EP4161531A1

EP4161531A1 - Compositions for the prevention and treatment of urinary tract infections and for use in cosmetics

Info

Publication number: EP4161531A1
Application number: EP21733386.3A
Authority: EP
Inventors: Marianne Boskamp
Original assignee: G Pohl Boskamp GmbH and Co KG
Current assignee: G Pohl Boskamp GmbH and Co KG
Priority date: 2020-06-09
Filing date: 2021-06-08
Publication date: 2023-04-12
Also published as: DE202021104247U1; WO2021250019A1

Abstract

The invention relates, in a first aspect, to compositions for the prevention and/or treatment of urinary tract infections and to corresponding medicinal products. In another aspect, the invention relates to compositions containing mannose, to cosmetic products comprising an embodiment of these compositions, and to their external application to the skin. The invention further relates to dispensers which comprise the compositions or cosmetic products according to the invention.

Description

Compositions for the prophylaxis and treatment of urinary tract infections and for cosmetic use

The invention relates to compositions for the prophylaxis and / or treatment of urinary tract infections and corresponding medical products. In a further aspect, the invention relates to compositions comprising the constituent mannose, cosmetic products comprising an embodiment of these compositions and their use for external application on the skin. The invention also relates to metering dispensers comprising the compositions or cosmetic products according to the invention.

State of the art

Urinary tract infections are a common problem among the population. They mainly affect the female part of the population.

Exemplary factors that favor a urinary tract infection include, among others, sexual activity per se, use of condoms, use of spermicide, improper post-bowel hygiene behavior, and the like.

Various approaches to the prophylaxis and treatment of urinary tract infections have already been described in the prior art. From WO2014040632, for example, a method for the prevention or treatment of urinary tract infections is known, comprising a synergistic combination of berberine and arbutin in an effective amount and an effective amount of an edible carrier. The prior art also describes the antibacterial effect of α-D-mannose (WO 2005/089733). A cosmetic use of compositions comprising various monosaccharides is known to the person skilled in the art from the laid-open specification US 2010/0190727.

Patients also often use herbal supplements such as teas or cranberry products, although there is usually no evidence of their effectiveness. In a very large number of cases, treatment of urinary tract infections includes antibiotics. As is well known to the person skilled in the art, however, frequent or extensive administrations of antibiotics are fundamentally undesirable.

In the prior art there is therefore a need for highly effective, well tolerated and easily manageable compositions and medical products for the prophylaxis or treatment of urinary tract infections. Furthermore, there is a need for well-tolerated and easily manageable compositions which are applied for the care and protection of the skin in the genital area, preferably in the external genital area, the protection of the skin also optionally being accompanied by a prevention of infections, preferably bacterial infections can.

Accordingly, the present invention is based, for example, on the object of providing such improved compositions for the prophylaxis or treatment of urinary tract infections and corresponding medical products which are effective, well tolerated and / or easy to handle. Furthermore, the present invention is also based on the object of providing improved compositions and cosmetic products for topical use which serve to protect and care for the skin, in particular to protect and care for the genital area, preferably the external genital area. In the context of the present invention, the term “topical application” denotes the localized application of the product on or on the body.

The object of the invention is achieved by the subject matter disclosed in the patent claims.

Disclosure of the invention

In summary, in a first aspect, the invention provides a composition for use in a method for the prophylaxis and / or treatment of urinary tract infections, characterized in that the composition is in the form of a gel and contains 1-50% mannose.

In a preferred embodiment of the invention the composition contains 2-30% mannose, preferably 2.5%, 5% or 25% mannose. In a preferred embodiment, the composition contains 0.25-5% of a gelling agent. The gelling agent is preferably selected from the group consisting of xanthan gum, carrageenan, alginates and water-soluble cellulose ethers, preferably hydroxyethyl cellulose.

In a further embodiment, the composition contains further constituents which can be selected from the group consisting of hyaluronic acid, lactic acid-lactate buffer, preservatives, humectants and water. The preservative is preferably selected from the group consisting of benzoic acid and its salts, sorbic acid and its salts, 2-phenoxyethanol, 2-phenylethanol, pentylene glycol, caprylyl glycol, ethylhexylglycerol and mixtures of the aforementioned substances. The humectant is preferably in the form of xylitol.

In a further embodiment, the composition has a pH of 2.5-5.5, preferably a pH of 3.0-5.0.

The composition according to the invention preferably contains 2-50% D-mannose, preferably 5% D-mannose, 0.25% hyaluronic acid, preferably sodium hyaluronate, 3% pentylene glycol, 1% xylitol, 1% sodium lactate solution (50%), 0.5% caprylyl Glycol (1,2-octanediol), 1.5% hydroxyethyl cellulose and at least 0.1% lactic acid (90%).

In a preferred embodiment, the urinary tract infection to be prevented and / or treated is an uncomplicated urinary tract infection, preferably caused by a pathogenic germ, more preferably caused by the bacterium Escherichia coli.

In a preferred embodiment, the composition according to the invention is administered topically. It is preferred that the composition according to the invention is administered topically in the genital area. In a further preferred embodiment, the composition according to the invention is administered topically in the area of the external genital area.

It is also preferred that the composition is applied at least once a day over a period of 1 to 14 days, preferably at least three times a day over a period of 1 to 7 days. In this context, topical administration is preferably carried out in the genital area, more preferably in the area of the external genital area. In a further aspect, the invention provides a medical product which is characterized in that it comprises a composition according to the invention as defined herein.

In a further aspect the invention provides a composition for external use on the skin, characterized in that the composition is in the form of a gel and contains 1-50% mannose. In a preferred embodiment, the application to the skin is an external application in the genital area, preferably a topical application in the female genital area, more preferably a topical application in the external female genital area.

It is furthermore an aspect of the invention to provide a composition for use in a method for the care of the external genital area, the composition being in the form of a gel and containing 1-50% mannose. In connection with this aspect, the composition according to the invention can be characterized in accordance with any of the embodiments described herein.

In a further aspect, the invention provides a cosmetic product, characterized in that the cosmetic product contains an embodiment of the compositions according to the invention, this being in the form of a gel and containing 1-50% mannose. In connection with this aspect, the composition according to the invention contained in the cosmetic product can be characterized in accordance with any of the embodiments described herein.

In a further aspect, the invention relates to the use of the composition according to the invention or the cosmetic product according to the invention for external use on the skin, preferably for external use in the female genital area.

In a further aspect, the invention relates to the provision of a metering dispenser, characterized in that it comprises an embodiment of the composition according to the invention or an embodiment of the cosmetic product according to the invention. In a preferred embodiment, the dosing dispenser is configured in such a way that a pump unit defines the delivery of the contents comprised in the dosing dispenser with a volume of 0.3 to 0.7 ml, preferably with a volume of 0.5 ml. In detail, the invention provides in a first aspect a composition according to the invention for use in a method for the prophylaxis and / or treatment of urinary tract infections, which is characterized in that it is in the form of a gel and contains 1-50% mannose. Thus, the first aspect relates on the one hand to compositions according to the invention for use in a method for the prophylaxis of urinary tract infections. The first aspect also relates to the composition according to the invention for use in a method for

Treatment of urinary tract infections. The first aspect also relates to the composition according to the invention for use in a method for

Prophylaxis and for the treatment of urinary tract infections.

In addition, in a further aspect, the invention provides a composition according to the invention for external use on the skin, preferably for

Use in the external genital area, more preferably for use in the external female genital area, characterized in that the composition is in the form of a gel and contains 1-50% mannose. This application includes cosmetic and / or care applications. The mannose content can vary within the stated concentration range depending on the embodiment. Preferably the concentration range of mannose is in the range of 1-25%, more preferably in the range of 1-10%, and further preferably in the range of 1-5%. In a particularly preferred embodiment, the composition according to the invention contains a mannose concentration of 2.5% to 5.5%, preferably 5%. Various embodiments of the compositions according to the invention with different mannose concentrations are shown in Example 8.

The abovementioned “composition” is also equivalently referred to herein as “composition according to the invention”, “composition of the invention” and the like. Embodiments of the composition described for this aspect of the invention apply equally to the further aspects of the invention. In particular, embodiments of constituents of the composition described for this aspect of the invention also apply equally to the further aspects of the invention.

In principle, certain embodiments of the application mentioned that are included herein result from the preferred embodiments described for the compositions according to the invention (or their constituents). Said “method” is preferably characterized in that it comprises the step of administering a composition according to the invention to a subject. In the context of the present invention, the administration of the composition according to the invention is preferably an application to the skin, i.e. an external superficial or topical application, this preferably being used in the genital area, preferably in the external genital area, more preferably in the external genital area of a female subject. The method can be a prophylactic and / or therapeutic method. The method can simultaneously or alternatively serve to protect and care for the skin, in particular to protect and care for the genital area, preferably the external genital area. In an alternative embodiment, the method mentioned can thus also be a cosmetic method. In principle, certain embodiments of the methods mentioned that are included herein result from the preferred embodiments described for the compositions according to the invention (or their constituents).

The “subject” herein is preferably a human subject, more preferably a female subject. In certain embodiments, the (female) subject is not under 12 years old. In certain embodiments, the (female) subject is between

12 and 75 years old, preferably between 12 and 30 years old, preferably between

13 and 25, such as between 15 and 22 years old. In certain embodiments, the female subject is a postmenopausal subject. In certain embodiments, the (female) subject is between 45 and 75 years old, preferably between 55 and 65 years old.

In certain embodiments, the subject has a urinary tract infection. In certain embodiments, the subject is susceptible to urinary tract infections. Preferably the subject has had one or more urinary tract infections. In certain embodiments, the subject has at least one symptom of a urinary tract infection. Herein a “symptom of a urinary tract infection” is preferably selected from the group consisting of burning sensation when urinating, pain when urinating (dysuria), frequent urge to urinate, urge to urinate, itching in the urethra, pain in the lower abdomen, decreased urine flow, and difficulties with the To hold urine. In certain embodiments, the occurrence of a urinary tract infection is related to sexual acts, preferably related to sexual acts, more preferably in Relation to first sexual activities in the age group 13-25 years.

In the context of the present invention, the aforementioned “symptoms of a urinary tract infection” are not necessarily to be understood as disease-related or pathological conditions of the subject, but rather the symptoms can also include unpleasant physical conditions or sensitivities, such as itching or reddening in the external genital area. The unpleasant physical conditions or sensitivities do not necessarily have to go hand in hand with an illness in the medical sense and do not necessarily require therapeutic treatment. The compositions according to the invention can also serve to reduce or prevent unpleasant physical states or unpleasant sensibilities by means of a caring, skin-calming and / or protective effect. The compositions according to the invention can thus also find a non-therapeutic and / or cosmetic application.

Urinary tract infections are well known to those skilled in the art and are not subject to any particular restrictions. As used herein, "urinary tract infections" include urinary tract infections (also known as "UTIs") and bladder infections (cystitis). According to preferred embodiments, the urinary tract infection is a urinary tract infection. According to preferred embodiments, the urinary tract infection is a recurrent urinary tract infection. According to a preferred embodiment, the urinary tract infection is characterized in that it comprises at least one symptom of a urinary tract infection. Embodiments of the urinary tract infection described for this aspect of the invention apply equally to the other aspects of the invention. In the context of the present invention, a urinary tract infection is preferably to be understood as an uncomplicated urinary tract infection. A urinary tract infection is classified as uncomplicated if there are no relevant functional or anatomical anomalies in the urinary tract, no relevant renal dysfunction and no relevant pre-existing or concomitant diseases that favor a urinary tract infection or serious complications. In a preferred embodiment of the invention, the urinary tract infection is caused by a pathogenic germ such as the bacterium Escherichia coli. In a preferred embodiment of the invention, the urinary tract infection is thus a bacterially caused urinary tract infection. “Gels” are well known to those skilled in the art as solutions of mostly high molecular weight gel formers in water.

As used herein, “mannose” is selected from D- and L-mannose, with D-mannose being preferably used in the present invention. In the present invention, the composition of the invention contains 1-50% mannose. In certain embodiments, the composition according to the invention contains 5-50% mannose, preferably 10-50% mannose, preferably 20-30% mannose. In certain embodiments, the composition according to the invention preferably contains 1-25% mannose, 1-5% mannose or 1-2.5% mannose. In a particularly preferred embodiment, the composition according to the invention contains 3-6% mannose, more preferably about 5% mannose or 5% mannose.

In general, it should be pointed out that, in connection with the present invention, percentages are percentages by weight.

In certain embodiments, the composition according to the invention is characterized in that it contains 0.1-5% gel former. In certain embodiments, the composition according to the invention contains 0.25-5% gelling agent, preferably 1-2% gelling agent, e.g. about 1.5% gelling agent.

"Gel formers", including gel formers for use in a subject, are well known to those skilled in the art, as are gels. In principle, they are not subject to any particular restrictions. In certain embodiments, the composition according to the invention is characterized in that the gelling agent is selected from the group consisting of xanthan gum (alternatively also referred to herein as xanthan gum), carrageenan, alginates and water-soluble cellulose ethers. A preferred but not limiting gelling agent herein is xanthan gum. Another preferred gel former from the group of water-soluble cellulose ethers is hydroxyethyl cellulose (2-hydroxyethylated cellulose derivative). In a preferred embodiment of the invention, the composition according to the invention comprises 1-3% hydroxyethyl cellulose, preferably 1.5% hydroxyethyl cellulose.

Without wishing to be bound by theory, the gelling agent in the compositions according to the invention together with the mannose preferably ensures an advantageous adhesive consistency and thus good adhesion to the target site and / or the gelling agent in the compositions according to the invention ensures together with the mannose also preferably for an advantageous viscosity, for example when used in a metering dispenser, such as a pump metering dispenser. In preferred embodiments, the gel former accordingly gives the compositions according to the invention, together with the mannose, an adhesive consistency. In preferred embodiments, the gel former accordingly gives the compositions according to the invention a consistency suitable for use in a metering dispenser. The application mentioned is preferably the application in a pump-dosing dispenser.

In preferred embodiments, the composition according to the invention contains water. In preferred embodiments, the composition according to the invention is an aqueous composition. In certain preferred embodiments, the composition according to the invention is prepared with water. In certain embodiments, the composition according to the invention comprises water in addition to the constituents mentioned in each case. Thus, in certain embodiments, the composition according to the invention comprises water as the remaining constituent. Some preferred embodiments of the composition according to the invention are exemplified in Example 8.

In certain embodiments, the composition according to the invention is characterized in that it contains further constituents, preferably selected from the group consisting of a buffer (for example lactic acid-lactate buffer), preservatives, humectants and water. In certain embodiments, the composition according to the invention comprises at least preservatives and humectants as further constituents. In certain embodiments, the composition according to the invention comprises at least buffers, preservatives and humectants as further constituents.

According to the invention, a preferred but not limiting further component is a buffer. Buffers, particularly buffers for use in a subject, are well known to those skilled in the art. A buffer is preferably used here which buffers at the stated preferred pH values. A concrete preferred buffer is lactic acid-lactate buffer.

According to the invention, a preferred but non-limiting further component is a preservative. Preservatives, particularly preservatives for use in a subject, are well known to those skilled in the art. In particular, it is also possible to use preservatives which are used in the field of cosmetics. In certain embodiments, the composition according to the invention is characterized in that the preservative is selected from the group consisting of benzoic acid and its salts, sorbic acid and its salts, 2-phenoxyethanol, 2-phenylethanol, pentylene glycol, caprylyl glycol, ethylhexylglycerol and mixtures of the aforementioned substances . According to the invention, the preservative is preferably selected from pentylene glycol, caprylyl glycol and a mixture thereof. In preferred embodiments, the composition according to the invention contains pentylene glycol and caprylyl glycol.

According to the invention, a preferred but not limiting further component is a humectant. Humectants, particularly humectants for use in a subject, are well known to those skilled in the art. In certain embodiments, the composition according to the invention is characterized in that the humectant is in the form of xylitol. However, a humectant as a further component is in any case optional, not least because of the presence of mannose, which also has this property.

In certain embodiments, the composition according to the invention thus comprises at least pentylene glycol and xylitol as further constituents. In certain preferred embodiments, the composition according to the invention comprises as further constituents at least lactic acid-lactate buffer, pentylene glycol and xylitol. In certain preferred embodiments, the composition according to the invention comprises as further constituents at least lactic acid-lactate buffer, pentylene glycol, caprylyl glycol and xylitol.

In certain embodiments, the composition according to the invention also comprises at least one care component, the care component preferably being dexpanthenol. A preferred embodiment of a composition according to the invention comprising dexpanthenol is given in Example 8. The composition according to the invention preferably comprises 0.1-5% dexpanthenol, preferably 1-4% dexpanthenol, more preferably 3% dexpanthenol.

In certain embodiments of the composition according to the invention, preferably in embodiments that aim at a care and / or cosmetic application, the composition according to the invention comprises as Another ingredient is hyaluronic acid. The hyaluronic acid is preferably in the form of sodium hyaluronate. In preferred embodiments, the composition according to the invention comprises 0.1-2% hyaluronic acid, preferably 0.2-0.5% hyaluronic acid, more preferably 0.25% hyaluronic acid. A preferred embodiment of the composition according to the invention comprising hyaluronic acid is set out in Example 8.

In certain embodiments, the composition according to the invention has an acidic pH. An acidic pH is also beneficial for the effect. In certain embodiments, the composition according to the invention is characterized in that it has a pH of 2.5-5.5, preferably a pH of 3.0-5.0.

In certain embodiments, the composition according to the invention is characterized in that it contains 10-50% D-mannose, 2-5% pentylene glycol, 0.25-5% xanthan gum, 1-10% xylitol, 0.2-3% sodium lactate solution (50 %), 0.1-1.0% caprylyl glycol and 0.1-1.0% lactic acid (90%). In certain embodiments, the composition according to the invention is characterized in that it contains 10-50% D-mannose (preferably 20-30% D-mannose, for example approx. 25% D-mannose), approx. 3% pentylene glycol, approx. 1.5% xanthan Gum, contains approx. 1% xylitol, approx. 1% sodium lactate solution (50%), approx. 0.5% caprylyl glycol and 0.1 - 1.0% lactic acid (90%). In certain embodiments, the composition according to the invention is characterized in that it contains 10-50% D-mannose, 3% pentylene glycol, 1.5% xanthan gum, 1% xylitol, 1% sodium lactate solution (50%), 0.5% caprylyl glycol and Contains at least 0.1% lactic acid (90%). In an exemplary embodiment, the composition according to the invention is characterized in that it contains approx. 25% D-mannose, approx. 3% pentylene glycol, approx. 1.5% xanthan gum, approx. 1% xylitol, approx. 1% sodium lactate solution (50% ), approx. 0.5% caprylyl glycol, approx. 0.33% lactic acid (90%) and water. In an exemplary specific embodiment, the composition according to the invention is characterized in that it contains 25% D-mannose, 3% pentylene glycol, 1.5% xanthan gum, 1% xylitol, 1% sodium lactate solution (50%), 0.5% caprylyl glycol, Contains 0.33% lactic acid (90%) and otherwise water.

In further preferred embodiments, the composition is characterized in that it contains 2-50% D-mannose, preferably 5% D-mannose, 0.25% hyaluronic acid, preferably 0.25% sodium hyaluronate, 3% pentylene glycol, 1% xylitol, Contains 1% sodium lactate solution (50%), 0.5% caprylyl glycol (1,2-octanediol), 1.5% hydroxyethyl cellulose and at least 0.1% lactic acid (90%).

In certain embodiments herein, the urinary tract infection is caused by a pathogen. In preferred embodiments, the germ is from a genus selected from the genera Escherichia, Klebsiella, Enterococcus, In preferred embodiments the germ is Escherichia coli,

In certain embodiments, the composition according to the invention is characterized in that the urinary tract infection to be prevented and / or treated is caused by a pathogenic germ, preferably by the bacterium Escherichia coli.

In certain embodiments, the composition according to the invention is characterized in that it is intended for topical application to the skin. Thus, the methods mentioned here preferably comprise the step of applying the composition according to the invention to the skin. In preferred embodiments, "on the skin" means the skin in the area of the external genital area, in particular the external vaginal area, in particular in the area of the urethral outlet, preferably in the area of the female urethral outlet. In further preferred embodiments, "on the skin" means the skin in the Area of the perineum, preferably in the area of the female perineum. In preferred embodiments, "on the skin" means the skin in the anal area, preferably in the female anal area. Certain embodiments include combinations of two or three of the above areas.

In preferred embodiments, the composition according to the invention is applied in the region of the urethral outlet and / or in the region of the perineum and / or in the anal region; preferably in the area of the urethral outlet, in the area of the perineum and in the anal area; preferably applied in the area of the urethral outlet.

In again preferred embodiments, the methods mentioned here, in particular the cosmetic methods, comprise the step of administering the composition according to the invention to the skin, preferably to the skin in the area of the external genital area. Cosmetic processes in the context of the present invention refer to all uses of the composition according to the invention in connection with the care and protection of the skin, which preferably also include the Regulating and / or improving the moisture content of the skin. For the purposes of the present invention, the care and protection of the skin can also be accompanied by the reduction or alleviation of unpleasant conditions or sensitivities, such as, for example, the alleviation of itching and / or redness in the genital area. Likewise, the use of the composition according to the invention in the context of a cosmetic process can preventively prevent these unpleasant conditions or sensitivities and serve to prevent them and thus overall the well-being of the subject.

The compositions according to the invention are distinguished by good skin tolerance, which can be found in Example 9.

In preferred embodiments, the “area” used here comprises the relevant region including a distance of up to 5 cm around the relevant region. In certain embodiments, the “area” used here comprises the region in question, including a distance of up to 3 cm, for example up to 2 cm, around the region in question.

The composition can, for example, in principle be applied once or several times a day. The application is not limited in time and can therefore in principle take place over several days, weeks or months. The composition is preferably used at least three times a day. The composition can, for example, be used in principle as required. In certain embodiments, the composition herein can be used on days on which at least one symptom of a urinary tract infection is present. The composition herein can, in certain embodiments, be used on days on which sexual intercourse is carried out.

In preferred embodiments, the composition according to the invention is applied one or more times a day at least in the region of the urethral outlet over a period of 1 to 21 days. In a preferred embodiment, the composition according to the invention is characterized in that it is applied at least once a day at least in the region of the urethral outlet over a period of 1 to 5 days. In a preferred embodiment, the composition according to the invention is characterized in that it is applied at least once a day in the region of the urethral outlet over a period of 1 to 5 days. In a preferred embodiment, the Composition according to the invention, characterized in that it is applied several times a day over a period of 1 to 5 days in the region of the urethral outlet.

In certain general embodiments, the composition according to the invention is used several times a day. In certain general embodiments, the composition of the invention is used at least once a day. In certain general embodiments, the composition of the invention is used once a day. In certain general embodiments, the composition of the invention is used twice a day. In certain general embodiments, the composition according to the invention is used after, more preferably before, more preferably before and after sexual intercourse. In certain general embodiments, the composition of the invention is used after each urination. Any combinations of the above embodiments are also contemplated herein.

Without wishing to be bound by theory, the composition according to the invention, which is intended for use in the methods mentioned or is included in a medical product according to the invention, preferably has one or more advantage (s) selected from the (non-limiting) mentioned below Benefits on: The composition forms a protective film that protects the urethra from invading bacteria. Mannose binds the pathogens and can thus prevent these germs from adhering to the mucous membrane. The lactic acid buffer supports the natural antibacterial vaginal flora. The composition according to the invention has no known interactions with orally administered preparations. The composition according to the invention has an adhesive consistency which preferably enables precise application and preferably ensures that the gel remains at the urethral outlet. There are no known findings that speak against the use of the composition according to the invention during pregnancy and lactation. The composition according to the invention can be applied before and / or after sexual intercourse, preferably to prevent foreign bacteria from rising into the bladder.

Thus, in preferred embodiments, the composition according to the invention forms a protective film. Thus, in preferred embodiments, the composition according to the invention protects the urethra from penetration Bacteria. Thus, in preferred embodiments, the composition according to the invention binds pathogens. Thus, in preferred embodiments, the composition according to the invention prevents pathogens from adhering (for example to the mucous membrane). Thus, in preferred embodiments, the composition according to the invention supports the natural antibacterial vaginal flora. Thus, in certain embodiments, the composition according to the invention is administered in combination with orally administered preparations. Thus, in preferred embodiments, the composition according to the invention enables precise application. Thus, in preferred embodiments, the composition according to the invention enables the gel to remain at the urethral outlet. Thus, in certain embodiments, the composition according to the invention is used during pregnancy. Thus, in certain embodiments, the composition according to the invention is used during breastfeeding. Thus, in preferred embodiments, the composition according to the invention reduces the rise of foreign bacteria into the bladder, in particular when applied after, before, or before and after sexual intercourse. In preferred embodiments, the composition according to the invention thus prevents foreign bacteria from rising into the bladder, in particular when applied after, before, or before and after sexual intercourse. Thus, in preferred embodiments, the composition according to the invention is applied after, before or both after and before sexual intercourse.

In a second aspect, the invention relates to a medical product, characterized in that it comprises a composition as defined herein in the first aspect. The invention thus also relates to a medical product comprising a composition according to the invention.

Preferred embodiments of the second aspect correspond to those of the first aspect. Accordingly, the composition according to the invention comprised by the medical product contains at least 1-50% mannose, for example i) preferably at least 0.25-5% gelling agent, preferably selected from the group consisting of xanthan gum, carrageenan, alginates and water-soluble cellulose ether, and / or ii) preferably further ingredients selected from the group consisting of lactic acid-lactate buffer, preservatives, humectants and water, the preservative preferably being selected from the group consisting of benzoic acid and its salts, sorbic acid and its salts, 2- Phenoxyethanol, 2-phenylethanol, pentylene glycol, caprylyl glycol, ethylhexylglycerin and mixtures of aforementioned substances, and wherein the humectant is preferably in the form of xylitol. The composition according to the invention comprised by the medical product preferably has a pH value of 2.5-5.5, preferably a pH value of 3.0-5.0.

The medical product is preferably characterized in that it enables the physical prophylaxis and / or treatment of urinary tract infections caused by pathogenic germs. Without wishing to be bound by theory, the medical product preferably forms a protective film that protects the urethra from invading bacteria, the medical product preferably binds the pathogens (and can thus preferably prevent these germs from adhering to the mucous membrane) and / or supports the medical product preferably (e.g. through the lactic acid buffer) the naturally antibacterial vaginal flora.

In one embodiment, the medical product is characterized in that it is used together with a medicament, for example an antibiotic.

Further preferred embodiments of the medical product correspond to the embodiments mentioned here for the composition according to the invention.

In a further aspect, the invention relates to a metering dispenser comprising the medical product according to the invention. In a further aspect, the invention relates to a metering dispenser comprising a preferred embodiment of the composition according to the invention as defined in the context of the present invention. In a related aspect, the invention relates to a metering dispenser comprising the composition according to the invention according to the first aspect. In a related aspect, the invention relates to a metering dispenser comprising the medical product according to the second aspect. In a related aspect, the invention relates to a metering dispenser comprising the cosmetic product as defined in the context of the present invention. “Dosing dispensers” are known to those skilled in the art and are not subject to any particular restrictions.

The dosing dispenser is preferably configured here in such a way that a dose contains 0.3 to 1.5 ml, preferably approx. 0.5 ml, of the composition according to the invention or of the medical product. In preferred embodiments, the metering dispenser herein is a metering pump dispenser. Further preferred embodiments of the metering dispenser correspond to the embodiments mentioned in connection with the first and second aspects.

In principle, an amount of the composition or the medical product used here preferably according to the invention has a volume of approx. 0.3 to approx. 2.0 ml, preferably from approx. 0.3 to approx. 1.5 ml, more preferably from 0, 3 to 1.0 ml, such as 0.5 ml.

In a further aspect, the invention relates to an applicator comprising the composition according to the invention according to the first aspect. In a related aspect, the invention relates to an applicator comprising the medical product according to the second aspect. Applicators are well known to those skilled in the art. Applicators preferably facilitate the application of a specific dose of the product.

In a further aspect, the invention relates to a composition according to the invention for use as a medical product. Preferred embodiments of this aspect correspond to the embodiments mentioned here in connection with any other aspects, in particular those of the first and second aspects.

In a further aspect, the invention relates to one according to the invention

Composition for topical treatment, preferably for topical prophylaxis and / or topical treatment of urinary tract infections. Preferred embodiments of this aspect correspond to those here in connection with any other aspects, in particular those of the first aspect

In a further aspect, the invention relates to one according to the invention

Composition for the treatment (preferably topical treatment) of at least one symptom of a urinary tract infection. Preferred embodiments of this aspect correspond to those here in connection with any other aspects, in particular those of the first aspect

In a further aspect, the invention relates to one according to the invention

Composition for forming a protective film, preferably a topical protective film, preferably in the area of the urethral outlet. Preferred Embodiments of this aspect correspond to those here in connection with any other aspects, in particular those of the first aspect

In a further aspect, the invention relates to a composition according to the invention for protecting the urethra from bacteria, in particular from invading bacteria, in particular in the region of the urethral outlet. Preferred embodiments of this aspect correspond to those here in connection with any other aspects, in particular those of the first aspect

In a further aspect, the invention relates to a medical product according to the invention for topical treatment, preferably for topical prophylaxis and / or topical treatment of urinary tract infections. Preferred embodiments of this aspect correspond to those here in connection with any other aspects, in particular those of the first and second aspects.

In a further aspect, the invention relates to a medical product according to the invention for the treatment (preferably topical treatment) of at least one symptom of a urinary tract infection. Preferred embodiments of this aspect correspond to those here in connection with any other aspects, in particular those of the first and second aspects.

In a further aspect, the invention relates to a medical product according to the invention for forming a protective film, preferably a topical protective film, preferably in the region of the urethral outlet. Preferred embodiments of this aspect correspond to those here in connection with any other aspects, in particular those of the first and second aspects.

In a further aspect, the invention relates to a medical product according to the invention for protecting the urethra from bacteria, in particular from invading bacteria, in particular in the area of the urethral outlet. Preferred embodiments of this aspect correspond to those here in connection with any other aspects, in particular those of the first and second aspects.

In a further aspect, the invention relates to a medical product according to the invention for use in a method for prophylaxis and / or for the treatment of urinary tract infections. Preferred embodiments correspond to this aspect the embodiments mentioned here in connection with any other aspects, in particular those of the first and second aspects.

In particular, the examples listed below also show the effectiveness of the composition according to the invention (or of the medical product) in the treatment and / or prevention of urinary tract infections. Among other things, the composition according to the invention (or the medical product) can also be used in an advantageous manner when prodromal symptoms of a urinary tract infection have already become noticeable.

Also provided herein are aspects or embodiments which correspond to the aspects or embodiments described above, but in which the term “contains” (or the like) is replaced by the term “comprises” (or the like).

Also provided herein are embodiments which correspond to the embodiments described herein, but in which the term “composition according to the invention” (or the like) is replaced by the term “medical product according to the invention” (or the like).

As used herein, the term “at least one” can be, according to certain embodiments, for example by “one, two or three” or “one to three”, as well as according to certain embodiments by “one or two”, and according to certain embodiments also by “two” , and in particular also be replaced by "a".

Also provided herein are embodiments that correspond to the embodiments described above, but do not include the term “approximately”.

Also provided herein are embodiments that correspond to the embodiments described above, but do not include the term “at least”.

Also provided herein are embodiments which correspond to the embodiments described above, but in which the term “composition” is replaced by “composition for use in a method for the prophylaxis and / or for the treatment of urinary tract infections”. Also provided herein are embodiments that correspond to the embodiments described above, in FIG but for which the term “medical product” has been replaced by “medical product for use in a method for prophylaxis and / or for the treatment of urinary tract infections”.

In the present invention, definitions of terms which are mentioned in connection with a specific aspect of the invention are preferably also applicable to any other aspects of the invention.

In the present invention, embodiments and in particular also preferred embodiments which are mentioned in connection with a specific aspect of the invention can also be applied to any other aspects of the invention.

In particular, embodiments of the invention that result from any combination of the embodiments mentioned herein are also provided. This also applies in particular to embodiments and combinations of the above embodiments which contain negative features. This also applies in particular to embodiments and combinations of embodiments which result from the examples herein.

Any combinations of the described embodiments are thus also encompassed by the present invention. Any combinations of the embodiments described as preferred are thus also encompassed by the present invention.

Brief description of the figures

FIG. 1 a) shows an exemplary composition according to the invention in dosed form, which was taken from a dosing dispenser, for example. b) shows the preferred application area and the preferred administration according to FIG. 1 c) in greater detail. c) shows in the overview a preferred application area and a preferred administration for a composition according to the invention.

Exemplary embodiments of the invention The exemplary embodiments described below are not to be construed as restrictive for the subject matter of the invention. A number of modifications will be apparent to the person skilled in the art, which are possible within the scope of the present claims.

example 1

An exemplary preferred specific composition according to the invention contains the constituents D-mannose, xanthan (xanthan gum) and sodium lactate-lactic acid buffer - and preferably water, pentylene glycol, xylitol and caprylyl glycol as further constituents.

A specific exemplary composition according to the invention, which was also used in Examples 3 to 7 disclosed here, is as follows:

The rest of the composition is water.

In a specific exemplary embodiment of the product, the package content is approximately 30 g. In a specific exemplary embodiment of the product, a single dose is approximately 0.5 ml.

Example 2

Exemplary, non-limited preferred embodiments of uses of compositions according to the invention include the following embodiments or any combinations thereof: 2a) A composition according to the invention is used to prevent and / or treat incipient urinary tract infections caused by pathogenic germs such as Escherichia coli.

2b) A composition is applied as follows in the area of the urethral outlet, with steps i) and iii) being optional: i) after using the toilet, the hands are cleaned as usual, ii) an application dose (e.g. one pump stroke) of a composition according to the invention is - as illustrated in FIGS. 1 to 3 - applied to the index finger and then applied in the area of the urethral outlet, iii) then the hands are washed thoroughly. The composition according to the invention can easily be rinsed off with water.

2c) A composition according to the invention is used prophylactically as follows: an application dose (e.g. one pump stroke, e.g. with a volume of approx. 0.5 ml, e.g. from a dosing dispenser) of a composition according to the invention is applied over a longer period of time, e.g. four, five or six weeks, whereby the application can take place one to several times a day - preferably after urination. Alternatively (and for example when sexual intercourse causes undesirable symptoms in the region of the urethral outlet), the composition according to the invention can also be applied in each case before and / or after sexual intercourse during this period. This can, for example, prevent foreign bacteria from rising into the bladder.

2d) A composition according to the invention is used for treatment of acute symptoms (such as a slight burning sensation in the urethral outlet, one of the first signs of a urinary tract infection) as follows: A dose (e.g. approx ml volume, for example a pump stroke from a metering dispenser) of a composition according to the invention is applied.

2e) A composition according to the invention is used in acute complaints (such as an existing urinary tract infection) during treatment with an orally administered antibiotic, for example at least one of the

Effects, selected from the following group, to achieve: 1) alleviation of a symptom of urinary tract infection (such as burning sensation caused by irritation at the urethral outlet), 2) protection of the mucous membrane, 3) (co) treatment of the

Urinary tract infection. Example 3

A 25-year-old woman suffering from recurrent urinary tract infections (five in the last 12 months, three of which had occurred in the last six months) associated with painful urination, frequent urination and an urge to urinate, used the formulation according to the example 1 as prophylaxis. The woman applied a pump stroke (approx. 0.5 ml) of the mentioned preparation in the area of her urethral opening for six weeks before sexual intercourse and regularly after urination. She had sexual intercourse with alternating (three different) sexual partners one to four times a week. During this time, no urinary tract infections occurred and the woman had no vaginal or urethral symptoms.

Example 4

A 62-year-old postmenopausal woman with recurring urinary tract infections was prescribed antibiotic treatment (fosfomycin 3000 mg 1xd for 1 day) after a positive urine culture and symptoms of a urinary tract infection ["UHI" or "UH"]. The woman had her first urinary tract infection at the age of 14, and suffered from recurring urinary tract infections before the menopause. She used the product described in Example 1 regularly after urination and after sexual intercourse, which she performed every 7 to 14 days. She used the product while taking the prescribed antibiotic and for 13 days after she stopped taking the antibiotic. The woman experienced an immediate and sustained reduction in urethral burning. Symptoms of urinary tract infection disappeared two days after starting treatment with the product.

Example 5

A 37-year-old woman had several recurring urinary tract infections (6 in the last 14 months, 3 of which had occurred in the last 3 months), which were associated with painful urination, increased urination, and an imperative to urinate. Their method of contraception was a diaphragm. She had sexual intercourse one to three times a week. Bacterial cultures were positive for Escherichia coli and any urinary tract infections were treated with antibiotics.

Four weeks after successful treatment of the last urinary tract infection, the woman felt a burning sensation in the urethral area and began treatment with the formulation according to Example 1 with one pump (approx. 0.5 ml) of the product after urination and before intercourse. This happened over a period of eight weeks. During this time the woman occurred no urinary tract infections and symptoms of an impending urinary tract infection (burning sensation in the urethral area) decreased. For example, the above observations show the effectiveness of the preparation in the treatment and prevention of urinary tract infections, even if prodromal symptoms of a urinary tract infection have already become noticeable.

Example 6

A girl had sexual intercourse for the first time when she was 15 years old. She and her boyfriend used a condom as a contraceptive. The next morning she felt pain and burning when urinating. The pain got worse as the day wore on. The doctor the girl consulted the following day diagnosed a urinary tract infection and prescribed an antibiotic. A week later, the couple had intercourse again. The next day, the girl felt a burning sensation and pain while urinating. She applied the formulation according to Example 1 as intended, and applied a pump stroke (approx. 0.5 ml) several times a day, always after urination. She continued using the formulation after each urination and before and after intercourse for three weeks. During this time, the couple had sexual intercourse five times. During this time, the girl was symptom-free and had no symptoms of a urinary tract infection such as burning sensation or pain when urinating.

Example 7

One day after a 21-year-old woman had sexual intercourse with her partner for the first time, she suffered from painful urination (alguria) and malaise, accompanied by symptoms of a urinary tract infection, such as an imperative to urinate. Before this relationship, the woman had only had sexual intercourse once, with another partner. On the second day of the symptoms (which occurred two days after sexual intercourse), which indicated a bladder infection, the woman began using the formulation from Example 1 several times a day for two weeks. After each urination, the woman used the formulation and applied the product with her freshly washed hands first to the area of the urethral opening, and then also to the anal area.

Before and after every time she had sexual intercourse with her partner, sometimes with and sometimes without a condom, she applied the preparation generously to the vaginal area of the urethral outlet and caudally on her perineum, including the anal area. She did this for two weeks, during which she and her partner every other day Had sexual intercourse and reported that the burning sensation she initially felt while urinating completely subsided and no new symptoms occurred.

The couple married after two months, and the woman took the product with her on her ten-day honeymoon. She used the product as described above. The preparation was applied by the woman to the vaginal area of her urethral opening and caudally to her perineum, including the anal area, after each urination and before and after sexual intercourse with her husband. During the entire honeymoon, during which the couple had sexual intercourse at least once a day, using a condom only for anal intercourse, and tried several, different, positions, no symptoms that could indicate an incipient urinary tract infection occurred.

Example 8

Various preferred embodiments of the compositions according to the invention are listed below by way of example.

1) recipe i

Ingredients g / 100g

D-mannose 25.00

Pentylene Glycol (1,2-pentanediol) 3.00

Xanthan gum 1.50

Xylitol 1.00

Caprylyl glycol (1,2-octanediol) 0.50

Sodium lactate-lactic acid buffer pH 4 0.80

The rest of the composition is water.

2) recipe 2

Ingredients g / 100g

D-mannose 5.00

Xylitol 1.00

Pentylene glycol (1,2-pentanediol) 3.00 caprylyl glycol (1,2-octanediol) 0.50 hydroxyethyl cellulose 1.50 Sodium hyaluronate 0.25

Sodium lactate-lactic acid buffer pH 5 0.50

The rest of the composition is water.

3) Recipe 3

Ingredients g / 100g

D-mannose 2.50

Dexpanthenol EP 3.00

Sodium lactate-lactic acid buffer pH 5 0.50

Potassium chloride 0.05

Calcium chloride (dihydrate) EP 0.02

Pentylene Glycol (1,2-pentanediol) 3.00

Caprylyl glycol (1,2-octanediol) 0.50

Xylitol 1.00

Lambda carrageenan 0.15

The rest of the composition is water.

Example 9

In order to test the tolerance of the compositions according to the invention, a clinical study was carried out with 33 female subjects. The average age of the test persons was 39 years (± 9.3 years; standard deviation). The study was carried out with a composition according to the invention according to formulation 2 as indicated in Example 8 over a period of 15 days. The test subjects were examined by a doctor before the start of the study and at the end of the study period. The test product in the form of the composition according to formulation 2 (see Example 8) was applied by the test subjects to the skin in the external genital area three times a day on each day of the study. At the end of the study period (15 days, application three times a day), the condition of the skin was examined and evaluated in the light of various objective parameters, including dryness, fissures, pustules, edema and others. The test results are summarized in Table 1. The result of the study has shown that the test product, assessed according to the objective parameters, has good skin tolerance. Table 1:

Claims

1. Composition for use in a method for the prophylaxis and / or treatment of urinary tract infections, characterized in that the composition is in the form of a gel and contains 1-50% mannose.

2. Composition for use according to claim 1, characterized in that the composition contains 2-30% mannose, preferably 2.5%, 5% or 25% mannose.

3. Composition for use according to claim 1 or 2, characterized in that the composition contains 0.25-5% gelling agent.

4. Composition for use according to one of the preceding claims, characterized in that the gel former is selected from the group consisting of xanthan gum, carrageenan, alginates and water-soluble cellulose ethers, preferably hydroxyethyl cellulose.

5. Composition for use according to one of the preceding claims, characterized in that the composition contains further components selected from the group consisting of hyaluronic acid, lactic acid-lactate buffer, preservatives, humectants and water.

6. Composition for use according to one of the preceding claims, characterized in that the preservative is selected from the group consisting of benzoic acid and its salts, sorbic acid and its salts, 2-phenoxyethanol, 2-phenylethanol, pentylene glycol, caprylyl glycol, ethylhexylglycerol and mixtures of the aforementioned substances.

7. Composition for use according to one of the preceding claims, characterized in that the composition has a pH of 2.5-5.5, preferably a pH of 3.0-5.0.

8. Composition for use according to one of the preceding claims, characterized in that the humectant is in the form of xylitol.

9. Composition for use according to one of the preceding claims, characterized in that the composition 2-50% D-mannose, preferably 5% D-mannose, 0.25% hyaluronic acid, preferably sodium hyaluronate, 3% pentylene glycol, 1% xylitol, 1 % Sodium lactate solution (50%), 0.5% caprylyl glycol (1,2-octanediol), 1.5% hydroxyethyl cellulose and at least 0.1% lactic acid (90%).

10. Composition for use according to one of the preceding claims, characterized in that the urinary tract infection to be prevented and / or treated is an uncomplicated urinary tract infection, preferably caused by a pathogenic germ, more preferably caused by the bacterium Escherichia coli.

11. Composition for use according to any one of the preceding claims, characterized in that the composition is administered topically.

12. Composition for use according to claim 11, characterized in that the composition is administered topically in the genital area, preferably in the area of the external genital area.

13. Composition for use according to one of the preceding claims, characterized in that the composition is applied at least once a day over a period of 1 to 14 days, preferably at least three times a day over a period of 1 to 7 days.

14. Composition for use in a method for caring for the external genital area, characterized in that the composition is in the form of a gel and contains 1-50% mannose.

15. Composition according to claim 14, characterized in that the composition is characterized as set out in any one of the preceding claims 2 to 9 and 11-13.

16. Cosmetic product, characterized in that it comprises a composition, the composition being in the form of a gel and comprising 1-50% mannose.

17. Cosmetic product according to claim 16, characterized in that the composition is characterized as set out in any one of the preceding claims 2 to 9 and 11-13.

18. Use of the composition according to any one of the preceding claims 1 to 15 or of the cosmetic product according to any one of the preceding claims 16 to 17 for external use on the flaut, preferably for external use in the intimate area, more preferably for external use in the female intimate area.

19. Dosing dispenser, characterized in that it comprises the composition according to any one of claims 1 to 15 or the cosmetic product according to claim 16 or 17.

20. Dosing dispenser according to claim 19, characterized in that it is configured so that a pump unit defines the delivery of the contents contained in the dosing dispenser with a volume of 0.3 to 0.7 ml, preferably with a volume of 0.5 ml .