DE102017121066A1 - Composition, in particular for the care of the intimate or vaginal area - Google Patents

Abstract

The present invention relates to a composition which is suitable for use in the care and / or in the prophylactic and / or therapeutic, preferably topical treatment of the genital area, and which comprises a combination ("active ingredient combination") of lactic acid-producing bacteria and at least one active substance contains antibacterial and / or anti-inflammatory and / or antioxidant effect.

Description

The present invention relates to the technical field of care, hygiene, cosmetics, pharmacy and medical devices.

In particular, the present invention relates to a composition which is suitable for use in the care or prophylactic and / or therapeutic treatment of disorders of the genital area, in particular a disturbed vaginal flora. Furthermore, the present invention relates to the use of a composition according to the present invention and, moreover, to an application device which contains the composition according to the invention.

The term intimate area usually refers to the body region of, in particular, the external human genitals or genitals. In the healthy state, the outer genital area and the female vagina of childbearing age are populated with numerous microorganisms or a special microbiome. This special microbiological ecosystem or microbiome comprises more than 50 different bacterial species. In the case of women of child-bearing potential, these are, in particular, bacteria of the genus Lactobacillus, in particular L. iners, L. delbruekii, L. crispatus, L. vaginalis, L. acidophilus, L. jensenii, L. buchneri and L. gasseri. In addition, the natural microbiome of the female genital tract, also known as the intimate or vaginal flora, contains microorganisms of the genus Bifidobacterium. The microorganisms of the female genitalia forming microorganisms are also referred to as Döderlein bacteria.

In particular, the aforementioned bacteria colonizing the mucous membranes of the female genital area are predominantly lactic acid-fermenting species, in particular lactic acid bacteria, d. H. Microorganisms which, as part of their metabolism, produce lactic acid from glucose and other monosaccharides. On the basis of the formation of a biofilm or of the specific microbiome by the numerous lactic acid bacteria, the pH in the genital area is kept in the acidic range, so that on this basis a colonization with undesired, especially pathogenic microorganisms is counteracted.

Both the microbiome and the biofilm on the mucosa of the genital area as well as the mucosa as such are extremely sensitive. Thus, the mucosa with increasing age, especially in women with the onset of menopause, increasingly thin and dries easier. In addition, hormonal changes, for example, by the intake of hormonal contraceptives, but also by stress or infections to an impairment of the mucous membrane and the microbiome in the genital area. The intake of antibiotics also leads to a sensitive disturbance of the intimate flora.

An impairment of the biofilm in the genital area leads to an increase in the pH, which results in significantly poorer growth conditions for the lactic acid bacteria or lactic acid-producing bacteria. Instead, due to the increased pH, optimal growth conditions are created for undesired and possibly pathogenic microorganisms, such as the yeast Candida albicans or the bacterium Gardnerella vaginalis.

As a result, the genital area or the mucous membrane of the genital area is no longer sufficiently protected from environmental influences. An imbalance of the intimate or vaginal flora is generally associated with an increased susceptibility to infections with pathogenic microorganisms. Accordingly, irritation, inflammation and infections in the genital area can occur even after visiting germ-laden baths or public swimming pools, visiting public toilets or after sexual intercourse. Especially common in this context are fungal infections with Candida albicans. An excessive colonization of the genital area with Gardnerella vaginalis can also lead to a vaginosis associated with unpleasant symptoms.

Infections of the genital area are also associated with the risk that the infections and inflammation spread and can extend to the internal sex organs, especially the uterus or ovaries in women, but also on the other organs in the abdomen, resulting in an intensive systemic, in general makes antibiotic therapy necessary. Repeated infections or recurrent infections can, at worst, lead to infertility in the long run.

Although there are approaches in the prior art to prevent or treat infections of the genital area, these often do not lead to the desired success.

In the context of normal personal hygiene, a washing with preferably surfactant-containing washing lotions or shower baths is provided for the care of the intimate area in particular. However, not only the pathogenic germs are inhibited in their growth or killed by the use of commercially available surfactant cleaning or care products. At the same time, the vaginal flora necessary for a balanced environment and naturally occurring vaginal flora is brought into imbalance or at worst almost completely killed. With commercial care and washing lotions thus the result is rather the opposite effect is achieved, namely virtually promote false colonization. As soon as a colonization or incorrect colonization of the genital area with pathogenic and undesirable germs is present and the lactic acid bacteria no longer find suitable growth conditions, normal personal hygiene is not sufficient to protect the genital area from environmental influences, in particular infections, or to restore the healthy vaginal flora.

In addition, there are approaches that provide the application of lactic acid bacteria or occurring in the natural vaginal flora bacteria in particular female genital area. Thus, among other gels or lotions are known, which are intended for vaginal use and contain lactic acid bacteria. The sole administration of lactic acid bacteria, however, has proved to be insufficient, since the growth conditions in the case of a damaged or imbalanced vaginal flora for lactic acid bacteria are generally so unfavorable that the lactic acid bacteria can not multiply after their application. A recovery of the intimate flora based on products containing lactic acid bacteria as the sole active ingredient is often unsuccessful against this background.

In this connection, probiotic tampons are known from the prior art, which are equipped with lactic acid bacteria. However, a problem with tampons of this type is that they lead to dehydration of the vaginal mucosa, especially in the case of long-term use. In addition, the lactic acid bacteria are often not released in sufficient quantity or efficiency from the tampons, so that overall good efficiency is not guaranteed.

In addition, the technique under the product names Symbiofem ^® Protect tampons are known in which are soaked in pure Vaseline oil and to prevent the penetration on this basis of polluted water into the vagina. The aim is to reduce the risk of infection on the basis of a mechanical barrier, in particular through the tampon, but also through the hydrophobic oil. However, such tampons also lead to dehydration of the mucous membranes and are not suitable for a longer term use against this background. In addition, with mechanical barriers of this type, it is not possible to prevent smear infections, such as those that can occur during toilet visits or sexual intercourse.

The present invention is therefore based on the object to provide a composition which is suitable for the care and / or for the prophylactic or therapeutic treatment of diseases, in particular a disturbed skin flora of the genital area, in particular the intimate area of women, the disadvantages described above The prior art should at least largely be avoided or at least mitigated.

In particular, the present invention has for its object to provide a composition which has a good efficiency in terms of support, but also on the restoration of a healthy or natural vaginal flora and which is also comfortable and easy to use.

To achieve the object described above, the present invention proposes a composition according to claim 1; Further, particularly advantageous embodiments are the subject of the relevant dependent claims.

Another object of the present invention is the use of a composition according to the relevant independent claim.

In addition, the subject of the present invention is an application device which contains a composition according to the present invention.

It goes without saying that in the following special embodiments, embodiments or the like, which are described only in connection with an aspect of the invention, also apply correspondingly in relation to the other aspects of the invention, without this requiring an explicit mention.

Furthermore, it must be noted in the context of the present invention that those skilled in the art should select each of the abovementioned relative or percentage, in particular weight-related quantities, that the sum of the respective ingredients, active ingredients, additives or auxiliaries or the like is always 100%. or 100 wt .-% result. This is understood by the skilled person but by itself.

Incidentally, the person skilled in the art may deviate from the number, range or quantity information given below, based on the application or the individual case, without departing from the scope of the present invention. In addition, it is true that all the parameter information or the like mentioned below can in principle be determined or determined using standardized or explicitly stated determination methods or else determination methods familiar to the person skilled in the art.

Having said that, the present invention will now be explained in detail below.

1. (a) Milchsäure produzierenden Bakterien, insbesondere der Gattung Lactobacillus und/oder Bifidobacterium, und
2. (b) mindestens einem Wirkstoff mit antibakterieller und/oder antiinflammatorischer und/oder antioxidativer Wirkung, insbesondere mindestens einem Pflanzenextrakt mit antibakterieller und/oder antiinflammatorischer und/oder antioxidativer Wirkung, vorzugsweise Magnolienextrakt (Magnolia sp.), und/oder insbesondere mindestens einem mineralischen, insbesondere metall-, metalloxid- und/oder metallsalz-basierten, vorzugsweise partikulären Wirkstoff mit antibakterieller und/oder antiinflammatorischer und/oder antioxidativer Wirkung,

enthält.The present invention - according to a first aspect of the invention - is thus a composition, in particular for use in the care and / or in the prophylactic and / or therapeutic, preferably topical treatment of the preferably female intimate and / or vaginal area, in particular for the treatment of a Damaged skin flora in the intimate and / or vaginal area and / or to support the skin flora in the intimate and / or vaginal area, wherein the composition is a combination ("drug combination") of

1. (a) lactic acid producing bacteria, in particular the genus Lactobacillus and / or Bifidobacterium, and
2. (b) at least one active substance having an antibacterial and / or antiinflammatory and / or antioxidant action, in particular at least one plant extract having an antibacterial and / or antiinflammatory and / or antioxidant action, preferably magnolia extract (Magnolia sp.), and / or in particular at least one mineral, in particular metal, metal oxide and / or metal salt-based, preferably particulate active ingredient having antibacterial and / or anti-inflammatory and / or antioxidant activity,

contains.

On the basis of the active ingredient combination according to the invention, namely lactic acid-producing bacteria on the one hand and at least one active ingredient having antibacterial, anti-inflammatory and / or antioxidant action on the other hand, in the composition of the invention, the natural skin flora in the genital area, especially the vaginal flora, on the one hand already supported and strengthened on a prophylactic level , In addition, the composition according to the invention is also suitable for restoring an already severely damaged or unbalanced skin flora in the genital area, which is no longer adequately protected against environmental influences, in particular pathogenic germs.

In the context of the present invention, it has surprisingly been found that lactic acid-producing bacteria, in particular of the genus Lactobacillus or Bifidobacterium, in combination with antibacterial, antiinflammatory or antioxidant plant extracts or in combination with mineral, in particular particulate active ingredients having antibacterial or antiinflammatory or antioxidant action have an excellent activity in the support or restoration of the skin flora in the genital area, especially the vaginal flora possess.

On the basis of the composition according to the invention, the genital area is adjusted to a slightly acidic environment, so that optimal growth conditions are created for the naturally occurring in the skin flora lactic acid bacteria and unfavorable conditions for pathogenic microorganisms. At the same time, the growth of pathogenic microorganisms is further inhibited by the antibacterial or anti-inflammatory or antioxidant active substance. The growth inhibition of the pathogenic microorganisms, so to speak, creates space for the growth of lactic acid bacteria, which can then gradually settle due to the acidic environment.

The present invention as a whole is associated with numerous advantages and particularities, which are discussed below in a non-limiting manner and are to be regarded as an indication of the patentability of the article according to the invention.

The additional use of lactic acid-producing bacteria, in particular in tyndallisierter and optionally lyophilisierter form, a colonization of the genital area with not commonly occurring in the vaginal flora microorganisms, especially pathogenic microorganisms such as Candida albicans or Gardnerella vaginalis, counteracted. The antibacterial or antiinflammatory or antioxidative components contained in the composition according to the invention furthermore prevent the growth of pathogenic germs or microorganisms undesired in the intimate area.

In particular, the composition according to the invention is also suitable for therapeutically treating an already damaged skin flora in the genital area, in particular a damaged vaginal flora, and restoring a balanced environment or a balanced colonization of the intimate area. In this context, a synergistic effect - without wishing to be limited to this theory - of lactic acid-producing bacteria on the one hand and the antibacterial or anti-inflammatory or antioxidant active ingredient on the other hand, as well as the embodiments of the invention show below. With regular use of the composition according to the invention, the proportion of lactobacilli and bifidobacteria in the skin flora of the genital area, in particular the vaginal flora, can be increased, whereas the proportion of undesired, especially pathogenic, germs is markedly reduced.

The composition of the invention is also characterized by its excellent compatibility. The active ingredient combination according to the invention is at least substantially free of side effects. In particular, a drying out of the mucous membranes can be prevented or the composition can also be enriched with mucous membrane caring or skin-care ingredients, so that in particular a longer-term application or application of the composition is possible and has an overall positive effect on the condition of the mucosa.

Furthermore, the composition according to the invention is distinguished from measures known from the state of the art for aiding or restoring a healthy skin flora in the genital area by a faster onset of action, which in particular - without wishing to be limited to this theory - the synergistic effect of lactic acid on the one hand and at least one active substance with antibacterial or antiinflammatory or antioxidant action, on the other hand. By the lactic acid-producing bacteria is already a spatial displacement of pathogenic or unwanted germs instead. In addition, the at least one antibacterial, anti-inflammatory or antioxidant active ingredient can inhibit the growth of the unwanted germs. The additional use of lactic acid can further accelerate the onset of action, since the pH in the genital area or in the skin flora is adjusted to a slightly acidic environment immediately after application by lactic acid, which further improves the growth conditions for naturally occurring bacteria in the vaginal flora ,

In the context of the present invention, a composition is thus provided which can prevent false colonization in the intimate area, in particular in women. By stabilizing the natural skin flora of the genital area infections and inflammation caused by pathogenic bacteria can be prevented. In addition, spillage and existing infections can be effectively treated with the composition of the present invention. The composition according to the invention is thus suitable both for use as a care or hygiene product in the context of daily intimate care and for the treatment of a skin flora in the genital area on a therapeutic level that has become unbalanced.

The lactic acid-producing bacteria used in the present invention are a very heterogeneous group of Gram-positive anaerobic but generally aerotolerant bacteria which have the ability to ferment sugars to lactic acid (which is commonly referred to as lactic acid fermentation). , In particular, species of the genera Lactobacillus, which are generally referred to as lactic acid bacteria, and Bifidobacterium belong to the group of lactic acid fermenting bacteria. In terms of their morphological properties, lactic acid-producing bacteria or lactic acid bacteria are very heterogeneous and are characterized by their specific metabolism. Unlike most other types of bacteria, lactic acid bacteria depend on carbohydrates and numerous supplines for energy. With regard to metabolism, lactic acid bacteria can be subdivided into homofermentative bacteria and heterofermentative lactic acid bacteria, with homofermentative bacteria being the end product of their fermentation metabolism produce exclusively lactic acid and produce heterofermentative bacteria or bifidobacteria in addition to lactic acid or lactate and other end products, in particular acetate or acetic acid, ethanol and CO ₂ .

Since lactic acid bacteria rely on a nutrient- and supplin-rich environment due to their degenerate or restricted metabolism, they settle mainly in milk and milk products, in the intestine or mucous membranes of mammals and in living or decomposing plants. For humans, the lactic acid bacteria are among the most important and useful representatives of the human intestinal flora, but also - as already mentioned - to the skin flora, especially the vaginal flora. Specifically, the microorganisms found in the vaginal flora are also referred to as Döderlein bacteria.

As already stated above, it has surprisingly been found within the scope of the present invention that the lactic acid-producing bacteria or their action in the composition according to the invention can be further assisted if the composition contains at least one active substance with antibacterial or antiinflammatory or antioxidant action. In this connection, it has been shown that, on the one hand, excellent efficacy can be achieved if the compositions contain lactic acid-producing bacteria in combination with at least one plant extract having an antibacterial or antiinflammatory or antioxidant effect. Particularly good results are achieved on the basis of a use of magnolia extract.

Magnolia extract can be obtained in particular from the flowers, the leaves or the bark, preferably the bark, of Magnolia sp., In particular Magnolia officinalis, preferably by production with supercritical oxygen. In addition to the characteristic essential oil, the ingredients of magnolia or magnolia extract also include sesquiterpenes, dimeric phenylpropanoids, in particular lignans and neolignans, benzylisoquinoline alkaloids, magnoflorin and phenylpropanoid glycosides. The main active ingredients of the magnolia extract are the biphenols magnolol and honokiol, which are distinguished by antioxidant, antimicrobial and anti-inflammatory properties. In the context of the present invention, in particular the antioxidative, antiinflammatory and antibacterial effects of the magnolia extract or of the ingredients of the magnolia extract are relevant.

In addition, magnolia extract not only inhibits the growth of microorganisms, especially on the skin, but also has a skin-conditioning effect, which further improves the effectiveness of the composition according to the invention.

As equally suitable for combination with lactic acid-producing bacteria for the preparation of a composition for use in the care and / or treatment of the Intimbereichs have proven mineral active ingredients with antibacterial, anti-inflammatory or antioxidant effect. In particular, these may be metal, metal oxide or metal salt-based particulate active substances having an antibacterial, anti-inflammatory and / or antioxidant action. In other words, in the context of the present invention, it can equally be provided that the composition according to the invention contains lactic acid-producing bacteria in combination with metal, metal oxide or metal salt-based particles having antibacterial or antiinflammatory or antioxidant action. These are preferably microparticles based on metals or metal oxides, which as such in particular have antimicrobial properties or are provided with an antimicrobial doping.

In addition, in the context of the present invention, it can likewise be provided that at least one plant extract, in particular magnolia extract, and metal, metal oxide or metal salt-based particulate active substances are used in combination as the active ingredient having an antibacterial or antiinflammatory or antioxidant effect ie a combination of both active substances.

The effectiveness of the compositions according to the invention based on the abovementioned components is also evidenced by the exemplary embodiments described below.

As regards the selection of the lactic acid-producing bacteria used in the present invention, these are in particular bacteria operating from the group of lactic acid fermentation, in particular in the normal flora of the human skin, in the male or female intimate area, in the vagina and / or vulva-occurring lactic acid fermenting bacteria , selected. In particular, the naturally occurring in the normal flora of the human skin, especially in the lactic acid producing bacteria in the female genital area, are the so-called Döderlein bacteria, which normally colonize the vagina of women of childbearing age. Especially these are the bacteria Bifidobacterium ssp., Lactobacillus delbruekii, Lactobacillus gasseri, Lactobacillus jensenii, Lactobacillus crispatus, Lactobacillus iners and Lactobacillus acidophilus.

Against this background, it may in particular be provided that the lactic acid-producing bacteria in the composition according to the invention are selected from the group of bacteria of the genus Lactobacillus, Bifidobacterium and / or Pediococcus, preferably Lactobacillus.

According to a particularly preferred embodiment of the present invention, the lactic acid-producing bacteria from the group of Bifidobacterium ssp., Lactobacillus iners, Lactobacillus delbruekii, Lactobacillus crispatus, Lactobacillus vaginalis, Lactobacillus acidophilus, Lactobacillus jensenii, Lactobacillus buchneri and / or Lactobacillus gasseri, especially Lactobacillus acidophilus selected.

Furthermore, with regard to the composition according to the invention, it can be provided that it contains the lactic acid-producing bacteria in the form of vital cells. In addition, it may also be provided that the composition contains the lactic acid-producing bacteria in the form of Überdauerungsformen, in particular in the form of spores. Furthermore, according to a further and particularly preferred embodiment of the composition according to the invention, it is also possible that the composition contains the lactic acid-producing bacteria in the form of inactive cells, in particular lyophilized or tyndallized cells.

According to a particularly preferred embodiment of the present invention, the lactic acid-producing bacteria are present in the composition according to the invention in the form of inactive cells, preferably in the form of lyophilized and / or tyndallized cells.

In the context of the present invention, lyophilized cells or bacteria are understood as meaning, in particular, bacteria which, by sublimation by lyophilization, also referred to as freeze-drying, are gently dried and stored or preserved in this manner. Tyndallized cells or bacteria are in the context of the present invention a heat-inactivated form of lactic acid-producing bacteria. In particular, it may also be envisaged to use lactic acid-producing bacteria in the context of the present invention for the hygiene article, which are first heat-inactivated by means of Tyndallization and subsequently rendered stable by lyophilization or freeze-drying. Tyndallized and then optionally lyophilized cells are characterized by the fact that they are no longer viable and thus inactive, but the integrity of the cell wall or the cell structures is retained. On this basis, the vaginal flora can be completely surprisingly supported or the cells could continue to possess immunostimulatory properties.

The advantage of using tyndallized and / or lyophilized bacteria for the composition according to the invention is, in particular, that the shelf life of the hygiene articles containing lactic acid-producing bacteria is improved, since uncontrolled proliferation of the lactic acid-producing bacteria during storage can be prevented. Moreover, it was completely surprising that even with inactivated, in particular heat-inactivated lactic acid-producing bacteria excellent efficacy in terms of the restoration or treatment of the vaginal flora is achieved. Without wishing to be limited to this theory, this can be attributed to a physical displacement of undesired microorganisms, in particular pathogenic germs, by the tyndallized and / or lyophilized cells. In addition, it is possible that the vaginal flora is supported on the basis of an immunostimulatory effect.

The tyndallized or lyophilized bacteria used according to this preferred embodiment thus lead on the one hand to a significantly improved shelf life or preservability of the composition and on the other hand to an outstanding effectiveness with respect to the restoration of a healthy skin flora in the genital area, especially a healthy vaginal flora, and on the prophylaxis or treatment of infections in the genital area, in particular vaginal infections.

Thus, according to a particularly preferred embodiment of the present invention, it may be provided in particular that the composition contains the lactic acid-producing bacteria in the form of tyndallized cells, preferably in the form of tyndallized cells of Lactobacillus acidophilus.

According to another equally possible embodiment of the present invention, it may also be provided that the composition comprises the lactic acid-producing bacteria in the form of tyndallized cells and in the form of vital cells, preferably in the form of tyndallized cells and vital cells of Lactobacillus acidophilus.

In order to ensure good effectiveness of the composition according to the invention, it is also preferred in the context of the present invention if the composition of the lactic acid-producing bacteria in an amount in the range of 10 ¹ to 10 ³⁰ CFU (colony forming units), in particular in the range of 10 ² to 10 ²⁰ cfu, preferably in the range of 10 ⁵ to 10 ¹⁸ cfu, preferably in the range of 10 ¹⁰ to 10 ¹⁵ cfu, based on the composition.

As far as the term Colony Forming Units (CFU) is concerned, synonymously referred to in English as Colony Forming Unit (CFU), this is a quantity which is commonly used in microbiology for the quantification of microorganisms. The number of living cells of microorganisms in a material is determined with the aid of cultivation methods known to those skilled in the art. In this case, a sample of the material whose microorganism content is to be determined is distributed evenly and usually at a high dilution on the surface of a culture medium so that the individuals of the microorganisms contained in the sample come to rest individually and spaced apart and become visible through growth and multiplication Training colonies. The number of colonies can be used to determine the number of individuals originally present in the sample. In the case of inactive cells or forms of survival, as can be used in the context of the present invention, in particular lyophilized or tyndallized cells, the number of colony-forming units corresponds to the number of cells in inactive cells.

In addition, it may be provided that the composition contains the lactic acid-producing bacteria in an amount in the range of 0.00001 to 15 wt .-%, in particular in the range of 0.0001 to 10 wt .-%, preferably in the range of 0, 0005 to 5 wt .-%, particularly preferably 0.001 to 2.5 wt .-%, most preferably 0.005 to 1 wt .-%, based on the composition contains. The abovementioned amounts are the inventively preferred amounts for the sum of all lactic acid-producing bacteria in the composition according to the invention.

With regard to the quantities of lactic acid-producing bacteria in the composition according to the invention, it is preferred according to the invention if the composition contains lactic acid-producing bacteria, specifically in the form of tyndallised and / or lyophilized cells, in an amount in the range from 0.0001 to 10% by weight. , in particular in the range of 0.001 to 5 wt .-%, preferably in the range of 0.01 to 1 wt .-%, preferably in the range of 0.05 to 0.5 wt .-%, based on the composition.

With regard to an embodiment of the composition according to the invention, according to which the lactic acid-producing bacteria may also be present in the form of vital cells, it is preferred if the composition according to the invention comprises them in an amount in the range from 0.0001 to 2.5% by weight. , in particular in the range of 0.0005 to 1 wt .-%, preferably in the range of 0.001 to 0.01 wt .-%, based on the composition.

In the event that the composition of the invention is to contain the lactic acid-producing bacteria in vital form, it is particularly preferred if they are present in combination with lyophilized or tyndallisierten cells in the composition of the invention. In this context, it has proved to be particularly advantageous if the composition contains lactic acid-producing bacteria in the form of vital cells on the one hand and lactic acid-producing bacteria in the form of tyndallized or lyophilized cells on the other hand in a defined weight-based quantitative ratio. It has proved to be particularly suitable if the composition comprises lactic acid-producing bacteria in the form of vital cells and lactic acid-producing bacteria in the form of tyndallized and / or lyophilized cells in a weight-based ratio in the range from 1: 500 to 100: 1, in particular in the range from 1: 100 to 50: 1, preferably in the range from 1:50 to 20: 1, preferably in the range from 1: 30 to 1: 1, particularly preferably in the range from 1:15 to 1: 5.

In the context of the present invention, it has moreover surprisingly been found that the composition according to the invention has a particularly good efficiency when the lactic acid-producing bacteria are used in combination with at least one active substance having an antibacterial, antiinflammatory or antioxidant effect. For, without wishing to be limited to this theory, the bacteria producing lactic acid cause a colonization of the mucous membranes in the genital area, in particular the vaginal mucous membrane, so that unwanted and pathogenic microorganisms are displaced. By the antibacterial, antiinflammatory or In addition, undesirable, especially pathogenic microorganisms can be inhibited in their growth antioxidative agents, so that complement the active components synergistically. On the basis of the growth inhibition of pathogenic microorganisms, so to speak space for the colonization of the mucous membrane with lactic acid bacteria is created.

According to a particularly preferred embodiment, it may be provided to use the lactic acid bacteria in combination with at least one antibacterial or antiinflammatory or antioxidant plant extract. Magnolia extract has been found to be particularly suitable, which has both antibacterial and antiinflammatory and antioxidant. Through the use of magnolia extract it is thus possible on the one hand to inhibit the growth of unwanted microorganisms, in particular pathogenic pathogens such as Candida albicans or Gardnerella vaginalis. In addition, inflammatory processes associated with infections, e.g. a vaginosis, occur, be alleviated. At the same time, magnolia extract has a skin-care effect in the compositions according to the invention.

With regard to a particularly good effectiveness, it has proved to be advantageous if the composition contains the at least one plant extract having an antibacterial or anti-inflammatory or antioxidant action in an amount in the range of 0.0001 to 15 wt .-%, in particular in the range of 0.001 to 10 wt .-%, preferably in the range of 0.001 to 5 wt .-%, particularly preferably 0.01 to 1 wt .-%, most preferably 0.05 to 0.5 wt .-%, based on the Composition containing.

The selection of the extract or the form of the extract is variable and can be tailored to the dosage form or application form:

In particular, it has proved to be advantageous to adjust the composition according to the invention to a defined drug / extract ratio. The so-called drug / extract ratio (DEV) characterizes the weight-related ratio of starting drug used to extract obtained. In other words, the drug / extract ratio thus indicates from which weight-related amount of drug used (for example Magnolia officinalis) which weight-related amount of extract is obtained. A drug / extract ratio of, for example, 10: 1 means that one part by weight of extract was obtained from 10 parts by weight of drug. The drug / extract ratio thus indicates how many parts by weight of a drug drug are required for the preparation of the weight-related extract equivalent.

The use of extracts with a defined drug / extract ratio is particularly relevant in the light of the fact that the quality of the extract has a decisive influence on the overall quality of the composition according to the invention. The aim in particular is to standardize the extract with regard to the concentration of the active ingredient, so that the final composition according to the invention can also be provided qualitatively and quantitatively with consistently good values with regard to the active substances and ingredients, in particular with regard to the antibacterial, antiinflammatory or antioxidant action can.

According to a first preferred embodiment of the present invention, it may be provided in this context that the at least one plant extract with antibacterial and / or anti-inflammatory and / or antioxidant action, in particular the magnolia extract, in the form of a dry extract, preferably with a drug / extract ratio in the range of 12: 1 to 4: 1, in particular in the range of 10: 1 to 5: 1, is used. Dry extracts are usually prepared by drying the plants or plant parts with subsequent extraction of the active ingredients. The resulting extracts are generally adjusted to a defined active substance content.

According to a further preferred embodiment, it can also be provided that the at least one plant extract with antibacterial and / or anti-inflammatory and / or antioxidant action, in particular the magnolia extract, in the form of a fluid extract, preferably with a drug / extract ratio in the range of 1: 5 to 3: 1, in particular in the range of 1: 3 to 2: 1, preferably in the range of 1: 2 to 1: 1, is used. Fluid extracts have proven to be particularly advantageous in view of the processability and handling in the preparation of the compositions according to the invention. Fluid extracts are particularly well suited for providing liquid compositions of the invention.

In addition, it can be provided according to the invention that the at least one plant extract having antibacterial and / or antiinflammatory and / or antioxidant action, in particular the magnolia extract, in the form of a thick extract, preferably with a drug / extract ratio in the range of 1: 1 to 8 : 1, in particular in the range of 2: 1 to 7: 1, preferably in the range of 3: 1 to 6: 1, is used.

According to a further embodiment of the present invention, it can also be provided that the at least one plant extract having an antibacterial and / or antiinflammatory and / or antioxidant action, in particular the magnolia extract, is used in the form of a tincture.

As far as a particularly preferred embodiment of the composition according to the invention is concerned, the plant extract is an extract obtained from plants of the genus Magnolia. In this context, it may be provided in particular that the at least one plant extract having antibacterial and / or anti-inflammatory and / or antioxidant action is an extract prepared from flowers, leaves and / or bark, in particular bark, from Magnolia sp., Preferably Magnolia officinalis , An extract prepared from the bark of Magnolia officinalis is characterized by particularly good antioxidant, antimicrobial and anti-inflammatory properties.

According to an equally preferred embodiment of the composition according to the invention, it may additionally be provided that mineral substances, in particular based on metals, metal oxides or metal salts, which are preferably present in the form of particles, are used as the antibacterial, anti-inflammatory or antioxidant active substance. On this basis, pathogenic or undesirable microorganisms can be inhibited in an extremely efficient manner in their growth.

It has proved to be particularly advantageous if the composition comprises the at least one mineral, in particular metal, metal oxide and / or metal salt-based active ingredient having antibacterial and / or anti-inflammatory and / or antioxidant activity in an amount in the range of 0.001 to 10 Wt .-%, in particular in the range of 0.01 to 5 wt .-%, preferably in the range of 0.05 to 2.5 wt .-%, preferably in the range of 0.1 to 1 wt .-%, based on the composition, contains.

With regard to this embodiment, it has proved to be particularly advantageous if the at least one mineral, in particular metal, metal oxide and / or metal salt-based, active substance with antibacterial and / or anti-inflammatory and / or antioxidant action on particles, in particular nano- and / or microparticles, preferably microparticles. A particularly good effect is achieved with nano- or microparticles, which are selected from the group of zinc oxide particles, copper oxide particles and / or titanium oxide particles. Metallic particles of the aforementioned type have antimicrobial properties which effectively inhibit growth of undesirable, especially pathogenic microorganisms.

To further improve the antimicrobial properties of the particles used, in particular to enhance it, it may also be provided that the particles have an antibacterial doping and / or coating, preferably selected from copper and / or manganese dopants. On this basis, growth inhibition with respect to pathogenic agents can be further strengthened.

In the context of the present invention, it can thus be provided that the composition according to the invention contains the lactic acid-producing bacteria in combination with at least one plant extract, in particular magnolia extract. Similarly, it may be provided that the composition of the invention contains the lactic acid-producing bacteria in combination with at least one mineral, especially metal, metal oxide and / or metal salt-based active ingredient having antibacterial or anti-inflammatory or antioxidant activity. Moreover, it can also be provided according to the invention that the lactic acid-producing bacteria are present in the composition according to the invention in combination with the at least one plant extract and moreover with at least one mineral, in particular metal, metal oxide and / or metal salt-based active ingredient. The outstanding properties of compositions according to the invention with the abovementioned active compound combinations are also substantiated on the basis of the exemplary embodiments described below in detail.

According to a particularly preferred embodiment of the composition according to the invention, it may also be provided that the composition contains lactic acid or its salts. The additional use of lactic acid, the growth conditions for naturally occurring in the skin flora of the genital area, especially in the vaginal flora, bacteria are further promoted, whereas unfavorable growth conditions are created for pathogenic or undesirable microorganisms. In particular, the pH in the genital area, especially on the mucosa of the genital area, is adjusted to a slightly acidic environment by the lactic acid, which is the colonization of the mucous membrane by desired bacteria, in particular the lactic acid-producing bacteria or the so-called Döderlein bacteria, further promotes.

As far as the amount of lactic acid used in the compositions according to the invention is concerned, this may vary within wide limits. Particularly good results in terms of effectiveness are achieved when the composition lactic acid or salts thereof in an amount in the range of 0.001 to 20 wt .-%, preferably in the range of 0.01 to 10 wt .-%, preferably in the range from 0.1 to 5 wt .-%, particularly preferably in the range of 1 to 3 wt .-%, based on the composition.

In addition to stimulating the growth and metabolic activity of the lactic acid-producing bacteria, in particular by setting a slightly acidic environment, lactic acid in the composition according to the invention also has a skin-care effect, which also improves the effective efficiency of the composition.

Moreover, it has proven to be advantageous with regard to the composition according to the invention if it additionally contains at least one antioxidant ingredient or at least one antioxidant. The use of antioxidants in the composition according to the invention protects the skin, in particular the cells of the mucous membrane in the genital area, from free radicals. In particular, by environmental influences, such as stress, infections, alcohol consumption or smoking, more free radicals can be released in the body. High levels of free radicals can cause cell and tissue damage. Through the use of antioxidants or at least one oxidative ingredient, the skin, in particular the mucosa of the genital area, can be protected from oxidative stress.

According to the invention, it is particularly preferred if the at least one antioxidant ingredient from the group of (i) vitamin E, in particular tocopherols and / or tocotrienols, (ii) vitamin A and / or provitamin A, (iii) vitamin C, (iv) palmitates , (v) lycopene and / or (vi) ubiquinone; particularly preferably (i) vitamin E, in particular tocopherols and / or tocotrienols, is selected.

Furthermore, as far as the amount of antioxidant ingredients used is concerned, it can vary widely. Particularly good results are achieved if the composition contains cosmetically and / or dermatologically acceptable antioxidant ingredients in an amount in the range from 0.01 to 5% by weight, in particular in the range from 0.05 to 2.5% by weight, preferably in the range of 0.01 to 1 wt .-%, based on the composition.

In order to further improve the properties or effective efficiency of the composition according to the invention, it may additionally be provided that the composition contains, in addition to magnolia extract and lactic acid, which already have certain skin-care properties, at least one further skin-care ingredient and / or ingredient with a skin care effect. At least one skin-care ingredient promotes the healing of inflamed skin or the regeneration of damaged skin in the genital area. In addition, the skin is supplied with moisture, which also accelerates the healing process. In addition, skin care ingredients lead to a certain sealing of the skin, which further counteracts dehydration and also protects against colonization by pathogenic bacteria.

In this context, it can be provided, in particular, that the at least one further skin care ingredient and / or ingredient with a skin-care effect from the group of (i) glycerol and / or its derivatives, in particular ethylhexylglycerol and / or glycerol, (ii) glycols, in particular Pentyleneglycol (1,2-dihydroxypentane), (iii) allantoin, ingredients of aloe vera, bisabolol, hyaluronic acid and / or their salts, inulin, panthenol and / or pantothenic acid, (iv) hydrogenated glycerides, in particular hydrogenated palmglyceride, (v) natural Gums, especially sclerotium gum and / or xanthan gum, (vii) capryl alcohol derivatives, especially dicaprylyl carbonate.

Particularly good results are achieved when the composition contains as further skin care ingredient and / or ingredient with skin-care effect dicaprylyl carbonate, ethylhexylglycerol, pentylene glycol, inulin, hydrogenated palm glyceride, sclerotium gum and / or xanthan gum.

The amount of other skin-care ingredients used can vary within wide ranges. Particularly good results are obtained when the composition contains skin care ingredients and / or skin care ingredients in an amount in the range of 1 to 50% by weight, especially in the range of 2 to 40% by weight, preferably in the range of 5 to 35 wt .-%, preferably in the range of 10 to 30 wt .-%, based on the composition contains.

In addition, it can be provided in the context of the present invention that the composition contains at least one cosmetically and / or dermatologically compatible emulsifier or stabilizer. The use of an emulsifier or stabilizer ensures the formation of a homogeneous composition. In addition, by means of an emulsifier or stabilizer, the quality of the composition according to the invention, in particular with regard to the formation of a stable foam or gel or a stable emulsion, can be controlled in a targeted manner.

Particularly good results are achieved according to the invention if the at least one emulsifier and / or stabilizer selected from the group consisting of (i) lauryl derivatives, in particular lauryl sulfate and / or inulin lauryl carbamate, preferably inulin lauryl carbamate, (ii) glycerides of fatty acids, in particular glycerides of palmitic acid, (iii) long-chain alcohols, in particular alcohols having 10 to 30 C atoms, preferably 14 to 22 C atoms, (iv) long-chain alkylpolyglycosides, in particular alkylpolyglycosides having 8 to 30 C atoms, preferably 12 to 20 C atoms, (v) phospholipids, in particular lecithins and / or lysolecithins, and / or (vi) stearoyl derivatives and / or their salts, in particular sodium stearoyl glutamate.

As regards the amounts of cosmetically or dermatologically compatible emulsifiers or stabilizers used in the composition according to the invention, it may be provided in particular that the composition contains them in an amount in the range from 0.1 to 20% by weight, in particular in the range from 1 to 15 wt .-%, preferably in the range of 2 to 10 wt .-%, preferably in the range of 3 to 8 wt .-%, based on the composition.

In view of the effectiveness of the composition according to the invention, it has also proven to be advantageous if the composition contains at least one cosmetically and / or dermatologically compatible humectant. By using at least one humectant, the durability of the compositions according to the invention can be improved, in particular with regard to avoiding drying out of the composition. In addition, the suppleness of the composition according to the invention can be obtained.

Particularly good results are achieved if the at least one humectant from the group of (i) siloxanes and / or silicones, in particular cyclomethicone and / or cyclopentasiloxane, (ii) glycerol, (iii) glycols, in particular pentylene glycol, (iv) polyalkylene glycols, in particular Polyethylene glycol and / or polypropylene glycol, and / or (v) sorbitol is selected. According to a particularly preferred embodiment of the present invention, the composition contains as humectant pentylene glycol and / or glycerol.

With regard to the amounts of a humectant, it may be provided, in particular, that the composition contains cosmetically and / or dermatologically acceptable humectants in an amount in the range from 0.1 to 20% by weight, in particular in the range from 1 to 10% by weight. %, preferably in the range of 2 to 8 wt .-%, based on the composition contains.

In order to further improve or tailor the properties of the composition according to the invention, it may also be provided that the composition contains at least one cosmetically and / or dermatologically tolerated excipient. In particular, the adjuvant may be selected from the group of binders, film formers, chelating agents, rheology modifiers, buffer substances and / or pH adjusters. The auxiliaries are substances which are known to the person skilled in the art in the field of the production of cosmetic or dermatological compositions and which they can purposefully use and combine.

Furthermore, it can also be provided that the composition contains at least one cosmetically and / or dermatologically compatible solvent. In particular, with regard to compositions according to the invention in liquid form, the use of a solvent has proven itself.

Particularly good results in the context of the present invention are achieved if the composition comprises at least one cosmetically and / or dermatologically acceptable solvent selected from the group of 1,2-hexanediol, ethanol, butyl acetate, 1,3-butanediol, cyclopentasiloxane, ethyl acetate, glycerol, Ethylene glycol, isopropyl alcohol, methyl propane diol, propylene glycol and / or water, especially glycerol and / or water. In particular, combinations or mixtures of solvents, e.g. Mixtures of glycerine and water are used in the present invention.

The amount of solvent used is variable and is readily adapted by the skilled person to the amounts of other ingredients used and to the application or dosage form. In particular, it can be provided in the context of the present invention that the composition cosmetically and / or dermatologically acceptable solvents in an amount in the range of 5 to 99 wt .-%, in particular in the range of 10 to 95 wt .-%, preferably in the range from 20 to 90% by weight, preferably in the range from 30 to 80% by weight, based on the composition.

Moreover, in the context of the present invention, in particular for the preparation of a composition according to the invention as a solid administration form z. B. in the form of suppositories or ovules, be provided that the composition contains at least one cosmetically and / or dermatologically acceptable carrier material. Particularly good results are achieved if the carrier material is selected from the group of water-insoluble carrier materials, in particular from the group of mono-, di- and / or triglycerides, and / or water-soluble carrier materials, in particular polyalkylene glycols, preferably polyethylene glycol. In particular, the compositions may also contain combinations of carrier materials, e.g. a blend based on polyethylene glycol (PEG) 1,500 and 6,000.

As far as the amount of support material in the compositions according to the invention is concerned, this can vary within wide limits. It goes without saying for the person skilled in the art to tailor the amount of carrier material to be used to the other ingredients and active ingredients of the composition according to the invention and taking into account the form of administration. According to the invention, it can be provided in particular that the composition is cosmetically and / or dermatologically compatible carrier material in an amount in the range from 5 to 99% by weight, in particular in the range from 10 to 95% by weight, preferably in the range from 20 to 90 Wt .-%, preferably in the range of 30 to 80 wt .-%, based on the composition contains.

As far as the form, in particular the form of application, of the compositions according to the invention are concerned, they may be in general customary application forms suitable for dermal or cosmetic or topical application. In particular, it may be provided that the composition is solid, liquid, gelatinous and / or pasty, preferably solid or liquid.

Depending on the form of application or state of matter, the person skilled in the art knows how to select the carrier and auxiliary substances and solvents required for this purpose. In particular, it is preferred according to the invention that liquid compositions according to the present invention have a solvent as defined above. In contrast, solid compositions may in particular contain or be based on a carrier material as defined above.

With regard to the administration form of the composition according to the invention, it can be provided in particular that the composition is present as a solution, gel, lotion, cream, suppository and / or ovule. On this basis, a comfortable applicability is guaranteed. In addition, compositions in the form of a suppository or ovule have a prolonged duration of action, since the ingredients and active ingredients are released over an extended period of time from the administration form at the site of action.

In addition, it may equally be provided that the composition is present as a sprayable and / or sprayable composition, in particular as a spray and / or aerosol. Also sprayable or sprayable compositions, in particular in the form of sprays or aerosols, are characterized by a particularly convenient applicability. Sprayable compositions are advantageous in that, during application, contact of the hands with the sensitive genital area can be avoided, which prevents further germ transmission.

According to another preferred embodiment of the composition according to the invention, it may also be provided that it is present as a foam-forming and / or foamable composition. A foam or a foam-forming or foamable composition is also characterized by a comfortable applicability and a long-lasting duration of action.

The composition according to the invention can thus be provided on the basis of all common application forms for cosmetic and care products or dermatological products that are generally known to those skilled in the art. In particular, as regards the provision of the composition according to the invention in the form of a foam, this is in particular formed by the use of blowing gases or pressure when using a foam-forming or foaming composition.

1. (a) Milchsäure produzierenden Bakterien, insbesondere der Gattung Lactobacillus und/oder Bifidobacterium,
2. (b) mindestens einem Wirkstoff mit antibakterieller und/oder antiinflammatorischer und/oder antioxidativer Wirkung, insbesondere mindestens einem Pflanzenextrakt mit antibakterieller und/oder antiinflammatorischer und/oder antioxidativer Wirkung, vorzugsweise Magnolienextrakt (Magnolia sp.), und/oder insbesondere mindestens einem mineralischen, insbesondere metall-, metalloxid- und/oder metallsalz-basierten, vorzugsweise partikulären Wirkstoff mit antibakterieller und/oder antiinflammatorischer und/oder antioxidativer Wirkung, und
3. (c) Milchsäure und/oder deren Salzen,

enthält. The present invention according to a first preferred embodiment is thus a composition, in particular for use in the care and / or in the prophylactic and / or therapeutic, preferably topical treatment of the preferably female intimate and / or vaginal area, in particular for the treatment of a disturbed skin flora in the intimate and / or vaginal area and / or to support the skin flora in the intimate and / or vaginal area, particularly preferably composition as described above, wherein the composition is a combination ("active ingredient combination") of

1. (a) lactic acid-producing bacteria, in particular the genus Lactobacillus and / or Bifidobacterium,
2. (b) at least one active substance having an antibacterial and / or antiinflammatory and / or antioxidant action, in particular at least one plant extract having an antibacterial and / or antiinflammatory and / or antioxidant action, preferably magnolia extract (Magnolia sp.), and / or in particular at least one mineral, in particular metal, metal oxide and / or metal salt-based, preferably particulate active ingredient having antibacterial and / or anti-inflammatory and / or antioxidant activity, and
3. (c) lactic acid and / or its salts,

contains.

1. (a) Milchsäure produzierenden Bakterien, insbesondere der Gattung Lactobacillus und/oder Bifidobacterium, in tyndallisierter und gegebenenfalls lyophilisierter Form,
2. (b) mindestens einem Wirkstoff mit antibakterieller und/oder antiinflammatorischer und/oder antioxidativer Wirkung, insbesondere mindestens einem Pflanzenextrakt mit antibakterieller und/oder antiinflammatorischer und/oder antioxidativer Wirkung, vorzugsweise Magnolienextrakt (Magnolia sp.), und/oder insbesondere mindestens einem mineralischen, insbesondere metall-, metalloxid- und/oder metallsalz-basierten, vorzugsweise partikulären Wirkstoff mit antibakterieller und/oder antiinflammatorischer und/oder antioxidativer Wirkung, und
3. (c) Milchsäure und/oder deren Salzen,

enthält.Another object of the present invention is also a composition, in particular for use in the care and / or in the prophylactic and / or therapeutic, preferably topical treatment of the preferably female intimate and / or vaginal area, in particular for the treatment of a disturbed skin flora in intimate and Vaginalbereich and / or to support the skin flora in the intimate and / or vaginal area, particularly preferably composition as described above, wherein the composition is a combination ("drug combination") of

1. (a) lactic acid-producing bacteria, in particular of the genus Lactobacillus and / or Bifidobacterium, in tyndallized and optionally lyophilised form,
2. (b) at least one active substance having an antibacterial and / or antiinflammatory and / or antioxidant action, in particular at least one plant extract having an antibacterial and / or antiinflammatory and / or antioxidant action, preferably magnolia extract (Magnolia sp.), and / or in particular at least one mineral, in particular metal, metal oxide and / or metal salt-based, preferably particulate active ingredient having antibacterial and / or anti-inflammatory and / or antioxidant activity, and
3. (c) lactic acid and / or its salts,

contains.

1. (a) Milchsäure produzierenden Bakterien, insbesondere der Gattung Lactobacillus und/oder Bifidobacterium, in tyndallisierter und gegebenenfalls lyophilisierter Form,
2. (b) mindestens einem Wirkstoff mit antibakterieller und/oder antiinflammatorischer und/oder antioxidativer Wirkung, insbesondere mindestens einem Pflanzenextrakt mit antibakterieller und/oder antiinflammatorischer und/oder antioxidativer Wirkung, vorzugsweise Magnolienextrakt (Magnolia sp.), und/oder insbesondere mindestens einem mineralischen, insbesondere metall-, metalloxid- und/oder metallsalz-basierten, vorzugsweise partikulären Wirkstoff mit antibakterieller und/oder antiinflammatorischer und/oder antioxidativer Wirkung,
3. (c) Milchsäure und/oder deren Salzen, und
4. (d) Inulinlaurylcarbamat, enthält.

Another object of the present invention is also a composition, in particular for use in the care and / or in the prophylactic and / or therapeutic, preferably topical treatment of the preferably female intimate and / or vaginal area, in particular for the treatment of a disturbed skin flora in the intimate and / or vaginal area and / or to support the skin flora in the intimate and / or vaginal area, more preferably composition as described above, wherein the composition is a combination ("active ingredient combination") of

1. (a) lactic acid-producing bacteria, in particular of the genus Lactobacillus and / or Bifidobacterium, in tyndallized and optionally lyophilised form,
2. (b) at least one active substance having an antibacterial and / or antiinflammatory and / or antioxidative action, in particular at least one plant extract having an antibacterial and / or antiinflammatory and / or antioxidant action, preferably magnolia extract (Magnolia sp.), and / or in particular at least one mineral, in particular metal, metal oxide and / or metal salt-based, preferably particulate active ingredient having antibacterial and / or anti-inflammatory and / or antioxidant activity,
3. (c) lactic acid and / or its salts, and
4. (d) inulin lauryl carbamate.

1. (a) Milchsäure produzierenden Bakterien, insbesondere der Gattung Lactobacillus und/oder Bifidobacterium, in tyndallisierter und gegebenenfalls lyophilisierter Form,
2. (b) mindestens einem Wirkstoff mit antibakterieller und/oder antiinflammatorischer und/oder antioxidativer Wirkung, ausgewählt aus mindestens einem Pflanzenextrakt mit antibakterieller und/oder antiinflammatorischer und/oder antioxidativer Wirkung, vorzugsweise Magnolienextrakt (Magnolia sp.), und/oder mindestens einem mineralischen, insbesondere metall-, metalloxid- und/oder metallsalz-basierten, vorzugsweise partikulären Wirkstoff mit antibakterieller und/oder antiinflammatorischer und/oder antioxidativer Wirkung,
3. (c) Milchsäure und/oder deren Salzen, und
4. (d) gegebenenfalls Inulinlaurylcarbamat,

enthält. Finally, the present invention according to this aspect of the invention is a composition, in particular for use in the care and / or in the prophylactic and / or therapeutic, preferably topical treatment of the preferably female intimate and / or vaginal area, in particular for the treatment of a disturbed skin flora in the intimate - And / or vaginal area and / or to support the skin flora in the intimate and / or vaginal area, particularly preferably composition, as described above, wherein the composition is a combination ("drug combination") of

1. (a) lactic acid-producing bacteria, in particular of the genus Lactobacillus and / or Bifidobacterium, in tyndallized and optionally lyophilised form,
2. (b) at least one active substance having an antibacterial and / or antiinflammatory and / or antioxidant action, selected from at least one plant extract having an antibacterial and / or antiinflammatory and / or antioxidant action, preferably magnolia extract (Magnolia sp.), and / or at least one mineral, in particular metal, metal oxide and / or metal salt-based, preferably particulate active ingredient having antibacterial and / or anti-inflammatory and / or antioxidant activity,
3. (c) lactic acid and / or its salts, and
4. (d) optionally inulin lauryl carbamate,

contains.

In the context of the present invention, a composition is thus provided which is particularly suitable for use in the prophylactic and / or therapeutic, preferably topical, treatment of the preferably female intimate and / or vaginal area, in particular for the treatment of diseases of the preferably female intimate and / or vaginal area suitable is. In particular, the composition according to the present invention is suitable for use in the prophylactic and / or therapeutic, preferably topical treatment of a damaged skin flora in the intimate and / or vaginal area and / or of inflammatory and / or infectious diseases in the intimate and / or vaginal area.

Inflammatory or infectious diseases may in particular be fungal infections with Candida albicans or vaginosis caused by Gardnerella vaginalis.

In addition, the composition is suitable for the prophylactic support of the natural skin flora in the genital area, in particular by using the composition as a care product in the context of personal hygiene.

In the context of the present invention, a composition for prophylactic or therapeutic, in particular dermatological or topical, treatment of disorders of the intimate area is thus provided overall, which is distinguished by high efficiency of action and, moreover, by good tolerability.

Another object of the present invention is also - according to a second aspect of the invention - the use of a composition, as described above, in the field of cosmetics, especially as a care product for the preferably female intimate and / or vaginal area, preferably to support and / or Restoration of the natural skin flora in the intimate and / or vaginal area.

The composition according to the invention can thus also be used as a cosmetic care or hygiene product for supporting the intimate flora, in particular the vaginal flora, but also for restoring an already damaged intimate flora or vaginal flora.

With regard to a composition for use in the field of cosmetics, it has proved to be particularly advantageous if it is present in the form of a lotion, a cream, a solution, a spray, a foam and / or an ovule.

For further details on this aspect of the invention, reference may be made to the preceding statements on the above aspects of the invention, which also apply correspondingly with respect to the application device according to the invention.

Finally, the present invention - according to a third aspect of the invention - an application device, in particular for the topical application of a composition in the intimate and / or vaginal area, preferably in the form of a container, wherein the container is a reservoir containing a composition as before has been described, and having a metering device, wherein the metering device is designed for discharging the composition and a drip or spray unit or a unit for generating a foam, in particular by means of compressed gas has.

In other words, the subject of the present invention is an application device or an application unit, which has the composition according to the invention in a device adapted to the desired application form of the composition. It is particularly preferred if the application device has a metering device which emits or releases a specific or defined amount of the composition for application. With regard to a composition which is in the form of a foam, it is preferred if the foam is formed by application of the composition by pressure or propellant gas.

The provision of a suitable application device for dispensing liquid, gelatinous, foam-forming or sprayable compositions is known in principle to the person skilled in the art, so that in this regard no further explanation is required at this point.

Further embodiments, modifications and variations as well as advantages of the present invention will be readily apparent to and realizable by those skilled in the art upon reading the description without departing from the scope of the present invention.

The following embodiments are merely illustrative of the present invention without, however, limiting the present invention thereto.

WORKING EXAMPLES

Providing compositions of the invention and comparative compositions

In order to investigate the compositions of the present invention in terms of their effectiveness, their efficiency of action, their compatibility as well as their durability or stability, compositions according to the invention and comparative compositions are provided. The compositions are used to treat damaged or disturbed vaginal flora. Subsequently, the success of the treatment is checked and the compositions are compared with regard to their effectiveness and compatibility. In addition, the compositions are used as a care product to study the long-term tolerability of healthy volunteers in support of the natural vaginal flora. Finally, there is also a comparison in terms of storage stability or durability.

The compositions described below are pump sprays for topical application to the genital area by spraying. The formulations of the compositions provided can be found in the following tables. The preparation of the formulations as such is carried out with the skilled person known per se technical means for the production of cosmetic or pharmaceutical, sprayable compositions. The formulations of the compositions provided in the exemplary embodiments are shown in the following tables. Composition A ingredient Amount [wt%] Lactobacillus acidophilus (tyndallised and lyophilized) 0.1 magnolia extract 0.1 dicaprylyl 10 Inulinlaurylcarbamat 1.5 excipients 12.37 water ad. 100 Composition B ingredient Amount [wt%] Lactobacillus acidophilus (tyndallised and lyophilized) 0.1 Cu ²⁺ -doped zinc oxide microparticles 0.1 dicaprylyl 10 Inulinlaurylcarbamat 1.5 excipients 12.37 water ad. 100 Composition C ingredient Amount [wt%] Lactobacillus acidophilus (tyndallised and lyophilized) 0.1 magnolia extract 0.1 lactic acid 1.8 dicaprylyl 10 Inulinlaurylcarbamat 1.5 excipients 12.37 water ad. 100 Composition D ingredient Amount [wt%] Lactobacillus acidophilus (tyndallised and lyophilized) 0.1 Cu ²⁺ -doped zinc oxide microparticles 0.1 lactic acid 1.8 dicaprylyl 10 Inulinlaurylcarbamat 1.5 excipients 12.37 water ad. 100 Composition E ingredient Amount [wt%] Lactobacillus acidophilus (tyndallised and lyophilized) 0.1 magnolia extract 0.1 lactic acid 1.8 tocopherol 0.3 dicaprylyl 10 Inulinlaurylcarbamat 1.5 excipients 12.37 water ad. 100 Composition F ingredient Amount [wt%] Lactobacillus acidophilus (tyndallised and lyophilized) 0.1 magnolia extract 0.1 Cu ²⁺ -doped zinc oxide microparticles 0.1 lactic acid 1.8 tocopherol 0.3 dicaprylyl 10 Inulinlaurylcarbamat 1.5 excipients 12.37 water ad. 100 Composition G ingredient Amount [wt%] Lactobacillus acidophilus (tyndallised and lyophilized) 0.1 tocopherol 0.3 dicaprylyl 10 cetearyl 1.5 excipients 12.37 water ad. 100 Composition H ingredient Amount [wt%] magnolia extract 0.1 tocopherol 0.3 dicaprylyl 10 cetearyl 1.5 excipients 12.37 water ad. 100 Composition I ingredient Amount [wt%] Cu ²⁺ -doped zinc oxide microparticles 0.1 tocopherol 0.3 dicaprylyl 10 cetearyl 1.5 excipients 12.37 water ad. 100 Composition J ingredient Amount [wt%] Lactobacillus acidophilus (tyndallised and lyophilized) 0.1 magnolia extract 0.1 lactic acid 1.8 tocopherol 0.3 dicaprylyl 10 cetearyl 1.5 excipients 12.37 water ad. 100

In addition to the above-mentioned sprayable compositions or compositions based on a pump spray, solid compositions in the form of vaginalovula with macrogol 1500 and 6000 (polyethylene glycol 1500 and 6000) as support material are also provided. Ovula based on a composition A 'contain tyndallized and lyophilized cells of Lactobacillus acidophilus and magnolia extract. A composition B 'in the form of ovules contains tyndallized and lyophilized cells of Lactobacillus acidophilus and Cu ²⁺ -doped zinc oxide microparticles. Another composition C 'also contains tyndallized and lyophilized cells of Lactobacillus acidophilus, magnolia extract and lactic acid. Another composition D 'in the form of an ovule contains tyndallized and lyophilized cells of Lactobacillus acidophilus, Cu ²⁺ -doped zinc oxide microparticles and lactic acid.

Efficacy studies for the treatment of disturbed vaginal flora

In the context of an efficacy study, a total of 104 subjects between the ages of 18 to 51 years are used, who suffer from a deficient colonization of the intimate area, in particular the vaginal flora. All subjects had recurrent infections over a period of at least one year, in particular with the fungus Candida albicans. The subjects are subdivided into 13 study groups of 8 test persons each and each treated with one of the previously described compositions A to I or A 'to D'.

The treatment regimen is as follows: The subjects for the compositions A to I apply over a period of 31 days in the morning and in the evening the particular composition to be tested topically in the genital area. Subjects for compositions A 'to D' apply the composition in the form of ovules once a day before sleep.

In order to check the success of the treatment with the compositions A to I and the compositions A 'to D', the vaginal status is determined or the vaginal flora is determined in each case at the beginning of the therapy phase and after completion of the treatment period. The bacterial or microorganism species contained therein are determined in a manner known to those skilled in the art. In particular, the vaginal flora is examined with regard to the presence of the fungus Candida albicans. In addition, the presence of the bacteria Gardnerella vaginalis, Atopobium vaginae, Escherichia coli, various types of streptococci, anaerobic bacteria, Trichomonas vaginalis and the number of desired and naturally occurring in the vaginal flora lactobacilli is detected.

Before the start of the therapy, it is determined in all subjects that their vaginal flora has the fungus Candida albicans in large numbers. In addition, the vaginal flora of some subjects streptococci, anaerobes, Gardnerella vaginalis, Trichomonas vaginalis and Atopobium vaginalis in comparison to a healthy vaginal flora in increased numbers. The proportion of lactic acid bacteria, especially Döderlein bacteria is relatively low or significantly reduced in all subjects compared to a healthy vaginal flora. Upon completion of the 4-week therapy, the vaginal status is re-recorded. Upon re-detection of the vaginal status, it can be seen that a satisfactory treatment success can be achieved with the compositions A to F according to the invention and with the compositions A 'to B'. In all subjects treated with the aforementioned compositions, a largely intact vaginal flora develops after a 4-week treatment period. In addition, no further or recurrent infections, in particular with Candida albicans, occurred during the treatment period. The best results are achieved with the compositions C to F and the compositions C 'and D'. Subjects treated with these compositions have established a completely intact vaginal flora during the treatment phase.

In subjects who use the comparison compositions G to I, although also show a slight decrease in the number of pathogenic germs, d. H. Candida albicans, Trichomonas vaginalis, Gardnerella vaginalis, Escherichia coli and Atopobium vaginae. However, the vaginal flora can not yet be considered intact upon completion of the treatment, since in particular the proportion of lactic acid fermenting bacteria or lactic acid bacteria is still too low compared to normal or healthy vaginal flora.

From the above, it is apparent that the compositions according to the invention are suitable both in the form of pump sprays and in the form of ovules in order to successfully treat a vaginal flora which has become unbalanced or a defective colonization of the intimate area with pathogenic microorganisms. The compositions according to the invention are suitable both for therapeutic treatment and for prophylactic treatment or prophylactic treatment for supporting or restoring an intact vaginal flora.

Compatibility studies of the composition according to the invention

In addition, in order to investigate the compatibility of the compositions of the invention in a long-term use, the composition of the invention E of 20 healthy subjects over a 6-month period is regularly used in the context of intimate care to support the vaginal flora. The test persons apply composition E according to the invention over a period of 6 months once a day by topical spraying on the genital area.

None of the subjects experienced any side effects over the treatment period of 6 months. The composition according to the invention is thus also distinguished by excellent compatibility and, in addition to the therapeutic or prophylactic, in particular dermatological, use is also suitable for use as a care or hygiene product in the field of cosmetics.

Durability and stability studies

In addition, the compositions according to the invention were investigated with regard to their durability. For this purpose, the composition E on the one hand and the composition J on the other was used. Composition E on the one hand and Composition J on the other hand differ only in the use of a different emulsion stabilizer. Composition E contains inulin lauryl carbamate, whereas in composition J cetearyl alcohol is used as emulsion stabilizer.

To examine the stability of the two compositions, they were stored darkened over a period of 24 months at room temperature. At the time of preparation (time 0) and after 6 months, 12 months, 18 months and 24 months storage time, the compositions were examined for changes. In this context it has been shown that composition E remains stable over the entire storage period of 24 months. There is no flocculation, clouding or phase separation in the emulsion. With composition J, a slight clouding is already observed after 12 months of storage, but the composition is basically still usable after 12 months of storage. After 18 months of storage, however, there is a phase separation, so that the composition was no longer usable. Consequently, the use of inulin lauryl carbamate can significantly improve the durability of the composition according to the invention or the stability of the emulsion.

Claims (10)

A composition, in particular for use in the care and / or in the prophylactic and / or therapeutic, preferably topical treatment of the preferably female intimate and / or vaginal area, in particular for the treatment of a damaged skin flora in the intimate and / or vaginal area and / or support the skin flora in the intimate and / or vaginal area, wherein the composition is a combination ("drug combination") of (a) lactic acid-producing bacteria, in particular of the genus Lactobacillus and / or Bifidobacterium, and (b) at least one active substance having an antibacterial and / or antiinflammatory and / or antioxidant action, in particular at least one plant extract having an antibacterial and / or antiinflammatory and / or antioxidant action, preferably magnolia extract (Magnolia sp.), and / or in particular at least one mineral, in particular metal, metal oxide and / or metal salt-based, preferably particulate active ingredient having antibacterial and / or anti-inflammatory and / or antioxidant activity. Composition after Claim 1 wherein the lactic acid-producing bacteria are selected from the group of lactic acid fermenting bacteria, in particular in the normal flora of the human skin, in the male or female intimate area, in the vagina and / or vulva occurring lactic acid fermenting bacteria, and / or wherein the lactic acid producing bacteria are selected from the group of bacteria of the genus Lactobacillus, Bifidobacterium and / or Pediococcus, preferably Lactobacillus, and / or wherein the lactic acid-producing bacteria are selected from the group of Bifidobacterium ssp., Lactobacillus iners, Lactobacillus delbruekii, Lactobacillus crispatus, Lactobacillus vaginalis, Lactobacillus acidophilus, Lactobacillus jensenii, Lactobacillus buchneri and / or Lactobacillus gasseri, especially Lactobacillus acidophilus; and / or wherein the composition comprises the lactic acid-producing bacteria (i) in the form of vital cells and / or (ii) in the form of persistence forms, in particular spores, and / or (iii) in the form of inactive cells, in particular lyophilized and / or tyndallised , preferably tyndallisierten cells contains; and / or wherein the composition contains the lactic acid-producing bacteria in the form of tyndallised cells, preferably in the form of tyndallized cells of Lactobacillus acidophilus, and / or wherein the composition contains the lactic acid-producing bacteria in the form of tyndallized cells and in the form of vital cells, preferably in the form of tyndallized cells and vital cells of Lactobacillus acidophilus; and / or wherein the composition of the lactic acid-producing bacteria in an amount in the range of 10 ¹ to 10 ³⁰ CFU (colony forming units), in particular in the range of 10 ² to 10 ²⁰ cfu, preferably in the range of 10 ⁵ to 10 ¹⁸ cfu preferred in the range of 10 ¹⁰ to 10 ¹⁵ CFU, based on the composition, and / or wherein the composition comprises the lactic acid-producing bacteria in an amount in the range of 0.00001 to 15% by weight, in particular in the range of 0.0001 to 10 wt .-%, preferably in the range of 0.0005 to 5 wt .-%, particularly preferably 0.001 to 2.5 wt .-%, most preferably 0.005 to 1 wt .-%, based on the composition contains, and or wherein the composition comprises lactic acid-producing bacteria in the form of tyndallized and / or lyophilized cells in an amount in the range from 0.0001 to 10% by weight, in particular in the range from 0.001 to 5% by weight, preferably in the range from 0 , 01 to 1 wt .-%, preferably in the range of 0.05 to 0.5% by weight, based on the composition, and / or wherein the composition contains lactic acid-producing bacteria in the form of vital cells in an amount in the range from 0.0001 to 2.5% by weight, in particular in the range from 0.0005 to 1% by weight, preferably in the range from 0.001 to 0.01% by weight, based on the composition, and / or wherein the composition comprises lactic acid-producing bacteria in the form of vital cells and lactic acid-producing bacteria in Form of tyndallized and / or lyophilized cells in a weight-based ratio in the range of 1: 500 to 100: 1, in particular in the range of 1: 100 to 50: 1, preferably in the range of 1: 50 to 20: 1, preferably in the range from 1:30 to 1: 1, more preferably in the range of 1:15 to 1: 5. A composition according to any one of the preceding claims, wherein the composition comprises the at least one plant extract having antibacterial and / or anti-inflammatory and / or antioxidant activity, in particular magnolia extract, in an amount in the range of 0.0001 to 15% by weight, in particular in the range of 0.001 to 10 wt .-%, preferably in the range of 0.001 to 5 wt .-%, particularly preferably 0.01 to 1 wt .-%, most preferably 0.05 to 0.5 wt .-%, based on the composition , contains; and / or wherein the at least one plant extract with antibacterial and / or anti-inflammatory and / or antioxidant action, in particular the magnolia extract, in the form of a dry extract, preferably with a Drug / extract ratio in the range of 12: 1 to 4: 1, in particular in the range of 10: 1 to 5: 1, is used and / or wherein the at least one plant extract with antibacterial and / or anti-inflammatory and / or antioxidant effect, in particular the magnolia extract, in the form of a fluid extract, preferably with a drug / extract ratio in the range from 1: 5 to 3: 1, in particular in the range from 1: 3 to 2: 1, preferably in the range from 1: 2 to 1: 1, and / or wherein the at least one plant extract with antibacterial and / or anti-inflammatory and / or antioxidant action, in particular the magnolia extract, in the form of a thick extract, preferably with a drug / extract ratio in the range of 1: 1 to 8: 1, in particular in the range of 2: 1 to 7: 1, preferably in the range of 3: 1 to 6: 1, is used and / or wherein the at least one plant extract with antibacterial and / or antiinflammatory and / or r antioxidative effect, in particular the magnolia extract, is used in the form of a tincture; and / or wherein the at least one plant extract with antibacterial and / or anti-inflammatory and / or antioxidant action is an extract prepared from flowers, leaves and / or bark, in particular bark, from Magnolia sp., preferably Magnolia officinalis. Composition according to one of the preceding claims, wherein the composition comprises the at least one mineral, in particular metal, metal oxide and / or metal salt-based active ingredient having antibacterial and / or anti-inflammatory and / or antioxidant activity in an amount in the range of 0.001 to 10 wt .-%, in particular in the range 0.01 to 5 wt .-%, preferably in the range of 0.05 to 2.5 wt .-%, preferably in the range of 0.1 to 1 wt .-%, based on the composition contains; and or wherein the at least one mineral, in particular metal, metal oxide and / or metal salt-based, active substance having an antibacterial and / or anti-inflammatory and / or antioxidant action is based on particles, in particular nano- and / or microparticles, preferably microparticles, in particular wherein the Particles are selected from the group of zinc oxide particles, copper oxide particles and / or titanium oxide particles, and / or in particular wherein the particles have an antibacterial doping and / or coating, preferably selected from copper and / or manganese dopants; and or wherein the composition contains lactic acid and / or salts thereof, in particular in an amount in the range of 0.001 to 20 wt .-%, preferably in the range of 0.01 to 10 wt .-%, preferably in the range of 0.1 to 5 wt .-%, more preferably in the range of 1 to 3 wt .-%, based on the composition; and or wherein the composition contains at least one cosmetically and / or dermatologically acceptable antioxidant ingredient, in particular wherein the at least one antioxidant ingredient is selected from the group of (i) vitamin E, in particular tocopherols and / or tocotrienols, (ii) vitamin A and / or provitamin A, (iii) vitamin C, (iv) palmitates, (v) lycopene and / or (vi) ubiquinone; particularly preferably (i) vitamin E, in particular tocopherols and / or tocotrienols; and or wherein the composition comprises cosmetically and / or dermatologically acceptable antioxidant ingredients in an amount in the range of 0.01 to 5 wt .-%, in particular in the range of 0.05 to 2.5 wt .-%, preferably in the range of 0.01 to 1 wt .-%, based on the composition contains. A composition according to any one of the preceding claims, wherein the composition contains at least one further skin care ingredient and / or skin care ingredient, in particular wherein the at least one skin care ingredient and / or skin care ingredient is selected from the group consisting of (i) glycerol and (ii) glycols, in particular pentyleneglycol (1,2-dihydroxypentane), (iii) allantoin, ingredients of aloe vera, bisabolol, hyaluronic acid and / or their salts, inulin, panthenol and / or its derivatives, in particular ethylhexylglycerol and / or glycerol / or pantothenic acid, (iv) hydrogenated glycerides, in particular hydrogenated palmglyceride, (v) natural gums, especially sclerotium gum and / or xanthan gum, (vii) capryl alcohol derivatives, especially dicaprylyl carbonate, and / or in particular wherein the composition is another skin care ingredient and / or ingredient with skincare We kung dicaprylyl carbonate, ethylhexylglycerol, pentylene glycol, inulin, hydrogenated palmglyceride, sclerotium gum and / or xanthan gum; and / or wherein the composition skin care ingredients and / or ingredients with skin-care effect in an amount in the range of 1 to 50 wt .-%, in particular in the range of 2 to 40 wt .-%, preferably in the range of 5 to 35 wt. -%, preferably 10 to 30 wt .-%, based on the composition contains; and / or wherein the composition contains at least one cosmetically and / or dermatologically compatible emulsifier and / or stabilizer, in particular wherein the at least one emulsifier and / or stabilizer is selected from the group of (i) lauryl derivatives, in particular lauryl sulfate and / or inulin lauryl carbamate, preferably Inulin lauryl carbamate, (ii) glycerides of fatty acids, in particular glycerides of palmitic acid, (iii) long-chain alcohols, in particular alcohols having 10 to 30 carbon atoms, preferably 14 to 22 carbon atoms, (iv) long-chain alkyl polyglycosides, in particular alkyl polyglycosides having 8 to 30 C-atoms, preferably 12 to 20 C-atoms, (v) phospholipids, in particular lecithins and / or lysolecithins, and / or (vi) stearoyl derivatives and / or their salts, in particular sodium stearoyl glutamate; and / or wherein the composition comprises cosmetically and / or dermatologically compatible emulsifiers and / or stabilizers in an amount in the range from 0.1 to 20% by weight, in particular in the range from 1 to 15% by weight, preferably in the range from 2 to 10 wt .-%, preferably in the range of 3 to 8 wt .-%, based on the composition. Composition according to one of the preceding claims, wherein the composition contains at least one cosmetically and / or dermatologically acceptable humectant, in particular wherein the at least one humectant is selected from the group of (i) siloxanes and / or silicones, in particular cyclomethicone and / or cyclopentasiloxane, (ii) glycerol, (iii) Glycols, in particular pentylene glycol, (iv) polyalkylene glycols, in particular polyethylene glycol and / or polypropylene glycol, and / or (v) sorbitol, and / or in particular wherein the composition contains as humectant pentylene glycol and / or glycerol; and or wherein the composition comprises cosmetically and / or dermatologically acceptable humectants in an amount in the range from 0.1 to 20% by weight, in particular in the range from 1 to 10% by weight, preferably in the range from 2 to 8% by weight, based on the composition contains; and or wherein the composition comprises at least one cosmetically and / or dermatologically acceptable adjuvant, in particular wherein the at least one adjuvant is selected from the group of binders, film formers, chelating agents, rheology modifiers, buffer substances and / or pH adjusters; and or wherein the composition contains at least one cosmetically and / or dermatologically acceptable solvent; and or wherein the composition comprises at least one cosmetically and / or dermatologically acceptable solvent selected from the group of 1,2-hexanediol, ethanol, butyl acetate, 1,3-butanediol, cyclopentasiloxane, ethyl acetate, glycerol, ethylene glycol, isopropyl alcohol, methylpropanediol, propylene glycol and / or water , in particular glycerol and / or water; and or wherein the composition cosmetically and / or dermatologically acceptable solvents in an amount in the range of 5 to 99 wt .-%, in particular in the range of 10 to 95 wt .-%, preferably in the range of 20 to 90 wt .-%, preferably im Range of 30 to 80 wt .-%, based on the composition contains; and or wherein the composition contains at least one cosmetically and / or dermatologically compatible carrier material, in particular wherein the carrier material is selected from the group of water-insoluble carrier materials, in particular from the group of mono-, di- and / or triglycerides, and / or water-soluble carrier materials, in particular polyalkylene glycols , preferably polyethylene glycol; and or wherein the composition cosmetically and / or dermatologically acceptable carrier material in an amount in the range of 5 to 99 wt .-%, in particular in the range of 10 to 95 wt .-%, preferably in the range of 20 to 90 wt .-%, preferably im Range of 30 to 80 wt .-%, based on the composition contains. Composition according to one of the preceding claims, wherein the composition is solid, liquid, gelatinous and / or pasty, preferably solid or liquid; and or wherein the composition is in the form of a solution, gel, lotion, cream, suppository and / or ovule and / or wherein the composition is in the form of a sprayable and / or sprayable composition, in particular as a spray and / or aerosol, and / or wherein the composition is foam-forming and / or / or foamable composition is present. Composition, in particular for use in the prophylactic and / or therapeutic, preferably topical treatment of the preferably female intimate and / or vaginal area, in particular for the treatment of diseases of the preferably female intimate and / or vaginal area, in particular a damaged skin flora in the intimate and / or or vaginal area and / or inflammatory and / or infectious diseases in the intimate and / or vaginal area. Use of a composition according to any one of the preceding claims in the field of cosmetics, in particular as a care product for the preferably female intimate and / or vaginal area, preferably to support and / or restore the natural skin flora in the intimate and / or vaginal area, in particular wherein the composition in Form of a lotion, a cream, a solution, a spray, a foam and / or an ovule is used. Application device, in particular for the topical application of a composition in the intimate and / or vaginal area, preferably in the form of a container, the container having a reservoir containing a composition according to one of the preceding claims, and a metering device, wherein the metering device for delivering the composition is formed and a drip or spray device or a device for generating a foam, in particular by means of compressed gas having.