Compositions for the prevention of urinary tract infections

Abstract

The present invention relates to a composition for use in the prevention of urinary tract infection.

Description

COMPOSITIONS FOR THE PREVENTION OF URINARY TRACTINFECTIONSFIELD OF INVENTION

[0001] The present invention relates to the field of urinary tract infections. More particularly, it concerns an anhydrous composition comprising at least one oil and at least one gum selected from the group consisting of gum arabic, xanthan gum, karaya gum, and any mixtures thereof, preferably the at least one gum is karaya gum. The present invention also relates to said composition for its use as a medicament. The present invention also relates to said composition for its use in the prevention of urinary tract infection in a subject in need thereof.BACKGROUND OF INVENTION

[0002] Urinary tract infections are common. They include acute cystitis, which is a bladder infection, mainly caused by the entry of bacteria naturally present in the digestive tract (Escherichia coli in 90% of cases) through the urinary meatus. This direct inoculation of the urethra with gastrointestinal flora occurs in particular during sexual intercourse; in France, 75% of women's urinary tract infections are linked to sexual intercourse.

[0003] To prevent urinary tract infections, urination after intercourse is recommended, as well as assiduous hygiene, wearing suitable, loose-fitting underwear and drinking sufficient fluids. Cranberry and D-mannose products are also recommended, but their effectiveness is very limited.

[0004] So, despite the existence of preventive dietary supplements and the application of hygienic and dietary measures, cystitis can still occur, affecting women's daily lives. In such cases, use of curative antibiotic therapy after each infectious episode is necessary;and in the case of very frequent recurrences (at least one per month), daily or weekly antibiotic prophylaxis may be proposed. However, antibiotic prophylaxis does not guarantee total efficacy, and exposes patients to the risks inherent in this therapeutic class (antibiotic resistance, increased allergies and other side effects). Treatment of urinary tract and bladder infections is generally based on the prescription of broad-spectrum antibiotics. However, this contributes to bacterial resistance and can induce harmful sideeffects. Today, antibiotic resistance is a major public health issue.

[0005] Other time-limited risk factors for urinary tract infection include swimming in a pool or seawater, travelling, lack of hydration and urination withheld for at least 2 hours.

[0006] There is thus still a need to effectively prevent urinary tract infections, particularly in women, while avoiding the use of antibiotics.

[0007] It would therefore be desirable to have an effective means of preventing urinary tract infections, representing an alternative to antibiotics. There is a real need for new solutions, which would act mechanically, to prevent urinary tract infections, while being easy to apply and to remove without the need for intervention by a health professional such as a doctor or nurse, that holds in place for a sufficient amount of time, that is mucoadhesive, that acts as a barrier against microorganisms and preferably that does not comprise biologically or chemically active agents. For achieving these technical effects, a composition could be administered in the urethra, wherein said composition should have adequate viscosity, remanence, adhesion, rheology, swelling property and barrier effect against microorganisms.

[0008] The inventors of the present application have surprisingly discovered that compositions according to the present invention are able to temporarily form a barrier in or at the entry of the urethra, avoiding the migration of micro-organisms such as bacteria and thus preventing the onset of urinary tract infections. The viscosity, remanence, adhesion, rheology, swelling property and barrier effect against microorganisms of the compositions according to the invention are indeed adequate to allow said compositions to temporarily form a barrier in or at the entry of the urethra while being easy to apply and to remove, thus ensuring good patient compliance.SUMMARY

[0009] The present invention relates to an anhydrous cosmetic or pharmaceutical composition comprising at least one gum and at least one oil, wherein said at least one gum is selected from the group consisting of: gum arabic, xanthan gum, karaya gum, and any mixtures thereof, provided that, if the at least one gum is xanthan gum, then the cosmetic or pharmaceutical composition does not comprise at least one compound selected from the group consisting of: cellulose, cellulose ethers, cellulose esters, hemicelluloses and any mixtures thereof.

[0010] Preferably, said at least one oil is at least one mineral oil, preferably said at least one oil is at least one mineral oil selected from the group consisting of paraffin oil, petrolatum and mixture thereof.

[0011] The present invention relates to a cosmetic or pharmaceutical composition which is anhydrous and comprises at least one gum and paraffin oil, wherein said at least one gum is selected from the group consisting of: gum arabic, xanthan gum, karaya gum, and any mixtures thereof, provided that, if the at least one gum is xanthan gum, then the cosmetic or pharmaceutical composition does not comprise at least one compound selected from the group consisting of: cellulose, cellulose ethers, cellulose esters, hemicelluloses and any mixtures thereof.

[0012] Preferably, the at least one gum is karaya gum.

[0013] Preferably, the content of the at least one gum in said cosmetic or pharmaceutical composition ranges from 10% w / w to 80% w / w, preferably from 10% w / w to 50% w / w, more preferably from 25% w / w to 45% w / w, even more preferably from 30% w / w to 45% w / w, by weight relative to the total weight of said cosmetic or pharmaceutical composition.

[0014] Preferably, the content of the at least one gum in said cosmetic or pharmaceutical composition ranges from about 10% w / w to about 80% w / w, preferably from about 10% w / w to about 60% w / w, more preferably from about 10% w / w to about 55% w / w, evenmore preferably from about 20% w / w to about 50% w / w, better from about 25% w / w to about 50% w / w, still better from about 30% w / w to about 45% w / w, by weight relative to the total weight of said cosmetic or pharmaceutical composition.

[0015] Preferably, the content of the at least one gum in said cosmetic or pharmaceutical composition ranges from 10% w / w to 80% w / w, preferably from 10% w / w to 60% w / w, more preferably from 25% w / w to 55% w / w, even more preferably from 30% w / w to 50% w / w, by weight relative to the total weight of said cosmetic or pharmaceutical composition.

[0016] Preferably, said cosmetic or pharmaceutical composition further comprises at least one further oil different from paraffin oil, preferably said at least one further oil different from paraffin oil is at least one mineral oil, more preferably said at least one further oil different from paraffin oil is petrolatum.

[0017] Preferably, the total content of the oil(s) in said cosmetic or pharmaceutical composition ranges from 10% w / w to 90% w / w, preferably from 40% w / w to 80% w / w, more preferably from 50% w / w to 75% w / w, even more preferably from 55% w / w to 70% w / w, by weight relative to the total weight of the cosmetic or pharmaceutical composition.

[0018] Preferably, said cosmetic or pharmaceutical composition comprises: from 10% w / w to 80% w / w, preferably from 10% w / w to 50% w / w, more preferably from 25% w / w to 45% w / w, even more preferably from 30% w / w to 45% w / w, of at least one gum, preferably of karaya gum, from 0.1 % w / w to 12% w / w, preferably from 2% w / w to 8% w / w, more preferably from 4% w / w to 6% w / w, even more preferably about 5% w / w, of paraffin oil, and qsp 100% w / w of petrolatum, the percentages being expressed by weight relative to the total weight of the cosmetic or pharmaceutical composition.

[0019] Preferably, said cosmetic or pharmaceutical composition comprises: from about 10% w / w to about 80% w / w, preferably from about 10% w / w to about 60% w / w, more preferably from about 10% w / w to about 55% w / w, even morepreferably from about 25% w / w to about 50% w / w, better from about 25% w / w to about 45% w / w, still better from about 30% w / w to about 45% w / w, of at least one gum, preferably of karaya gum, from about 0.1% w / w to about 12% w / w, preferably from about 2% w / w to about 8% w / w, more preferably from about 4% w / w to about 6% w / w, even more preferably about 5% w / w, of paraffin oil, and qsp 100% w / w of petrolatum, the percentages being expressed by weight relative to the total weight of the cosmetic or pharmaceutical composition.

[0020] Preferably, said cosmetic or pharmaceutical composition comprises: from 10% w / w to 80% w / w, preferably from 10% w / w to 60% w / w, more preferably from 25% w / w to 55% w / w, even more preferably from 30% w / w to 50% w / w, of at least one gum, preferably of karaya gum, from 0.1 % w / w to 12% w / w, preferably from 2% w / w to 8% w / w, more preferably from 4% w / w to 6% w / w, even more preferably about 5% w / w, of paraffin oil, and qsp 100% w / w of petrolatum, the percentages being expressed by weight relative to the total weight of the cosmetic or pharmaceutical composition.

[0021] Preferably, the weight ratio of the total amount of gums, selected from gum arabic, xanthan gum, karaya gum, and any mixtures thereof, to the total amount of oil(s), present in the cosmetic or pharmaceutical composition, is of less than or equal to 1, preferably it ranges from 3:7 to 4.5:5.5. More preferably, the gum is karaya gum and the weight ratio of the amount of karaya gum to the total amount of oils, present in the cosmetic or pharmaceutical composition, is strictly less than 1, preferably it ranges from 3:7 to 4.5:5.5.

[0022] Preferably, said cosmetic or pharmaceutical composition is in a semi-solid galenic form, preferably said cosmetic or pharmaceutical composition is in a semi-solid galenic form selected from the group consisting of: ointment, paste, and gel.

[0023] Preferably, said cosmetic or pharmaceutical composition does not comprise any pharmaceutically active agent.

[0024] Preferably, said cosmetic or pharmaceutical composition further comprises at least one pharmaceutically active agent, preferably selected from the group consisting of: antiseptic agents, antibacterial agents, antibiotics, antifungal agents, analgesics or anesthetic agents, soothing agents and any mixtures thereof.

[0025] Preferably, said cosmetic or pharmaceutical composition has a dynamic viscosity ranging from 3,000 mPa.s to 50,000 mPa.s, preferably from 4,000 mPa.s to 20,000 mPa.s, said dynamic viscosity being measured at 37°C using a viscometer with a mobile speed of 5 rpm.

[0026] The present invention also relates to a pharmaceutical composition, for use as a medicament, wherein said pharmaceutical composition is anhydrous and comprises at least one gum and at least one oil, wherein said at least one gum is selected from the group consisting of: gum arabic, xanthan gum, karaya gum, and any mixtures thereof, provided that, if the at least one gum is xanthan gum, then the pharmaceutical composition does not comprise at least one compound selected from the group consisting of: cellulose, cellulose ethers, cellulose esters, hemicelluloses and any mixtures thereof.

[0027] The present invention further relates to a pharmaceutical composition, for use in the prevention of urinary tract infection in a subject in need thereof, wherein said pharmaceutical composition is anhydrous and comprises at least one gum and at least one oil, wherein said at least one gum is selected from the group consisting of: gum arabic, xanthan gum, karaya gum, and any mixtures thereof, provided that, if the at least one gum is xanthan gum, then the pharmaceutical composition does not comprise at least one compound selected from the group consisting of: cellulose, cellulose ethers, cellulose esters, hemicelluloses and any mixtures thereof.

[0028] Preferably, said pharmaceutical composition is administered via urethral route to said subject, preferably said pharmaceutical composition is administered via urethral route to said subject prior to the exposition to a temporal risk factor, more preferably said pharmaceutical composition is administered via urethral route to said subject prior to theexposition to a temporal and time-limited risk factor, even more preferably said pharmaceutical composition is administered via urethral route to said subject prior to the exposition to a temporal and time-limited risk factor selected from the group consisting of: a sexual intercourse, a swimming in a pool or seawater, travel, lack of hydration, urination withheld for at least 2 hours, better said pharmaceutical composition is administered via urethral route to said subject prior to the exposition to a temporal risk factor wherein the risk factor is a sexual intercourse.DEFINITIONS

[0029] In the present invention, the following terms have the following meanings:

[0030] “About”, before a figure or number, refers to plus or minus 10% of the face value of that figure or number. In one embodiment, “about”, before a figure or number, refers to plus or minus 5% of the face value of that figure or number.

[0031] “Active agent” refers to an agent that has a therapeutic effect. The agent may be a chemical or a biological substance.

[0032] “Administration via urethral route” refers to the delivery of a composition into the urethra or at the opening of the urethra. The “administration via urethral route” excludes intra-vesical delivery (in particular via the trans-urethral route) and is limited to the delivery of a composition into the urethra or at the opening of the urethra, and not to the bladder.

[0033] “Anhydrous composition” refers to a composition comprising less than 1% w / w of water, preferably less than 0.1% w / w of water, more preferably no water. Preferably the anhydrous composition does not comprise any water other than the residual water from the manufacturing process of said anhydrous composition or present in the raw materials included in said anhydrous composition.

[0034] “At least” means “greater than or equal to” and is thus different from “strictly greater than” which does not comprise “equal to”.

[0035] “Carboxymethylcellulose” or “CMC” refers to the chemical substance having the CAS number 9000-11-7. It is a polymer belonging to cellulose ethers. “Carboxymethylcellulose” is used interchangeably with “sodium carboxymethylcellulose” which is the chemical substance having the CAS number 9004- 32-4. Preferably, sodium carboxymethylcellulose according to the invention fulfils at least one of the following characteristics: viscosity ranging from 2,500 to 4,500 mPa.s (cPs) at 25°C measured using a rotational viscometer, pH ranging from 6.5 to 8.0, loss on drying ranging from 0.0% w / w to 10.0% w / w, Na Chloride content ranging from 0.00% w / w to 0.25% w / w, Na Chloride content calculated versus dry substance ranging from 7.0% w / w to 8.8% w / w, degree of substitution ranging from 0.65 to 0.90 preferably of 0.7, weight average molecular weight of about 725,000, purity of at least 95% w / w, preferably of at least 99% w / w.

[0036] “Carrageenan” refers to a natural polysaccharide extracted from red seaweed.

[0037] “Cellulose” refers to a polysaccharide which constitutes the primary structural component of plant cell walls and which is composed of linear chains of [3-D-glucose units (from 15 to 15,000 units) linked together by [3(1 — >4) glycosidic bonds.

[0038] “Cellulose derivatives” refers to chemically modified cellulose, where the hydroxyl groups (-OH) on the glucose units of the cellulose are replaced with other functional groups. Preferably, “cellulose derivatives” include cellulose ethers and cellulose esters. Preferably, “cellulose esters” include cellulose acetate, cellulose triacetate, cellulose propionate, cellulose acetate propionate (cap), cellulose acetate butyrate (cab), cellulose nitrate, cellulose sulfate, and any mixtures thereof. Preferably, “cellulose ethers” include methylcellulose, ethylcellulose, methyl-ethyl cellulose, hydroxy-ethyl cellulose, hydroxypropyl cellulose, hydroxy ethyl-methyl cellulose, hydroxypropyl methylcellulose, ethyl hydroxyethyl cellulose, carboxymethyl cellulose, and any mixtures thereof.

[0039] “CIS code” or “Code Identifiant de Specialite” is an 8-digit numerical code that identifies a drug regardless of its presentation (or packaging).

[0040] “Comprising” or “comprise” is to be construed in an open, inclusive sense, not limited to the features following this term.

[0041] “Consisting of’ or “consist” is to be construed in a close, non-inclusive sense, limited to the features following this term.

[0042] “Dose” refers to the volume of composition according to the invention administered at one time.

[0043] “Drop” or “droplet” refers to a small liquid particle.

[0044] “Emulsion” refers to a fluid colloidal system in which liquid droplets are dispersed in a liquid.

[0045] “Excipient” refers to any chemically or biologically inactive ingredient, which is required for the formulation of a composition according to the invention.

[0046] “Fatty substance” refers to an organic compound that is insoluble in water at ordinary room temperature (25°C) and at atmospheric pressure (1.013 25*105Pa or 1 atm) (solubility of less than 5 percent, preferably 1 percent and even more preferentially 0.1 percent). They have in their structure at least one hydrocarbon-based chain containing at least 6 carbon atoms or a sequence of at least two siloxane groups. In addition, the fatty substances are generally soluble in organic solvents under the same temperature and pressure conditions, such as for instance chloroform, ethanol, benzene, or decamethylcyclopentasiloxane.

[0047] “From X to Y” refers to the range of values between X and Y, the limits X and Y being included in said range.

[0048] “Gel” refers to a non-fluid polymer network that is expanded throughout its whole volume by a fluid. In the present application, said fluid is not water; preferably, said fluid is non-hydrophilic.

[0049] “Gum” refers to a substance comprising essentially polysaccharides, preferably being a plant exudate. According to the present invention, a “gum” may be selected fromthe group consisting of: gum arabic, carob gum, gum ghati, guar gum, xanthan gum, karaya gum, tara gum, tragacanth gum, gellan gum, agar gum, psyllium gum, tamarind gum, konjac gum, chicle gum, guarana gum, quillaia gum, mesquite gum, chitosan gum, chondrus gum, raffia gum, oak gum and any mixtures thereof. Preferably, a “gum” according to the present invention may be selected from the group consisting of: gum arabic, carob gum, gum ghatti, guar gum, xanthan gum, karaya gum, tara gum, tragacanth gum and any mixtures thereof.

[0050] “Hemicelluloses” refers to polysaccharides present in plant cell walls. They are branched and composed of various sugar monomers, including glucose, xylose, mannose, galactose, rhamnose, and arabinose. Preferably, “hemicellulose” includes xylan, glucuronoxylan, arabinoxylan, glucomannan, xyloglucan and any mixtures thereof.

[0051] “Hydrocarbons” refers to compounds consisting of carbon and hydrogen only.

[0052] “Hydrophilic” refers to the capacity of a molecular entity or of a substituent to interact with polar solvents, in particular with water.

[0053] “Karaya gum” refers to the chemical substance having the CAS number 91671- 85-1 and the European Community (EC) Number 293-987-4 or the CAS number 9000- 36-6 and the European Community (EC) Number 232-539-4. Karaya gum is also known as food additive E416. Preferably, karaya gum according to the invention fulfils at least one of the following characteristics: a powder white to light beige, slight acetic acid smelling and taste; a viscosity of at least 1,000 mPa.s, preferably of at least 2,000 mPa.s, more preferably of about 2,400 mPa.s, said viscosity being measured at 20°C for 24 hours using a Brookfield RVT viscometer with a spindle 3 at 20 rpm; a pH (1% w / w solution) equal to or less than 5.5, preferably of about 4.81; and a granulometry of less than 140 pm.

[0054] “Mucosa” refers to a membrane lining the body's natural cavities, particularly the mouth and external genitalia. The epithelium of a mucosa in such areas is stratified, also known as squamous or squamous-like, but without a homy layer.

[0055] “Oil” refers to a fatty substance that is liquid at room temperature (25°C) and atmospheric pressure (760 mmHg, i.e. 105Pa). The term “oil” includes mineral oils, vegetable oils, animal oils and mixtures thereof. The oils may be volatile or non-volatile. “Volatile oils” refers to oils which are liquid at room temperature, having a non-zero vapor pressure, at room temperature and atmospheric pressure, ranging in particular from 0.13 Pa to 40 000 Pa (103 to 300 mmHg). “Non-volatile oil” refers to an oil that has a vapor pressure of less than 103 mmHg (0.13 Pa). “Mineral oils” include paraffin oil, petrolatum, silicone oil and any mixtures thereof. “Silicone oil” refers to an oil containing at least one silicon atom, and in particular containing Si-0 groups. “Vegetable oils” refer to oils of vegetable origin, such as triglycerides consisting of fatty acid esters of glycerol in which the fatty acids can have varied chain lengths from C4 to C24, it being possible for the latter to be saturated or unsaturated and linear or branched; these oils are in particular triglycerides of heptanoic acid or octanoic acid. “Animal oils” refer to oils of animal origin.

[0056] “Ointment” refers to a composition consisting of at least one oil in which liquid or solid substances may be dissolved or dispersed.

[0057] “Paraffin oil” refers to the chemical substance having the CAS number 8012- 95-1. It is a mixture of hydrocarbons belonging to mineral oils, liquid at 25°C.

[0058] “Paste” refers to a composition containing high proportions of powder(s) (for example, the powder(s) represent(s) at least 50% w / w relative to the total weight of the composition) dispersed in at least one oil.

[0059] “Petrolatum” or “petroleum jelly” or “Vaseline®” or “white Vaseline®” refers to the chemical substance having the CAS number 8009-03-8. It is a semi-solid mixture of hydrocarbons (with carbon numbers mainly higher than 25).

[0060] “Particle” refers to a very small part of a material element. Advantageously, the mean diameter of the particles ranges from 1 nm to 10 pm, preferably from 1 nm to 1 pm, preferably from 10 nm to 10 pm, more preferably from 10 nm to 500 nm, even more preferably from 1 nm to 100 nm. “Powder” refers to a set of dry and more or less fine solid particles. “Dry” refers to a material, composition or substance comprising less than1% w / w of water, preferably less than 0.5% w / w of water, more preferably less than 0.01% w / w of water.

[0061] “Pharmaceutical composition” refers to a composition comprising at least one pharmaceutically acceptable excipient and optionally at least one pharmaceutically acceptable active agent.

[0062] “Pharmaceutically acceptable” refers to generally safe, non-toxic and neither biologically nor physiologically nor otherwise undesirable for mammalian animals, in particular for humans, dogs, cats and non-human primate animals.

[0063] “Rpm” or “revolutions per minute” refers to the number of turns in one minute.

[0064] “Skin” refers to the outer covering of the body formed by the epidermis and dermis, joined to the underlying surface by subcutaneous cellular tissue. The epidermis is the body's outer covering epithelium, made up of several layers of cells that undergo keratinization, a homy transformation, on reaching the surface.

[0065] “Subject” or “patient” refers to a mammalian animal, wherein “mammalian animal” refers to a human or a non-human mammalian animal. In one embodiment, “subject” refers to a human (man or woman). In one embodiment, “subject” refers to a non-human mammalian animal, preferably to a non-human mammalian animal selected from the group consisting of a cat, a dog, a horse and a non-human primate such as a monkey.

[0066] “Solution” refers to a liquid or solid phase containing more than one substance, when for convenience one (or more) substance, which is called the solvent, is treated differently from the other substances, which are called solutes.

[0067] “Suspension” refers to a dispersion of solid particles in a liquid.

[0068] “Therapeutically effective amount” or “effective amount” of a composition refers to a nontoxic but sufficient amount of said composition to provide the desired therapeutic effect. In the present application, unless otherwise indicated, the amount is expressed in volume.

[0069] “Treating” or “treatment” refers to any action which makes it possible to prevent, delay, reduce in severity and / or frequency or suppress at least one symptom associated with a pathological condition, or to prevent, slow down or suppress the underlying cause of a pathological condition, or the improvement or remediation of damage. In one embodiment, “treatment” refers to a curative treatment. In another embodiment, “treatment” refers to a preventive treatment. In another embodiment, “treatment” refers to a preventive and / or curative treatment.

[0070] “Urethral route” or “urethral route of administration” or “urethral administration” refers to an administration either into the urethra or at the opening of the urethra (i.e. on the urethral orifice, i.e. periurethral). In particular, a composition administered via urethral route may be deposited on all or part of the urethra. Thus, an administration via urethral route excludes cutaneous administration (i.e. on the skin), as urethra is a mucosa.

[0071] “Urinary tract infection” refers to any type of infection due to a micro-organism ascending in the urinary tract via the urethra. In particular, urinary tract infection may refer to cystitis and recurrent cystitis, whether complicated or not, and with or without risk factors for complications. . Recurrent cystitis is a succession of urinary tract infection episodes of greater than to two per year or greater than one per half-year. For example, risk factors for cystitis complications may include certain comorbidities, pregnancy, and functional or anatomical abnormalities of the urinary system. In particular, complications of cystitis may include pyelonephritis.

[0072] “Viscosity” or “dynamic viscosity” refers, for a laminar flow of a fluid, to the ratio of the shear stress to the velocity gradient perpendicular to the plane of shear. Otherwise expressed, dynamic viscosity is a physical quantity that characterizes a fluid's resistance to laminar flow. Viscosity may be measured by methods well-known to a skilled person in the art. In particular, viscosity may be measured at 37°C using a viscometer with a mobile speed of 5 rpm, preferably using a Brookfield DV3+ viscometer.DETAILED DESCRIPTIONComposition according to the invention

[0073] This invention relates to a composition which is anhydrous and which comprises at least one oil and at least one gum selected from the group consisting of gum arabic, xanthan gum, karaya gum, and any mixtures thereof, preferably the at least one gum is karaya gum.

[0074] Preferably, the at least one gum is selected from the group consisting of: gum arabic, carob gum, gum ghatti, guar gum, xanthan gum, karaya gum, tara gum, tragacanth gum, gellan gum, agar gum, psyllium gum, tamarind gum, konjac gum, chicle gum, guarana gum, quillaia gum, mesquite gum, chitosan gum, chondrus gum, raffia gum, oak gum and any mixtures thereof. More preferably, the at least one gum is selected from the group consisting of: gum arabic, carob gum, gum ghatti, guar gum, xanthan gum, karaya gum, tara gum, tragacanth gum and any mixtures thereof. Even more preferably, the at least one gum is selected from the group consisting of: gum arabic, xanthan gum, karaya gum, and any mixtures thereof. Better, the at least one gum is karaya gum.

[0075] If the at least one gum is xanthan gum, guar gum, gellan gum, agar gum, or any mixtures thereof, then the pharmaceutical composition does not comprise at least one compound selected from the group consisting of: cellulose, cellulose derivatives, hemicelluloses and any mixtures thereof. If the at least one gum is xanthan gum, guar gum, gellan gum, agar gum, or any mixtures thereof, then the pharmaceutical composition does not comprise at least one compound selected from the group consisting of: cellulose, cellulose ether, cellulose ester, hemicelluloses and any mixtures thereof. The cellulose derivatives are preferably selected from the group consisting of cellulose ethers, cellulose esters and any mixtures thereof. Preferably, if the at least one gum is xanthan gum, guar gum, gellan gum, agar gum, or any mixtures thereof, then the pharmaceutical composition does not comprise at least one compound selected from the group consisting of: cellulose, cellulose acetate, cellulose triacetate, cellulose propionate, cellulose acetate propionate (cap), cellulose acetate butyrate (cab), cellulose nitrate, cellulose sulfate, methylcellulose, ethylcellulose, methyl-ethyl cellulose, hydroxy-ethyl cellulose, hydroxypropyl cellulose,hydroxy ethyl-methyl cellulose, hydroxypropyl methylcellulose, ethyl hydroxyethyl cellulose, carboxymethyl cellulose, xylan, glucuronoxylan, arabinoxylan, glucomannan, xyloglucan and any mixtures thereof.

[0076] Preferably, the at least one gum is karaya gum and the pharmaceutical composition does not comprise at least one compound selected from the group consisting of: cellulose, cellulose derivatives, hemicelluloses and any mixtures thereof. More preferably, the at least one gum is karaya gum and the pharmaceutical composition does not comprise at least one compound selected from the group consisting of: cellulose, cellulose ether, cellulose ester, hemicelluloses and any mixtures thereof. Even more preferably, the at least one gum is karaya gum and the pharmaceutical composition does not comprise at least one compound selected from the group consisting of: cellulose, cellulose acetate, cellulose triacetate, cellulose propionate, cellulose acetate propionate (cap), cellulose acetate butyrate (cab), cellulose nitrate, cellulose sulfate, methylcellulose, ethylcellulose, methyl-ethyl cellulose, hydroxy-ethyl cellulose, hydroxypropyl cellulose, hydroxy ethyl-methyl cellulose, hydroxypropyl methylcellulose, ethyl hydroxyethyl cellulose, carboxymethyl cellulose, xylan, glucuronoxylan, arabinoxylan, glucomannan, xyloglucan and any mixtures thereof.

[0077] Preferably, the pharmaceutical composition does not comprise at least one compound selected from the group consisting of: cellulose, cellulose derivatives, hemicelluloses and any mixtures thereof. More preferably, the pharmaceutical composition does not comprise at least one compound selected from the group consisting of: cellulose, cellulose ether, cellulose ester, hemicelluloses and any mixtures thereof. Even more preferably, the pharmaceutical composition does not comprise at least one compound selected from the group consisting of: cellulose, cellulose acetate, cellulose triacetate, cellulose propionate, cellulose acetate propionate (cap), cellulose acetate butyrate (cab), cellulose nitrate, cellulose sulfate, methylcellulose, ethylcellulose, methylethyl cellulose, hydroxy-ethyl cellulose, hydroxypropyl cellulose, hydroxy ethyl-methyl cellulose, hydroxypropyl methylcellulose, ethyl hydroxyethyl cellulose, carboxymethyl cellulose, xylan, glucuronoxylan, arabinoxylan, glucomannan, xyloglucan and any mixtures thereof.

[0078] Preferably, the total content of gum(s) present in the composition of the invention, ranges from about 10% w / w to about 80% w / w, more preferably from about 10% w / w to about 50% w / w, even more preferably from about 25% w / w to about 45% w / w, better from about 30% w / w to about 45% w / w, by weight relative to the total weight of the composition.

[0079] Preferably, the total content of gum(s) present in the composition of the invention, ranges from about 10% w / w to about 80% w / w, preferably from about 10% w / w to about 60% w / w, more preferably from about 10% w / w to about 55% w / w, even more preferably from about 20% w / w to about 50% w / w, better from about 25% w / w to about 45% w / w, still better from about 30% w / w to about 45% w / w, by weight relative to the total weight of the composition.

[0080] Preferably, the total content of gum(s) present in the composition of the invention, is greater than or equal to about 10% w / w, about 11% w / w, about 12% w / w, about 13% w / w, about 14% w / w, about 15% w / w, about 16% w / w, about 17% w / w, about 18% w / w, about 19% w / w, about 20% w / w, about 21% w / w, about 22% w / w, about 23% w / w, about 24% w / w, about 25% w / w, about 26% w / w, about 27% w / w, about 28% w / w, about 29% w / w, about 30% w / w, about 31 % w / w, about 32% w / w, about 33% w / w, about 34% w / w, about 35% w / w, about 36% w / w, about 37% w / w, about 38% w / w, about 39% w / w, about 40% w / w, about 41% w / w, about 42% w / w, about 43% w / w, about 44% w / w, about 45% w / w, about 46% w / w, about 47% w / w, about 48% w / w, about 49% w / w, about 50% w / w, about 51% w / w, about 52% w / w, about 53% w / w, about 54% w / w, about 55% w / w, about 56% w / w, about 57% w / w, about 58% w / w, about 59% w / w, about 60% w / w, about 61% w / w, about 62% w / w, about 63% w / w, about 64% w / w, about 65% w / w, about 66% w / w, about 67% w / w, about 68% w / w, about 69% w / w, about 70% w / w, about 71% w / w, about 72% w / w, about 73% w / w, about 74% w / w, about 75% w / w, about 76% w / w, about 77% w / w, about 78% w / w, about 79% w / w or about 80% w / w, by weight relative to the total weight of the composition.

[0081] Preferably, said at least one gum is at least one gum selected from the group consisting of: gum arabic, xanthan gum, karaya gum, and any mixtures thereof, and the total content of gum(s) ranges preferably from about 10% w / w to about 80% w / w, morepreferably from about 10% w / w to about 50% w / w, even more preferably from about 25% w / w to about 45% w / w, better from about 30% w / w to about 45% w / w, by weight relative to the total weight of the composition.

[0082] Preferably, said at least one gum is at least one gum selected from the group consisting of: gum arabic, xanthan gum, karaya gum, and any mixtures thereof, and the total content of gum(s) ranges preferably from about 10% w / w to about 80% w / w, preferably from about 10% w / w to about 60% w / w, more preferably from about 10% w / w to about 55% w / w, even more preferably from about 20% w / w to about 50% w / w, better from about 25% w / w to about 45% w / w, still better from about 30% w / w to about 45% w / w, by weight relative to the total weight of the composition.

[0083] Preferably, said at least one gum is at least one gum selected from the group consisting of: gum arabic, xanthan gum, karaya gum, and any mixtures thereof, and the total content of gum(s) ranges preferably from about 10% w / w to about 80% w / w, preferably from about 20% w / w to about 70% w / w, more preferably from about 30% w / w to about 65% w / w, even more preferably from about 35% w / w to about 60% w / w, better from about 40% w / w to about 55% w / w, by weight relative to the total weight of the composition.

[0084] More preferably, said at least one gum is karaya gum and the content of karaya gum ranges preferably from about 10% w / w to about 80% w / w, more preferably from about 10% w / w to about 50% w / w, even more preferably from about 25% w / w to about 45% w / w, better from about 30% w / w to about 45% w / w, by weight relative to the total weight of the composition.

[0085] More preferably, said at least one gum is karaya gum and the content of karaya gum ranges preferably from about 10% w / w to about 80% w / w, preferably from about 10% w / w to about 60% w / w, more preferably from about 10% w / w to about 55% w / w, even more preferably from about 20% w / w to about 50% w / w, better from about 25% w / w to about 45% w / w, still better from about 30% w / w to about 45% w / w, by weight relative to the total weight of the composition.

[0086] Preferably, said at least one oil is selected from the group consisting of: mineral oils, vegetable oils, animal oils and any mixtures thereof.

[0087] Preferably, the total content of oil(s), present in the composition of the invention, preferably ranges from about 10% w / w to about 90% w / w, more preferably from about 40% w / w to about 80% w / w, even more preferably from about 50% w / w to about 75% w / w, better from about 55% w / w to about 70% w / w, by weight relative to the total weight of the composition.

[0088] Preferably, the total content of oil(s), present in the composition of the invention, preferably ranges from about 10% w / w to about 90% w / w, preferably from about 45% w / w to about 90% w / w, more preferably from about 50% w / w to about 75% w / w, even more preferably from about 55% w / w to about 75% w / w, by weight relative to the total weight of the composition.

[0089] Preferably, the weight ratio of the total amount of gum(s) to the total amount of oil(s) ranges from 1:9 to 9:1, preferably from 1:9 to 6:4, more preferably from 2:8 to 5.5:4.5, even more preferably from 3:7 to 4.5:5.5. More preferably, the weight ratio of the amount of karaya gum to the total amount of oil(s) ranges from 1:9 to 9:1, preferably from 1:9 to 6:4, more preferably from 2:8 to 5.5:4.5, even more even more preferably from 3:7 to 4.5:5.5.

[0090] Said mineral oil may be selected from the group consisting of paraffin oil, petrolatum and mixture thereof.

[0091] Preferably, the at least one oil is at least one mineral oil. More preferably, the at least one oil is at least one mineral oil selected from the group consisting of: paraffin oil, petrolatum, silicone oil and any mixtures thereof. Even more preferably, the at least one oil is at least one mineral oil selected from the group consisting of: paraffin oil, petrolatum and any mixtures thereof.

[0092] Preferably, the at least one oil can be provided by a compound selected from the group consisting of: Plastibase® 50W (marketed by Glasshouse Pharmaceuticals) and Plastibase® 55W (marketed by Glasshouse Pharmaceuticals).

[0093] Preferably, the at least one oil comprises paraffin oil. Even more preferably, the at least one oil comprises paraffin oil and the content of paraffin oil ranges preferably from about 0.1% w / w to about 12% w / w, preferably from about 2% w / w to about 8% w / w, more preferably from about 4% w / w to about 6% w / w, even more preferably about 5% w / w, by weight relative to the total weight of the composition.

[0094] Preferably, the weight ratio of the total amount of gum(s) to the amount of paraffin oil, present in the composition of the invention, is greater than or equal to 5, preferably it ranges from 5 to 10, more preferably it ranges from 6 to 9. More preferably, the weight ratio of the amount of karaya gum to the amount of paraffin oil, present in the composition of the invention, is greater than or equal to 5, preferably it ranges from 5 to 10, more preferably it ranges from 6 to 9.

[0095] Preferably, the weight ratio of the total amount of gum(s) to the amount of paraffin oil, present in the composition of the invention, ranges from 10:5 to 80:5, preferably from 10:5 to 55:5, more preferably from 25:5 to 45:5, even more preferably from 6:1 to 9: 1. More preferably, the weight ratio of the amount of karaya gum to the amount of paraffin oil, present in the composition of the invention, ranges from 10:5 to 80:5, preferably from 10:5 to 55:5, more preferably from 25:5 to 45:5, even more preferably from 6:1 to 9:1.

[0096] Preferably, the at least one oil comprises petrolatum. Even more preferably, the at least one oil comprises petrolatum and the content of petrolatum ranges preferably from about 10% w / w to about 90% w / w, more preferably from about 45% w / w to about 75% w / w, even more preferably from about 50% w / w to about 70% w / w, better from about 55% w / w to about 65% w / w, by weight relative to the total weight of the composition.

[0097] Preferably, the weight ratio of the total amount of gum(s) to the amount of petrolatum, present in the composition of the invention, is less than or equal to 1, preferably it ranges from 1:8.5 to 6:3.5, more preferably from 2:7.5 to 5.5: 4.0, even more preferably from 3:6.5 to 4.5: 5.0. More preferably, the weight ratio of the amount of karaya gum to the amount of petrolatum, present in the composition of the invention, is less thanor equal to 1, preferably it ranges from 1:8.5 to 6:3.5, more preferably from 2:7.5 to 5.5:4.0, even more preferably from 3:6.5 to 4.5:5.0.

[0098] Preferably, the at least one oil comprises paraffin oil and petrolatum. Even more preferably, the at least one oil comprises paraffin oil and petrolatum and the total content of paraffin oil and petrolatum preferably ranges from about 10% w / w to about 90% w / w, more preferably from about 40% w / w to about 80% w / w, even more preferably from about 50% w / w to about 75% w / w, better from about 55% w / w to about 70% w / w, by weight relative to the total weight of the composition.

[0099] Preferably, the weight ratio of the amount of petrolatum to the amount of paraffin oil ranges from 10: 1 to 13:1.

[0100] Preferably, the weight ratio of the amount of petrolatum to the amount of paraffin oil, present in the composition of the invention, ranges from 35:5 to 85:5, preferably from 40:5 to 75:5, more preferably from 50:5 to 65:5. Otherwise expressed, Preferably, the weight ratio of the petrolatum to the paraffin oil, present in the composition of the invention, ranges from 7 to 17, preferably from 8 to 15, more preferably from 10 to 13.

[0101] Preferably, the silicone oil according to the invention is selected from the group consisting of: volatile silicone oils such as cyclopolydimethylsiloxanes (INCI name: cyclomethicone), such as cyclopentasiloxane, cyclohexasiloxane, octamethylcyclotetrasiloxane, decamethylcyclopentasiloxane, dodecamethylcyclohexasiloxane; linear silicones such as heptamethylhexyltrisiloxane, heptamethyloctyltrisiloxane, hexamethyldisiloxane, octamethyltrisiloxane, decamethyltetrasiloxane or dodecamethylpentasiloxane; non-volatile silicone oils such as polymethylsiloxanes (PDMS), and phenyl polymethylsiloxanes such as phenyl trimethicones, phenyl dimethicones, phenyltrimethylsiloxydiphenylsiloxanes, diphenyl dimethicones, diphenylmethyldiphenyltrisiloxanes, 2-phenylethyl trimethylsiloxysilicates and polymethylphenylsiloxanes; polysiloxanes modified with fatty acids, fatty alcohols or polyoxyalkylenes, and any mixtures thereof.

[0102] Preferably, the at least one oil is at least one vegetable oils. More preferably, the at least one oil is at least one vegetable oil selected from the group consisting of:wheatgerm oil, olive oil, sweet almond oil, palm oil, rapeseed oil, coconut oil, cottonseed oil, alfalfa oil, poppy oil, pumpkin oil, marrow oil, blackcurrant oil, evening primrose oil, millet oil, barley oil, quinoa oil, rye oil, safflower oil, candlenut oil, passion flower oil, musk rose oil, sunflower oil, com oil, soybean oil, marrow oil, grapeseed oil, sesame seed oil, hazelnut oil, apricot kernel oil, macadamia oil, castor oil, avocado oil,jojoba oil, shea butter, caprylic / capric acid triglycerides, argan oil, and any mixtures thereof.

[0103] Preferably, the at least one oil is at least one animal oils. More preferably, the at least one oil is at least one animal oil selected from the group consisting of: fish oil, krill oil, whale oil, seal oil, menhaden oil, halibut-liver oil, cod-liver oil, tuna oil, tallow oil, bovine oil, caballine oil, ovine oil, mink oil and otter oil, and any mixtures thereof.

[0104] Preferably, said composition comprises: from about 10% w / w to about 80% w / w, preferably from about 15% w / w to about 60% w / w, more preferably from about 20% w / w to about 50% w / w, even more preferably from about 25% w / w to about 45% w / w, better from about 30% w / w to about 45% w / w, of at least one gum, preferably of karaya gum, from about 0.1 % w / w to about 12% w / w, preferably from about 2% w / w to about 8% w / w, more preferably from about 4% w / w to about 6% w / w, even more preferably about 5% w / w, of paraffin oil, and from about 40% w / w to about 80% w / w, more preferably from about 45% w / w to about 75% w / w, even more preferably from about 50% w / w to about 70% w / w, better from about 55% w / w to about 65% w / w, of petrolatum, the percentages being expressed by weight relative to the total weight of the composition.

[0105] Preferably, said composition comprises: from about 10% w / w to about 80% w / w, preferably from about 10% w / w to about 55% w / w, more preferably from about 25% w / w to about 50% w / w, even more preferably from about 25% w / w to about 45% w / w, better from about 30% w / w to about 45% w / w, of at least one gum, preferably of karaya gum, from about 0.1 % w / w to about 12% w / w, preferably from about 2% w / w to about 8% w / w, more preferably from about 4% w / w to about 6% w / w, even more preferably about 5% w / w, of paraffin oil, andfrom about 40% w / w to about 85% w / w, preferably from about 40% w / w to about 80% w / w, more preferably from about 45% w / w to about 75% w / w, even more preferably from about 50% w / w to about 70% w / w, of petrolatum, the percentages being expressed by weight relative to the total weight of the composition.

[0106] Preferably, the composition according to the invention may further comprise one or more further excipients, in particular pharmaceutically acceptable, or GRAS (Generally Recognized as Safe) excipients. In a preferred embodiment, the composition according to the invention may further comprise one or more further excipients selected from the group consisting of: polyvinyl alcohol, poloxamers (in particular Poloxamer 407), medium-chain triglycerides (in particular Mygliol 812, or lipophilic Labrafac™ WL 1349 marketed by Gatefosse), fatty acid ester mono-di -triglycerides (in particular Suppocire® BS2X Pastille marketed by Gatefosse), polyethylene glycols (in particular PEG 600), psyllium, calcium chloride, calcium sulfate, sodium hydrogen phosphate, gelling agents and any mixtures thereof. The gelling agents may in particular be selected from the group consisting of: polysaccharides other than gums, gelatin and any mixtures thereof. The polysaccharides may in particular be selected from the group consisting of: starches, pectins, alginic acid or sodium alginate, and any mixtures thereof.

[0107] Preferably, the composition according to the invention may further comprise at least one additional compound, different from the compounds of the invention mentioned above and different from the further excipients mentioned above, said at least one additional compound being selected from the group consisting of: moisturizing agents, lubricating agents, repairing agents and any mixtures thereof. More preferably, suitable moisturizing agents may be selected from the group consisting of: glycerin, hyaluronic acid, propylene glycol, sodium PCA, aloe vera gel, panthenol, sorbitol, urea, lactic acid, honey, allantoin, polysaccharides other than gums, squalane, hydroxyethyl urea, D- mannose, cranberry, and any mixtures thereof. More preferably, suitable lubricating agents may be selected from the group consisting of: dimethicone, cyclomethicone, propylene glycol, glycerin, polyethylene glycol, hyaluronic acid, polyquatemium-7, polysorbate 80, squalane, lanolin and any mixtures thereof. More preferably, suitable repairing agents may be selected from the group consisting of: panthenol, allantoin, aloevera gel, hyaluronic acid, glycosaminoglycans (GAG), niacinamide, Centella asiatica extract, ceramides, vitamin E (tocopherol), bisabolol, calendula extract, madecassoside, collagen, peptides, zinc oxide and any mixtures thereof.

[0108] In one embodiment, the pharmaceutical composition further comprises at least one compound selected from the group consisting of: cellulose, cellulose derivatives, hemicelluloses and any mixtures thereof. Preferably, the pharmaceutical composition further comprises at least one compound selected from the group consisting of: cellulose, cellulose ether, cellulose ester, hemicelluloses and any mixtures thereof. More preferably, the pharmaceutical composition further comprises at least one compound selected from the group consisting of: cellulose, cellulose acetate, cellulose triacetate, cellulose propionate, cellulose acetate propionate (cap), cellulose acetate butyrate (cab), cellulose nitrate, cellulose sulfate, methylcellulose, ethylcellulose, methyl-ethyl cellulose, hydroxy-ethyl cellulose, hydroxypropyl cellulose, hydroxy ethyl-methyl cellulose, hydroxypropyl methylcellulose, ethyl hydroxyethyl cellulose, carboxymethyl cellulose, xylan, glucuronoxylan, arabinoxylan, glucomannan, xyloglucan and any mixtures thereof.

[0109] Preferably, said composition further comprises at least one further excipient selected from the group consisting of: lecithin, gelatin, pectin and any mixtures thereof.

[0110] More preferably, said composition further comprises lecithin, preferably from 0.5% w / w to 25% w / w of lecithin, more preferably from 1% w / w to 20% w / w of lecithin, even more preferably from 5% w / w to 15% w / w of lecithin, better about 10% w / w of lecithin, by weight relative to the total weight of the composition. Indeed, the presence of lecithin in the composition according to the invention allows obtaining a composition texture which is silkier, more homogeneous and softer in contact with mucosa than composition without lecithin. In particular, when lecithin is added to the composition according to the invention during the preparation of said composition, the composition texture is modified and is silkier, more homogeneous and softer in contact with mucosa. Without wishing to be bound by theory, it seems that lecithin may promote polymer dispersion in the oil(s) when present in the composition according to the invention.

[0111] Preferably, said composition further comprises gelatin.

[0112] Preferably, said composition further comprises pectin.

[0113] Preferably, said composition further comprises gelatin and pectin.

[0114] Preferably, said composition comprises less than 1% w / w of carrageenan, preferably less than 0.1% w / w of carrageenan, more preferably no carrageenan.

[0115] Preferably, said composition comprises less than 1% w / w of cellulose gum, preferably less than 0.1% w / w of cellulose gum, more preferably no cellulose gum.

[0116] Preferably, said composition comprises less than 1% w / w of calcium channel blocker, preferably less than 0.1% w / w of calcium channel blocker, more preferably no calcium channel blocker. For example, calcium channel blocker may be nifedipine or diltiazem.

[0117] In one embodiment, the composition according to the invention does not comprise any pharmaceutically active agent. This ensures that the composition according to the invention does not have any biologically or chemically adverse effects. In a particular embodiment, the composition according to the invention does not comprise any antibiotic.

[0118] In an alternative embodiment, the composition according to the invention may further comprise at least one active agent, in particular at least one active agent selected from the group consisting of: antiseptic agents, antibiotics, antifungal agents, analgesics or anesthetic agents, soothing agents and any mixtures thereof. Preferably, suitable antiseptic agents may be selected from the group consisting of: thyme, bay leaf, honey, heather, propolis, cranberry, D-Mannose, and any mixtures thereof. More preferably, suitable antiseptic agents may be selected from the group consisting of: chlorhexidine, povidone-iodine, hydrogen peroxide, cetylpyridinium chloride, benzalkonium chloride, triclosan and any mixtures thereof. Preferably, suitable antibiotic(s) may be selected from the group consisting of: mupirocin, neomycin, bacitracin, polymyxin B, erythromycin, metronidazole, gentamicin, sulfamethoxazole, trimethoprim, fosfomycin, metabolites thereof and any mixtures thereof; more preferably, suitable antibiotic(s) may be selectedfrom the group consisting of: mupirocin, neomycin, bacitracin, polymyxin B, erythromycin, metronidazole, gentamicin and any mixtures thereof. Preferably, suitable antifungal(s) agents may be selected from the group consisting of: nystatin, clotrimazole, miconazole, fluconazole, ketoconazole, amphotericin B, econazole and any mixtures thereof. Preferably, suitable analgesics or anesthetic agents may be selected from the group consisting of: lidocaine, benzocaine, tetracaine, procaine and any mixtures thereof. Preferably, suitable soothing agents may be selected from the group consisting of: hyaluronic acid, aloe vera, honey, glycerin, chamomile extract, marshmallow root extract and any mixtures thereof.

[0119] Preferably, the composition according to the invention is preservative-free. A preservative-free composition refers to a composition comprising less than 1% w / w of preservative, preferably less than 0.1% w / w of preservative, more preferably no preservative.

[0120] Preferably, the composition according to the invention is a cosmetic composition or a pharmaceutical composition. More preferably, the composition according to the invention is a cosmetic composition. Alternatively, more preferably, the composition according to the invention is a pharmaceutical composition.

[0121] Preferably, the composition according to the invention is a suspension, wherein the liquid of the suspension is the at least one oil and the solid particles are at least the polysaccharides of the at least one gum.

[0122] Preferably, the composition according to the invention is either liquid or in a semi-solid galenic form. More preferably, the composition according to the invention is in a semi-solid galenic form. Even more preferably, the composition according to the invention is in a semi-solid galenic form selected from the group consisting of: ointment, paste, and gel. Better, the composition according to the invention is in the galenic form of a paste.

[0123] Preferably, said composition according to the invention has a dynamic viscosity ranging from 3,000 mPa.s to 50,000 mPa.s, preferably from 4,000 mPa.s to 20,000 mPa.s,said dynamic viscosity being measured at 37°C using a viscometer with a mobile speed of 5 rpm.Composition according to the invention for its use

[0124] The present invention also relates to a composition according to the invention as described above, for use in the prevention of urinary tract infection in a subject in need thereof.

[0125] The present invention also relates to a method of preventing a urinary tract infection by administering to a subject in need thereof an effective amount of a composition according to the invention as described above.

[0126] The present invention also relates to the use of a composition according to the invention as described above, for the manufacture of a medicament for the prevention of urinary tract infection in a subject in need thereof.

[0127] The present invention also relates to the use of a composition according to the invention as described above, for the prevention of a urinary tract infection in a subject in need thereof.

[0128] Preferably, the composition according to the invention is administered via urethral route to the subject in need thereof.

[0129] Preferably, said urinary tract infection, in particular cystitis and recurrent cystitis, is induced by a micro-organism selected from the group consisting of: Staphylococcus aureus, Staphylococcus saprophyticus. Klebsiella pneumoniae, Proteus mirabilis, Enterococcus spp. such as Enterococcus faecalis, Pseudomonas aeruginosa, Citrobacter spp., Candida spp., Serratia spp., Proteus vulgaris, group B streptococcal (GBS), bacteria belonging to the Enterobacteriaceae family such as Escherichia coli, and any combinations thereof. More preferably, said urinary tract infection, in particular cystitis and recurrent cystitis, is induced by a micro-organism selected from the group consisting of: Staphylococcus aureus, Klebsiella pneumoniae, Proteus mirabilis, Enterococcus spp. such as Enterococcus faecalis, Pseudomonas aeruginosa, Candida spp., group B streptococcal (GBS), bacteria belonging to the Enterobacteriaceae family such asEscherichia coli, and any combinations thereof. More preferably, said urinary tract infection, in particular cystitis and recurrent cystitis, is induced by a micro-organism selected from the group consisting of: Staphylococcus aureus, Staphylococcus saprophyticus, Klebsiella pneumoniae, bacteria belonging to the Enterobacteriaceae family such as Escherichia coli, and any combinations thereof. Even more preferably, said urinary tract infection, in particular cystitis and recurrent cystitis, is induced by a bacterium belonging to the species Escherichia coli.

[0130] Preferably, said composition is administered at a dose ranging from about 5 pL to about 5000 pL. more preferably from about 5 pL to about 1000 pL, even more preferably from about 5 pL to about 500 pL, better from about 10 pL to about 100 pL, still better from 12 about pL to 80 about pL.

[0131] Preferably, the subject is a human, more preferably said subject is a woman.

[0132] Preferably, said composition according to the invention is administered prior to the exposition to a risk factor for urinary tract infection, more preferably a time-limited risk factor for urinary tract infection. The risk factor for urinary tract infection may be selected from the group consisting of: a sexual intercourse, a swimming in a pool or seawater, travel (in particular a travel during from about 2 hours to about ten hours), poor hygiene conditions, lack of hydration, absence of urination (in particular for at least 2 hours). Even more preferably, said composition is administered prior to the exposition to a risk factor for urinary tract infection, wherein said risk factor is a sexual intercourse. Even more preferably, said composition is administered prior to a sexual intercourse to a woman.

[0133] Indeed, the inventors of the present invention have surprisingly discovered that a composition according to the invention is able to form a barrier in or at the entry of the urethra to prevent the spread of infection into the urinary tract. In addition, said composition is able to be evacuated outside the subject body during urination.

[0134] Thus, a composition according to the invention provides a physical barrier to micro-organisms, particularly potentially pathogenic bacteria, preventing their diffusion in the urethra and to the bladder.

[0135] To this end, compositions according to the invention may be administered, for example via an injection device (notably via a syringe), directly into the urethra or at the opening of the urethra.

[0136] In particular, compositions according to the invention may be deposited on all or part of the urethra. This type of application simultaneously seals off the urethra from any micro-organism entry during sexual intercourse or during any other risk factor for urinary tract infection, in particular time-limited risk factor for urinary tract infection as mentioned above.

[0137] Preferably, compositions according to the invention enable a deformable and muco-adhesive form of said compositions to be obtained in situ.

[0138] In particular, once placed in the urethra, the compositions according to the invention form a barrier which remains in place for a sufficiently long time, due to the development of a mucoadhesion phenomenon on the surface of the urothelium.

[0139] Preferably, therefore, compositions according to the invention possess mucoadhesive and detachment properties. In particular, they are capable of transient adhesion to the urothelium surface.

[0140] The compositions according to the invention can be deformed in the urethra, enabling adhesion and barrier effect to be achieved simultaneously.

[0141] In particular, the compositions according to the invention may be administered for repeated use, for example 10 times a month.

[0142] The present invention also relates to medical devices comprising at least one composition according to the invention.

[0143] For the purposes of the present invention, “medical device” is the generic term used to designate any instrument, apparatus, equipment, material or other article, used alone or in combination, for therapeutic purposes, for the control, treatment or alleviation of a disease.

[0144] Compositions according to the invention may be prepared using techniques well known to the skilled person. For example, they may be manufactured by obtaining a homogeneous mixture of the various ingredients of the composition and / or by a hot dispersion of the various ingredients.

[0145] The resulting composition according to the invention may then be subjected to a sterilization step. In particular, the sterilization step may be carried out by moist heat (autoclaving at 121°C for 20 minutes), electron beam (beta radiation), gamma irradiation or sterilization using ethylene oxide.

[0146] All the optional features described in the present application for the composition according to the invention apply mutatis mutandis for the composition according to the invention for its use, in particular for its use as a medicament and for its use in the prevention of urinary tract infection.EXAMPLES

[0147] The present invention is further illustrated by the following examples.

[0148] For the following examples, four compositions according to the invention were prepared, whose formulations were as follows (all the percentages are expressed by weight relative to the total weight of the composition):

[0149] The karaya gum used was those marketed by company “Alland & Robert”: product named “GUM KARAYA POWDER 899T”. The Vaseline® used was those marketed by company “Cooperation Pharmaceutique Francaise": product named “VASELINE OFFICINALE COOPER, pommade” (CIS code: 65707226). The paraffin oil used was those marketed by company “GIFRER BARBEZAT”: product named “HUILE DE PARAFFINE GIFRER, solution buyable” (CIS code: 6 340 747 9).

[0150] The compositions according to the invention were compared with a comparative composition (named “comparative composition C” or “Paraffin oil / V aselin® (5 / 95 w / w %)”), said comparative composition comprising 95% w / w of Vaseline® and 5% w / w of paraffin oil. The Vaseline® used was those marketed by company “Cooperation Pharmaceutique Francaise": product named “VASELINE OFFICINALE COOPER, pommade” (CIS code: 6 570 722 6). The paraffin oil used was those marketed by company “GIFRER BARBEZAT”: product named “HUILE DE PARAFFINE GIFRER, solution buyable” (CIS code: 6 340 747 9).Example 1: ViscosityMaterials and Methods

[0151] The dynamic viscosities of the 5 compositions (four compositions according to the invention and comparative composition C) were measured at 37°C using a Brookfield DV3+ viscometer (mobile: SC4-14; SSA measuring chamber: 6 RP; thermostatic bath: Julabo F12-ED; Oven: VWR INCU-Line IL 10 oven).

[0152] The measuring protocol of the dynamic viscosities was as follows:- Sample volume: 2 g- Measurement temperature: 37°C- Mobile speed: 5 rpm- Measurement time: 1 hour after start of measurement

[0153] The samples were prepared by placing the compositions to be analyzed in anoven at 60°C for 24 hours; then, under magnetic stirring, 2 g of the compositions to be analyzed were removed and placed in the SSA: 6RP chamber; then, mobile SC4-14 was added to the SSA: 6RP chamber; then, the assembly was placed on the measuring instrument; then, measurement started according to set parameters; and then, the dynamic viscosity value (mPa.s) were read after 1 hour of stabilization.

[0154] The analytical parameters for measurement of the compositions at 37°C after addition of 10% water were: pipette 200 pL of purified water onto the surface of the composition after one hour of homogenization; and then, read the dynamic viscosity (mPa.s) obtained 5 minutes after deposition. Results

[0155] Dynamic viscosity is a physical quantity that characterizes a fluid's resistance to laminar flow. If the flow is too low or too high, the desired performance will not be achieved.

[0156] The results of the assessment of the dynamic viscosity at 37°C before and after addition of 10% water are presented in the following table:

[0157] The results presented in the table above correspond to the average value obtainedfrom 3 individual measurements on each sample.

[0158] In view of these results, gum mass concentration such as karaya gum mass concentration has a significant impact on formulation viscosity: the higher the gum (karaya gum) content in the formulation, the higher the measured dynamic viscosity. Yet, a higher viscosity supports the remanence of the composition (=its ability to stay in place in the urethra).

[0159] After 5 minutes, the presence of water significantly increases the viscosity of the various formulations tested. The higher the gum concentration, the greater the increase in viscosity in the presence of water. An aqueous gel is formed on the surface of the paste as soon as water is introduced. The formation of a surface hydrogel facilitates adhesion / remanence and durability over time by limiting the composition dissolution.

[0160] Thus, upon administration in the urethra, in contact with the biological fluids (in- vivo hydration), the compositions according to the invention have a viscosity increase, supporting their remanence at the opening of or in the urethra.Example 2: DetachmentMaterials and Methods

[0161] Materials: 5 mL syringe, 1 mL syringe, 3 mm outer - 2 mm inner catheter, purified water, 30 cm graduated ruler.

[0162] Samples preparation: the compositions to be studied (four compositions according to the invention and comparative composition C) were hot-packed in a 1 ml syringe.

[0163] Carrying out the analysis: in devices was placed vertically, with a water syringe at the top and a composition syringe at the bottom, the measurement time required for water to drain from the device has been determined.

[0164] The aim of this comparative in vitro test is to estimate the pressure required toevacuate the compositions. From a safety point of view, this value should not exceed 30 cm H2O, i.e. 30 mbar (a normal bladder pressure is of about 60 crnFEO).Results

[0165] The results of the assessment of the detachment at different water pressure levels are presented in the following table:

[0166] The results presented above correspond to the average of 3 individual tests carried out for each composition.

[0167] As it can be seen from the results, regarding the detachment ability of the composition, all the compositions according to the invention achieved almost instantaneous detachment at water pressure levels of 30 cm and above, demonstrating that the compositions according to the invention are easy to remove from the urethra during urination, thus without the need for intervention by a health professional such as a doctor or nurse. Example 3: Adhesion on a dry surface: adhesion on a vertical surface at 37 °CMaterials and Methods

[0168] Materials: plexiglass plate (21 cm x 30 cm x 5 mm), oven at 37°C, stopwatch, 30 cm ruler.

[0169] Samples preparation: compositions K40 and K45 according to the invention and comparative composition C were placed in an oven at 60°C for 24 hours; 500 pL of the composition to be analyzed was withdrawn using a positive-displacement pipette under magnetic stirring; the glass plate was placed horizontally; on a glass plate, 100 pL of the composition to be analyzed was evenly deposited in the compartments provided; the glass plate was placed vertically in a 37°C oven; the flow distance of each composition was recorded every 5 minutes for 60 minutes.Results

[0170] The results were that after 24 hours at 37°C, compositions K40 and K45 according to the invention remained fully maintained on the smooth, vertical surface. The gum-free comparative composition C completely liquefied in less than 15 minutes.

[0171] Thus, the compositions according to the invention are able to adhere to the urethral wall at 37°C and thus to remain in place after having being administered via urethral route. They will not liquefy at 37°C and will not leak outside the urethra nor into the bladder, unlike the comparative composition C which does not include a gum such as karaya gum.Example 4: Adhesion on a dry surface: tack analysis on flat surface at 37°C without shear stressMaterials and Methods

[0172] Materials: precision scale MSA5203S (supplier: Sartorius), rheometer MCR 301 thermostat SN80078876 (supplier: Anton Paar), thermocryostat ED (v.2) (supplier: Julabo), mobile PP50 (supplier: Anton Paar), magnetic bars, recipient.

[0173] Preparation: a layer approximately 3 mm thick of the composition to be analyzed (four compositions according to the invention and comparative composition C) was deposited on the PP50 mobile (circular plate 50 mm in diameter) at 37°C. Analysis was then started (parameters: air gap 1mm, pull-off speed 10,000 pm / s, no pre-shearing) and results were recorded. The test was repeated 3 to 4 times for each composition to be analyzed.Results

[0174] The results were as presented in the following table:

[0175] As it can be seen in the above table, the compositions according to the invention require a higher tearing energy than the comparative composition C. Thus, their adhesion capacity to the urethra is higher.Example 5: Barrier effectMaterials and Methods

[0176] A soft agar was prepared and autoclaved for 20 min at 121°C. The autoclaved soft agar was then cooled and pour into sterile Petri dishes and leaved to molten. Then, acentral trench in each Petri dish was dug using a pipette cone and 2 mL of either composition K45 according to the invention or a comparative composition B (a mixture comprising a grind of soft agar and a hydrogel) was poured into the trench. A culture of Escherichia coli was added on one side of the central trench in each Petri dish and the dishes were incubated for up to 96 hours (4 days) at 30°C.Results

[0177] After 24 hours, bacteria were present on the other side of the central trench in the Petri dishes containing the comparative composition B in the central trench, in contrast to Petri dishes containing the composition K45 according to the invention. This demonstrates the barrier effect of the compositions according to the invention.

[0178] Thus, as it can be seen from the results, the compositions according to the invention, comprising a gum such as karaya gum, were able to block the passage of bacteria, demonstrating the barrier effect of the compositions according to the invention.

Claims

CLAIMS1. A cosmetic or pharmaceutical composition which is anhydrous and comprises at least one gum and paraffin oil, wherein said at least one gum is selected from the group consisting of: gum arabic, xanthan gum, karaya gum, and any mixtures thereof, provided that, if the at least one gum is xanthan gum, then the cosmetic or pharmaceutical composition does not comprise at least one compound selected from the group consisting of: cellulose, cellulose ethers, cellulose esters, hemicelluloses and any mixtures thereof.

2. The cosmetic or pharmaceutical composition according to claim 1, wherein the at least one gum is karaya gum.

3. The cosmetic or pharmaceutical composition according to claim 1 or 2, wherein the content of the at least one gum in said pharmaceutical composition ranges from 10% w / w to 80% w / w, preferably from 10% w / w to 60% w / w, more preferably from 25% w / w to 55% w / w, even more preferably from 30% w / w to 50% w / w, by weight relative to the total weight of said cosmetic or pharmaceutical composition.

4. The cosmetic or pharmaceutical composition according to any one of claims 1 to 3, wherein said cosmetic or pharmaceutical composition further comprises at least one further oil different from paraffin oil, preferably said at least one further oil different from paraffin oil is at least one mineral oil, more preferably said at least one further oil different from paraffin oil is petrolatum.

5. The cosmetic or pharmaceutical composition according to any one of claims 1 to 4, wherein the total content of the oil(s) in said pharmaceutical composition ranges from 10% w / w to 90% w / w, preferably from 40% w / w to 80% w / w, more preferably from 50% w / w to 75% w / w, even more preferably from 55% w / w to 70% w / w, by weight relative to the total weight of the cosmetic or pharmaceutical composition.

6. The cosmetic or pharmaceutical composition according to any one of claims 1 to 5, wherein said pharmaceutical composition comprises:from 10% w / w to 80% w / w, preferably from 10% w / w to 60% w / w, more preferably from 25% w / w to 55% w / w, even more preferably from 30% w / w to 50% w / w, of at least one gum, preferably of karaya gum, from 0.1% w / w to 12% w / w, preferably from 2% w / w to 8% w / w, more preferably from 4% w / w to 6% w / w, even more preferably about 5% w / w, of paraffin oil, and qsp 100% w / w of petrolatum, the percentages being expressed by weight relative to the total weight of the cosmetic or pharmaceutical composition.

7. The cosmetic or pharmaceutical composition according to any one of claims 1 to 6, wherein the weight ratio of the total amount of gums, selected from gum arabic, xanthan gum, karaya gum, and any mixtures thereof, to the total amount of oil(s), present in the cosmetic or pharmaceutical composition, is of less than or equal to 1, more preferably the gum is karaya gum and the weight ratio of the amount of karaya gum to the total amount of oils, present in the cosmetic or pharmaceutical composition, is strictly less than 1.

8. The cosmetic or pharmaceutical composition according to any one of claims 1 to 7, wherein said pharmaceutical composition is in a semi-solid galenic form, preferably said pharmaceutical composition is in a semi-solid galenic form selected from the group consisting of: ointment, paste, and gel.

9. The cosmetic or pharmaceutical composition according to any one of claims 1 to 8, wherein said pharmaceutical composition does not comprise any pharmaceutically active agent.

10. The cosmetic or pharmaceutical composition according to any one of claims 1 to 8, wherein said pharmaceutical composition further comprises at least one pharmaceutically active agent, preferably said pharmaceutical composition further comprises at least one pharmaceutically active agent selected from the group consisting of: antiseptic agents, antibacterial agents, antibiotics, antifungal agents, analgesics or anesthetic agents, soothing agents and any mixtures thereof.

11. The cosmetic or pharmaceutical composition according to any one of claims 1 to 10, wherein said composition has a dynamic viscosity ranging from 3,000 mPa.s to 50,000 mPa.s, preferably from 4,000 mPa.s to 20,000 mPa.s, said dynamic viscosity being measured at 37°C using a viscometer with a mobile speed of 5 rpm.

12. A pharmaceutical composition, for use as a medicament, wherein said pharmaceutical composition is anhydrous and comprises at least one gum and at least one oil, wherein said at least one gum is selected from the group consisting of: gum arabic, xanthan gum, karaya gum, and any mixtures thereof, provided that, if the at least one gum is xanthan gum, then the pharmaceutical composition does not comprise at least one compound selected from the group consisting of: cellulose, cellulose ethers, cellulose esters, hemicelluloses and any mixtures thereof.

13. A pharmaceutical composition, for use in the prevention of urinary tract infection in a subject in need thereof, wherein said pharmaceutical composition is anhydrous and comprises at least one gum and at least one oil, wherein said at least one gum is selected from the group consisting of: gum arabic, xanthan gum, karaya gum, and any mixtures thereof, provided that, if the at least one gum is xanthan gum, then the pharmaceutical composition does not comprise at least one compound selected from the group consisting of: cellulose, cellulose ethers, cellulose esters, hemicelluloses and any mixtures thereof.

14. The pharmaceutical composition for use according to claim 13, wherein said pharmaceutical composition is administered via urethral route to said subject, preferably said pharmaceutical composition is administered via urethral route to said subject prior to the exposition to a temporal risk factor, more preferably said pharmaceutical composition is administered via urethral route to said subject prior to the exposition to a temporal and time-limited risk factor, even more preferably said pharmaceutical composition is administered via urethral route to said subject prior to the exposition to a temporal and time-limited risk factor selected from the group consisting of: a sexual intercourse, a swimming in a pool or seawater, travel,lack of hydration, urination withheld for at least 2 hours, better said pharmaceutical composition is administered via urethral route to said subject prior to a sexual intercourse.

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