MXPA98008423A - Method of avoiding the irritation of skin caused by enzymes feca - Google Patents

Abstract

The present invention relates to skin irritation, such as diaper rash, which occurs when the skin is allowed to remain in contact with proteolytic enzymes found in faeces, is avoided by inactivating faecal proteolytic enzymes by contact with clays. organophilic. Organophilic clays are applied to the skin in areas that are likely to come in contact with feces or clothing such as diapers. A composition suitable for practicing the method of the invention comprises an amount of an organophilic clay effective to inactivate the proteolytic enzymes of the irritating faeces, dispersed in a non-toxic pharmaceutically acceptable dermatological vehicle. A fabric incorporating organophilic clay, preferably dispersed in a matrix of a super absorbent polymer, is useful for preparing diapers for infants that can help to avoid irritation of the skin by fecal enzymes

Description

METHOD OF AVOIDING SKIN IRRITATION CAUSED BY FECAL ENZYMES BACKGROUND OF THE INVENTION Field of the Invention: This invention relates to methods for preventing skin irritation such as diaper rash and more particularly to the prevention and treatment of diaper rash caused by fecal enzymes. s Brief Description of the Prior Art Diaper rash is a form of contact dermatitis, which afflicts infants whose wet and / or dirty diapers do not change rapidly. Due to the practical impossibility to quickly meet all the needs of infants, even those infants who receive a high level of care, sometimes suffer from diaper rash. Recently it has come to be understood that the initial stages of some types of diaper rash are the result of skin irritation caused by contact with digestive enzymes present in the infant's stool, particularly trypsin, uimotrypsin and elastase. These enzymes are proteolytic enzymes produced in the gastrointestinal tract to digest food. In infants, stools tend to be watery and contain, among other materials such as bacteria, some amounts of digestive enzymes without degrading. It has been found that these enzymes, if they remain in contact with the skin for any appreciable period of time, cause an irritation that is bothersome on its own and may predispose the skin to infection by microorganisms. Conventional methods to prevent or relieve diaper rash have included the application of powders to keep the skin dry and creams and ointments to protect the skin from contact with irritants. However, diaper rash continues to be a problem for infants and their parents. Similar conditions leading to skin irritation by proteolytic enzymes present in the faeces are found in patients who have colostomies and the like. Such patients would also benefit from improved treatments to avoid skin irritation due to fecal enzymes. In accordance with the above, there has continued to be a need for additional methods to avoid and treat diaper rash and similar skin irritations. SUMMARY OF THE INVENTION The need for additional methods to prevent diaper rash has now been met by the method of this invention, wherein fecal proteolytic enzymes are inactivated by contact with organophilic clays. A composition suitable for practicing the method of the invention comprises an amount of an organophilic clay, effective to inactivate the irritating faecal proteolytic enzymes, dispersed in a non-toxic pharmaceutically acceptable dermatological vehicle. In a further embodiment of the invention, a composition containing organophilic clay, for example a super absorbent polymer containing an organophilic clay, is incorporated into a cloth that is used to make garments, such as diapers, which may come into contact with stools that contain enzymes that irritate the skin. According to the above, it is an object of the invention to provide a method for preventing diaper rash. An additional object is to avoid contact dermatitis due to fecal enzymes. A further object is to provide a composition for application to the skin that can prevent diaper rash. A further object is to provide a composition for application to the skin that can avoid contact dermatitis - due to proteolytic enzymes, such as those present in the faeces.

A further object is to provide a method for inactivating faecal enzymes that irritate the skin. An additional object is to test a composition capable of inactivating faecal enzymes that irritate the skin. A further object is to provide a composition capable of inactivating faecal enzymes that irritate the skin that can be incorporated into a fabric. A further object is to provide a fabric that incorporates a composition that is capable of inactivating faecal enzymes that irritate the skin. An additional object is to provide a garment, such as a diaper, which incorporates a composition that is capable of inactivating fecal enzymes that irritate the skin. Other objects of the invention will be apparent from the description of the following invention. DETAILED DESCRIPTION OF THE INVENTION AND MODALITIES PREFERRED According to a method of the invention, the irritant effects of faecal proteolytic enzymes are alleviated by contacting the enzymes with materials that inactivate the enzymes, by adsorbing them or rendering them incapable of carrying out their natural proteolytic activity. In particular, it has been found that organophilic clays can adsorb faecal enzymes, thus preventing them from contacting the skin and also inactivating such enzymes, thus rendering them incapable of causing skin irritation. According to a method of the invention, the feces containing the irritant proteolytic enzymes are contacted with an amount of organophilic clay sufficient to reduce the activity of the enzymes and thus reduce or eliminate their ability to cause skin irritation. In order to ensure that the organophilic clay comes in contact with the proteolytic enzymes, it is placed in an anatomical region that is not likely to contact the stool, for example, when applied to the skin in those areas usually covered by a diaper. infant or by applying it to the diaper itself or incorporating it into the diaper structure. In a preferred embodiment, the organophilic clay is incorporated in a pharmaceutically acceptable skin-coating material that is applied to the skin, for example, of an infant, in the region that is subjected to contact with the feces. The medium containing the organophilic clay is often applied sufficiently, for example, after each diaper change and in sufficient quantity to maintain an effective amount of the organophilic clay associated with the skin, where it can adsorb and deactivate fecal enzymes . The amount of organophilic clay applied to the skin is obviously not critical, provided it is used enough to produce a substantial reduction in irritation caused by fecal enzymes. Typically, the amount of organophilic clay applied to the skin will be at least 0.25 milligrams per square centimeter. The organophilic clay used in the method of the invention is typically applied to the skin in a dermatological composition comprising a suspension of the organophilic clay in a pharmaceutically acceptable carrier. Suitable vehicles include, organic and aqueous liquid vehicles, lotions, creams, emulsions, gel or the like. The organophilic clay can also be applied in a finely divided form as a mixture with a medicinal powder for external use, for example, as a mixture with a talcum powder or a finely divided starch powder. The protective composition can also act as a barrier to prevent fecal enzymes from coming into contact with the skin. The vehicle may contain emollients to aid in the healing of irritated skin and dispersants if necessary to keep the organophilic clay in suspension. The vehicle must preferably be inert with respect to the organophilic clay, that is, it must be free of materials that by themselves adsorb the organophilic clay and thus deactivate the inactivation and adsorption properties of the organophilic clay that are the basis for its ability to inactivate proteolytic faecal enzymes. In general, compounds having relatively long hydrocarbon chains, i.e., C-8 or longer, should be excluded from the protective composition because such hydrocarbon chains tend to interact with the organophilic clay and reduce or destroy their hydrocarbon properties. Adsorption for proteolytic faecal enzymes. Accordingly, a dermatological composition incorporating the organophilic clay for use in the method of this invention can incorporate from about 3% to about 5% by weight of the organophilic clay in a conventional dermatological vehicle. Preferably, the composition comprises from about 3% to about 20% by weight and more preferably from about 5% to about 10% by weight. Suitable vehicles include hydrophobic vehicles such as, mineral oil or petrolatum or mixtures thereof or hydrophilic carriers such as water-based creams including mineral oil and / or petrolatum emulsions in water and water-based media thickened with viscosity adjusting agents. Suitable thickening agents for water-based carriers include polyoxyethylenes, for example, polyethylene glycols and derivatives having a molecular weight of from about 3000 to about 20,000.; polycarboxylic acids, for example, polyacrylic acid and salts thereof; cellulose derivatives such as hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose, methylcellulose, sodium carboxymethylcellulose; and hydrophilic organic polymers such as poly (vinyl alcohol), poly (vinylpyrrolidone), sodium salt of poly (acrylic acid) and the like. Natural gums such as xanthan gum, carrageenan, gum tragacanth and the like are also useful as thickeners for water-based vehicles. The thickener can also be a colloidal dispersion of a hydrophilic clay such as montmorillonite, bentonite, beidelite, hectorite, saponite and stevensite that originate naturally or the like and their synthetically produced analogues. The dermatological composition incorporating an organophilic clay must have a sufficient viscosity to allow easy diffusion in the skin and still preserve the active ingredient in a generally intact layer on the skin to be protected. Dermatological vehicles are well known to the skilled practitioner and the selection and formulation of an appropriate vehicle is within the capacity of such a practitioner without undue experimentation. The organophilic clay comprising the barrier and / or fecal enzyme that adsorbs and inactivates the material in the protective compositions used in the method of this invention, can be any commercially available organophilic clay suitable for the use of the medicament. Such organophilic clays are well known and can be prepared from any of the clays of the class of smectites known to swell in water and / or hydrophilic solvents to form viscous suspensions. Suitable clays include, montmorillonite, bentonite, beidelite, hectorite, saponite and stevensite that originate naturally and their counterparts synthetically made. These clays have a laminar structure, where the alkali metal ions are distributed between the lamellae. The treatment of the clay with long chain organic amphiphilic compounds such as long chain quaternary amines results in the exchange of the alkali metal ions by cationic organic molecules and thus the organophilic clay. The quaternary ammonium compounds used in the preparation of the organophilic clay component of the skin protecting composition used in the method of the invention, typically have one or more long chain substituents, for example, 14-20 carbon atoms and two or three short chain substituents such as methyl groups. A preferred quaternary ammonium compound is dihydrogenated semisodium dimethyl ammonium chloride. Because sebum contains a large proportion of stearic acid, which contains 18 carbon atoms, the resulting clay is often referred to as a quaternium 18 clay, for example, quaternium 18 bentonite or quaternium hectorite 18. The composition and preparation of such organophilic clays is described in the US Pat. 4,861,584. A preferred organophilic clay for use in the method of this invention is quaternium bentonite 18. The organophilic clay used in the method of this invention is preferably activated by complete dispersion with a solvent, such as propylene carbonate which is known as increase the adsorption capacity of clay for organic materials. The organophilic clay used in the method of the invention could also be incorporated into a garment, such as a diaper, which may come into contact with the feces. Fecal enzymes that come in contact with - Il ¬ the organophilic clay in the diaper, will be inactivated and consequently are unable to cause irritation to the skin adjacent to the garment. The organophilic clays can be incorporated into a garment, such as a diaper, by applying them as a coating on the fibers of the garment or as a coating on the weft before the garment is made. The garment can also be impregnated with the organophilic clay either by immersing it in a liquid vehicle in which the organophilic clay is suspended and subsequently removed from the vehicle, for example, by evaporation or by sprinkling the garment alone with the clay organophilic or in a mixture with a medicated powder vehicle for external use, as described above. In a preferred embodiment of a fabric according to the invention, which can be made into a garment such as a diaper, an organophilic clay can be incorporated in a super absorbent polymer and the composition thus prepared can be incorporated into a fabric, for example , a non-woven fabric, by methods conventionally used to incorporate the super absorbent polymers in such fabrics. Such superabsorbent polymers are well known and comprise, inter alia, degraded polymers of acrylic acid, carboxymethyl cellulose degraded with epichlorohydrin, polyamino acid, such as polyaspartic acid, degraded with, for example, lysine, cellulose graft polymers, for example, wood pulp and carboxylic monomers and the like. The preparation of such super absorbent monomers is conventional and is generally achieved by polymerizing the monomers in suspension or aqueous solution in an organic solvent in the presence of a suitable initiator of the free radical polymerization. The organophilic clay can be combined with such a super absorbent polymer by any means that ensures adequate dispersion in the polymer matrix. For example, an organophilic clay, for example, quaternium 18 bentonite, can be dispersed as a finely divided suspension in an aqueous suspension of a super absorbent polymer as originated in the manufacture of such polymers by the polymerization of the conventional hydrophilic monomers in suspension or aqueous solution. This dispersion can be achieved by high shear mixing. A solid powder containing the organophilic clay dispersed in the super absorbent polymer can then be prepared by conventional drying procedures such as spray drying, jet drying and the like. The super absorbent polymer containing an organophilic clay can be incorporated into the fabric suitable for use in absorbent garments such as diapers and the like by conventional methods. For example, the super absorbent polymer can be coated on the nonwoven or woven fabric or the fibers thereof or it can be bagged into the fabric or between the layers of the woven and nonwoven fabric to form a composite fabric. The super absorbent polymer can be incorporated into a fabric web, by impregnating the web with a suspension or solution of the polymer in water or other suitable vehicle, followed by drying the impregnated web. The super absorbent polymer containing an organophilic clay can also be incorporated into a foam layer, for example, a layer of polyurethane foam, which is then fixed to a layer of fabric or placed between layers of fabric to form a fabric suitable for use in a garment, such as a diaper. The super absorbent polymer containing an organophilic clay can also be incorporated into a nonwoven fabric, by suspending the polymer in a finely divided form in a suspension of the precursor fibers and then forming the nonwoven web by a wet layering method conventional. Diapers made of fabric containing organophilic clay, when used by infants, can help to avoid skin irritation caused by fecal enzymes. EXAMPLE This example illustrates the effectiveness of quaternium 18 bentonite as an adsorbent and deactivator of fecal proteolytic enzymes. The tests were conducted in solutions of three proteolytic digestive enzymes, chymotrypsin, trypsin and elastase, to demonstrate the effectiveness of a bentonite clay converted to organophilic by treatment with quaternium 18 (hereinafter referred to as "quaternium 18 bentonite" and "Q-18B") in adsorbing and / or deactivating these enzymes. The amount of enzyme immobilized by adsorption on Q-18B was determined by high pressure liquid chromatography (HPLC) and the denaturing effect of Q-18B was determined by measuring the loss of enzyme activity in standard activity tests and compare the loss in activity with the loss of activity due to the removal of the enzyme by adsorption. In order to conduct the tests that determine the effectiveness of adsorption and inactivation of Q-18B, aqueous solutions of chymotrypsin, trypsin and elastase were prepared in a phosphate buffer at pH 8, a pH at which it has been shown that these enzymes have a maximum proteolytic activity. The test solutions contained 0.4 milligrams per milliliter (mg / ml) of chymotrypsin, 0.2 mg / ml of trypsin and 1.0 mg / ml of elastase, respectively. These respective concentrations represent the average fecal concentrations of the infant of these three main fecal proteolytic enzymes. The total amount of enzymatic activity in each solution was measured using 1.0 ml of aliquots of each solution, using the triplicate experiments and taking an average of these three measured values. The effect of inactivation and adsorption of Q-18B in each of the enzymes in the solution was determined by the following procedure. Samples of the test comprising 10.0 ml of the enzyme solutions were prepared for each enzyme. Each sample of the test was added 1.0 grams of Q-18B and the mixture was mixed with a magnetic stirrer for 10 minutes at low speed. The mixture was then filtered through a prewashed No. 1 filter paper and the filtrate was collected and its volume was carefully measured. A corresponding control sample was prepared by filtering 10 ml of the enzyme solution through a filter paper. The filtrate was then transferred to a dialysis tube having a dialysis cut of 2000 daltons and the dialysis was carried out for 4 hours at 4 ° -ß ° C against deionized water. The retentate from the dialysis step was lyophilized to produce a residual enzyme powder. A known weight of the recovered enzyme was dissolved in a phosphate buffer at pH 8 and the activity of the enzyme was determined as described above. Because the test procedure itself caused some enzyme loss and enzymatic activity, a control was directed by dissolving another aliquot of the lyophilized recovered enzyme in an appropriate mobile phase and by measuring the amount of enzyme by chromatography. of high pressure liquids (HPLC). The inactivation and adsorption effect of Q-18B was determined by comparing the enzyme loss and enzymatic activity of the samples of the treated test, with the loss observed for the control samples. The details of the analytical procedures and the results obtained are described below. In order to prepare samples for the analysis of the amount of activity of the enzyme and protein, the lyophilized retentate was dissolved in 6.0 ml of water and divided into two 3.0 ml portions. These solutions were lyophilized again to produce solid waste. In this way, each experimental determination gave two residues of the same weight, which could be used to determine the amount of activity enzyme and the enzyme protein that remains in the enzyme solutions after treatment with Q-18B. Determination of the amount of enzyme as protein: Chymotrypsin: A standard chymotrypsin solution was prepared by dissolving 2.30 mg of chymotrypsin in 2.30 ml of water to give a solution having an enzyme concentration of 1.0 mg / ml. An amount of 50 microliters (μl) of this solution was injected into a high performance liquid chromatograph using a Progel TSK Butyl-NPR column with gradient elution using a mobile phase having an initial composition of 2.3 M sulphate ammonium in a pH 8 phosphate buffer and a final composition of the simple phosphate buffer, with a gradient time of 10 minutes. The retention time was determined to be 6.1-6.2 minutes. Each of the freeze-dried residues from the test and control samples was dissolved in 2.0 ml of water and each of the solutions was filtered through a pre-washed cotton ball and subjected to HPLC using the procedure above. The results of the determinations are summarized in Table 1 below. Trypsin: A standard trypsin solution was prepared by dissolving 2.50 mg of trypsin in 2.50 ml of water to give a solution having an enzyme concentration of 1.0 mg / ml. An amount of 50 microliters (μl) of this solution was injected into a high performance liquid chromatograph using a Progel TSK Butyl-NPR column with the gradient elution using a mobile phase having an initial composition of 2 M sulphate ammonium in a Tris HCl regulator, pH 7.5 and a final composition of the simple regulator free of ammonium sulfate, with a gradient time of 10 minutes. The retention time was determined to be 6.61 minutes for beta-trypsin and 1. 12 minutes for alpha-trypsin. Each of the freeze-dried residues from the test and control samples was dissolved in 2.0 ml of water and each of the solutions was filtered through a pre-washed cotton ball and subjected to HPLC using the procedure above. The results of the determinations are summarized in Table 1 below, where the total concentration of trypsin (alpha- and beta-) is given. Elastase: A standard elastase solution was prepared by dissolving 1.90 mg of elastase in 0.95 ml of water to give a solution having an enzyme concentration of 2.0 mg / ml. An amount of 50 microliters (μl) of this solution was injected into a high performance liquid chromatograph using a Progel TSK Butyl-NPR column with the gradient elution using a mobile phase having an initial composition of 2 M sulphate ammonium in a Tris HCl regulator, pH 7.5 and a final composition of the simple regulator free of ammonium sulfate, with a gradient time of 10 minutes. The retention time was determined to be 7.75 minutes. Each of the freeze-dried residues from the test and control samples was dissolved in 2.0 ml of water and each of the solutions was filtered through a pre-washed cotton ball and subjected to HPLC using the procedure above. The results of the determinations are summarized in Table 1 below. Table 1 Loss of Enzyme Protein from 1 to Solution by Treatment with Q-18 Control Sample of the test Enzyme Quantity Amount Percentage Theoretical percentage recovered from loss recovered from loss (mg) (mg) (mg) Chymotrypsin 2. 0 1. 54047 22. 98 0. 25687 87. 16 Trypsin 1 0 1. 10293 0 without 90 detect Elastase 5. 0 0. 8867 82. 23 0. 38767 92 .25 Determination of the activity of the enzyme: Chymotrypsin: A standard chymotrypsin solution was prepared by dissolving 0.40 mg of chymotrypsin in 5.0 ml of the phosphate buffer. The concentration of the enzyme was analyzed by the following procedure: The reagents were prepared as follows: Reagent A: 80 mM of the Tris HCl buffer, pH 7.8 at 25 ° C; Reagent B: 1.18 mM sodium benzoyl ethyl tyrosine ester solution; prepared by initially dissolving the reagent in 31.7 ml of methanol and diluting it to a volume of 50 ml with deionized water; Reagent C: 1 mM of the hydrochloric acid solution; Reagent D: phosphate buffer (the chymotrypsin enzyme solution was used at the concentration of 2-5 units / ml in reagent D). A reaction solution was prepared by mixing 1.42 ml of Reagent A, 1.40 ml of Reagent B and 0.08 ml of Reagent C. The solution was mixed by inversion and the optical absorbance at a wavelength of 256 nm (A256nm) was monitored until it was constant. Accordingly, 0.1 ml of the enzyme solution in Reagent D was added to the reaction solution, the solutions were mixed by inversion and the A256nm was monitored for approximately 5 minutes. The maximum speed of increase in optical absorbance (? A256nm / min), was taken as the measure of the concentration of the enzyme. We presented a model that uses only Reagent D without the enzyme and the A256nm / min for the model subtracted from that for the solution of the enzyme to produce a value proportional to the concentration of the enzyme. Samples of the test were analyzed by dissolving the lyophilized residue of the divided dialysis retentate, containing a maximum of 2.0 mg of chymotrypsin, in 5.0 ml of Reagent D and by determining the current chymotrypsin concentration by the procedure described above, using 0.1 ml of the solution. The results of the test are presented in Table 2 below. Trypsin: A standard trypsin solution was prepared by dissolving 0.40 mg of trypsin in 10.0 ml of the phosphate buffer solution (cold). The concentration of the enzyme was analyzed by the following procedure: The reagents were prepared as follows: Reagent E: 67 mM of the sodium phosphate buffer, pH 7.6 at 25 ° C; Reagent F: 0.25 mM of the ethyl ester solution of sodium benzoyl L-arganine Reagent G: trypsin enzyme solution containing 350-700 units / ml in Reagent E. A reaction solution was prepared by equilibrating 3. 00 ml of Reagent E at 25 ° C and the optical absorbance at a wavelength of 253 nm (A253nm) was monitored until it was constant. Accordingly, 0.2 ml of Reagent G was added to the reaction solution, the solutions were mixed by inversion and the A253nm was monitored for approximately 5 minutes. The maximum speed of increase of the optical absorbance (? A25Snm / min), was taken as the measure of the concentration of the enzyme. We presented a model that uses Reagent G without the enzyme and the A256nm / p? In for the model that was subtracted from that for the solution of the enzyme to produce a value proportional to the concentration of the enzyme. Samples of the test were analyzed by dissolving the lyophilized residue of the divided dialysis retentate, containing a maximum of 1.0 mg of chymotrypsin, in 10.0 ml of Reagent E and by determining the current chymotrypsin concentration by the procedure described above, using 0.2 ml. of the sample solution. The results of the test are presented in Table 2 below. Elastase: A color-endpoint metric method was used to determine the amount of elastase in the test samples, that is, the freeze-dried residue of split dialysis retentate. The reagents were prepared as follows: Reagent H: 200 mM of the Tris buffer, pH 8.8 at 37 °; Reagent I: elastase-orcein substrate; Reagent J: Elastase enzyme solution containing 25-100 units / ml in Reagent H. A series of solutions of the elastase substrate was prepared by dissolving heavy amounts of Reagent I in Reagent H. A quantity of the solution of The test or standard was then mixed with the substrate solutions as follows: Solutions / 'Reagent Est. 1 Est. 2 Est. 3 Est. 4 Est. 5 Est.

Reagent I (mg) 1.0 2.0 4.0 8.0 16.0 0.00 Reagent H (mg) 6.00 6.00 6.00 6.00 6.00 6.00 A standard elastase solution was prepared by mixing 12.06 ml of elastase in 2.0 ml of the regulator to give a solution having 1.03 mg of elastase per milliliter. An amount of 0.01 ml of the standard elastase solution was added to the substrate solutions and the solution was mixed by turbulence and incubated for 12-16 hours at 37 ° C. The optical density at a wavelength of 590 nanometers (A590) of the standards was measured and a standard curve prepared. Samples of the test were analyzed by dissolving the lyophilized residue of the divided dialysis retentate, containing a maximum of 5.0 mg (600 units) of elastase, 2.0 ml of the regulator and by incubating 0.01 ml of the test solutions with the mixture. of the substrate for 20 minutes at 37 ° C. The A590 was measured for the test samples and the standard solution was prepared by the procedure above and the amount of enzyme was calculated. The results of the determination are presented in Table 2 below. Table 2 Loss of Enzyme Protein from the Solution by the Treatment of Q-18 B Control Sample of the test Enzyme Quantity Quantity Percentage Quantity Theoretical percentage recovered from loss recovered from loss (units) (units) (units) Chymotrypsin 104 47.4 54.42 6.29 93.94 Trypsin 8060 5467 32.17 782.5 90.3 Elastase 350 158.2 54.8 135.5 61.29 The data presented in the example illustrates that a substantial fraction of the proteolytic faecal enzymes responsible for skin irritation, diaper rash and the like, is inactivated by contact with organophilic clays such as quaternium bentonite 18. The invention which has now been fully described, it should be understood that it can be incorporated into other specific forms and variations without departing from its spirit or essential characteristics. According to the foregoing, the embodiments described above are to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims rather than by the foregoing description and all changes that fall within the meaning and scope of the invention. The equivalence range of the claims is intended to be understood in the same.

Claims (71)

1. NOVELTY OF THE INVENTION Having described the present invention, it is considered as a novelty and therefore the property described in the following claims is claimed as property. A method for protecting the skin of humans and mammals from irritation caused by contact with feces containing proteolytic enzymes comprising contact with feces containing proteolytic enzymes capable of irritating the skin coming into contact with said feces, with an amount of an organophilic clay sufficient to substantially reduce the activity that irritates the skin of said proteolytic enzymes. The method according to claim 1, characterized in that it comprises the application of said organophilic clay to said skin. 3. The method according to claim 2, characterized in that it comprises the application of said organophilic clay which is applied to said skin in a pharmaceutically acceptable dermatological vehicle. 4. The method according to claim 3, characterized in that said vehicle is a lotion. 5. The method according to claim 3, characterized in that said vehicle is a gel. 6. The method according to claim 3, characterized in that said vehicle is a cream. The method according to claim 3, characterized in that said vehicle is medicinal powder for external use. The method according to claim 1, characterized in that said organophilic clay is a reaction product of a clay selected from the group consisting of naturally occurring montmorillonite, bentonite, beidelite, hectorite, saponite and stevensite and their synthetically produced analogues, with a long-chain organic quaternary ammonium compound. The method according to claim 8, characterized in that said organophilic clay is activated. The method according to claim 8, characterized in that said organophilic clay is a reaction product of bentonite with a long-chain organic quaternary ammonium compound. The method according to claim 10, characterized in that said organophilic clay is activated. The method according to claim 10, characterized in that said organophilic clay is quaternium 18 bentonite. 13. The method according to claim 12, characterized in that said quaternium 18 bentonite is activated. 14. A composition for protecting the skin against activity that irritates the skin of the proteolytic enzymes found in faeces, characterized in that it comprises an organophilic clay dispersed in a pharmaceutically acceptable dermatological vehicle. 15. The composition according to claim 14, characterized in that said organophilic clay is present in an amount of about 3% to about 50% by weight. 16. The composition according to claim 15, characterized in that said organophilic clay is present in an amount of about 3% by weight to about 20% by weight. 17. The composition according to claim 15, characterized in that said organophilic clay is present in an amount of about 3% by weight to about 10% by weight. The composition according to claim 14, characterized in that said organophilic clay is a reaction product of a clay selected from the group consisting of naturally occurring montmorillonite, bentonite, beidelite, hectorite, saponite and stevensite and their synthetically produced analogues, with a long-chain organic quaternary ammonium compound. 19. The composition according to claim 18, characterized in that said organophilic clay is activated. The composition according to claim 18, characterized in that said organophilic clay is a reaction product of bentonite with a long-chain organic quaternary ammonium compound. 21. The composition according to claim 20, characterized in that said organophilic clay is activated. 22. The composition according to claim 20, characterized in that said organophilic clay is quaternium 18 bentonite. The composition according to claim 22, characterized in that said quaternium 18 bentonite is activated. 24. A solid composition characterized in that it comprises an organophilic clay dispersed in a hydropermeable matrix. 25. The composition according to claim 24, characterized in that said matrix is a super absorbent polymer. 26. The composition according to claim 25, characterized in that said super absorbent polymer is a polymer degraded from an unsaturated carboxylic acid. 27. The composition according to claim 26, characterized in that said unsaturated carboxylic acid is an acrylic acid. 28. The composition according to claim 25, characterized in that said super absorbent polymer is a degraded polymer of an amino acid 29. The composition according to claim 28, characterized in that said amino acid is aspartic acid. 30. The composition according to claim 24, characterized in that said organophilic clay is present in an amount of about 3% to about 50% by weight. The composition according to claim 24, characterized in that said organophilic clay is present in an amount of about 3% by weight to about 20% by weight. 32. The composition according to claim 24, characterized in that said organophilic clay is present in an amount of about 3% by weight to about 10% by weight. The composition according to claim 24, characterized in that said organophilic clay is a reaction product of a clay selected from the group consisting of naturally occurring montmorillonite, bentonite, bs delita, hectorite, saponite and stevensite and their synthetically produced analogs, with a long-chain organic quaternary ammonium compound. 34. The composition according to claim 33, characterized in that said organophilic clay is activated. 35. The composition according to claim 33, characterized in that said organophilic clay is a reaction product of bentonite with a long-chain organic quaternary ammonium compound 36. The composition according to claim 35, characterized in that said organophilic clay is activated. 37. The composition according to claim 35, characterized in that said organophilic clay is quaternium bentonite 18. 38. The composition according to claim 37, characterized in that said quaternium bentonite 18. 39. A fabric comprising a non-woven web and woven, having incorporated therein an organophilic clay 40. The fabric according to claim 39, characterized in that said organophilic clay is dispersed in a hydropermeable matrix 41. The fabric according to claim 40, characterized in that said matrix is a super absorbent polymer. . 42. The fabric according to claim 41, characterized in that said super absorbent polymer is a polymer degraded from an unsaturated carboxylic acid. 43. The fabric according to claim 42, characterized in that said unsaturated carboxylic acid is an acrylic acid. 44. The fabric according to claim 41, characterized in that said super absorbent polymer is a degraded polymer of an amino acid 45. The fabric according to claim 44, characterized in that said amino acid is aspartic acid. 46. The fabric according to claim 41, characterized in that said organophilic clay is present in an amount of about 3% to about 50% by weight. 47. The fabric according to claim 41, characterized in that said organophilic clay is present in an amount of about 3% by weight to about 20% by weight. 48. The fabric according to claim 41, characterized in that said organophilic clay is present in an amount of about 3% by weight to about 10% by weight. 49. The fabric according to claim 41, characterized in that said organophilic clay is a reaction product of a clay selected from the group consisting of naturally occurring montmorillonite, bentonite, beidelite, hectorite, saponite and stevensite and their synthetically produced analogs, with a long-chain organic quaternary ammonium compound. 50. The fabric according to claim 49, characterized in that said organophilic clay is activated. 51. The fabric according to claim 49, characterized in that said organophilic clay is a reaction product of bentonite with a long-chain organic quaternary ammonium compound. 52. The fabric according to claim 51, characterized in that said organophilic clay is activated. 53 The fabric according to claim 51, characterized in that said organophilic clay is quaternium bentonite 18. 54. The fabric according to claim 53, characterized in that said quaternium bentonite 18 is activated. 55. A garment made of a fabric comprising a woven and nonwoven weft, having incorporated in it an organophilic clay. 56. The garment according to claim 55, characterized in that said organophilic clay is dispersed in a hydropermeable matrix. 57. The garment according to the claim 56, characterized in that said matrix is a super absorbent polymer. 58. The garment according to the claim 57, characterized in that the garment is a diaper. 59. The diaper according to claim 58, characterized in that said super absorbent polymer is a polymer degraded from an unsaturated carboxylic acid 60. The diaper according to claim 59, characterized in that said unsaturated carboxylic acid is acrylic acid. 61. The diaper according to claim 58, characterized in that said super absorbent polymer is a degraded polymer of an amino acid. 62. The diaper according to claim 61, characterized in that said amino acid is aspartic acid 63. The diaper according to claim 58, characterized in that said organophilic clay is present in said matrix in an amount of about 3% to about 50% by weight. 64. The diaper according to claim 58, characterized in that said organophilic clay is present in said matrix in an amount of about 3% by weight to about 20% by weight. 65. The diaper according to claim 58, characterized in that said organophilic clay is present in said matrix in an amount of about 3% by weight to about 10% by weight. 66. The diaper according to claim 58, characterized in that said organophilic clay is a reaction product of a clay selected from the group consisting of naturally occurring montmorillonite, bentonite, beidelite, hectorite, saponite and stevensite and their synthetically produced analogues., with a long-chain organic quaternary ammonium compound. 67. The diaper according to claim 66, characterized in that said organophilic clay is activated. 68. The diaper according to claim 66, characterized in that said organophilic clay is a reaction product of bentonite with a long-chain organic quaternary ammonium compound. 69. The diaper according to claim 68, characterized in that said organophilic clay is activated. 70. The diaper according to claim 68, characterized in that said organophilic clay is quaternium bentonite 18. 71. The diaper according to claim 70, characterized in that said quaternium bentonite is activated.