A method to inhibit the production of exoproteins from Gram positive bacteria, such as harmful proteins produced by Staphylococcus species, is described. The method is particularly useful to inhibit the production of TSST-1, alpha-toxin and/or enterotoxins A, B and C from Staphylococcus aureus bacteria. The method is based on exposing Gram positive bacteria to alkyl polyglycoside incorporated into an absorbent product. Alternate methods include bringing Gram positive bacteria into contact with the alkyl polyglycoside in other forms, e.g., when formulated with a pharmaceutically acceptable carrier or incorporated in or on a non-absorbent substrate. Typically, the alkyl polyglycoside has a hydrophilic/lipophilic balance (HLB) of at least about 10 and an alkyl group with an average of 8 to 14 carbon atoms.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Disposable absorbent articles which are suitable for use in the present method generally are particularly adapted to receive simple and/or complex body fluids. For purposes of discussion, the absorbent article specifically discussed herein is a catamenial tampon. However, it would be readily understood by persons skilled in the art that the present method may also employ other disposable absorbent articles wherein inhibition of exoproteins from Gram positive bacteria would be beneficial.

Specifically, catamenial tampons suitable for use in the present invention include an absorbent. The absorbent can be formed from fibers which are assembled into an absorbent sheet or ribbon. Alternatively, the absorbent can be formed from absorbent fibers which are assembled and compressed into a generally elongated and/or cylindrical configuration. The absorbent is desirably formed from cellulosic fibers, such as cotton and rayon. For example, the absorbent can be 100% cotton, 100% rayon, a blend of cotton and rayon fibers, or other materials known to be suitable for tampons.

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

The alkyl polyglycoside can generally be represented by the formula: H-(Z)n-O--R where "Z" is a saccharide residue having 5 or 6 carbon atoms, "n" is a number having a value between 1 and about 6, and "R" represents an alkyl group, typically having 8 to 18 carbon atoms. The "n" represents the average number of saccharide residues in a particular sample of alkyl polyglycoside. Although, as indicated above, the present alkyl polyglycosides can include an oligosaccharide, e.g., where "n" equals about 4 6, alkyl polyglycosides with a smaller average number of saccharide residues are commonly preferred. Typically, the present alkyl polyglycosides have an "n" which is no more than about 4 and, desirably no more than about 2. As defined herein, the term "alkyl polyglycoside" also encompasses alkyl monosaccharides, i.e., where "n" equals 1.

It will be understood that as referred to herein, an "alkyl polyglycoside" may consist of a single type of alkyl polyglycoside molecule or, as is typically the case, may include a mixture of different alkyl polyglycoside molecules. The different alkyl polyglycoside molecules may be isomeric and/or may be alkyl polyglycoside molecules with differing alkyl groups and/or saccharide portions. By the term "alkyl polyglycoside isomers," reference is meant to alkyl polyglycosides which, although including the same alkyl ether residues, may vary with respect to the location of the alkyl ether residue in the alkyl polyglycoside as well as isomers which differ with respect to the orientation of the functional groups about one or more chiral centers in the molecules. For example, an alkyl polyglycoside can include a mixture of molecules with saccharide portions which are mono, di- or oligosaccharides derived from more than one 6 carbon saccharide residue and where the mono-, di- or oligosaccharide has been etherified by reaction with a mixture of fatty alcohols of varying carbon chain length.

Where more than one saccharide residue is present on average per alkyl polyglycoside molecule (i.e., where "n" is greater than 1), the individual saccharide subunits within the same molecule may be identical or different. Where the individual subunits are not all identical, the order and distribution of subunits is typically random. This is not necessarily the case, e.g., where n=2 and the glycoside includes a specific disaccharide, such as sucrose or fructose. It will be understood that the alkyl polyglycoside may include a mixture of different alkyl polyglycoside molecules and/or a mixture of alkyl polyglycoside isomers. Generally, the present alkyl plyglycosides comprise a mixture of alkyl polyglycoside molecules having alkyl groups with varying chain lengths and include a distribution of mono-, di- and oligosaccharides. For example, the alkyl polyglycosides can include a distribution of mono-, di- and oligosaccharides made up of glycosyl residues. The "alkyl group" portion of the alkyl polyglycosides is generally a linear alkyl group (i.e., a straight chain alcohol residue), typically having an even number of carbon atoms. The present alkyl polyglycosides desirably include alkyl groups having 8 to 14 carbon atoms and/or where the average number of carbon atoms in the alkyl chain is 8 to 12 and, desirably, 9 to 11. One example of a suitable alkyl polyglycoside is a mixture of alkyl polyglycoside molecules with alkyl chains having 8 to 10 carbon atoms.

The alkyl polyglycosides can also be characterized in terms of their hydrophilic/lipophilic balance ("HLB"). This can be calculated based on their chemical structure using techniques well known to those skilled in the art. The HLB of the alkyl polyglycosides used in the present methods typically falls within the range of about 10 to about 15. Desirably, the present alkyl polyglycosides have an HLB of at least about 12 and, more desirably, about 12 to 14.

Alkyl polyglycosides in general are known to have excellent surface tension reduction, wetting and dispersant properties. Alkyl polyglycosides can be produced using conventional methodology. For example, U.S. Pat. Nos. 5,527,892 and 5,770,543, the disclosure of which is herein incorporated by reference, describe alkyl polyglycosides and/or methods for their preparation. Since alkyl polyglycosides are derived from saccharides and fatty alcohols, these compounds are readily biodegradable.

Commercially available examples of suitable alkyl polyglycosides include Glucopon 220, 225, 425, 600 and 625, all available from Henkel Corporation. These products are all mixtures of alkyl mono- and oligoglucopyranosides with alkyl groups based on fatty alcohols derived from coconut and/or palm kernel oil. Glucopon 220, 225 and 425 are examples of particularly suitable alkyl polyglycosides. Glucopon 220 is an alkyl polyglycoside which contains an average of 1.4 glucosyl residues per molecule and a mixture of 8 and 10 carbon alkyl groups (average carbons per alkyl chain--9.1). Glucopon 225 is a related alkyl polyglycoside with linear alkyl groups having 8 or 10 carbon atoms (average alkyl chain--9.1 carbon atoms) in the alkyl chain. Glucopon 425 includes a mixture of alkyl polyglycosides which individually include an alkyl group with 8, 10, 12, 14 or 16 carbon atoms (average alkyl chain--10.3 carbon atoms). Glucopon 600 includes a mixture of alkyl polyglycosides which individually include an alkyl group with 12, 14 or 16 carbon atoms (average alkyl chain 12.8 carbon atoms). Glucopon 625 includes a mixture of alkyl polyglycosides which individually include an alkyl group having 12, 14 or 18 carbon atoms (average alkyl chain 12.8 carbon atoms). Another example of a suitable commercially available alkyl polyglycoside is TL 2141, a Glucopon 220 analog available from ICI.

Vaginal tampons suitable for use in this invention are usually made of absorbent fibers, including natural and synthetic fibers, compressed into a unitary body of a size which may easily be inserted into the vaginal cavity. They are normally made in an elongated cylindrical form in order that they may have a sufficiently large body of material to provide the required absorbing capacity, but may be made in a variety of shapes. The tampon may or may not be compressed, although compressed types are now generally preferred. The tampon may be made of various fiber blends including both absorbent and nonabsorbent fibers, which may or may not have a suitable cover or wrapper. The cover or wrapper for absorbent products, such as tampons and sanitary napkins, is often made from a sheet of spunbonded fibers, e.g., a spunbond polypropylene sheet.

In one embodiment, the present absorbent product includes a porous cover sheet which typically contains at least about 3 wt. %, desirably no more than about 16 wt. % and, more desirably, about 5 to about 10 wt. % alkyl polyglycoside (as add-on wt. %). A suitable example of such an absorbent product is a catamenial tampon having a porous cover sheet which includes the alkyl polyglycoside. Typically, such a tampon would have a cover sheet formed from spunbond fibers of a hydrophobic polymeric material, e.g., a spunbond polypropylene cover layer, with the alkyl polyglycoside coated on the outside of the fibers. In another embodiment, the absorbent product can be a sanitary napkin which includes an absorbent distribution layer incorporating the alkyl polyglycoside. Sanitary napkins of this type would typically have an absorbent distribution layer which includes at least about 5 wt. % of the alkyl polyglycloside and desirably no more than about 15 wt. % of the alkyl polyglycoside (as add-on wt. %).

The fibers from which the present absorbent products are made may be produced, for example, by the meltblowing or spunbonding processes, including those producing bicomponent, biconstituent or polymer blend fibers which are well known in the art. These processes generally use an extruder to supply melted thermoplastic polymer to a spinneret where the polymer is fiberized to yield fibers which may be staple length or longer. The fibers are then drawn, usually pneumatically, and deposited on a moving foraminous mat or belt to form the nonwoven fabric. The fibers produced in the spunbond and meltblown processes are microfibers as defined above. The manufacture of spunbond and meltblown webs is discussed generally above.

As mentioned, the nonwoven also may be a bonded carded web. Bonded carded webs are made from staple fibers, which are usually purchased in bales. The bales are placed in a picker, which separates the fiber. Then, the fibers are sent through a combing or carding unit, which further breaks apart and aligns the staple fibers in the machine direction to form a generally machine direction-oriented fibrous nonwoven web. Once the web is formed, it then is bonded by one or more of several known bonding methods. One such bonding method is powder bonding, wherein a powdered adhesive is distributed through the web and then activated, usually by heating the web and adhesive with hot air. Another suitable bonding method is pattern bonding, wherein heated calendar rolls or ultrasonic bonding equipment are used to bond the fibers together, usually in a localized bond pattern, though the web can be bonded across its entire surface if so desired. Another suitable bonding method, particularly when using bicomponent staple fibers, is through-air bonding.

The present absorbent articles contain an effective amount of the inhibiting alkyl polyglycoside compound to substantially inhibit the formation of exoproteins such as TSST-1 when the absorbent product, such as a tampon or sanitary napkin, is exposed to Gram positive bacteria. Where the alkyl polyglycoside is present as part of an absorbent layer of an absorbent product, at least about 0.005 millimoles of alkyl polyglycoside compound per gram of an absorbent may be effective for reducing exoprotein production. Desirably, the product includes at least about 0.05 millimoles alkyl polyglycoside compound per gram of absorbent and, more desirably, about 0.1 millimoles per gram of absorbent to about 2.0 millimoles per gram of absorbent. Although "compound" is used in the singular, one skilled in the art would understand that it includes the plural. That is, the absorbent article can include more than one type of alkyl polyglycoside molecule.

Where the alkyl polyglycoside is formulated as a composition which includes a pharmaceutically acceptable carrier, the composition typically contains at least about 0.01% (wt/vol) and desirably at least about 0.04% (wt/vol) alkyl polyglycoside (based on the total weight of the formulation). Generally, the composition contains no more than about 0.3% (wt/vol) alkyl polyglycoside. Particularly suitable formulations for use in vaginal cleansing applications can contain at least about 0.25 mmol, desirably no more than about 5 mmol and, more desirably about 0.5 to 3 mmol of the alkyl polyglycoside. Formulations which include about 1 to 2 mmol of the alkyl polyglycoside are typically employed in the present methods.

It is generally not necessary to impregnate the entire absorbent body of an absorbent product, such as a tampon, with the inhibitory agent. Optimum results both economically and functionally, can often be obtained by concentrating the material on or near an outer surface where it will be most effective during use.

An exemplary absorbent material is a nonwoven web composed of 3.0 denier polyethylene 5 sheath/polypropylene core bicomponent staple fibers having a length of 38 millimeters. Such bicomponent fibers can be obtained from Chisso Corporation and are typically supplied with a vendor fiber finish. The staple fibers can be sent through an opener and uniformly mixed together before being carded into a web at a line speed of 15.24 meters per minute (50 feet per minute). Once the web is formed, it can be sent through a through-air bonder (drum type) with an air temperature of 131.degree. C. Typical dwell times within the bonder are between 3 and 4.5 seconds. The resultant web, which has a basis weight of 100 gsm and a density of 0.06 gm/cm.sup.3, can then be wound up on a roll.

Other suitable absorbent materials include materials which include hydrophilic natural and/or synthetic fibers. For example, a material formed from a mixture of cotton and rayon fibers is an absorbent material that can be used to form the absorbent core of absorbent products such as tampons and sanitary napkins.

The alkyl polyglycoside treating composition may contain other additives as appropriate for the desired result so long as they do not have a major detrimental effect on the activity of the alkyl polyglycoside. Examples of such additives include additional conventional surfactants, such as esters like cetiol (myreth-3-myrisate), ethoxylated hydrocarbons or ionic surfactants, or co-wetting aids such as low molecular weight alcohols. As mentioned, the composition is desirably applied from high solids, advantageously 80% or less solvent or water, so as to minimize drying and its attendant costs and deleterious effects. The treating composition may be applied in varying amounts depending on the desired results and application. For sanitary napkin distribution layer applications, for example, effective results are obtained within a range of about 5% to about 20 wt. % solids (add-on) based on the dry weight of the fabric, with a range of about 6 wt. % to 10% being desirable from the perspective of both cost and performance. As used herein, the term "add-on wt. %" refers to the amount of alkyl polyglycoside employed as a percentage of the dry weight of the uncoated substrate. Thus, 10 wt. % (add-on) is equal to 9.1 wt. % based on the total weight of the coated substrate (10/110=9.1). Unless otherwise explicitly stated herein, all amounts of alkyl polyglycoside on a substrate (absorbent or non-absorbent) are stated in terms of add-on wt. %, even though often simply referred to as "wt. %". This is not the case for amounts of alkyl polyglycoside present as part of a fluid composition, where the amounts are stated either in mmolar or % (w/v) as a percentage of the total composition. The actual amount can be readily selected by those skilled in the art based on the teaching of this application. For example, a catamenial tampon designed to be inserted into a body cavity and subsequently in intimate contact with the vaginal epithelium may require substantially less alkyl polyglycoside than an absorbent article worn exterior to the body.

As will be recognized by those skilled in the art, many substrate materials may be employed in the present method including nonwovens such as spunbond, meltblown, carded webs and others as well as woven webs and even films and the like where improved fluid distribution is desired. It will also be recognized by those skilled in this art that some alkyl polyglycoside may be used as internal additives, that is, added to the polymer melt directly or in a concentrate form. After fiber formation, such additives can migrate to the fiber surface and impart the desired effect. For further discussion of internal addition of additives, see for example, U.S. Pat. No. 5,540,979, the contents of which are incorporated herein by reference. The substrate basis weight is not critical and may vary widely depending on the application. For sanitary napkin distribution layer applications, spunbond and bonded carded webs are often used with basis weights generally in the range of from about 7 gsm to about 175 gsm.

The compositions may be applied to the absorbent article using conventional methods for applying an inhibitory agent to the desired absorbent article. For example, unitary tampons without separate wrappers, may be dipped directly into a liquid bath having the composite and then can be air dried, if necessary to remove any volatile solvents. For compressed tampons, impregnating any of its elements is best done before compressing. The compositions when incorporated on and/or into the tampon materials may be fugitive, loosely adhered, bound, or any combination thereof. As used herein the term "fugitive" means that the composition is capable of migrating through the tampon materials. For example, the alkyl polyglycoside may be blended together with a polymeric material that is to be processed into a component of an absorbent or non-absorbent product.

Alternatively, an alkyl polyglycoside containing solution may be applied directly onto an individual layer of material before it is incorporated into an article to be manufactured, such as an absorbent product. For example, an aqueous solution containing the alkyl polyglycoside can be sprayed onto the surface of a porous cover sheet or absorbent layer designed to be incorporated into an absorbent article. This can be done either during the production of the individual layer or during a fabrication process which incorporates the layer into the article being manufactured.

Nonwoven webs coated with alkyl polyglycoside can be prepared by conventional processes. For example, alkyl polyglycoside can be applied to one or both sides of a traveling web. It will be appreciated by those skilled in the art that the application can be carried out as an inline treatment or as a separate, offline treatment step. A web, such as a spunbond or meltblown nonwoven, can be directed over support rolls to a treating station including rotary spray heads for application to one side of the web. An optional treating station may include rotary spray heads to apply to alkyl polyglycoside to the opposite side of the web. Each treatment station generally receives a supply of treating liquid from a reservoir. The treated web may then be dried if needed by passing over dryer cans or other drying means and then wound as a roll or converted to the use for which it is intended. Alternative drying apparatus such as ovens, through air dryers, infra red dryers, air blowers, and the like may also be utilized.

One example of a representative absorbent article is a catamenial tampon which includes alkyl polyglycoside. The alkyl polyglycoside may be incorporated into the absorbent portion of the tampon and/or on or in a cover layer. Tampons with an alkyl polyglycoside, such as Glucopon 220, deposited on the cover layer are particularly suitable for inhibiting the production of bacterial exoproteins by Gram positive bacteria such as S. aureus.

The compositions of the present invention can be prepared and applied in other suitable forms, including without limitation, aqueous solutions, lotions, balms, gels, salves, ointments, boluses, suppositories, and the like. For example, the active component of the compositions of this invention can be formulated into a variety of formulations such as those employed in current commercial douche formulations, or in higher viscosity douches. The compositions of this invention may also contain preservatives. Compounds which can impart greater viscosity, such as propylene glycol, may also be added to the compositions of this invention. Generally, higher viscosity compositions are preferred in order to create formulations that will tend to remain in the vagina for a relatively long time period after administration.

The inhibitory alkyl polyglycoside composition may additionally employ one or more conventional pharmaceutically-acceptable and compatible carrier materials useful for the desired application. The carrier can be capable of co-dissolving or suspending the materials used in the composition. Carrier materials suitable for use in the instant composition, therefore, include those well-known for use in the cosmetic and medical arts as a basis for ointments, lotions, creams, salves, aerosols, suppositories, gels and the like. A suitable carrier can be comprised of alcohols and surfactants.
 

Claim 1 of 5 Claims

1. A method to produce a tampon that inhibits the production of exoprotein from Gram positive bacteria located in and around the vagina, the method comprising: treating a porous nonwoven sheet formed from hydrophobic polymer with a liquid vaginal cleansing composition comprising a pharmaceutically acceptable carrier and alkyl polyglycoside to produce cover sheet material with at least 5 add-on wt. % alkyl polyglycoside having the general formula: H-(Z).sub.n-O--R wherein Z is a saccharide residue having 5 or 6 carbon atoms, n is 4 6, and R is an alkyl group having 8 to 18 carbon atoms; wherein the alkyl polyglycoside has a hydrophilic/lipophilic balance of 10 to 15; and forming said tampon comprising an absorbent material, at least a portion of which is covered by the cover sheet material.

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