CZ20031469A3 - Composition for inhibition of exoprotein production from gram-positive bacteria - Google Patents

Abstract

Absorbent and non-absorbent substrates are disclosed. The absorbent and non-absorbent substrates disclosed herein contain an effective amount of an alkyl polyglycoside for inhibiting the production of potentially harmful toxins such as TSST-1, alpha toxin and/or enterotoxins A, B, and C from S. aureus . The absorbent substrates containing the alkyl polyglycoside disclosed herein may be tampons or sanitary napkins, and the non-absorbent substrates may be incontinence devices.

Description

Technical field

The invention relates to a method for inhibiting the formation of exoprotein by Gram-positive bacteria in compositions where such formation may occur, such as a mestructive tampon.

BACKGROUND OF THE INVENTION

The use of disposable absorbent compositions such as tampons, non-absorbent compositions such as incontinence compositions, and vaginal cleansing compositions is widespread. For example, the use of disposable absorbent compositions for absorbing human exudates is widespread. Said disposable absorbent compositions typically comprise an absorbent of a suitable weight processed to the desired shape determined by the intended use. In the area of menstrual tampons, the disposable absorbent article is intended to be inserted into the body cavity and to absorb body fluids expelled by women during the menstrual period.

The female body undergoes a complex process that keeps the vagina and physiologically related areas in a physiological state. For women aged from menarche to menopause, the vagina provides an ecosystem suitable for various microorganisms. Bacteria are the predominant species of microorganisms found in the vagina; 1 gram of vaginal exudate of most women contains about 10 ⁹ bacteria. The vaginal bacterial flora includes both aerobic and anaerobic bacteria. The most common isolated bacteria include Lactobacillus, Corynebacetrium, Gardnerella vaginalis, Staphylococcus, Peptococcus, Streptococcus aerobic and anaerobic, and Bacteroides. Other types of microorganisms that are isolated from the vagina in some cases include yeasts (eg Candida albicans), protozoa (eg Trichomonas vaginalis), mycoplasmas (eg Mycoplasma hominis), chlamydia (eg Chlamydia trachomatis) and viruses (eg Herpes simplex ). The latter group of organisms is generally associated with vaginitis or venereal disease, although sometimes said organisms may be present in the vagina in low amounts without causing any symptoms of the disease.

The amount and species of bacteria found in the vagina are influenced by physiological, social and idiosyncratic factors. Physiological factors include age, menstruation day and the effect of pregnancy. For example, the vaginal flora during the menstruation period includes species of the genus Lactobacterium, Corynebacterium and mycoplasma. Social and idosyncratic factors include the method of contraception used, sexual practices, systemic diseases (such as diabetes) and applied medication.

Bacterial proteins and metabolites produced in the vagina can affect other microorganisms and the human host. For example, the environment in. The vagina between menses is mildly acidic with a pH in the range of about 3.8 to about 4.5. This pH range is generally considered to be the most favorable for maintaining normal flora. At these pH values, the vagina environment is suitable for multiple microorganisms in a balanced ecological system that has a beneficial role in providing protection and resistance to infection, and makes the vagina environment unsuitable for some bacterial species such as Staphylococcus aureus (S.aureus). Said low pH is

as a result of the cultivation of lactobacilli and their production of acid products. Microorganisms in the vagina can also produce antimicrobial compounds such as hydrogen peroxide and bactericides acting on other bacterial species. One example of such compounds are lactocins, lactobacil products acting on other types of lactobacils.

Some microbe products can affect a host, a human. For example, S. aureus can produce and secrete various exoproteins, including enterotoxins, toxin-1 toxic shock syndrome (TSST-1), and enzymes such as protease and lipase into its environment. S.aureus occurs in the vagina in about 16% of healthy menstrual women. About 25% of S. aureus microbes isolated from the vagina have the ability to form TSST-1.

Toxic Shock Syndrome (TSS) occurring during menstruation and severe and in some cases fatal multisymptomal conditions are associated with colonization of S. aureus microbes. The above disease is caused by TSST-1 and other enterotoxins produced by staphylococci.

Symptoms of TSS generally include fever, diarrhea, vomiting and rapid fall in blood pressure. A typical rash also occurs. About 6% of patients experience systemic organ failure. TSS initiation is not the result of invasion of S.aureus microorganisms into the vaginal cavity. TSST-1 is produced only by S.aureus growth and multiplication. Only after entering the bloodstream does TSST-1 act systemically and induce the symptoms described as TSS.

Several attempts have already been made to reduce or eliminate pathogenic microorganisms and menstruation occurring

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TSS by incorporating one or more compounds having biostatic, biocidal and / or detoxifying properties. For example, a menstrual tampon containing L-ascorbic acid was prepared to detoxify the toxin found in the vagina of women during menstruation. Other authors have used monoesters and diesters of polyhydric aliphatic alcohols as the monoester of lauric acid with glycerol as detoxifying compounds incorporated into the composition. Also described is the use of other nonionic surfactants such as alkyl esters, alkylamines and alkylamides as agents to eliminate the problem caused by esterase degradation (see, e.g., U.S. Patent Nos. 5,685,872; 5,618,554; and 5,612,045).

In addition to the use of some surfactants as detoxifying agents, surfactants have also been used to treat nonwoven materials intended for multiple applications involving contact with body fluids such as menstrual flow, to increase their wicking effect or their ability to distribute effluents rapidly, to utilize the absorbency of the disposable absorbent article. Although said conventional surfactants may increase the wettability, they often fail to effectively reduce the viscoelasticity of the mestruent effluent in a manner allowing an increase in the wicking effect to the degree of the method of the invention.

It is described that the use of specific surfactants including alkyl polyglycosides can not only reduce the viscoelastic properties of the fluid with which they are intended to come into contact, such as menstrual flow, but also can provide surfactant properties to aid in rapid fluid distribution. Such results

9-4 are described using alkyl polyglycosides of 8-10 carbon atoms in the alkyl chain, deposited on the fibers forming the absorbent distribution layer of the absorbent article, such as sanitary paper for medical use. In the above work, it is proposed to use about 0.2% to about 5% alkyl polyglycoside based on the total weight of the absorbent material.

Many feminine hygiene products and cleaning products for internal use are mainly used by women in liquid form.

Many liquid irrigation products are used to rinse and clean the vagina and to prevent vaginal infections as well as contraception. Compositions intended for vaginal lavage can be prepared from various components. The most common substance for vaginal cleansing is wine vinegar. However, there is insufficient evidence to suggest that vinegar-containing compositions effectively and decisively affect changes in pH values in the vagina for a sufficient period of time to support the growth of the physiological vaginal flora and to limit infections.

It is described that if either an acidic or alkaline solution is used for irrigation daily, there will be no overall changes in the pH of the vagina or vaginal mucosa. It is also described that during the lavage, the pH of the vagina adapts to the pH of the solution used for lavage. However, within 30 minutes after the acidic wash, the pH of the vagina is shifted to the alkaline range.

Thus, there remains a need for compositions that effectively inhibit the production of exoproteins such as TSST-1 by Gram-positive bacteria. In particular, it would be advantageous to develop novel vaginal cleansing compositions which could be incorporated as a means to inhibit the formation of exoproteins by gram positive bacteria. TO

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a wider acceptance of these compositions would be desirable that, in addition to suppressing the formation of exoproteins, said composition (s) also effectively assist in the distribution and / or uptake of the liquid complex over the surface of a disposable absorbent composition and It would be desirable for said compositions not to be significantly influenced by lipase and esterase enzymes and to have other desirable properties regarding enhancing the wetting properties of hydrophobic materials such as nonwoven materials typically used as cover layers for absorbent articles. The selection of compounds inhibiting the formation of exoproteins is not as easy as some compounds, such as block copolymers of propylene oxide and ethylene oxide, can stimulate toxin formation by Gram-positive bacteria. In addition, the desired compositions should not alter the usual flora found in the vagina region.

SUMMARY OF THE INVENTION

It has been found that alkyl polyglycosides can inhibit the production of exoproteins (exoproteins) by Gram-positive bacteria. Exposure to an effective amount of an alkyl polyglycoside (alkylpolyglycosides) of the invention may inhibit the formation of potentially harmful toxins such as those produced by species of the genera Staphylococcus and / or Streptococcus. For example, alkyl polyglycoside (alkyl polyglycosides) can be used to inhibit the production of TSST-1, alpha-toxin and / or enterotoxins A, B and C produced by S.aureus. The alkyl polyglycoside typically has a hydrophilic / lipophilic balance (HLB) of at least about 10 and / or an average number of carbon atoms in the alkyl chain of 8 to 12. The alkyl polyglycoside may be used alone or in combination with one or more surfactants (such as myreth- 3-myristate, glycerol monolaurate and / or laureth-4) * 9 * 9 And / or with other additives (eg, a reducing agent (s) such as ascorbic acid, sodium bisulfite, vitamin E). Said reducing agents may act as oxygen inhibiting agents and may promote the ability of the combined agent to reduce toxin production.

The alkyl polyglycoside compositions or compositions of the invention are materials which, in contact with S. aureus bacteria or other gram-positive bacteria, which may come into contact with disposable absorbent compositions, allow reduction of the formation of exoproteins such as TSST-1. The compounds in the disposable absorbent compositions of the present invention are also believed to be effective in suppressing the production of other species of bacterial toxins, in particular alpha toxin and staphylococcal enterotoxins A, B and C. In particular, the alkyl polyglycosides described herein are effective as inhibitors of the above exoprotein when the compound is contained near the outer surface of the disposable absorbent article or is incorporated or coated onto a non-absorbent substrate with or without the use of a pharmaceutically acceptable carrier. The alkyl polyglycoside may be used in combination with one or more other compounds, for example compounds such as myreth-3-myristate, glycerol monolaurate and / or laureth-4.

The alkyl polyglycosides described for use in the method of the invention are particularly useful for inhibiting the formation of bacterial endotoxins when incorporated into or for use in disposable absorbent compositions. In particular, it has been found that the incorporation of an alkyl polyglycoside into at least the outer layer of a disposable composition such as a tampon may be effective. The outer layer may be an absorbent cover layer or may simply be an outer layer of the absorbent itself. The alkyl polyglycoside can be impregnated into the outermost layer of the absorbent, for example, into an absorbent layer, for example, into an absorbent layer, for example, into an absorbent layer, e.g. The outer layers of absorbent material having a thickness of 1-2 mm.

When the alkyl polyglycoside is contained in the cover layer, the cover layer is usually made of a liquid permeable material such as a porous nonwoven layer made of fibers of a hydrophobic polymer. Of course, the absorbent composition can be made such that the alkyl polyglycoside is contained in all the absorbent material.

The invention also relates to the inhibition of exoprotein formation by Gram-positive bacteria on non-absorbing substrates. Said substrates containing alkyl polyglycoside compositions are particularly useful for inhibiting the production of TSST-1, alpha-toxin and enterotoxins A, B and C produced by S. aureus. Examples of suitable non-absorbent substrates into or at least a portion of which an alkyl polyglycoside is incorporated include non-absorbent agents used in incontinence, barrier type contraceptives, and contraceptive tampons. Typical examples of non-absorbent compositions in this disclosure include those used in conjunction with incontinence or contraception, but it will be apparent to those skilled in the art that the present method can be applied to other non-absorbent compositions where inhibition of exoprotein production by Gram positive bacteria would be beneficial. One specific example of a non-absorbent composition used in female incontinence is a barrier composition such as an incontinence coating device made of a resilient material such as rubber. Another example of a non-absorbent substrate is an applicator used in conjunction with the introduction of a tampon. For example, the applicator may comprise an alkylpolyglycoside deposited on the outer surface so that when the applicator is used to introduce a tampon into a woman's vagina, the alkylpolyglycoside (e.g., in the form of a cream or wax) is transferred from the applicator to the walls of the vagina. Non-absorbent substrates typically contain at least about 3 wt. % and preferably about 5 to about 10 wt. alkylpolyglycoside (% of added alkylpolyglycoside relative to the weight of the substrate itself).

The invention also relates to compositions suitable for inhibiting the formation of exoproteins by Gram-positive bacteria. Said compositions are particularly suitable for inhibiting the production of TSST-1 and / or enterotoxins A, B and C by S.aureus. Compositions comprising an alkyl polyglycoside and a pharmaceutically acceptable carrier can be prepared and administered in various suitable forms including, but not limited to, aqueous solutions, lotions, balms, gels, wound ointments, ointments, boluses, suppositories, and the like. For example, the active ingredient of the compositions of the invention may be formulated into various vaginal cleansing formulations such as formulations of the generally available rinsing formulations or in the form of high viscosity rinsing formulations. Examples of suitable formulations intended as vaginal cleansers include formulations containing about 0.1 mmol to about 5.0 mmol alkyl polyglycoside.

The alkyl polyglycoside compositions of the invention may further comprise other additional ingredients commonly used in pharmaceutical compositions as determined and at the concentrations recommended in the art. Said compositions may contain other compatible pharmaceutical ingredients for combination therapy such as complementary antimicrobial ingredients, antiparasitic agents, itching relieving agents, local anesthetics or anti-inflammatory agents.

When using an alkyl polyglycoside in the form of an absorbent article, an incontinence device, or a contraceptive or vaginal cream or the like, where the alkyl polyglycoside is introduced into the

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In the case of vagina, the said alkyl polyglycoside is used in such a manner and in such an amount as to minimize its effect on the natural vaginal flora. The alkyl polyglycoside compositions of the present invention generally allow significant inhibition of exoprotein formation by Gram-positive bacteria, for example, reducing the amount of protein produced by at least about 75%, and preferably by at least about 90%.

It has been found that the use of alkyl polyglycosides not only reduces the viscoelastic properties of the composite body fluid, but also provides surfactant properties to aid rapid body fluid distribution. The alkyl polyglycoside used is usually a compound of 8-14 carbon atoms in the alkyl chain and is contained in the outer surface and / or outer surface of the disposable absorbent composition, e.g. in an amount corresponding to at least 3% by weight. % and more preferably at least about 6 wt. based on the weight of the material constituting the outer layer of the product. The alkyl polyglycoside may suitably be applied to said material in the form of an aqueous solution, for example in the form of an aqueous solution thereof at a concentration of from about 40 to about 60% by weight.

When using alkyl polyglycosides as part of a menstrual tampon or in another form where it is introduced into the vaginal affecting area, it is desirable to use said alkyl polyglycoside in a manner and amount to minimize its effect on the natural vaginal flora. The alkyl polyglycoside compositions of the invention generally allow for significant inhibition of exoprotein formation by gram-positive bacteria (e.g., reduce the amount of exoprotein produced by at least about 75%, preferably at least about 90%) without causing significant imbalance in the naturally occurring flora in the vaginal tract.

The term nonwoven or fabric includes a fabric having a structure comprising interspersed single fibers or yarns but which are not interleaved in a regular or identifiable manner as is the case with fabric prepared by weaving. The term also applies to products prepared from fibers and strips, staple or tow fibers as well as foamed products and films by further spinning, perforating or otherwise processing leading to textile-type products. The nonwoven or fabric is prepared in a number of ways such as melt blown, extruded, and carded nonwoven. The basis weights of nonwovens are generally expressed in ounces of material per square yard (grams) or grams per square meter (g / m ² ), and the fiber diameters are usually appropriately reported in micrometers. Values in the axis can be converted to values expressed in g / m ² by multiplying the values in the axis by a factor of 33.91.

The term microfibers as used herein refers to small diameter fibers with a mean fiber diameter of not more than about 75 µm, for example fibers with a mean diameter of from about 0.5 to about 50 µm, or particularly microfibers with a mean fiber diameter of from about 2 to about 40 µm. Another frequently used value for fiber fineness is denier, which is defined by the weight of a fiber of 9000 meters in grams and can be calculated from the product of the square of the fiber diameter, density in g / cm ^2, and a factor of 0.00707. Lower denier denotes finer fibers and higher denier denotes thicker or heavier fibers. For example, a 15 µm diameter polypropylene fiber can be converted to denier by multiplying the diameter value, multiplying the result by 0.89 g / cm ^2, and then multiplying it by 0.00707. The polypropylene fiber with a diameter of 15 pm has a value in denier of about 1.42 (15 ² .0,89.0,00707). Outside the US, a tex unit is usually used, defined as a fiber weight of 1 km in grams. Tex can be calculated as denier / 9.

The term melt-extruded fibers refers to small diameter fibers prepared by extruding molten thermoplastic material into fibers using a system of fine, usually circular capillaries contained in a spinneret, followed by rapid reduction of extruded fiber diameter by methods described, for example, in U.S. Patent 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. The extruded fibers cool rapidly and are generally not sticky when transferred to the collecting surface. The fibers thus prepared are generally continuous and have an average diameter often greater than 7 µm, typically between about 10 to about 20 µm.

The term meltblown fibers refers to fibers prepared by extrusion of molten thermoplastic material by a system of fine, usually circular capillaries, such as molten threads or fibers into parallel flows. typically heated gas (e.g., air) at high velocities, allowing the fibers of the molten thermoplastic material to be attenuated and reduced in diameter to the diameter corresponding to the microfiber. The fibers thus obtained are then carried by a high velocity gas flow and fed to the collecting surface, often still in an adhesive state, forming a structure in which the prepared fibers are randomly distributed. The method described above is disclosed, for example, in U.S. Patent No. 3,849,241. The meltblown fibers may be continuous or discontinuous and generally may have a mean diameter of less than about 10 µm.

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The term carded or nonwoven webs refers to carded webs by methods known to those skilled in the art and further described, for example, in U.S. Patent No. 4,488,928, which is incorporated herein by reference. Briefly, in a carding process, a blend comprising, for example, staple fibers together with binder fibers or other binder components is used as a raw material, which is processed by combing or otherwise to a homogeneous mass by weight. The obtained structure is heated or otherwise processed to activate the adhesive component to provide an integrated, usually resilient, nonwoven product.

The term polymer as used herein includes, but is not limited to, homopolymers, copolymers such as block, graft, random and alternating copolymers, terpolymers, etc., and mixtures and modifications thereof. Further, unless specifically limited, the term polymer includes all possible geometric configurations of the material. Said configurations may include, but are not limited to, isotactic, syndiotactic and atactic polymers.

The term hydrophilic as used herein means that the polymeric material has a free surface energy of such a value that it is wettable with an aqueous medium, i.e. a liquid medium whose main component is water. The term hydrophobic as used herein means that the materials are non-hydrophilic. The term naturally hydrophobic refers to materials that are hydrophobic by virtue of their own chemical composition without additional additives or without processing affecting hydrophobicity. It should be noted that the hydrophobic materials can be internally or externally treated with surface active agents and the like to obtain hydrophilic properties.

The term porous hydrophobic polymeric material used in the present description includes any molded article with the proviso that it is porous and contains all or part of the hydrophobic polymer. Such a substrate may have a leaf-like shape such as a sheet of foamed material. The sheet-like material may also have a fibrous structure such as a woven or non-woven fabric or structure. Said substrate may consist of hydrophobic polymeric fibers as such, or the hydrophobic fibers may be incorporated into said fibrous structure. Said fibrous structure is preferably a nonwoven such as, but not limited to, said fibrous structure prepared by melt blown or extruded melt processing. Said substrate may also be a laminate consisting of one or more sheets in the form of sheets. For example, the layers may be independently selected from the group consisting of melt blown structures or extruded melt structures. However, other sheet-like materials may be used in addition to the above melt blown or extruded structures. In addition, the layers constituting the layered structure may be prepared from the same hydrophobic polymer or different hydrophobic polymers.

The term hydrophobic polymer as used herein means any wettable or non-wettable polymer, i.e., a polymer lacking water affinity. Examples of hydrophobic polymers include, but are not limited to, polyolefins such as polyethylene, copolymers and:

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Ethylene-propylene and ethylene-vinyl acetate copolymers;

styrene polymers such as poly (styrene), poly (2-methylstyrene), styrene-acrylonitrile copolymers containing less than about 20 mol%. tril acrylates, halogenated hydrocarbon polymers such as poly (tetrafluoroethylene), tetrafluoroethylene-ethylene copolymers, poly (trifluoroethylene); vinyl polymers such as poles (vinyl butyrate) and poles (methacrylonitrile), acrylic polymers such as poles (butyl acetate), poles (ethyl acrylate), and polyesters such as poles (ethylene terephthalate) and poles (butylene terephthalate). The hydrophobic polymer may also contain minor amounts of additives as is conventional in the art. The hydrophobic polymer may contain, for example, pigments, gloss-removing agents, antistatic agents, stabilizers, oxygen scavengers and the like.

The term polyolefin as used herein means a polymer prepared by addition polymerization of one or more monomers containing only carbon and hydrogen atoms. Examples of such polymers include polyethylene, polypropylene, poles (1-butene), poles (2-pentene) and the like. In addition, the term includes mixtures of two or more polyolefins and random and block copolymers prepared from two or more different unsaturated monomers. In terms of their commercial significance, the most desired polyolefins are polyethylene and polypropylene.

As already mentioned, the coated porous substrate may comprise hydrophobic polymer fibers. Said fibers are substantially homogeneously coated with a hydrophilic polymeric material. The hydrophobic polymeric fibers may be, for example, polyolefin fibers. The hydrophobic polyolefin fibers can be prepared by any method known in the art. For practical reasons, however, fibers are usually prepared by melt extrusion processes and then processed into a fibrous structure such as

nonwoven structure. The term melt extrusion method used in connection with nonwoven webs refers to nonwoven webs prepared by any melt extrusion process to prepare a nonwoven web wherein melt extrusion is followed by preparing said web, usually in parallel, on a perforated support surface. Said term includes among other methods generally known in the art such as melt blown processing, melt extrusion conformation, and the like.

The term tiling used in this specification means a tiling used to apply pressure or to press against a particular part of the body.

The term surface and its plural generally refer to the outer or topmost edge of the object to which the term refers.

The term durable used in conjunction with the coating of a porous substrate with a hydrophilic material means that the coated porous substrate remains wettable after at least three exposures to an aqueous medium such as water, saline, and urine and other body fluids. One method of assessing durability for a porous substrate in the form of a fibrous structure involves a modified laboratory load followed by washing and drying (wash / dry cycle). Typically, said fibrous structure will remain wettable for at least five cycles of exposure, washing and drying. However, it is desirable that said coated porous substrate remain wettable for at least about ten cycles. Said laboratory stress test (exposure) and washing / drying process are described in U.S. Patent 5,258,221, which is incorporated herein by reference.

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The term hydrophilic polymeric material as used herein means that said polymeric material has a free surface energy such that the material is wettable with an aqueous medium. That is, the aqueous medium wets the hydrophilic polymeric material through which the porous substrate is coated.

The free surface energy of the hydrophilic polymer material may for example be at least 50 dyne / cm (50.10 J ^-7). As another example, a hydrophilic polymeric material whose free surface energy is in the range of about 50 to about 72 dynes / cm (50 ° ^-7 to 72 ° -107 ^-7 J).

The term aqueous medium as used herein means any liquid medium in which water constitutes a major component. Thus, the term includes water as such and aqueous solutions and dispersions. Thus, aqueous media can be understood as liquid body excrements such as urine, menstrual discharge and saliva.

The term wettable and variations thereof used in this specification means wettability with an aqueous medium, i.e., the aqueous medium flows over the surface of the substrate. The term is interchangeable with the term water wettable and variations thereof and has the same meaning.

The term complex body fluid is intended to describe a fluid which is generally characterized in that it is a viscoelastic composition comprising individual components generally having inhomogeneous physical and / or chemical properties. In many cases, it is precisely the inhomogeneous properties of the specific components that adversely affect the effectiveness of absorbent articles when applied to complex fluids such as blood, menstrual discharge, mouth, nose and the like. Unlike complex fluids, simple fluids such as urine, physiological saline, water, and the like, generally characterized as Newtonian ··· «9 • 9 · • 99 • 9 ·

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9 to 99 liquids, contain one or more components generally having homogeneous physical and / or chemical properties. As a result of said homogeneous properties, said one or more simple fluid components behave substantially similarly during absorption or adsorption.

The term absorbent composition as used herein refers to compositions that absorb and retain body fluids, and more particularly to compositions intended to be placed on or near the skin and to absorb and retain various secreted body fluids. The term single use as used herein refers to absorbent articles which are not intended to be washed or otherwise cleaned or reused as a single use absorbent article. Examples of disposable absorbent compositions include, but are not limited to: medical devices including bandages and swabs for medical, dental, surgical and / or nasal use; personal hygiene absorbent articles such as feminine hygiene articles (e.g., diapers, sanitary napkins and menstrual tampons), diapers, workout garments, incontinence articles, and the like, wherein inhibition of exoprotein formation by gram positive bacteria is beneficial.

The term personal care products refers to diapers, workout suits, absorbent panties, adult incontinence products, sanitary napkins and feminine hygiene products such as sanitary napkins and tampons, and the like. The term medical devices include bandages and swabs for medical, dental, surgical and / or nasal use, surgical drapes and the like.

Description of the figures in the attached drawings

Fig. 1 is a graph representing the estimation of contamination of the inner surface area of the tampons as a function of the weight of the load in g for prototypes of tampons containing coating layers that have been coated in different ways. The codes in the graph correspond to the following coating treatments that were used for each tampon prototype: L - 7 wt. Laureth-4; P - 18 wt. Laureth-5 PPG-5; S - 8 wt. Steareth-2; and T-14 wt. Glucopon 220.

Fig. 2 is a graph representing an estimate of the contaminated area of the outer surface of the tampons as a function of the weight of the load in g for prototypes of tampons containing coating layers that have been coated in different ways. The codes in the graph correspond to the following coating treatments that were used for each tampon prototype: L - 7 wt. Laureth-4; P - 18 wt. Laureth-5 PPG-5; S - 8 wt. Steareth-2; and T-14 wt. Glucopon 220.

DETAILED DESCRIPTION OF THE INVENTION

Disposable absorbent compositions suitable for use in the present invention are those adapted to contain a single and / or complex body fluid. For the purpose of the following description, a menstrual tampon was chosen as the specifically described product. However, it will be apparent to those skilled in the art that the invention is applicable to other absorbent compositions where inhibition of exoproteins by Gram-positive bacteria would be beneficial.

Specifically, menstrual tampons suitable for use in the present invention comprise an absorbent. Said absorbent may be made of fibers arranged in an absorbent layer or an absorbent layer

tape. Alternatively, the absorbent may be made of absorbent fibers arranged and compressed generally into an elongated and / or cylindrical shape. It is desirable to make the absorbent from cellulose fibers such as cotton and rayon. For example, the absorbent may comprise 100% cotton, 100% rayon, a blend of cotton and silk fibers, or other materials known as suitable tampon raw materials.

When the object is to process the absorbent into a layer or tape, a mixture of cotton and rayon is often used.

Two methods known as carding and air jet lamination are used to process the absorbent into a layer or tape.

Depending on the desired absorbency of the final tampon, the tampon may have different basis weights of the absorbent layer. The US Food and Drug Administration (FDA) has set absorbency standards for tampon sizes known as junior, regular, super, and super-plus. In order to achieve the absorptivities required by the FDA in the four sizes, absorbent layers having a basis weight of about 100 g per square meter (g / m ² ) and about 120 g / m ² , about 170 g / m ^{2 are respectively used.} and about 230 g / m ² . Typically, the carding process is controlled so that the layers have a weight in the range of about 40 to about 60 mm, preferably about 50 mm. The basis weight and / or length of the absorbent may be chosen to prepare tampons of various sizes.

The absorbent may be partially or completely covered by a cover layer. Desirably, the cover layer is liquid pervious. The term fluid permeable means that fluids such as water or body fluids may pass through the coating. The cover layer may be hydrophilic or hydrophobic.

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The term hydrophilic means that the coating has an affinity for water absorption or a tendency to associate with water. The term hydrophobic means antagonism to the water-binding or the tendency not to water. It is also possible to treat the topsheet with a surfactant or other material to make it hydrophilic or more hydrophilic.

If the absorbent is intended to contain body fluid, it is desirable that the cover layer contain an alkyl glycoside at the points of contact with the body fluid.

The liquid-permeable layer can be made of woven or non-woven materials having a porous backing. Said woven materials include fabrics made of rayon, cotton or polyolefins. The polyolefins may be in the form of staple fibers or filaments. The nonwoven material may be a nonwoven fabric, structures made by carding processes, or hydrodynamic processing. Nonwoven fabrics and carded structures are commercially available from Kimberly-Clark Corporation at 401 N.Lake St., Neenah, WI 54957. Another nonwoven material that can be used as the cover layer is a 100% polyester binder bonded material. This material is known as the PBCW powder-bonded-carded web. PBCW is commercially available from HDK Industries Inc, based at 304 Arcadia Dr., Greenville, SC 29609. The cover layer can also be made of an apertured thermoplastic film having a thickness of two or three dimensions. Perforated thermoplastic films are commercially available from several suppliers. Two of these suppliers are Pantex Srl,

Pantex Sud Srl, Via Terracini sne. based at 51031 Agliana, Pistioia, Italy, and Applied Extrusion Technology with P.O.Box 582 Postal Address.

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Although the cover layer is prepared primarily from a hydrophobic polymeric material, for example a porous nonwoven layer made of hydrophobic polymer fibers, treating the cover layer with an alkyl polyglycoside can render the surface wettable with aqueous liquids. An example of a particularly suitable covering material is a nonwoven fabric made of a hydrophobic polymer such as polypropylene or polyethylene. Said coating material has a typical basis weight of from about 0.1 to about 0.8 axis (3.391 to 27.128 g / m ² ) and contains the necessary amount of alkyl polyglycoside to render the coating surface wettable with an aqueous liquid. Said alkyl polyglycoside is deposited on the fibers in the form of a durable coating which allows the coating, i.e., the porous substrate, to remain wettable with water after at least three exposures to an aqueous medium such as water, saline, urine or other body fluids. In addition, it is desirable to select said alkyl polyglycoside to sufficiently inhibit the formation of exoproteins such as TSST-1 by Gram-positive bacteria. This can be achieved, for example, by coating a layer of porous polypropylene nonwoven material with an alkyl polyglycoside having an HLB of about 12 to 15.

When the alkylpolyglycoside-containing absorbent compositions of the present invention are exposed to S. aureus or other Gram positive bacteria, they can reduce the formation of potentially harmful exoproteins produced by said bacteria. In particular, said alkyl polyglycoside (s) allow inhibition of the formation of potentially harmful proteins produced by Staphylococcus and / or Streptococcus species.

Said alkyl polyglycoside is usually used in an amount of at least about 3% by weight. and more usually in an amount of about 6 to about 10 wt. In some cases, it may be desirable to use higher amounts of alkyl polyglycoside, e.g., up to about 20% by weight of the nonwoven substrate. (in an amount corresponding to the added amount relative to the substrate). The term added amount in% wt. means the amount of the amount of alkyl polyglycoside used, expressed as a percentage of the dry weight of the uncoated substrate. It follows that the addition of 10 wt. as an added amount of 9.1 wt. calculated on the total weight of the coated substrate (10/110 = 9.1). Unless otherwise indicated, all data relating to the amount of alkyl polyglycoside deposited on the substrate (both absorbing and non-absorbing) is given as an added amount in% by weight. although this amount is simply indicated as wt. However, the abovementioned expression of the amounts does not apply to the masses of alkyl polyglycosides which are part of the liquid compositions, wherein the amounts are given in mmol or% (w / w) relative to the total mixture. The amount of alkyl polyglycoside used in a specific absorbent composition depends on the particular form and use of the composition. The amount of alkyl polyglycoside used for a particular application depends on the particular form and / or use of the composition and / or composition. The actual amount of alkyl polyglycoside will be readily determined by those skilled in the art based on the above disclosure. For example, a menstrual tampon intended for insertion into the body cavity and subsequent intimate contact with the vaginal epithelium will require the use of less alkyl polyglycoside than the absorbent composition applied externally to the body.

In non-absorbent products, the alkyl polyglycoside compositions of the invention may reduce the formation of S. aureus or other gram-positive bacteria in contact with the invention.

of harmful exoproteins. In particular, exposure to alkylpolyglycosides (alkylpolyglycosides) may inhibit the formation of harmful exoproteins produced by Staphylococcus and / or Streptococcus species.

The non-absorbent substrates of the invention are particularly adapted for contact with fluids such as menstrual discharge, blood products and the like. Typically, said substrates comprise an outer layer formed of a hydrophobic material comprising an alkyl polyglycoside deposited so as to come into contact with the fluid for which the composition is designed.

For example, the composition may be a female incontinence device made primarily of a hydrophobic polymeric material having an impermeable outer layer made of rubber or other hydrophobic polymeric material.

The alkyl polyglycoside may be represented by the general formula;

H- (Z) n -O-R wherein Z is a carbohydrate residue of 5 or 6 carbon atoms, n is a number from about 1 to about 6 and R is an alkyl group usually having 8 to 18 carbon atoms.

Commercially available examples of suitable alkyl glycosides include Glucopon 220, 225, 425, 600, and 625, all of which are available from Henkel Corporation. All of said products are mixtures of alkyl monoglucopyranosides and alkyl oligoglucopyranosides having alkyl groups derived from coconut and / or palm oil. Glucopon 220, 225 and 425 are examples of particularly suitable alkyl polygylocosides. Glucopon 220 is an alkylpolygylcoside having an average of 1.4 glucose residues in

• ·

One molecule containing a mixture of alkyl groups of 8 to 10 carbon atoms (the average number of carbon atoms in the alkyl chain is 9.1). Glucopon 225 is a related alkyl polyglycoside with alkyl groups having a straight chain of 8 to 10 carbon atoms (the average number of atoms in the alkyl chain is 9.1). Glucopon 425 is a mixture of alkyl polyglycosides which individually contain alkyl groups of 8, 10, 12, 14 or 16 carbon atoms (average number of carbons in the alkyl chain is 10,3) Glucopon 600 is a mixture of alkyl polyglycosides which individually contain alkyl groups of 12, 14 or 16 carbon atoms (average number of carbons in the alkyl chain is 12.8). Glucopon 625 is a mixture of alkyl polyglycosides which individually contain alkyl groups of 12, 14 or 18 carbon atoms (the average number of carbons in the alkyl chain is 12.8). Another example of a suitable commercially available alkyl polyglycoside is TL 2141, a Glucopone 220 analogue available from ICI.

It will be appreciated that the term alkylpolyglycoside used in this specification may comprise one kind of alkylpolyglycoside molecule, or may conveniently include a mixture of different alkylpolyglycoside molecules. The various alkyl polyglycoside molecules may be isomeric and / or may be alkyl polyglycoside molecules having different alkyl moieties and / or carbohydrate moieties. The term alkyl polyglycoside isomers refers to alkyl polyglycosides which, although having the same alkyl ether moieties, may differ in the position of the alkyl ether moiety in the alkyl glycoside and the term also includes isomers that differ in the orientation of functional groups at one or more chiral centers of the molecule. For example, an alkylglycoside may comprise a mixture of molecules having carbohydrate moieties consisting of mono-, di-, or oligosaccharides derived from more than one monohydrate moiety of a 6-carbohydrate moiety. and wherein said di- or oligosaccharides are etherified by reaction with fatty alcohols of different carbon chain lengths.

Desirably, the alkyl polyglycosides for use herein contain alkyl groups having an average number of carbon atoms in the alkyl chain of 9 to 11. An example of a suitable alkyl polyglycoside is a mixture of alkyl polyglycoside molecules having alkyl chains of 8 to 10 carbon atoms.

Said alkyl polyglycosides for use in an absorbent composition and other products and compositions described in the present application may be characterized by an HLB value. Said value can be calculated based on their structure by methods generally known in the art. The HLB value of the alkyl polyglycosides for use in the invention is generally in the range of about 10 to about 15. Desirably, the HLB value of the alkyl glycosides for use in the invention is at least about 12, and more preferably about 12 to about 14.

The generally known property of alkyl glycosides is their excellent surface tension reducing capacity, and their wetting and dispersing properties. Alkyl polyglycosides can be prepared by conventional methods. For example, U.S. Patent Nos. 5,527,892 and 5,770,543, the disclosure of which is incorporated herein by reference, disclose alkyl polyglycosides and / or methods for their preparation. Since alkyl polygylcosides are derived from carbohydrates and fatty alcohols, said compounds are readily biodegradable.

In one embodiment, the absorbent means comprises a liquid pervious cover layer which typically comprises at least about 3 wt. % and not more than about 20 wt. alkyl polyglycoside, and even more desirable when

contains about 6 to about 10 wt. alkylpolyglycoside. A suitable example of an absorbent article is a menstrual tampon containing a liquid-permeable cover comprising an alkyl polyglycoside. Typically, such a tampon comprises a nonwoven covering layer of fibers of a hydrophobic polymeric material, for example a layer of nonwoven polypropylene, wherein the outside of the fibers is coated with an alkyl polyglycoside.

In another embodiment of the invention, the alkyl polyglycoside is formulated into a composition comprising a pharmaceutically acceptable carrier. Said composition typically comprises at least about 0.01% (w / v) alkyl polyglycoside and desirably when it comprises at least about 0.4% (w / v) alkyl polyglycoside (based on the total weight of the composition). Generally, the composition comprises no more than about 0.3% (w / v) alkyl polyglycoside. Particularly suitable vaginal cleansing compositions contain at least about 0.25 mmol, desirably when the content does not exceed about 5 mmol and more preferably contains about 0.5 to 3 mmol of alkyl polyglycoside. Compositions typically containing about 1 to 2 mmol of alkyl polyglycoside are used in the methods of the invention.

Said alkyl polyglycoside drug composition may contain other additives as appropriate for the desired use as long as they have no significant adverse effect on the activity of the alkyl polyglycoside. Examples of said additives include other conventional surfactants such as ethoxylated hydrocarbons or ionic surfactants, or other wettability enhancers such as low molecular weight alcohols. As already mentioned, the composition of the invention is desirable to be applied as a high solids composition, preferably containing 80% or less of solvent or water, to minimize desiccation and associated costs and undesirable effects. The drug composition may be administered in varying amounts depending on the desired results and the type of administration. In applications where the composition is applied, for example, to a diaper, effective results are obtained by using the composition in an amount corresponding to about 5% to 20% solids based on the dry weight of the fabric, with an addition range of about 6% to 10% both in terms of price and performance.

A further embodiment of the invention relates to a non-absorbent product comprising a coating which typically comprises at least about 3% by weight, preferably an amount not exceeding about 16% by weight, and even more preferably about 5 to about 10% by weight. alkyl polyglycoside (in weight% as added amount). A suitable example of such a non-absorbent product is a pouch having an alkylpolyglycoside-containing coating. Typically, such a dressing has a cover layer made of nonwoven fibers of a hydrophobic polymeric material such as a cover made of a nonwoven polypropylene fabric wherein the outer surface of the fibers is coated with an alkyl polyglycoside. The term tiling used in this specification means a tiling used to apply pressure or to press against a particular part of the body.

Fibers suitable for making the absorbent compositions of the present invention can be prepared, for example, by meltblown or extruded spinning, including bicomponent, biconstitution or blended polymer fibers known in the art. In these methods, an extruder is generally used to introduce molten thermoplastic polymer into a spinneret wherein the polymer is spun into fibers which may be staple-length fibers or longer fibers. The fibers are then drawn, usually pneumatically, and the fibers are fed to a web or web. The obtained fibers produced by the above spinning methods are typically the microfibers described above.

As mentioned above, said nonwoven may be a bonded nonwoven made by carding. The carded nonwoven fabrics are prepared from staple fibers, which are usually supplied in packages. The bale is placed in a screed where the fibers are loosened. Then, the fibers are fed to a carding or carding unit where the staple fibers are further loosened and arranged in the machine direction, generating machine-oriented fibers forming the fibrous nonwoven structure. After the structure has been prepared, it is then joined by one or more of the known bonding methods. One method is powder bonding, which involves dispersing the powdered adhesive through the structure and then activating it, usually by heating the structure and the adhesive with hot air. Another suitable bonding method is structural bonding, wherein the fiber bonding is performed on calender rollers or ultrasonic equipment, usually at localized bonding points, although the structure can be bonded over the entire surface if desired. Another suitable bonding method, especially when using bicomponent staple fibers, is through air passage.

The absorbent compositions of the present invention comprise an effective amount of an inhibitory alkylpolyglycoside to allow significant inhibition of exoprotein formation such as TSST-1 when an absorbent such as a menstrual tampon or a sanitary napkin is exposed to Gram positive bacteria. When the alkylpolyglycoside compound forms part of 1

% of the absorbent or absorbent composition, to effectively reduce the formation of exoproteins, at least about 0.005 mmol of alkyl polyglycosides per gram of absorbent can be effective.

Preferably, one gram of absorbent contains at least about 0.05 mmol of alkyl polyglycosides, and even more preferably one gram of absorbent contains about 0.1 mmol to about 1.0 mmol of alkyl polyglycosides. Although the term compound is used in the singular, it will be apparent to those skilled in the art that the term plural is also meant. That is, the absorbent composition may comprise more than one alkyl polyglycoside compound.

In a non-absorbent agent, it is generally not necessary to impregnate the entire body with an inhibitory agent. In many cases, optimum results, both economically and functionally, can be obtained by concentrating the inhibitory agent on or near the outer surface where it is most effective in use.

A material suitable for use as an absorbent in the absorbent compositions described in this application comprises a nonwoven structure consisting of bicomponent sheathed polyethylene / polypropylene core staple fibers of about. 38 mm. Said bicomponent fibers are commercially available from Chisso Corporation as supplied by the manufacturer. Said staple fibers may be first processed in a disintegrating machine and then mixed homogeneously and further processed by carding into a web at a linear speed of 15 meters per minute (about 50 feet per minute). After the web has been formed, it can be further processed by joining by air passage (in a drum device) at an air temperature of about 131 ° C. A typical residence time in the coupling device is between about 3 to about 4.5 seconds. The resulting structure having a basis weight of about 100 g / m ² and a density of about 0.06 g / cm ³ can then be wound onto

9

9 9 cylinder.

Other materials suitable for use as absorbents include natural hydrophilic and / or synthetic fibers. For example, a material made of a blend of cotton and rayon fibers is an absorbent material suitable for making all or part of an absorbent or absorbent such as a menstrual tampon and a sanitary napkin.

The alkyl polyglycoside drug composition used to prepare the absorbent compositions of the invention may contain other additives as appropriate for the desired use, provided they do not have a significant adverse effect on the activity of the alkyl polyglycoside. Examples of said additives include other conventional surfactants such as ethoxylated hydrocarbons or ionic surfactants, or other wettability enhancers such as low molecular weight alcohols. As already mentioned, the composition of the invention is desirable to be applied as a high solids composition, preferably containing 80% or less of solvent or water, to minimize desiccation and associated costs and undesirable effects. The drug composition may be administered in varying amounts depending on the desired results and the type of administration. In applications where the composition is applied, for example, to a sanitary napkin, effective results are obtained by using the composition in an amount corresponding to about 5% to 20% solids on dry fabric basis, with an addition range of about 6% to 10% both in terms of price and performance. It will also be apparent to those skilled in the art that the methods of the invention can treat multiple types of substrates, including nonwovens such as meltblown meltblown meltblown, carded and other meltblown webs, as well as woven structures and even films and the like where it is desirable to improve fluid distribution. It will also be apparent to those skilled in the art that some alkyl polyglycosides can be used as internal additives, i.e., they can be added to the polymer melt directly or in a concentrated form. After the fibers have been prepared, the additives may migrate to the fiber surface and impart the desired effect to the fiber. Further description regarding internal additives is given, for example, in U.S. Patent No. 5,540,979, the disclosure of which is incorporated herein by reference.

The content of alkyl polyglycoside is generally at least about 3 wt. % and more usually about 6 to 10 wt. % by weight, expressed in wt. added to the weight of the outer layer of the non-absorbent substrate. In some cases, it may be desirable to use higher amounts of alkyl polyglycosides, e.g., up to about 20 wt. in an amount corresponding to the added amount relative to the weight of the outer layer. For incontinence compositions, for example, it is possible to achieve effective results using alkyl polyglycoside solids in the range of about 5% to about 15% calculated as an added amount based on the weight of the outer layer. The term added amount in% wt. means the amount of the amount of alkyl polyglycoside used, expressed as a percentage of the dry weight of the uncoated substrate. Accordingly, the addition of 10 wt. as an added amount of 9.1 wt. calculated on the total weight of the coated substrate (10/110 = 9.1). Unless otherwise indicated, all data relating to the amount of alkyl polyglycoside introduced onto the substrate is given as an added amount in% by weight. However, the abovementioned expression of the amounts does not apply to the masses of alkyl polyglycosides which are part of the liquid compositions, the amounts indicated being in mmol% or% by weight. relative to the total mixture.

The compositions may be applied to the absorbent article by conventional means suitable for applying the inhibitory agent to the desired absorbent article. For example, the menstrual tampon in the liner may be directly dipped in a liquid bath containing said composition and then, if necessary, air dried to remove any volatile solvents. For a tampon that is compressed, it is best to perform impregnation prior to compression. Compositions upon incorporation on and / or into the tampon may be volatile, may have free adherence to the tampon, be bonded, or may be any combination of the above properties. The term volatile as used herein means that the composition may migrate through the tampon. For example, the alkyl polyglycoside may be mixed with a polymeric material to be processed into a component of the absorbent composition.

Alternatively, the alkyl polyglycoside containing solution may be applied directly to the individual layer of material prior to incorporation into an article of manufacture such as an absorbent article. For example, an aqueous solution of an alkyl polyglycoside may be applied by spraying onto the surface of a liquid-permeable cover layer or onto an absorbent material to be incorporated into the absorbent composition. This can be done either during the production of the material or during the assembly process in which said material is assembled onto the absorbent article to be produced.

Non-woven structures coated with alkyl polyglycoside can be prepared by conventional methods. The alkyl polyglycoside can be applied to one or both sides of the structure that is displaced. It will be apparent to those skilled in the art that such an application may be accomplished by in-line processing or in a separate, off-line stage. Structure such as nonwoven

The spinning fabric with extrusion or blow molding can be guided. directly through the support rollers to a surface treatment unit in which the rotary spray head is sprayable on one side of the structure. Optionally, the coating unit may comprise rotary spray heads to apply the alkyl polyglycoside to the opposite side of the structure. Each coating unit includes a spray fluid supply from a reservoir. The treated structure can then be dried, if necessary, by passing through drying drums or other drying means and wound or further processed for the intended use. It is also possible to use alternative drying devices such as driers, circulating air driers, infrared driers, fans and the like.

An example of a typical absorbent composition is an alkylpolyglycoside containing menstrual tampon. The alkyl polyglycoside may be incorporated into the tampon absorbent and / or onto the topsheet or tampon sheath. Alkylpolyglycoside containing swabs such as Glucopon 220 coated on a coating are particularly useful for inhibiting the formation of bacterial exoproteins by Gram-positive bacteria such as S. aureus.

The inhibitory alkyl polyglycoside composition may further comprise one or more commonly used, pharmaceutically acceptable and compatible carriers suitable for the application. The carrier may co-participate in dissolving or suspending the ingredients of the composition. As carriers suitable for use according to the invention, it is therefore possible to use carriers generally known for use in cosmetics and medicine, which are used as bases for ointments, lotions, creams, healing ointments, aerosols, suppositories, gels and the like. A suitable carrier may contain alcohols and surfactants.

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The compositions may be applied to non-absorbent compositions by conventional means suitable for applying the inhibitory composition to the desired composition. For example, the composition may be directly immersed in a liquid bath containing said composition and, if necessary, air dried to remove any volatile solvents. The compositions, when incorporated into and / or into the tampon material, may be volatile, free of adherence, bonded, or may be any combination of these properties. As used herein, the term volatile means that the composition may migrate through the material. For example, the alkyl polyglycoside may be mixed with a polymeric material to be processed into a component contained in the absorbent or non-absorbent product.

Alternatively, the alkyl polyglycoside containing solution may be applied directly to the individual layer of material prior to incorporation into the article of manufacture as a non-absorbent. For example, an aqueous solution containing an alkyl polyglycoside may be sprayed onto the surface of a layer of material to be incorporated into a non-absorbent product. This can be done during the production of said layer or during the assembly process in which said material is assembled to the final desired product.

Examples of typical personal hygiene products include incontinence or contraceptive products that contain alkyl polyglycosides. The alkyl polyglycoside may be incorporated into the outer layer or onto the outer layer of the composition. Compositions comprising an alkylpolyglycoside such as Glucopon 220 introduced on the outer layer are particularly useful for inhibiting the formation of bacterial exoproteins by gram positive bacteria such as S. aureus.

The following examples serve to further illustrate the invention and to help those skilled in the art to use the invention. However, these examples do not limit the scope of the invention in any way.

DETAILED DESCRIPTION OF THE INVENTION

Example A

The effect of Glucopon 220 on S. aureus growth and TSST-1 production was evaluated by introducing this compound at the desired concentrations expressed in millimoles / milliliters (millimolar concentrations are hereinafter referred to as mM) in 100 ml of culture medium placed in a sterile culture flask. 500 ml Corning fleaker ™.

The culture broth is prepared as follows: Dissolve 37 g of brain and heart culture medium (BHI) in 880 ml of distilled water and sterilize. BHI medium is commercially available from Difco ™ Laboratories, Becton Dickinson Microbiology Sysrems, Cockeysvi11e, MD 21030-0243. Said BHI medium is supplemented with 100 ml fetal bovine serum (FBS), which is commercially available from Sigma Chemical Company, P.O.Box 14508, St. Louis, MO 63178-9916. To the BHI-FBS mixture was then added 10 mL of sterile 0.021 mol / L magnesium chloride hexahydrate (Sigma Chemical Company). 10 ml of sterile 0.027 mol / L L-glutamine solution (Sigma Chemical Company) are then added to the BHI-FBS mixture.

Glucopon 220 is added directly to the culture broth, sterilized and further diluted with sterile broth to the desired final concentrations.

• · · ·

The inoculum for the inoculum of Glucopon 220-containing culture broth is prepared as follows: S.aureus MN8 is spotted on a plate containing tryptic soy agar (TSA; Difco Laboratories) and incubated at 35 ° C. The test organism in this embodiment of 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 colonies were harvested with a sterile inoculation loop and used to inoculate 10 ml of culture broth. The tube containing the inoculated culture broth is incubated in an air atmosphere at 35 ° C. After 24 hours, the culture is removed from the incubator and mixed on an S / P vortex mixer. 0.5 ml of the above 24-hour culture was used to inoculate 10 ml of culture broth introduced into a second tube and the broth was incubated in an atmosphere of air at 35 ° C. After 24 hours of incubation, the culture is removed from the incubator and mixed thoroughly on an S / P vortex mixer. The optical density of the cultured liquid was determined on a microplate evaluation device (Bio-Tek Instruments, Model EL309, Box 998, Winooski, Vermont 05404-0998). The amount of inoculum required to obtain 5.10 ⁶ CFU (number of colony forming units) / ml is determined using a predetermined standard curve.

Flasks containing culture media both without Glucopon 220 (control samples) and media containing different concentrations of Glucopon 220 were used in the experiment. The contents of each flask were inoculated with the amount of inoculum determined above. The flasks are sealed with sterile aluminum foil and incubated at 37 ° C in an atmosphere of air in a Lab-Line laboratory water bath with orbital motion of 180 rpm. The LaB-Line bath was obtained in this case from VWE Scientific Products, 1430 Waukegan Road, McGaw Park, IL 60085. Five milliliters were removed from each flask at the required time intervals to determine the optical density of the cultured fluid. The number of colony forming units of S.aureus microbes is determined in the culture fluid using standard plate read methods.

After 24 hours of incubation, the experiment was repeated using fresh medium. However, in this case, the aliquot obtained from the 24-hour culture flask containing the corresponding amount of Glucopon 220 is used as the inoculum. The method described above is used to determine the amount of the corresponding inoculum containing 5.10 ⁶ CFU / ml. For example, a S. aureus culture obtained in 2 mM Glucopon 220 is used as an inoculum in an appropriate amount to inoculate fresh medium containing 2 mM Glucopon 220. The concentrations of Glucopon 220 used in this example included concentrations of 20, 10, 4, 2, 1 and 0.5. mM. No microbial growth was observed in the presence of 10 and 20 mM Glucopon 220. No growth was observed up to 26 hours after inoculation, even at a concentration of 4 mM Glucopon 220, and therefore no re-inoculation into fresh medium was performed after the first 24 hours of incubation.

Of the remaining cultured fluid, 5 ml was processed for TSST-1 determination as follows: The fluid was centrifuged for 15 minutes at 2-10 ° C at 2500 rpm. The supernatant was sterilized by filtration through an Autovial® filter for use without a 2 µm pore syringe (Whatman Inc, Clifton, NJ). The resulting liquid is frozen in a Fisherbrand ^R 1.2 x 75 polystyrene culture tube, Fisher Scientific, 585 Alpha Drive, Pittsburgh, PA 15328.

The amount of TSST-1 in ml was determined by a non-competitive sandwich enzyme immunoassay (ELISA). Samples

9 •

cultured fluids as well as reference standard TSST-1 were analyzed in triplicate. The following assay method was used: four necessary reagents, rabbit polyclonal anti-TSST-1 IgG (# LTI-101), rabbit polyclonal anti-TSST-1 IgG conjugated to horseradish peroxidase (# LTC-101), TSST-1 (#TT-606) and normal rabbit serum (NRS), devised if free from anti-TSST-1 (#NRS-10), were obtained from Toxin Technology Inc., 7165 Curtiss Avenue, Sarasota, FL 34231. 10 με / ml solution of rabbit polyclonal anti-TSST-1 IgG in phosphate buffered saline (PBS) pH 7.4. Said PBS is prepared from 0.016 molar NaH 2 PO 4, 0.004 molar NaH 2 PO 4 · H 2 O, 0.003 molar KCl and 0.137 molar NaCl, all of which are available from Sigma Chemical Company. 100 μΐ of polyclonal rabbit anti-TSST-1 IgG solution is pipetted into the wells of polystyrene microplates, catalog number 439454 from Nunc-Denmark. Plates were coated by incubation overnight at room temperature. Unbound antitoxin is removed by dewatering to dryness.

TSST-1 was concentrated to 10 ng / ml in PBS with phosphate buffered saline (pH 7.4) containing 0.05% (v / v) Tween-20 (PBS-Tween) available from Sigma Chemical Company and 1 % NRS (v / v) and then the TSST-1 solution is incubated at. 4 OC overnight. Test samples were combined with 1% NRS (v / v) and incubated overnight at 4 ° C.

Pipette 100 μΐ of a 1% (w / v) solution of sodium casein in PBS (Sigma Chemical Company) into wells of polystyrene microplates, cover plates and incubate for one hour at 35 ° C. Unbound BSA is removed by washing three times with PBS-Tween. Pipette TSST-1 (10 ng / ml) with NES, NES-treated test samples and reagent-containing control samples in a volume of 200 μΐ into the appropriate wells of the first and seventh columns of the plate. Add 100 μΐ PBS-Tween to the remaining wells. The TSST-1 reference standard and test samples are then diluted 5-fold successively into PBS-Tween by transferring 100 μΐ from well to well. Prior to transfer, samples are always mixed by repeated aspiration and expression. This is followed by incubation for 1.5 h at 35 ° C, followed by a 5-fold wash with PBS-T and a 3-fold wash with distilled water to remove unbound toxin.

Dilute rabbit polyclonal anti-TSST-1 IgG conjugated to horseradish peroxidase according to the manufacturer's instructions and add 50 μΐ to each well of the microtiter plate, except for well A-1, conjugate control well. The plates were overlapped and incubated for one hour at 35 ° C.

After incubation, the plates were washed five times with PBS-Tween and three times with distilled water. After washing, 100 μΐ of horseradish peroxidase substrate buffer containing 5 mg o-phenylenediamine and 5 μΐ of 30% hydrogen peroxide (both available from Sigma Chemical Company) in 11 ml citrate buffer pH 5.5 is added to the wells. The citrate buffer is prepared from 0.012 molar anhydrous citric acid and 0.026 molar sodium hydrogen phosphate, both of which are available from Sigma Chemical Company. The plates were incubated for 15 minutes at 35 ° C. The reaction is terminated by adding 50 μΐ of a 5% sulfuric acid solution. The color intensity induced by the colorimetric reaction in each well is read in a BioTek Model EL309 microplate reader (OD 490 nm). The TSST-1 concentration in the test samples is determined from the regression equation derived for each reference toxin assay.

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9 9 9 9 9 9 9 9 9 99 99

The efficacy of Glucopon 220 as a TSST-1 production inhibiting agent is shown in Table 1 below. Results are reported in TSST-1 units (ng / OD units) and in percentage of TSST-1 content relative to untreated controls.

Table 1

Glucopon 220 (mM) FROM (10 h) TSST-1 (ng / OD j.) TSST-1 (% vs. control FROM (24 h) TSST-1 (ng / OD j.) TSST-1 (% vs. control first 24 h incubation 0 mM 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 1 1% 0.5 mM 7.45 143 76% 10.71 187 13 %

a second 24 h incubation

0 mM 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

Prototypes of tampons with coating layers treated with a variety of nonionic surfactants were subjected to the effects of microbes in a laboratory to determine the effects of surface treatment on the formation of TSST-1 microbes.

Staphylococcus aureus.

The liner was made by coating a commercially available 0.4 axis (13.56 g / m ² ) polypropylene nonwoven liner. Surface treatment was accomplished by diluting the surfactant to the desired concentration with purified water and applying the solution to the nonwoven by a Butterworth applicator. The amount of solution applied was the deposition pressure and material feed rate.

The coated topsheet was used to prepare a prototype tampon containing an absorbent layer composed of a blend of cotton fibers and rayon. An uncompressed absorbent layer made of cotton and rayon fibers was covered with a treated nonwoven liner. The uncompressed layer was then provided with a binder thread hole. The absorbent uncompressed layer and the cover layer were then drawn through the thread and the layers were joined through the two layers and the fabricated composition was subjected to compression and then introduced into a tampon applicator.

The amount of various surface treatment agents added was determined by the weight of the extractables. Corrections were made to the extractable component values of the untreated liner, the extraction efficiency of the particular surfactant, and the solids content of the surfactant. Three samples were taken from the treated nonwoven liner and the extraction efficiency of three experiments was calculated for one added amount of each surfactant.

As control samples, model samples were prepared using untreated nonwoven liner and reference samples of various surfactants.

• 9 ····

The model samples were treated by extraction under the same conditions as the corresponding coated coatings.

The tampon prototypes to be tested were randomly selected from each group of prototypes having different types of coatings. Each tampon prototype was gripped with sterile forceps. The thread was cut with sterile scissors and the swab was placed in a sterile polystyrene tube with a stopper connecting end down.

Each tampon was then inoculated with 10.5 ml of inoculum medium containing 5.10 ⁶ CFU / ml S.aureus MN8 (the strain was obtained from Dr. Pat Schlievert, Department of Microbiology, University of Minnesota Medical School, Minneapolis, MN). After incubation for 24 hours at 35 ° C in stoppered tubes, the swabs were placed in sterile digestive bags to which sterile fluid was added. The liquid swabs were then left in the digestive bag. Fluid samples were then removed from the bag for sterile testing in a sterile manner.

The plate count samples were processed by vortexing, pipetting a 5 ml sample and placing a 5 ml sample in a new, 50 ml sterile centrifuge tube. Then, the sample was sonicated in a Virtis Virsonic 475 Sonicator for 15 seconds at 80 output power. After ultrasonic treatment of all samples, the number of colony forming units in µm was determined by standard plate method.

Determination of TSST-1 concentration

Five milliliters of cultured fluid was processed for analysis for TSST-1 content as follows: fluid in

The cultivation was centrifuged at 4 ° C and 9000 rpm for 5 minutes. The supernatant is then sterilized by filtration through a 0.45 µm filter and frozen at -70 ° C in two aliquots in 1.5 ml freeze flasks fitted with a screw cap.

The amount of TSST-1 in ml was determined by a non-competitive sandwich enzyme immunoassay (ELISA). The cultured fluid and reference standard TSST-1 samples were analyzed in triplicate. The following assay method was used: four necessary reagents, rabbit polyclonal anti-TSST-1 IgG (# LTI-101), rabbit polyclonal anti-TSST-1 IgG conjugated to horseradish peroxidase (# LTC-101), TSST-1 (#TT-606) and normal rabbit serum (NPS), devised as free of anti-TSST-1 (#NRS-10), were obtained from Toxin Technology Inc., 7165 Curtiss Avenue, Sarasota, FL 34231. Seventy-two μΐ The rabbit polyclonal anti-TSST-1 IgG (# LTI-101) is approximately diluted to have an absorbance at a 1: 100 dilution. at 205 nm 0.4. The resulting mixture was added to 6.5 ml of 0.5 molar carbonate buffer, pH 9.6, and 100 µΐ of the obtained solution was pipetted into the wells of polystyrene microplates, catalog number 439454 from Nunc-Denmark. The plates were then covered and incubated overnight at 37 ° C. Unbound antitoxin is removed by washing four times with phosphate buffered saline (pH 7.2) (0.016 molar NaHPCU and 0.9% [w / v] NaCl, both components available from Sigma Chemical Company) containing 0.5% [ v / v] Tween 20 (PBS-Tween), also available from Sigma Chemical Company, where washing is performed on an automated plate washer. Then, 100 μΐ of a 1% w / v solution of Bovine Serum Albumin (BSA), fraction V, is applied to the plates in the 0.5 molar carbonate buffer described above. BSA fraction V is available from Sigma Chemical Company. then cover the plates

And incubated for 1 hour at 37 ° C. Unbound BSA is removed by washing six times with 250 μΐ PBS-Tween. The test samples are then treated with normal rabbit serum for 15 minutes (final concentration 10% [v / v]. The TSST-1 reference standard is gradually diluted to a concentration of 1-20 ng / ml in PBS-Tween and the test samples treated with NRS are Gradually dilute into PBS-Tween so that the final concentration of TSST-1 is between 1-20 ng and 100 μΐ aliquots of the standard and the test samples are pipetted into appropriate wells, then incubated for two hours at 37 ° C and then washed four times with 250 ml of PBS-Tween to remove unbound toxin The rabbit polyclonal anti-TSST-1 IgG conjugated to horseradish peroxidase is diluted according to the manufacturer's instructions Final dilution of the conjugate is determined by performing a standard TSST-1 dilution with undiluted conjugate at 1: 2 and 1 dilutions. The dilution giving the results that is most comparable to that of the previous conjugate used shall be selected. The plates are covered and incubated for one hour at 37 ° C.

After incubation, the plates are washed six times with 250 μΐ PBS-Tween and three times with water. After washing, the wells are treated with 100 μΐ of a horseradish peroxidase substrate solution containing said solution containing sodium citrate (0.015 molar) (pH = 4), 2,2'-azino-bis (3-ethylbenzthiazoline-6-sulfonic acid) diammonium salt. (0.6 millimolar) and 0.009% (v / v) hydrogen peroxide, all of which are available from Sigma Chemical Company. The color intensity in each well is then measured over time using a reading device, a BioTek Model EL340 Microplate reader (OD 405), and Kineticalc ^R software available from Biotek Instruments Inc. The TSST-1 concentrations in the test samples are derived for each determination from the reference toxin regression equations.

The efficacy of Glucopon 220 as an inhibitor of TSST-1 production is shown in Table II below.

Table II

Surface treatment Solids content TSST-1 Final components (% w / w) (ng / ml) Count [S.aureus] x JO ⁹ (CFU / ml)

Laureth-4 7% 531.8 4, 57 Laureth-5 PPG-5 18% 609.2 3, 82 Glucopon 220 3% 554.8 6, 41 Glucopon 220 14% 327.5 6, 99 Steareth-2 8% 680.7 5, 76

Example C - suction properties

By applying a solution containing the indicated amount (in terms of solids content) of the selected nonionic surfactant to the polypropylene nonwoven structure (0.4 axis, i.e. 13.6 g / m ² ), a coating material similar to that used to prepare the tampon is prepared. The above solutions are prepared in HPLC grade water, except when using Steareth-2, which is dissolved in HPLC grade water containing 3 wt. hexanol. The nonwoven is then coated at a feed rate of 75 fpm (22.9 m / min). The material sample is then dried (drying drum temperature 107.2 ° C) and cut into lengths of 4 or 8 inches (10.16 or 20.3 cm) before use. Table III below lists the following: · tabulce · · uvedené uvedené uvedené uvedené uvedené uvedené uvedené uvedené uvedené

the concentration of the solutions used, the amount of wetness and the pressures on the coating rollers of the covering material in various ways.

used for nonwoven impregnation

Surfactant

Table III

Targeted amount for wet impregnation (wt%)

Pressure on application rollers (psi), [kPa]

3% Glucopon 220 100 ALIGN! % 7 [48,3] 12% Glucopon 220 100 ALIGN! % 8 [55,1] Laureth-4 100 ALIGN! % 8 [55,1] 8.7% PPG Laureth-4 150 % 4 [27,6] 3% Steareth-2 200 % 3 [20,7]

An absorbent belt is prepared from a 2/3 rayon blend and 1/3 cotton blend and cut into 4 inch (10.16 cm) lengths. The aforementioned 4 inch long treated nonwoven webs are placed on the said rayon / cotton absorbent webs. Each sample is then subjected to three inserts of 0.25 ml low viscosity artificial menstrual fluid, similar to that described in WO 98/09662. The inserts were applied at a rate of 2.5 ml / min at three minute intervals. For each insult, the soak time (in seconds) required to allow the menstrual fluid to soak into the sample overlay was recorded. The results obtained are shown below in Table IV.

· · · * * * * * * * * * * * * * * * * * * * * * *

Table IV

Surface Concentration Soaking time (s) active (% by weight) first second third

means inzult Glucopon 220 3 % 6.97 8.87 10.84 Glucopon 220 6 % 6.85 8.73 9.70 Glucopon 220 9 % 6.78 7.75 8.13 Glucopon 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 Laureth-5 PPG-5 3 ° / /O 6.53 7.47 7.93 Laureth-5 PPG-5 6 % 6.84 8.18 8.84 Laureth-5 PPG-5 9 % 7.10 8.39 8.82 Laureth-5 PPG-5 13 % 6.96 7.79 8.07 Steareth-2 3 ° / / 0 33.42 8.61 9.38 Steareth-2 6 % 7.13 8.37 9.21 Steareth-2 (hexanol) 6 % 7.81 8.38 10.79

Example D - distribution test

By spraying a solution containing the indicated amount (in terms of the solids content) of the selected nonionic surfactant on the polypropylene nonwoven web with a planar surface area. A weight of 4 axes (13.6 g / m ² ) was prepared to cover material similar to that used to prepare the tampon (see description in Example C). Before use, the sample is dried in an oven and cut into 8 inch (20.3 cm) lengths. Prepare a ribbon-shaped absorbent made of blends of 2/3 rayon and 1/3 cotton, and cut the tape into 8 inch (20.3 cm) lengths.

The 8-inch treated material samples were weighed and placed one at a time on individual 8-inch artificial silk / cotton absorbent tapes. 5 ml of the low viscosity solution are then introduced onto the treated cover at a rate of 10 ml / h. The absorbent layer is then cut into 8 1 inch pieces and each sample is weighed to obtain a saturation profile of a particular treated sample. Fluid distribution is obtained by calculating the degree of saturation (amount of fluid absorbed) in each one-inch segment of a particular sample. For a given sample, it is then possible to determine the distribution profile by assigning each saturation segment to each other. The determined fluid distribution can be used to calculate the saturation degree (SR) for a given 8 inch absorbent strip. In the formula for calculating SR 1 below, each letter A to H means the amount of fluid absorbed in one single-plate segment of said eight-inch strip, wherein the segments are indicated alphabetically by letters (A-H) from one end of the strip to the other end.

SR = [(4 * A) + (4 * H)] / (D + E) + [(4 * A) + (4 * G)] / (D + E) + 2 * F)] / (D + E)

This method provides the highest values for a sample in which the fluid is distributed evenly over the entire 8 inch length of the test strip. Said ratio is calculated in the same way as the moment where the amount of fluid in each section is multiplied by the distance that the fluid has traveled by suction. This ratio is higher when the liquid is sucked into the furthest. Since weighing is used in the described method, the SR evaluation gives different values for samples of the same material of different length. For samples having a constant length, the sample having the highest SR value distributes the fluid most efficiently.

The saturation degree values defined above for each treated sample (by various nonionic surfactants, in amounts corresponding to the amounts added) are shown below in Table V. The results show no significant differences in any treatment with the nonionic surfactant as a function of the concentration of nonionic surfactant used. means. Therefore, yet another method was used to confirm these results obtained by the SR method. The mean and standard deviation for the eight segments were calculated. Then, the coefficient of variation (COV) was calculated for the eight segments. A COV of 0 means that the same amount of fluid has been absorbed in each of the eight segments, i.e., the fluid is perfectly distributed across the surface. While in the SR method, the higher the value, the better suction efficiency, while the COV-DSN test is the opposite.

51 • * · ·· · · • ·· ·· ·· · • · · • · · · • · · ··· · · • · · · ···

Table V Surface active Concentration Saturation COV-DSN means (% by weight) degree 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 Glucopon 220 3% 1.48 4.17 Glucopon 220 6% 1.48 4.17 Glucopon 220 9% 1.48 4.17 Glucopon 220 13 % 1.48 4.17 Laureth-5 PPG-5 3% 1.62 4.12 Laureth-5 PPG-5 6% 1.62 4.12 Laureth-5 PPG-5 9% 1.62 4.12 Laureth-5 PPG-5 13 % 1.62 4.12 Steareth-2 3% 1.06 4.18 Steareth-2 6% 1.62 4.18 Steareth-2 (hexanol) 6% 0.83 4.55

Example E

The effect of Glucopon 220 on S. aureus growth and alpha-toxin production (alpha-hemolysin) was evaluated by introducing this compound at the desired concentrations expressed in millimoles / milliliter (millimolar concentrations are hereinafter referred to as mM) into 100 ml of culture medium placed in sterile

4 4 4 4 4 4 4 44 44 4 4 4 444 4 4 4 4 4 4 4 4 4 ft

4 4444 4444

444 44 444 44 44 4 '4 Corning fleaker ™ 500 ml flask. Glucopon 220 was added directly to the culture medium, sterilized by filtration and diluted with sterile culture medium to the desired final concentrations.

The experiment was performed as described in Example A except that the microorganism used in the assay of this example, S.aureus RN6390, was obtained from Dr. Richard Novick, Skirhall Institute for Biomolecular Medicine, New York University Medical Center, New York, New York. Culture flasks containing culture medium without Glucopon 220 (control) or with different concentrations of Glucopon 220 were included in the experiment.

Each culture flask was inoculated with S, aureus as described in Example A. The flasks were then sealed with sterile aluminum foil and incubated for 24 hours in an air atmosphere at 35 ° C in a Lab-Line water bath with orbital movement at 180 rpm.

Then, 5 ml of cultured fluid was processed for alpha-hemolysin content analysis as follows. The culture flask fluid is adjusted to standard absorbance (1.0) and centrifuged for 15 minutes at 2-10 ° C at 2500 rpm.

The supernatant was clarified using an Autovial ^R 5 filter for use without a 0.2 µm pore syringe (Whatman Inc, Clifton, NJ). The resulting liquid was frozen at -20 ° C in a Fisherhrand ^R size culture tube. 12 x 75 mm, manufactured by Fisher Scientific, 585 Alpha Drive, Pittsburgh, PA 15328.

The amount of alpha-hemolysin is. determined by hemolytic assay using rabbit red blood cells. Was used

9 9 9 9

9

The following procedure is followed: defibrinated red rabbit blood cells (rrbc: Remel) are washed three times with Tris-salt buffer containing 50 mM Tris / Tris-HCl and 100 mM NaCl, pH 7.0. Centrifuge for 7 minutes at 800xg. The reagents used are available from Sigma Chemical Corporation. Said rrbc is suspended in 200 ml Tris-salt buffer at a concentration of 0.5%. The culture supernatant is diluted successively with culture medium. One part of the diluted sample is combined with 9 parts rrbc. All determinations are made in triplicate.

Negative controls (one part Tris-salt buffer for 9 parts rrbc) and positive controls (one part 10% SDS for 9 parts rrbc) were used as control samples for hemolysis. 10 control samples are prepared. All samples included in the assay are incubated at 37 ° C for 30 minutes and then centrifuged at 800xg for 10 minutes. The hemolysis content of test and control samples is determined on a BioTek Model EL309 Microplate Evaluation Instrument. Units of activity are expressed as reciprocal dilutions of each test sample giving 50% lysis.

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

Table VI

Glucopon 220 (mM) Number of units of alpha-hemolysin alpha-hemolysin (% relative to control) mM 1 mM 0.5 mM

2,2 4,4

0.0% 6.9% 13.8% ··· ··· · e · f · c · ♦ · * · 9 · 9 · 9 · 9 98 · »

Example F - Fluid distribution test in a swab

By the method described in Example B, tampon prototypes were prepared containing a porous cover layer coated with either 7 wt. of Laureth-4, 18 wt. % PPG-5 Laureth-5, wt. % Steareth-2 or 14 wt. Glucoponu 220.

The prepared tampon prototypes were practically used on a test basis and were then analyzed to determine the percentage of outer surface that was contaminated (cover layer) and contamination of the inner core (absorbent layer). A regression model using a critical point was used to estimate the percentage of contamination of the inner and outer areas of the tampon as a function of the impurity load in grams. In principle, in a critical point model, the results can be processed by regression analysis into two lines, the first showing the contaminated area's load dependence up to the critical point and the second showing the above-critical dependence.

The results are shown in Figures 1 and 2 and in Tables VI and VII below. Fig. 1 is a graph showing an estimate of the contaminated area in% as a function of the load in grams for internal contamination of prototypes with coating layers coated with different coatings. Fig. 2 is a graph showing an estimate of the contaminated area as a percentage of the load in grams for external contamination of prototypes with coatings coated with different coatings. The results presented in Tables VII and VIII show that Glucopon 220 promotes fluid distribution on both the outer surface and the inner core. The results obtained with Glucopon 220 when used to treat tampons are significantly better than those obtained with Steareth-2 and are comparable to those using Laureth-4 and PPG-5 Laureth-5 for the same purpose.

· · • «· · ·» »» »» »

Table VII

Surfactant

Critical point

Curve slope estimate (outer surface)

1st line 1 2nd line

7% Laureth-4 2,0 25.88 7.66 18 % PPG-5 Laureth-5 2.2 28.88 3.78 14 % Glucopon 220 1.6 31, 77 4.58 8% Steareth-2 2.6 20.33 2.65

Table VII

Surfactant Critical Estimation of the Slope of a Device Point Curve (Outer Surface)

1st line 2nd line

7% Laureth-4 2,0 25.88 7, 66 18 % PPG-5 Laureth-5 2.2 28.88 3, 78 14 % Glucopon 220 1.6 31.77 4, 58 8% Steareth-2 2.6 20.33 2, 65

Reference is made to various publications in the specification of the present application. These publications are fully incorporated into this disclosure by reference in order that the description of the state of the art to which the invention pertains is more complete.

In the above description, the invention has been described by various specific and illustrative embodiments and methods. However, it will be appreciated that several different variations and modifications may be made without departing from the spirit and scope of the invention.

Claims (6)

A menstrual tampon comprising absorbent material, characterized in that at least the outer layer of said tampon comprises an alkyl polyglycoside in an amount effective to inhibit the formation of exoproteins by Gram-positive bacteria upon exposure of said tampon to said bacteria. The tampon of claim 1, wherein the outer layer comprises an alkyl polyglycoside in an amount effective to inhibit the formation of TSST-1 by Staphylococcus aureus. The tampon of claim 1, wherein the outer layer comprises an alkyl polyglycoside in an amount effective to inhibit alpha toxin formation by Staphylococcus aureus. 4. that Tampon according to claim 1 the outer layer is a cover layer. c í se t and m, The tampon of claim 4, characterized in that the cover layer is liquid pervious. c í se t and m, 6. that Tampon according to claim 1 the outer layer being the outer absorbent part c í se layers t and m, 7. Tampon according to claim 1 c í se t and m, that the alkyl polyglycoside is contained throughout the absorption material 8. Tampon according to claim 1 c í se t and m, the alkyl polyglycoside contains an alkyl group of 8 to 18 carbon atoms. The tampon of claim 8, wherein the alkyl group is a straight chain alkyl group. 10. The tampon of claim 8, wherein the alkyl polyglycoside comprises an alkyl group of 8 to 14 carbon atoms. 11. The tampon of claim 8 wherein said alkyl polyglycoside is an alkyl polyglucoside. The tampon of claim 1, wherein the alkyl polyglycoside has an HLB value of 10 to 15. The tampon of claim 1, wherein the alkylpolyglycoside has the general formula: H- (Z) n -O-R wherein Z is a carbohydrate residue of 5 or 6 carbon atoms, n is a number from 1 to 6 and R is a straight chain alkyl group of 8 to 18 carbon atoms. 14. The tampon of claim 13 wherein R is a straight chain alkyl group of 8 to 14 carbon atoms. The tampon of claim 1, wherein the alkyl group has an average number of carbon atoms of 8 to 12. The tampon of claim 1, wherein the outer layer comprises at least 3 wt. And φ alkylpolyglycoside based on the dry weight of the outer layer. 17. The tampon of claim 1 wherein the outer layer comprises no more than about 20 wt. alkylpolyglycosides based on the dry weight of the outer layer. The tampon of claim 5, wherein the liquid pervious cover layer comprises from 6% to 10% by weight. alkylpolyglycosides based on the dry weight of the liquid pervious cover layer. 19. An absorbent article comprising a liquid pervious cover layer comprising at least 6 wt. alkylpolyglycosides based on the dry weight of the coating. 20. An absorbent composition according to claim 19 wherein said alkyl polyglycoside has an HLB value of 1.2 to 15. 21. An absorbent composition according to claim 19 wherein the alkyl polyglycoside comprises an alkyl chain having an average number of carbon atoms of 8 to 12. 22. An absorbent article according to claim 19 wherein the alkyl polyglycoside comprises a straight chain alkyl group of 8 to 12 carbon atoms. 23. A menstrual tampon comprising an absorbent material and a liquid pervious cover layer, wherein the cover layer comprises at least 3 wt. an alkylpolyglycoside based on the dry weight of the coating; and, 000 alkyl 0 glycolide has an HLB of 12 to 15 and the alkyl group has an average number of carbon atoms of 8 to 12. 24. The tampon of claim 23 wherein said alkyl polyglycoside comprises an alkyl group of 8 to 10 carbon atoms. 25. The tampon of claim 23 wherein the liquid-permeable cover layer is a porous nonwoven web. 26. The tampon of claim 25, wherein the nonwoven porous layer is made of hydrophobic polymer fibers. 27. The tampon of claim 26 wherein said alkyl polyglycoside is deposited on said fibers. 28. The tampon of claim 26 wherein said porous nonwoven layer is a nonwoven web made of polypropylene or polyethylene fibers or a mixture thereof. 29. A non-absorbent substrate comprising an alkyl polyglycoside in an amount effective to inhibit the formation of exoprotein by Gram-positive bacteria, wherein said alkyl polyglycoside comprises an alkyl group having an average carbon number of 8 to 14. 30. The substrate of claim 29 comprising an effective amount of an alkyl polyglycoside to inhibit the formation of TSST-1 by Staphylococcus aureus. A aa aaa a aa a a a a a a a a aaa aaa a a a aa a aa a aa a aaa a aaa a a a aa 31. The substrate of claim 29 comprising an effective amount of an alkyl polyglycoside to inhibit Staphylococcus aureus alpha-toxin production. 32. The substrate of claim 29, wherein the alkyl polyglycoside comprises an alkyl group of 8 to 18 carbon atoms. 33. The substrate of claim 29, wherein the alkyl group has a straight chain. 34. The substrate of claim 33, wherein the alkyl polyglycoside comprises an alkyl group of 8 to 14 carbon atoms. 35. The substrate of claim 29, wherein said alkyl polyglycoside is an alkyl polyglucoside. 36. The substrate of claim 29, wherein said alkyl polyglycoside has an HLB value of 10-15. The substrate of claim 29, wherein the alkyl polyglycoside has the general formula: H- (Z) _n -OR wherein Z is a carbohydrate residue of 5 or 6 carbon atoms, n is a number from 1 to 6 and R is a straight chain alkyl group of 8 to 18 carbon atoms. 38. The substrate of claim 37 wherein Z is a glycosyl residue. • 9 9 9 9 9999 9 ··· «« · · · · 39. The substrate of claim 29, wherein said substrate is a composition for use in female incontinence. 40. The substrate of claim 29, wherein said substrate is a contraceptive. 41. The substrate of claim 40, wherein said contraceptive is a barrier contraceptive. 42. The substrate of claim 40, wherein said contraceptive is a contraceptive tampon. 43. The substrate of claim 29, wherein said alkyl polyglycoside comprises an alkyl group having an average carbon number of 9 to 11. 44. The substrate of claim 29, wherein said alkyl polyglycoside comprises a straight chain alkyl group of 8 to 10 carbon atoms. 45. A non-absorbent absorbent comprising an alkyl polyglycoside in an amount effective to inhibit the formation of Stapbycoccus aureus. 46. The substrate of claim 45, wherein said alkyl polyglycoside has an HLB value of 10 to 15 and the alkyl group has an average number of carbon atoms of 8 to 12. 47. A non-absorbent adsorbent characterized in that it is 9 9999 9 9 9 9 9 It contains an alkyl polyglycoside in an amount effective to inhibit the formation of alpha-toxin by Staphylococcus aureus. 48. The substrate of claim 47, wherein said alkyl polyglycoside has an HLB value of 10 to 15 and the alkyl group has an average number of carbon atoms of 8 to 12. 49. A composition for inhibiting exoprotein formation by Gram-positive bacteria comprising an effective amount of an alkyl polyglycoside and a pharmaceutically acceptable carrier, wherein said alkyl polyglycoside comprises an alkyl group having an average carbon number of 8 to 14. The composition of claim. 49 comprising an alkyl polyglycoside in an amount effective to inhibit the formation of TSST-1 by Staphylococcus aureus. 51. The composition of claim 49 wherein said alkyl polyglycoside comprises a straight chain alkyl group. 52. The composition of claim 49 wherein said alkyl polyglycoside has an HLB value of at least 10. 53. The composition of claim 49 wherein said alkyl polyglycoside has the general formula: H- (Z) _n -OR wherein Z represents a saccharide residue of 5 or 6 carbon atoms, "n represents a number from. 1 to about 4 and R is a straight chain alkyl group of 8 to 14 carbon atoms. • · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · 54. The composition of claim 53 wherein: wherein Z is a glucosyl residue. 55. The composition of claim 49, wherein said alkyl polyglycoside has an HLB of 12 to 56. The composition of claim 49 wherein said alkyl polyglycoside comprises an alkyl group containing from 9 to 11 carbon atoms. 57. The composition of claim 49 wherein said composition is a vaginal cleansing composition. 58. The composition of claim 49 wherein said composition comprises from 0.25 mmol to 5 mmol of alkyl polyglycoside. 59. The composition of claim 49 wherein said alkyl polyglyside comprises a straight chain alkyl group of 8 to 10 carbon atoms. 60. The composition of claim 49 comprising an alkyl polyglycoside in an amount effective to inhibit Staphylococcus aureus alpha-toxin production. 61. A vaginal cleaning composition comprising 0.25 mmol to 5 mmol of an alkyl polyglycoside and a pharmaceutically acceptable carrier, wherein said alkyl polyglycoside has an HLB of at least 10 and comprises an alkyl group having an average carbon number of 8 to 12. 62. The composition of claim 61 wherein said alkyl polyglyside comprises an alkyl group. 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 99 99 99999 99 99 straight chain of 8 to 10 carbon atoms. 63. The composition of claim 61 wherein said alkyl polyglycoside has an HLB of 12-15. 64. A vaginal cleaning composition comprising an alkyl polyglycoside in an amount effective to inhibit the formation of TSST-1 by Staphylococcus aureus. 65. The composition of claim 64, wherein said alkyl polyglycoside has an HLB value of at least 10 and comprises an alkyl group having an average number of carbon atoms of 8 to 12. 66. A vaginal cleaning composition comprising an alkyl polyglycoside in an amount effective to inhibit Staphylococcus aureus alpha-toxin production. 67. The composition of claim 66 wherein said alkyl polyglycoside has an HLB of at least 10 and comprises an alkyl group having an average number of carbon atoms of 8 to 12. 68. A method for inhibiting exoprotein formation by Gram-positive bacteria, the method comprising: exposure of gram positive bacteria to an effective amount of an alkyl polyglycoside, wherein said alkyl polyglycoside contains an alkyl group having an average carbon number of 8 to 14 and has an HLB of at least 10. 69. The method of claim 68 wherein said Gram-positive bacteria is exposed to the composition 9 9 9. 9 9 9 9 9 9 9 9 9 9 99 ·· · 9 · 9 9 9 9 9 99 99 which comprises an alkyl polyglycoside and a pharmaceutically acceptable carrier. 70. The method of claim 68 wherein the Gram-positive bacteria is exposed to a non-absorbent substrate comprising said alkyl polyglycoside. 71. The process of claim 68 wherein said alkyl polyglycoside comprises an alkyl group of 8 to 14 carbon atoms. 72. The process of claim 68 wherein said alkyl polyglycoside has the general formula: H- (Z) n -O-R wherein Z is a carbohydrate residue of 5 or 6 carbon atoms, n is a number from 1 to about 4 and R is a straight chain alkyl group of 8 to 14 carbon atoms. 73. The method of claim 72 wherein Z is a glucosyl residue. 74. The method of claim 68 wherein said alkyl polyglycoside has an HLB of 12-15. 75. The method of claim 68 wherein said alkyl polyglycoside comprises a straight chain alkyl group. 76. The process of claim 68 wherein said alkyl polyglycoside comprises a straight chain alkyl group of 8 to 10 carbon atoms. 77. The process of claim 68 wherein said alkyl polyglycoside comprises an alkyl group having a chain having an average of 9 to 1.1 carbon atoms. 78. The method of claim 68 comprising exposing Staphylococcus aureus to a composition comprising an alkyl polyglycoside in an amount effective to inhibit TSST-1 production. 79. The method of claim 68 comprising contacting the Staphylococcus aureus with a composition comprising an alkyl polyglycoside in an amount effective to inhibit alpha-toxin production. 80. A method of inhibiting the formation of exoproteins by Gram-positive bacteria, the method comprising: contacting the Gram positive bacteria with a substrate comprising an effective amount of an alkyl polyglycoside, wherein said alkyl polyglycoside has an HLB of at least 10 and contains an alkyl group having an average carbon number of 8 to 14. 81. The method of claim 80 wherein said substrate is a non-absorbent material. 82. The method of claim 80 wherein said substrate is an absorbent material. by 83. The method of claim 82 wherein said absorbent material is an aforementioned personal hygiene product. · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · 84. The method of claim 83 wherein said personal hygiene composition is a feminine hygiene composition. 85. The method of claim 84, wherein said absorbent material is an absorbent product for use in healthcare. 86. A method for inhibiting the formation of exoproteins by Gram-positive bacteria, comprising: contacting an absorbent composition comprising an effective amount of an alkyl polyglycoside with said gram-positive bacteria, wherein said alkyl polyglycoside has an HLB value of 10 to 15 and comprises an alkyl group having an average carbon number of 8 to 14. 87. The method of claim 86 wherein said absorbent composition comprises a cover layer comprising at least 5 wt. alkylpolyglycosides calculated as added amount. 88. The method of claim 86 wherein said absorbent composition is a tampon comprising a cover layer which comprises an alkyl polyglycoside. 89. A method of preparing a tampon capable of inhibiting the formation of exoproteins by Gram-positive bacteria, the method comprising: processing a layer of porous nonwoven material made of a hydrophobic polymer with an alkylpolyglycoside into a material for use as a coating comprising at least 5 wt. alkyl polyglycosides calculated as an added amount, wherein said alkyl polyglycoside has an HLB value of 10 to 15 and contains an alkyl group having an average of 8 to 14 carbon atoms; and making said tampon such that at least a portion of the absorbent material is covered by the tampon covering layer material. ···· ·· Load weight (g) Estimated area affected in% • · ··· 1/2 —I cn ~ σ r ^- Estimated area affected in%