SI22285A - Tampon containing ph-regulating and antibacterially and antimicotically active formulation, and procedure of its manufacture - Google Patents

Abstract

The submitted invention relates to a tampon which contains a pH-regulating formulation with antibacterial and antimicotical activity and has the ability to maintain suitable moisture within the vagina and to maintain or create its physiological pH, exhibiting also the antibacterial and antimicotical effect at the same time. The tampon in the sense of the invention contains a starting material for the manufacture of tampons, onto which the formulation is applied, i.e. a solution of chitozane and/or chitozane material in diluted organic acid or its derivative, preferentially lactic acid. The submitted invention relates also to the procedure of manufacture of such a tampon and to its application in prevention and/or treatment of vaginal inflammations.

Description

The present invention relates to a tampon containing a pH regulating and antibacterial and antimycotic active formulation, which has the ability to maintain its humidity and its physiological pH in the vagina, while having an antibacterial and antimycotic action. The tampon of the invention comprises a starting material for the manufacture of tampons, to which a formulation is applied which is a solution of chitosan and / or chitosan material in dilute organic acid or a derivative thereof, preferably lactic acid. The present invention also relates to a process for the manufacture of such a tampon and to its use in the prevention and / or treatment of vaginal inflammation.

Technical problem and state of the art

Recently, we have noticed that the modern way of life and some fashion trends, such as the way of dressing, lead to more use of vaginal tampons. Today, their use is not only related to the period of menstruation, but is used by women throughout the cycle as a protection against physiological or pathological discharge from the vagina. This type of use often causes inconvenience, such as more frequent occurrence and recurrence of inflammation of the vagina. Clinical experience shows that vaginal discharge and inflammation are the main reason for visits to the gynecological outpatient clinic. Inflammation of the vagina is accompanied by a discharge that women often try to eliminate by washing with water, which further reduces the acidity of the vagina.

Under the influence of estrogens, glycogen accumulates in women of reproductive age in the vaginal epithelium. Anaerobic glycogen metabolism in epithelial cells and, above all, its degradation by the vaginal flora are the cause of the low pH in the vagina, which is between 3.6 and 4.5 in most women [Boskey ER, Telsch KM, Whaley KJ,

Moench TR, Cone RA. Acid production by vaginal flora in vitro is consistent with the rate and extent of vaginal acidification. Infect Immun. 1999; 67: 5170-5]. This slightly acidic condition in the vagina provides an effective barrier to the growth of pathogenic microorganisms, which is usually associated with vaginal infection, since such microorganisms do not grow below pH 5.

In vaginal inflammation, bacterial vaginosis, the pH rises, causing a decrease in lactobacilli counts, thus reducing the natural defense of the vagina and, as a consequence, the various bacteria grow freely [Tomas MS, Bru E, Nader-Macias ME. Comparison of growth and hydrogen peroxide production by vaginal probiotic lactobacilli under different culture conditions. Am J Obstet Gynecol 2003; 188: 35-44]. A similar change in the acidity of the vagina and its subsequent inflammation can also be caused by the frequent use of tampons.

It is also known that infection of the vagina and external genitalia is one of the risk factors for bladder infection, which is one of the main causes of water leakage (so called urinary incontinence) in older women.

Many formulations and techniques have been developed in the past to overcome the problem of reduction in vaginal acidity and to restore the desired normal acidic state and the desired vaginal flora. Such efforts have included the development of formulations such as solutions, gels, suppositories, vaginals and the like, which are inserted into the vagina in their prepared form. However, these types of formulations have drawbacks in terms of practicality and acceptability. Thus, e.g. vaginaletes containing, inter alia, a combination of lactic acid and chitosan while releasing the active substance or dissolving directly into the mucous membranes cause excessive local concentration or acidity, which can be uncomfortable for users.

It is known from the literature that chitosan can exhibit antibacterial and antifungal properties. Chitosan is a natural antimicrobial agent used both in the food industry to prevent the growth of bacteria and fungi in food, as well as in the pharmaceutical industry, where, for example, chitosan. they add to various medicated vaginal creams. Chitosan is known to reduce the activity of Candida albicans, a potential cause of vaginal candidiasis, and Staphylococcus aureus, a potential cause of toxic shock syndrome. It is also used during pregnancy, for example chitosan supplementation. in the vaginal gel, it helps to maintain a proper pH in the vagina, which is supposed to be a prevention against the birth.

Lactic acid is produced by lactic acid bacteria, which are found in the healthy environment of the vaginal flora and are important for natural defense against infection and inflammation. The acidic environment of the vagina pH 3.85-4.00 promotes the reproduction of lactic acid bacteria that are capable of reproduction and survival only in this pH environment. The increased number of lactic acid bacteria displaces other bacteria and protects the body from invading harmful bacteria that cause various unpleasant infections and inflammations. The vagina maintains the natural acidic ecosystem in the pH range 3.85 - 4.00.

US 6,710,220 B2 describes a pH lowering formulation and tampons containing a formulation for the purpose of lowering the pH of the vagina. That formulation contains an organic acid polymer (e.g. lactic acid polymer), a solid organic acid and a wetting agent. This formulation applies from a solution of acetone to a suitable buffer strip, and the document addresses in particular the use of the buffer especially during menstruation.

US 2005/0124799 A1 describes an invention which relates to products such as disposable absorbent products containing cationic polysaccharides, preferably chitosan materials together with acidic pH buffering agents. This document discusses the combination of chitosan with acidic pH buffering agents to prevent odors resulting from the use of such products, in particular hygienic substrates consisting of several different components. of several differently treated layers.

The patent application CN 1365833 mentions a process for the preparation of an absorbent product to which chitosan is dissolved in dilute acid, the product being intended to prevent bedding or related side effects on the skin.

DETAILED DESCRIPTION OF THE INVENTION

In order to solve the above problems and taking into account the fact that on the mass or. the frequency of the use of tampons cannot be affected, the purpose of the present invention was to develop new improved tampons, the use of which would not have the negative effects mentioned above, e.g. increased risk of inflammation and which, when used frequently, would maintain the vagina's humidity and maintain and / or create a physiological pH within the vagina, while having antibacterial and antifungal effects. The subject of the present invention is therefore a tampon containing a pH regulating and antibacterial and antifungal active formulation, which, when used in the vagina, has the following advanced and novel properties: lowers and / or maintains the pH of the vagina at physiological pH, maintains the proper humidity of the vagina and has antibacterial and antifungal action.

Despite numerous separate applications of chitosan or chitosan materials and organic acids, such as e.g. So far, to our knowledge, no lactic acid, on cellulosic material, has been methodically studied and performed simultaneously by the simultaneous application of both components, chitosan and / or chitosan material, and the corresponding organic acid or its derivative, preferably lactic acid or its derivatives, to input material which is suitable for the manufacture of tampons, and which in the tampon represents the absorption layer or. a component for the purpose of producing tampons according to the invention, with the following being fulfilled and harmonized:

technical requirements for the application of a solution of chitosan and / or chitosan material in a suitable organic acid or derivative thereof, preferably lactic acid or a derivative thereof, to a starting material suitable for the manufacture of tampons, also by means of a spray technique; after such a solution of chitosan and / or chitosan material in a suitable organic acid, preferably lactic acid, or a derivative thereof, that after the phase of application to the starting material will allow for the technological and ecologically sound production of the tampon on the tampon machine, and requires the production of the final product, the tampon , which will meet the prescribed technological standards and which will lower and / or maintain the pH of the vagina at its physiological pH, maintain adequate vaginal humidity and have antibacterial and antifungal action.

In order to produce a new improved and modified tampon according to the invention and in accordance with the above requirements, we have developed and optimized a formulation for application to a starting material for the manufacture of tampons, which is a solution of chitosan and / or chitosan material in an organic acid or a derivative thereof, having the following Features:

- the chitosan and / or chitosan material exhibits antibacterial and antifungal properties, and is preferably present in the formulation at a concentration higher than 0.5% by weight;

- the chitosan and / or chitosan material is completely soluble in the formulation (the downside, eg chitosan, is alkaline and insoluble in aqueous medium, soluble only in the acidic medium of specific acids);

- the pH of the solution is appropriate to the physiological pH of the vagina, and preferably the pH is in the range 3.6-4.4; and

- has a viscosity that allows the solution to be applied to the input material for the production of tampons, preferably by spray technique;

whereby this formulation simultaneously enables

- the amount of the formulation applied and the form of application are such that the applied formulation is well absorbed into the input material for the manufacture of tampons;

- the tampon input material thus treated can be molded on a tampon machine into a finished product, a tampon that meets the standards prescribed in the art, and

- the quantity of active ingredients, especially preferably chitosan and lactic acid, is such that the tampon has the following desired properties when used in the vagina: it has the ability to maintain adequate vaginal humidity, has the ability to lower and / or maintain the pH of the vagina at physiological pH and is antibacterial, and antifungal activity.

A formulation for use according to the invention in the form of a solution prepared from chitosan and / or chitosan material and the corresponding organic acid or derivative thereof, wherein chitosan and / or chitosan material and organic acid or a derivative thereof may be in any such molar ratio giving the formulation of the characteristics listed above.

Suitable organic acid for use in the formulation of the invention may be lactic acid, polylactic acid, citric acid or boric acid. Organic acid derivatives can be used, e.g. lactic acid derivatives such as any acidic lactate. The use of dilute lactic acid is preferred in the invention. In particular, the use of from 3% to 20% lactic acid solution is suitable for the preparation of the formulation, and in view of the limitations of the physiological pH requirement and the final viscosity of the formulation, the use of about 5% lactic acid solution is particularly preferred in the invention.

Chitosan suitable for use in the formulation of the invention is water-insoluble chitosan, whether chitosan with low or high average molecular weight. Like chitosan materials or. chitosan derivatives are suitable e.g. sulfonated chitosan (partially) and carboxymethylated chitosan. Particularly preferred is the use of chitosan with a low average molecular weight.

Chitosan solutions with a concentration equal to or greater than 0.5% by weight of chitosan are known to have antibacterial and antifungal properties, and a maximum maximum upper concentration of chitosan solution from the point of view of its viscosity and thus useful for application by the spray technique, is about 2 wt. %.

In a preferred embodiment of the invention, the formulation for application to the tampon starting material is a 0.5-2.0% solution of chitosan and / or chitosan material (calculated on the concentration in the formulation), in dilute organic acid or a derivative thereof, to be prepared formulations use a 3-20% organic acid solution or derivative thereof.

According to the invention, a formulation in the form of 0.5-2.0% solution of chitosan and / or chitosan material (recalculated to the concentration in the formulation) in lactic acid is particularly suitable, the formulation being prepared by pouring into the aqueous suspension of chitosan and / or chitosan adds 3% -20% lactic acid solution, especially preferably 5% lactic acid, to complete solubility when heated (to about 40 ° C).

According to a still more preferred embodiment of the invention, the formulation for application to the tampon starting material is a solution of chitosan in lactic acid, containing, calculated on the final concentration of the two components in the solution, 0.8-1.2% by weight of chitosan in 0.8-1 , 2% lactic acid solution, and in particular about 1% chitosan in about 1% lactic acid solution. Particularly preferred is a solution containing chitosan with a low average molecular weight.

The highest suitable viscosity of the formulation of the invention is such that it can be sprayed onto the starting material. The viscosity of the solution can range from 1 to 1000 mPa.s at 25 ° C, and the preferred viscosity of the formulation ranges from 200-800 mPa.s.

Suitable input materials for the production of tampons or. their absorption components are cellulosic materials such as e.g. cotton, viscose, modal or lyocell, and carboxymethyl cellulose (CMC) treated cellulosic materials such as e.g. CMC treated cotton or CMC viscose. Particularly preferred is the use of viscous material.

The starting material for making tampons to which the solution of the invention relates is preferably in the form of a strip.

Furthermore, other polymeric materials which can be treated as fibers may be suitable as starting materials for the production of tampons, allowing for the proper absorption and reversible / irreversible binding of the active ingredients of the invention to the starting material to which the formulation is sprayed.

The tampon of the present invention has an absorbent component made from a starting material for tampons, preferably a cellulosic material, in particular a viscous material to which the formulation of the invention is applied, wherein the formulation is 0.5-2.0% chitosan solution and / or chitosan material (converted to the final concentration in the formulation), in dilute organic acid or a derivative thereof, preferably lactic acid, using a 3-20% organic acid solution and / or derivative thereof to prepare the formulation.

According to a preferred embodiment, the tampon contains a tampon starting material, to which a formulation containing from 0.8 to 1.2% by weight of chitosan in a 0.8-1.2% solution of lactic acid is applied, calculated to the final concentration in the formulation. Particularly preferred is a tampon containing a starting material for the manufacture of tampons, to which a formulation comprising, based on the final concentration in solution, about 1% by weight of chitosan in about 1% lactic acid solution has been applied.

According to a preferred embodiment, the formulation is applied to the input material for the production of tampons using a spray technique. Due to its properties, the formulation enables its uniform, homogeneous and constant spray on the input material. It is well absorbed into the input material so that no unwanted adhesive layer is formed on the surface of the material, which can be deposited on those rotating parts of the tampon machine that come in contact with the buffer strip. The spraying technique is advantageous both ecologically, technologically as well as economically, since it does not contain waste solution, such as for example. in the technique of substance application by the technique of immersion in the bath, where the bath is exhausted and needs to be replaced, resulting in a waste solution. Spraying technique, unlike e.g. Diving techniques allow only a solution to be applied to the tampon material as is actually needed to produce the final product with the desired pH-regulating and antibacterial and antifungal properties, in as precise a predetermined and selected quantity as possible. There is no waste solution in the spraying process, the aqueous solution used or. the formulation of the invention also does not contain any environmentally hazardous substances that are problematic from a technological as well as an ecological point of view.

We have developed a process for the production of a new buffer with pH regulating and antibacterial and antimycotic properties, the production of which does not require additional investment on the existing tampon making machine due to the additional requirements that would result from the application of the formulation to the starting material, such as. additional drying equipment on the tampon making machine, additional safety and environmental requirements due to the use of e.g. what specific solvent in the formulation, etc.

The described formulation provides a continuous process for the manufacture of a tampon according to the invention, wherein the formulation relates, preferably by spray technique, to a tampon fabric material, preferably a viscous tampon strip, immediately prior to entry of a fly into a tampon machine, followed by entry with a treated inlet formulation material for making tampons into a tampon making machine and making tampons.

In a further embodiment of the present invention, the formulation of the invention may be applied or administered. spray on the input material for the production of tampons in the process of making the buffer strip, which is separate from the process of making tampons. From the input material thus treated, preferably a viscous tampon tape, a tampon is then produced on a separate tampon machine.

Typical but non-limiting examples of tampons of the invention are tampons having an absorbent component or a tampon. a layer made of starting material for the manufacture of tampons in the form of 20-25 cm long and 4-6 cm wide viscous tampon tape with a viscous fiber mass of 2-4 g, to which was applied prior to entering the tampon making machine with a spray technique of 0, 2-0.5 g of formulation containing, calculated on the final concentration in the formulation, 0.8-1.2% by weight of chitosan in 0.81.2% lactic acid solution.

Particularly suitable is the application of the formulation to a tampon viscose tape in an amount of 0.080.2 g formulation per 1 g of viscose fibers.

The use of the formulation of the invention based on chitosan and / or chitosan materials and organic acids or their derivatives, especially lactic acid, is also economically advantageous, since the active ingredients are relatively cheap, so their use in tampons does not have a significant impact on the price of the final product. This makes the new tampons of the invention very affordable for users.

From the results of the analyzes and tests presented hereinafter, we conclude that tampons of the invention containing the starting material treated with the formulation of the invention, when used in the vagina, are effective in preventing both the formation and recurrence of fungal and bacterial inflammation of the vagina . Due to their properties, they can be used frequently, not only during menstruation but also beyond that period. Due to the antibacterial and antimycotic action of the active ingredients, they can be used as a means of preventive and / or curative treatment in gynecology (eg as a preventative agent against inflammation, white flow, etc.).

Based on the tests performed so far, we also believe that using tampons according to the invention or. by preventing vaginal infections, the risk of bladder inflammation, which is one of the main factors for urinary incontinence in older women, can also be reduced. By using tampons of slightly larger dimensions, the urethra could be further compressed, so that there would be two ways of preventing water leakage, preventive and curative.

The following examples are intended only to illustrate the present invention and do not in any way limit its scope.

Implementation examples

Preparation of a solution of chitosan in lactic acid production of tampons containing this solution

Example 1 g of chitosan (low average molecular weight chitosan, Aldrich company) was dissolved in 500 ml of water with the gradual addition of 5% lactic acid (80 ml) and heated to 40 ° C to give a pH in the range of 3.6 and 3.8. The final actual concentration of chitosan in solution is 0.86% and the final actual lactic acid concentration is 0.8 wt. %. The viscosity of the solution was 653 mPa.s at 25 ° C.

The prepared solution was manually sprayed onto the starting material for the manufacture of a tampon, which is in the form of a pre-fabricated 5 cm viscous buffer strip, in an amount corresponding to 0.3-0.5 g of the solution per 2.5 g of viscous fibers (2.5 g of viscose fibers corresponds to the mass of viscous fibers required to produce one tampon). According to a method known in the art, tampons were made from a solution of treated buffer tape on a tampon machine.

Analysis of tampons making chitosan solution in lactic acid according to Example 1

1. Mechanical properties

Tampons whose starting viscous material was sprayed with a solution of chitosan in lactic acid as indicated in Example 1 and a reference tampon made from a starting viscous material were determined in accordance with the standard methods applicable in the art, appropriate technological parameters were determined.

Table 1: Mechanical properties / technological parameters of tampons containing a solution of chitosan in lactic acid according to Example 1 and reference tampons.

Tampon parameters Tampons containing solution of chitosan in milk acid, according to Example 1 Reference tampons Length 50,5 mm 50,5 mm Diameter 12,7 mm 12,7 mm Weight 2,70 g 2,50 g Stability 50.6 N 50.2 N Absorption ability 11,3 ml 10,5 ml

The technological parameters of the tampons prepared as indicated in Example 1 are within the range of specific production standards.

2. Determination of chemical properties: The pH value of the tampons and the nitrogen content of the tampons were analyzed by measuring the pH of the distilled water (50 ml) into which the tampons had previously been immersed. The results of the measurements are given in Table 2.

Table 2: pH value of the distilled water into which the tampons were immersed

Temperature; pH of distilled water Reference tampons Tampons containing chitosan solution in lactic acid, by example 1 25 ° C; 6.0 6,1 4.7 38 ° C; 6.6 6,9 5.0

The results show that the tampons prepared as in Example 1 effectively lower the pH in distilled water, suggesting a potential decrease in pH or maintaining the pH at physiological pH in the vagina.

Tampons sprayed with starting material with a solution of chitosan in lactic acid according to Example 1 determined the total nitrogen content by the Kjeldahl method (SIST EN 25663), on the basis of which the qualitative binding of chitosan to tampons can be monitored. The results of the nitrogen content of the tampons prepared as in Example 1 and of the reference tampons are given in Table 3.

Table 3: Total nitrogen concentration (%)

Nitrogen content (%) Reference viscous tampons Tampons containing solution of chitosan in milk acid according to example 1 Content rise 0.015 0.03 100 0.013 0.024 85 0.014 0.038 171 0.012 0,026 th most common 117

The results show that chitosan is present on modified tampons.

3. Spectrophotometric determination of the chitosan content of the tampons made according to Example 1

Using a spectrophotometric method based on the principle of coupling sulfone dye to chitosan, it was measured that the buffer made as in Example 1 had a chitosan content of 3.3 mmol / kg. The modified chitosan content of the reference buffer is 0 mmol / kg.

4. Antibacterial and antifungal properties of tampons made according to Example 1

Test results for antibacterial and antimycotic properties (according to ASTM

E2149-01) Tampons containing a solution of chitosan in lactic acid according to Example 1 showed that viscous tampons containing a solution of Example 1 reduced Staphylococcus aureus by 97%, Streptococcus. Agal by 100%, MRSA by 91% and Candida by 68%.

Based on the tests and analyzes carried out so far, it is concluded that the tampon with the addition of the formulation of the invention, when used in the vagina, with the release of active ingredients, has the following advanced and novel properties: maintains the physiological pH of the vagina, maintains adequate vaginal humidity and has antifungal and antibacterial activity .

Claims (28)

A pH-regulating and antibacterial and antimycotic activity buffer having an absorbent component made from a starting material for the manufacture of tampons, to which a formulation which is a solution of chitosan and / or chitosan material in an organic acid or derivative thereof is applied, and having the following characteristics: chitosan and / or chitosan material exhibits antibacterial and antifungal properties; chitosan and / or chitosan material is completely soluble in the formulation; the pH of the solution corresponds to the physiological pH of the vagina; and has such a viscosity that it is possible to apply the solution to the input material for the production of tampons, also by spraying technique. 2. pH regulating and antibacterial and antifungal activity buffer according to claim 1, characterized in that the absorbent component is made of a starting material for the manufacture of tampons, to which is formulated a solution of chitosan and / or chitosan material in organic acid or a derivative thereof having the following characteristics: chitosan and / or chitosan material exhibits antibacterial and antifungal properties and is present in the formulation at a concentration higher than 0.5% by weight; chitosan and / or chitosan material is completely soluble in the formulation; pH of the solution in the pH range 3.6-4.4; and having a viscosity in the range of 1 to 1000 mPa.s. 3. pH regulating and antibacterial and antimycotic activity buffer according to any one of claims 1 to 2, characterized in that the input material for the production of tampons is cellulosic material selected from the group consisting of cotton, viscose, modal or lyocell, or cellulose material treated with carboxymethyl cellulose. A pH-regulating buffer with antibacterial and antimycotic activity according to any one of claims 1-3, characterized in that the input material for the production of the tampons is a viscous material. 5. pH regulating and antibacterial and antifungal activity buffer according to any one of claims 1-4, characterized in that the chitosan and / or chitosan material used to prepare the formulation applied to the starting material for the production of tampons is selected from the group , which comprises water-insoluble chitosan such as chitosan with low or high average molecular weight, sulfonated chitosan (partially) and carboxymethylated chitosan. 6. pH regulating and antibacterial and antifungal activity buffer according to claim 5, characterized in that chitosan chitosan with low average molecular weight is used. 7. pH-regulating and antibacterial and antifungal activity buffer according to claim 6, characterized in that chitosan with a low average molecular weight in the concentration of 0.5-2.0 wt is present in the formulation applied to the tampon input material .%. A pH regulating and antibacterial and antifungal activity buffer according to any one of claims 1-7, characterized in that the organic acid used to prepare the formulation applied to the starting material for the production of tampons is selected from the group consisting of lactic acid , polylactic acid, citric acid and boric acid. A pH-regulating buffer with antibacterial and antimycotic activity according to any one of claims 1-8, characterized in that the organic acid is lactic acid. A pH-regulating buffer with antibacterial and antimycotic activity according to any one of claims 1-9, characterized in that a 3-20% lactic acid solution is used to prepare the formulation for application to the starting material for making tampons. A pH-regulating buffer with antibacterial and antimycotic activity according to any one of claims 1-10, characterized in that about 5% lactic acid solution is used to prepare the formulation for application to the starting material for the manufacture of tampons. A pH-regulating buffer with antibacterial and antimycotic activity according to any one of claims 1-5, characterized in that the organic acid derivative is a lactic acid derivative. 13. pH regulating and antibacterial and antifungal activity buffer according to claim 12, characterized in that the organic acid derivative is any acidic lactate. A pH-regulating buffer with antibacterial and antimycotic activity according to any one of claims 1-13, characterized in that the formulation for application to the starting material for the production of tampons contains, from 0.5-2.0 wt. % of chitosan and / or chitosan material in dilute organic acid or a derivative thereof, using a 3-20% solution of an organic acid or a derivative thereof, and having a viscosity of 200800 mPa.s at 25 ° C. 15. pH regulating and antibacterial and antifungal activity buffer according to claim 14, characterized in that low molecular weight chitosan and dilute lactic acid are used to prepare the formulation. A pH-regulating buffer with antibacterial and antimycotic activity according to any one of claims 1-11 and 14-15, characterized in that a formulation containing, calculated on the concentration in the formulation, 0.8- 1.2 wt.% Chitosan in 0.8-1.2% lactic acid solution. 17. pH regulating and antibacterial and antifungal activity buffer according to claim 16, characterized in that a formulation containing about 1% by weight of low average molecular weight chitosan is applied to the starting material for the production of tampons. in about 1% lactic acid solution. A pH regulating and antibacterial and antifungal activity pad according to any one of the preceding claims, characterized in that the formulation is applied to the starting material for the production of tampons in an amount of 0.08-0.2 g formulation per 1 g of viscous starting material fibers. 19. A process for the manufacture of a buffer having a pH regulating and antibacterial and antimycotic activity, characterized in that a formulation which is a solution of chitosan and / or chitosan material is applied to the input material for the production of tampons before entering the tampon machine. Organic acid or a derivative thereof having the following characteristics: chitosan and / or chitosan material exhibits antibacterial and antifungal properties; chitosan and / or chitosan material completely soluble in the formulation; the pH of the solution corresponds to the physiological pH of the vagina; and having such a viscosity that makes it possible to apply the solution to the starting material for the production of tampons, including by spraying technique; followed by the entry with the formulation of the treated input material for the production of tampons into the tampon machine and tampon machine. 20. A method of manufacturing a buffer with pH regulating and antibacterial and antimycotic activity according to claim 19, characterized in that a formulation is used which is a solution of chitosan and / or on the input material for the production of tampons. chitosan material in an organic acid or derivative thereof, having the following characteristics: chitosan and / or chitosan material exhibits antibacterial and antifungal properties and is present in the formulation at a concentration higher than 0.5% by weight; chitosan and / or chitosan material is completely soluble in the formulation; The pH of the solution is in the pH range 3.6 to 4.4; and having a viscosity in the range of 1 to 1000 mPa.s; followed by the entry with the formulation of the treated input material for the production of tampons into the tampon machine and tampon machine. 21. A process for making a buffer having pH regulating and antibacterial and antimycotic activity according to any one of claims 19-20, characterized in that the formulation is applied to the input material for the production of tampons by spray technique. A method according to any one of claims 19-21 for the manufacture of a buffer having pH regulating and antibacterial and antifungal activity according to any one of claims 1-18. 23. A method of manufacturing a buffer having pH regulating and antibacterial and antimycotic activity according to any one of claims 19-21, characterized in that it is continuous and in which the input material for the production of tampons, immediately prior to its entry into the tampon machine, is a spray technique is applied to a formulation containing, based on the concentration in the formulation, 0.5-2.0% by weight of chitosan and / or chitosan material in dilute organic acid or a derivative thereof, using a 3-20% solution to prepare the formulation organic acid or a derivative thereof, and having a viscosity of 200-800 mPa.s at 25 ° C, followed by the entry of the formulation of the treated input material for the manufacture of tampons into a tampon-making and tampon-making machine. 24. A method of manufacturing a buffer having pH regulating and antibacterial and antimycotic activity according to any one of claims 19-22, characterized in that the formulation is applied to the input material for the production of tampons in the process of making the buffer strip, which is separated from the process of making tampons, followed by Separate manufacture of tampons based on the formulation of the treated input material on the tampon machine. 25. A process for making a buffer having pH regulating and antibacterial and antimycotic activity according to any one of claims 19-24, characterized in that a formulation containing, calculated on a concentration in the formulation, 0.8 is applied to the starting material for the production of tampons by the spray technique. -1.2 wt% chitosan in 0.8-1.2% lactic acid solution, in an amount of 0.08-0.2 g formulation per 1 g of viscous starting material fibers, followed by the production of a tampon based on the formulated treated input material on the tampon making machine. A pH-regulating buffer as well as antibacterial and antimycotic activity according to any one of claims 1-18, which is capable of maintaining its applied humidity in the vagina and maintaining and generating its physiological pH. A pH regulating and antibacterial and antifungal activity buffer according to any one of claims 1-18 and 26 for use in the vagina for the preventive and / or curative treatment of vaginal fungal and bacterial inflammation and / or urinary incontinence in women. A pH-regulating buffer with antibacterial and antimycotic activity according to any one of claims 1-18 and 26-27 for use in the vagina for the reduction of microorganisms causing vaginal inflammation such as Staphylococcus aureus, Streptococcus Agal, MRSA and Candida.