSST-1 concentrations are 1-20 ng) were added to each well Pipette in volume by volume. This was then incubated at 37 ° C. for 2 hours and washed four times with 250 mL PBS-twin to remove unbound toxins. Rabbit polyclonal anti-TSST-1 IgG conjugated with horseradish peroxidase was diluted according to the manufacturer's instructions. The final use dilution of the conjugate was determined by following the standard curve of the TSST-1 comparison standard with undiluted, 1: 2 dilution and 1: 4 dilution conjugates. Dilutions were chosen that gave the most comparable results with many previous conjugates. 100 μl of this dilution was placed in each microtiter well. The plate was covered and incubated at 37 ° C. for 1 hour.

After incubation, the plates were washed six times in 250 μl PBS-twin and three times with distilled water. After washing, the wells were washed with 0.015 M sodium citrate (pH 4.0), 0.6 mM 2,2'-azino-bis- (3-ethylbenzthiazoline-6-sulfonic acid) diammonium salt and 0.009% (v / v) hydrogen peroxide (all 100 ml of Horseradish Peroxidase Substrate Solution, available from Sigma Chemical Company. The intensity of the hue response in each well was evaluated over time using a Biotek Model EL340 microplate reader (OD 405 nm) and Kineticc® software (available from Biotech Instruments, Inc.). . TSST-1 concentrations of test samples were derived from comparative toxin regression equations for each assay procedure.

The efficacy of Glucophone 220 in inhibiting TSST-1 production is shown in Table II below.

Surface treatment agent Solids (% by weight) TSST-1 (ng / mL) Final [Staphylococcus aureus] x 10 ⁹ CFU / mL Laureth-4 7 wt% 531.8 4.57 PPG-5 Lauretsu-5 18 wt% 609.2 3,82 Glucophone 220 3 wt% 554.8 6.41 Glucophone 220 14 wt% 327.5 6.90 Steareth-2 8 wt% 680.7 5.76

Example C-Inhalation Test

A cover material similar to that used to make tampons was prepared by coating a polypropylene spunbond web (0.4 osy) with a solution containing a specified amount (based on solids) of the selected nonionic surface treatment agent. The solution was prepared with HPLC grade water except for steareth-2 dissolved in HPLC grade water containing 3 wt% hexanol. The spunbond material was coated at a linear speed of 75 fpm. The samples were then dried before use (dry can temperature-225 ° F.) and cut to 4 or 8 inches long. Table III below shows the solution concentration, wet pick up level and nip pressure used to coat the spunbond cover material with various surfacing agents.

Surfactants Target Wet Pickups (wt%) Nip pressure 3% Glucophone 220 100% 7 psi 12% Glucophone 220 100% 8 psi 9% Lauretsu-4 100% 8 psi 8.7% PPG Laureth-5 150% 4 psi 3% steareth-2 200% 3 psi

Absorbent ribbons formed from blends of 2/3 rayon and 1/3 cotton fibers were prepared and cut to 4 inches in length. 4 inch long treated spunbond webs were placed over a 4 inch piece of rayon / face absorber. Each sample was then infused three times with 0.25 mL of simulated low viscosity menstrual blood similar to that described in PCT WO 98/09662. Insulation was delivered at a rate of 2.5 mL / min at 3 minute intervals. The inhalation time (seconds) at which simulated menstrual blood passes into the cover sample was recorded for each insult. The results are shown in Table IV below.

Surfactants density (weight%) Suction time (seconds) 1st 2nd 3rd Glucophone 220 3% 6.97 8.87 10.84 Glucophone 220 6% 6.85 8.73 9.70 Glucophone 220 9% 6.78 7.75 8.13 Glucophone 220 13% 6.90 7.95 8.23 Laureth-4 3% 6.71 7.74 8.27 Laureth-4 6% 6.82 8.01 8.56 Laureth-4 9% 6.51 7.27 7.59 Laureth-4 13% 6.51 7.46 7.97 PPG-5 Lauretsu-5 3% 6.53 7.47 7.93 PPG-5 Lauretsu-5 6% 6.84 8.18 8.84 PPG-5 Lauretsu-5 9% 7.10 8.39 8.82 PPG-5 Lauretsu-5 13% 6.96 7.79 8.07 Steareth-2 (IPA) 3% 33.42 8.61 9.38 Thrarereth-2 (IPA) 6% 7.13 8.37 9.21 Steareth-2 (hexanol) 6% 7.81 8.38 10.79

Example D-Dosing Test

A cover material similar to that used to make tampons was prepared by spraying a solution containing a selected amount of nonionic treatment agent in a specified amount (based on solids) into 0.4 osy polypropylene spunbond web (see description in Example C). The samples were then dried in an oven before use and cut to 8 inches long. Absorbent ribbons formed from blends of 2/3 rayon and 1/3 cotton fibers were made and cut to an 8 inch length.

The 8 inch long treated samples were weighed and each sample was placed on top of an 8 inch piece of rayon / cotton absorber, respectively. The treated cover was then insulated with 5 mL of low viscosity menstrual blood solution at a rate of 10 mL / hr. The absorber layer was then cut into eight 1 inch fragments and each sample was weighed to obtain the saturation profile of the specific treated sample. Fluid distribution was obtained by calculating the degree of saturation (the amount of liquid absorbed) for each 1 inch segment of a particular sample. For a given sample, the distribution profile can be obtained by adding together individual saturated segments. Fluid distribution can be used to calculate saturation (“SR”) for one given 8 inch absorber strip. In the equation for "SR" shown below, the letters "A" through "H" each represent the amount of liquid absorbed in a given one-inch segment of an eight-inch strip, where the segment has one end to the other end of the strip. The letters A-H are displayed in succession.

SR = [(4 * A) + (4 * H)] / (D + E) + [(4 * A) + (4 * G)] / (D + E) +

[(2 * C) + (2 * F)] / (D + E)

This method gives the highest weight to the sample that distributes the fluid evenly across the 8 inch long test strip. This ratio is calculated in the same way as the torque multiplied by the fluid wicked distance to the fluid in each section. This ratio gives a higher value to the material that wicked the fluid farthest. Because of the weight used in this method, the SR evaluation scale will provide different values for the same material sample of different length. For samples of constant length, the specimen with the highest SR value distributes the fluid most effectively.

The saturation for each treatment sample (various nonionic surface treatment additive levels) is shown in Table V below. No significant difference was seen for any of the nonionic treatments tested as a function of each nonionic treatment concentration tested. The second method was used to confirm the results obtained by the "SR" method. The mean and standard deviation of eight segments were calculated. The coefficient of dispersion ("COV"-standard deviation divided by the mean) was then calculated for the eight segments. A COV value of " 0 " means that there is an equal amount of fluid in each of the eight segments, i.e. a complete uniform distribution of the fluid. Thus, for the "SR" method, higher values mean better wicking performance, while the opposite applies in COV-DSN tests.

Surfactants density (weight%) Saturation COV-DSN Laureth-4 3% 1.51 4.11 Laureth-4 6% 1.51 4.11 Laureth-4 9% 1.51 4.11 Laureth-4 13% 1.51 4.11 Glucophone 220 3% 1.48 4.17 Glucophone 220 6% 1.48 4.17 Glucophone 220 9% 1.48 4.17 Glucophone 220 13% 1.48 4.17 PPG-5 Lauretsu-5 3% 1.62 4.12 PPG-5 Lauretsu-5 6% 1.62 4.12 PPG-5 Lauretsu-5 9% 1.62 4.12 PPG-5 Lauretsu-5 13% 1.62 4.12 Steareth-2 (IPA) 3% 1.06 4.18 Steareth-2 (IPA) 9% 1.62 4.18 Steareth-2 (hexanol) 6% 0.83 4.55

Example E

The effect of Glucophone 220 on the growth of Staphylococcus aureus and the production of alpha-toxin (alpha-hemolysin) was determined by adding the desired concentration (mmole / mL, mM) to 100 mL of growth medium in sterile 500 mL Corning Flicker®. Determined by putting. Glucophone 220 was added directly to the growth medium, filtered sterilized and diluted in sterile growth medium to obtain the desired final concentration.

This experiment was obtained except that the test microorganism Staphylococcus aureus RN6390 of this Example was obtained from Richard Novick, Ph.D., the Skirball institute for Biomolecular Medicine, New York University Medical Center, New York, New York. The procedure described in Example A was followed. Experiments included flicker of growth medium without glucophone 220 (control) or flicker of growth medium with varying concentrations of glucophone 220.

Each flicker was inoculated with Staphylococcus aureus RN6390 following the procedure described in Example A. Flicker was blocked with sterile aluminum foil and incubated for 24 hours at 35 ° C. in atmospheric air in a lap-line rotary shake bath at 180 rpm.

5 mL of culture fluid was prepared for alpha-hemolysin analysis as follows: The culture fluid was adjusted to standard absorbance (1.0) and centrifuged at 2500 rpm for 15 minutes at 2-10 ° C. The supernatant was filtered sterilized through a motorcycle egg 5 murine rinse filter (pore size 0.2 micron) (Watman, Inc., Clifton, NJ). The resulting fluid was frozen at -20 ° C in a Fisherbrand® 12 x 75 mm polystyrene culture tube (Fisher Scientific, Pittsburgh Alpha Drive 585, 15328 PA, USA).

The amount of alpha-hemolysin was determined by hemolysis analysis using rabbit red blood cells. The method used was as follows: Rabbit red blood cells (rrbc: Remel) from which fibrin was removed were washed three times in Tris-Brine buffer (pH 7.0) consisting of 50 mM Tris / Tris-HCl and 100 mM NaCl. Centrifuged at 800 × g for 7 minutes. Reagents were obtained from Sigma Chemical Corporation. rrbc was suspended in 200 mL Tris-Brine buffer to a concentration of 0.5%. Culture supernatants were serially diluted in medium. One part diluted sample was combined with 9 parts rrbc. All sample analyzes were done in triplicate. Controls for hemolysis consisted of a negative control (1 part tris-saline buffer in 9 parts rrbc) and a positive control (1 part 10% SDS in 9 parts rrbc). The same 10 control groups were prepared. All assay samples were incubated at 37 ° C. for 30 minutes and then centrifuged at 800 × g for 10 minutes. Hemolysis amounts of samples and controls were measured at 405 nm with a Biotek model EL309 microplate reader. Units of activity are expressed as the inverse of the dilution rate of each test sample giving 50% cytolysis.

The effect of Glucophone 220 on alpha-toxin production is shown in Table VI.

Glucophone 220 (mM) Alpha-hemolysin unit Alpha-hemolysin (% Of control) none 32 2 mM 0 0.0% 1 mM 2.2 6.9% 0.5 mM 4.4 13.8%

Example F-Tampon Fluid Dispensing Test

A tampon prototype comprising a porous cover coated with 7 wt% Laureth-4, 18 wt% PPG-5 Laureth-5, 8 wt% Steareth-2, or 14 wt% Glucophone 220 is provided in Example B. Prepared according to the described procedure. Tampon prototypes were used for practical use tests and analyzed to determine% surface stains for the outer surface (cover) and inner core (absorbent layer). The change point regression model was used to estimate the percentage of internal and external stain areas based on the amount (g) loaded in the product used. In essence, the point of change model uses two regression lines, a first regression line that describes the function between the area percentage and the loading amount (g) to the point of change, and a second regression line that describes the function after the point of change. Fitting.

The results are shown in FIGS. 1 and 2 and Tables VI and VII. 1 is a graph showing the expected stain area percentage as a function of the amount (g) loaded for the internal stain pattern of prototypes with covers coated with various surface treatment agents. FIG. 2 is a graph showing the expected stain area percentage as a function of the amount (g) loaded for the external stain pattern of tampon prototypes with covers coated with various surface treatment agents. The results in Tables VII and VIII show that Glucophone 220 improves fluid distribution for both the outer surface and the inner core. The results obtained with Glucophone 220 were substantially better than the results obtained for the prototype with the steareth-2 treated cover, and the tampon prototype treated with Laureth-4 and PPG-5 Laureth-5 It was comparable to that observed for.

Surfactant (% by weight) Change Outside slope evaluation First regression line first regression line 7% Lauretsu-4 2.0 25.88 7.66 18% PPG-5 Lauretsu-5 2.2 28.28 3.78 14% Glucophone 220 1.6 31.77 4.58 8% Steareth-2 2.6 20.33 2.65

Surfactant (% by weight) Change Outside slope evaluation First regression line first regression line 7% Lauretsu-4 3.6 17.69 7.25 18% PPG-5 Lauretsu-5 5.1 16.87 1.14 14% Glucophone 220 4.3 17.56 2.83 8% Steareth-2 4.9 16.10 -0.96

Several documents have been cited throughout this application. These documents are incorporated herein by reference in their entirety for the purpose of more fully describing the technical state to which this invention pertains.

The present invention has been described in various specific and illustrative embodiments and techniques. However, it should be understood that many variations and modifications may be made while remaining within the spirit and scope of the invention.

Claims (89)

A menstrual tampon comprising an absorbent material comprising at least an outer layer of the tampon in an amount of alkyl polyglycosides effective to inhibit exoprotein production from the Gram positive bacteria when the tampon is exposed to the Gram positive bacteria. The tampon of claim 1, wherein the outer layer comprises an alkyl polyglycoside in an amount effective to inhibit TSST-1 production from Staphylococcus aureus . The tampon of claim 1, wherein the outer layer comprises an amount of alkyl polyglycoside effective to inhibit alpha-toxin production from Staphylococcus aureus. The tampon of claim 1, wherein the outer layer is a cover. The tampon of claim 4, wherein the cover is liquid permeable. The tampon of claim 1, wherein the outer layer is an outer portion of the absorber layer. The tampon of claim 1, wherein the alkyl polyglycoside is distributed throughout the absorbent material. The tampon of claim 1, wherein the alkyl polyglycoside has an alkyl group having 8 to 18 carbon atoms. The tampon of claim 8, wherein the alkyl group is a straight chain alkyl group. The tampon of claim 8, wherein the alkyl polyglycoside has an alkyl group having 8 to 14 carbon atoms. The tampon of claim 1, wherein the alkyl polyglycoside is an alkyl polyglucoside. The tampon of claim 1, wherein the alkyl polyglycoside has an HLB of 10-15. The tampon of claim 1, wherein the alkyl polyglycoside is represented by the formula: H-(Z) n-O-R (Wherein "Z" is a saccharide residue having 5 or 6 carbon atoms, "n" is a number having a value ranging from 1 to 6 and R represents a straight chain alkyl group having 8 to 18 carbon atoms) The tampon according to claim 13, wherein R represents a straight chain alkyl group having 8 to 14 carbon atoms. The tampon of claim 1, wherein the alkyl polyglycoside has an alkyl group having an average of 8 to 12 carbon atoms. The tampon of claim 1, wherein the outer layer comprises at least 3% by weight of alkyl polyglycoside based on the dry weight of the outer layer. The tampon of claim 16, wherein the outer layer comprises 20 wt% or less of alkyl polyglycoside based on the dry weight of the outer layer. The tampon of claim 5, wherein the liquid permeable cover comprises 6 to 10 weight percent alkyl polyglycoside based on the dry weight of the liquid permeable cover. An absorbent article in which the cover comprises at least 6 weight percent alkyl polyglycoside based on the dry weight of the cover. 20. The absorbent article of claim 19 wherein the alkyl polyglycoside has an HLB of 12-15. 20. The absorbent article of claim 19 wherein the alkyl polyglycoside has an alkyl chain having an average of 8 to 12 carbon atoms. 20. The absorbent article of claim 19 wherein the alkyl polyglycoside has a straight chain alkyl group having 8 to 10 carbon atoms. Absorbent material and liquid permeable, wherein the cover comprises at least 3 weight percent alkyl polyglycoside based on the dry weight of the cover, the alkyl polyglycoside having an HLB of 12 to 15 and an alkyl group having an average of 8 to 12 carbon atoms Menstrual tampons comprising a cover. 24. The tampon of claim 23, wherein the alkyl polyglycoside has a straight chain alkyl group having 8 to 10 carbon atoms. The tampon of claim 23, wherein the liquid permeable cover is a porous nonwoven sheet. 27. The tampon of claim 25, wherein the porous nonwoven sheet is formed from fibers of a hydrophobic polymer. 27. The tampon of claim 26, wherein the alkyl polyglycoside is coated over the fibers. 27. The tampon of claim 26, wherein the porous nonwoven sheet is a spunbond web formed from polypropylene or polyethylene fibers or mixtures thereof. A nonabsorbing substrate comprising an alkyl polyglycoside having an alkyl group having an average of 8 to 14 carbon atoms in an amount effective to inhibit exoprotein production from Gram-positive bacteria. The substrate of claim 29 comprising an alkyl polyglycoside in an amount effective to inhibit TSST-1 production from Staphylococcus aureus. 30. The substrate of claim 29 comprising an alkyl polyglycoside in an amount effective to inhibit alpha-toxin production from Staphylococcus aureus. 30. The substrate of claim 29, wherein the alkyl polyglycoside has an alkyl group having 8 to 18 carbon atoms. 30. The substrate of claim 29, wherein the alkyl group is a straight alkyl group. The substrate of claim 33, wherein the alkyl polyglycoside has an alkyl group having 8 to 14 carbon atoms. 30. The substrate of claim 29, wherein the alkyl polyglycoside is an alkyl polyglucoside. 30. The substrate of claim 29, wherein the alkyl polyglycoside has an HLB of 10 to 15. 30. The substrate of claim 29, wherein the alkyl polyglycoside is represented by the formula H-(Z) n-O-R (Wherein "Z" is a saccharide residue having 5 or 6 carbon atoms, "n" is a number having a value ranging from 1 to 6 and R represents a straight chain alkyl group having 8 to 18 carbon atoms) 38. The substrate of claim 37, wherein "Z" is a glycosyl residue. 30. The substrate of claim 29, which is a female incontinence mechanism. The substrate of claim 29 which is a contraceptive device. 41. The substrate of claim 40, wherein the contraceptive device is a barrier contraceptive device. 41. The substrate of claim 40, wherein the contraceptive device is a contraceptive sponge. 30. The substrate of claim 29, wherein the alkyl polyglycoside has an alkyl group having an average of 9 to 11 carbon atoms. 30. The substrate of claim 29, wherein the alkyl polyglycoside has a straight chain alkyl chain having 8 to 10 carbon atoms. A nonabsorbing substrate comprising an alkyl polyglycoside in an amount effective to inhibit the production of Staphylococcus aureus. 46. The substrate of claim 45, wherein the alkyl polyglycoside has an HLB of 10 to 15 and an alkyl group having an average of 8 to 12 carbon atoms. A nonabsorbing substrate comprising an alkyl polyglycoside in an amount effective to inhibit alpha-toxin production from Staphylococcus aureus. 48. The substrate of claim 47, wherein the alkyl polyglycoside has an HLB of 10 to 15 and an alkyl group having an average of 8 to 12 carbon atoms. A composition for inhibiting exoprotein production from Gram-positive bacteria comprising an effective amount of an alkyl polyglycoside having an alkyl group having an average of 8 to 14 carbon atoms and a pharmaceutically acceptable carrier. 50. The composition of claim 49 comprising an alkyl polyglycoside in an amount effective to inhibit TSST-1 production from Staphylococcus aureus. The composition of claim 49, wherein the alkyl polyglycoside has a straight alkyl group. The composition of claim 49 wherein the alkyl polyglycoside has at least 10 HLB. The composition of claim 49 wherein the alkyl polyglycoside is represented by the formula: H-(Z) n-O-R Wherein "Z" is a saccharide residue having 5 or 6 carbon atoms, "n" is a number having a value ranging from 1 to about 4, and "R" is a straight chain alkyl group having 8 to 14 carbon atoms Indicates) The composition of claim 53 wherein "Z" is a glucosyl residue. 50. The composition of claim 49, wherein the alkyl polyglycoside has an HLB of 12. 50. The composition of claim 49, wherein the alkyl polyglycoside has an average of 9 to 11 carbon atoms in the alkyl chain. The composition of claim 49 which is a vaginal cleansing composition. The composition of claim 49 comprising 0.25 mmol to 5 mmol of alkyl polyglycosides. The composition of claim 49 wherein the alkyl polyglycoside has a straight chain alkyl group having from 8 to 10 carbon atoms. 50. The composition of claim 49 comprising an alkyl polyglycoside in an amount effective to inhibit alpha-toxin production from Staphylococcus aureus. A vaginal cleansing composition comprising 0.25 mmol to 5 mmol of an alkyl polyglycoside having at least 10 HLB and an alkyl group having an average of 8 to 12 carbon atoms and a pharmaceutically acceptable carrier. 62. The composition of claim 61, wherein the alkyl polyglycoside has a straight chain alkyl group having 8 to 10 carbon atoms. 62. The composition of claim 61, wherein the alkyl polyglycoside has an HLB of 12 to 15. A vaginal cleansing composition comprising an alkyl polyglycoside in an amount effective to inhibit TSST-1 production from Staphylococcus aureus. 65. The composition of claim 64, wherein the alkyl polyglycoside has at least 10 HLB and an alkyl group having an average of 8 to 12 carbon atoms. A vaginal cleansing composition comprising an alkyl polyglycoside in an amount effective to inhibit alpha-toxin production from Staphylococcus aureus. 67. The composition of claim 66, having an alkyl group having at least 10 HLB and an average of 8 to 12 carbon atoms. A method for inhibiting exoprotein production from Gram-positive bacteria, comprising exposing Gram-positive bacteria to an effective amount of an alkyl group having an average of 8 to 14 carbon atoms and an alkylpolyglycoside having an HLB of 10 or more. 69. The method of claim 68, comprising exposing the Gram-positive bacteria to a composition comprising an alkyl polyglycoside and a pharmaceutically acceptable carrier. 69. The method of claim 68, comprising exposing the Gram-positive bacteria to a nonabsorbing substrate comprising an alkyl polyglycoside. 69. The method of claim 68, wherein the alkyl polyglycoside has an alkyl group having 8 to 14 carbon atoms. 69. The method of claim 68, wherein the alkyl polyglycoside is represented by the formula: H-(Z) n-O-R Wherein "Z" is a saccharide residue having 5 or 6 carbon atoms, "n" is a number having a value ranging from 1 to 4, and "R" represents a straight chain alkyl group having 8 to 14 carbon atoms ) 73. The method of claim 72, wherein "Z" is a glucosyl residue. 69. The method of claim 68, wherein the alkyl polyglycoside has an HLB of 12-15. 69. The method of claim 68, wherein the alkyl group is a straight chain alkyl group. 69. The method of claim 68, wherein the alkyl polyglycoside has a straight chain alkyl group having 8 to 10 carbon atoms. 69. The method of claim 68, wherein the alkyl polyglycoside has an alkyl chain having an alkyl group having an average of 9 to 11 carbon atoms. 69. The method of claim 68, comprising contacting a composition comprising Staphylococcus aureus comprising an amount of alkyl polyglycosides effective to inhibit TSST-1 production. The method of claim 68 comprising contacting a composition comprising Staphylococcus aureus, wherein the composition comprises an amount of alkyl polyglycoside effective to inhibit alpha-toxin production. A method for inhibiting exoprotein production from Gram-positive bacteria, comprising contacting a Gram-positive bacterium with a substrate comprising an effective amount of at least 10 HLB and an alkyl polyglycoside having an alkyl group having an average of 8 to 14 carbon atoms. 81. The method of claim 80, wherein the substrate is a nonabsorbent material. 81. The method of claim 80, wherein the substrate is an absorbent material. 83. The method of claim 82, wherein the absorbent material is a personal hygiene product. 84. The method of claim 83, wherein the personal hygiene product is a feminine hygiene product. 85. The method of claim 84, wherein the absorbent material is an absorbent medical article. A method for inhibiting exoprotein production from Gram-positive bacteria, comprising contacting Gram-positive bacteria with an absorbent article comprising an effective amount of an alkyl polyglycoside having an HLB of 10 to 15 and an alkyl group having an average of 8 to 14 carbon atoms. 87. The method of claim 86, wherein the absorbent article comprises a cover material comprising at least 5 weight percent (additional amount) of alkyl polyglycosides. 87. The method of claim 86, wherein the absorbent article is a tampon comprising a cover sheet comprising alkyl polyglycosides. The porous nonwoven sheet formed from the hydrophobic polymer was treated with an alkyl polyglycoside having an HLB of 10 to 15 and an alkyl group having an average of 8 to 14 carbon atoms to obtain a cover sheet material having at least 5% by weight (additional amount) of alkyl polyglycoside. Manufacturing, Forming a tampon such that at least a portion comprises an absorbent material covered with the cover sheet material Tampon production method which can suppress the production of exoprotein from Gram-positive bacteria, including.