AQUEOUS COMPOSITION, PARTICULARLY FOR THE TREATMENT OF MUCOUS MEMBRANES AND / OR WOUNDS

Description

FIELD OF APPLICATION AND STATE OF THE ART

[0001] The invention relates to an aqueous composition which is particularly suitable for the treatment of mucous membranes and / or wounds.

[0002] For the treatment of mucous membranes and wounds, iodine-containing products have become established. These contain iodine in the form of iodophores, such as povidone-iodine. These are characterized by good tolerability. Due to possible allergies and sensitizations, as well as the known absorption of iodine by the body, the use of these agents is limited.

[0003] For this reason, products containing cationic antimicrobial agents have been proposed.

[0004] An aqueous composition containing polyhexamethylene biguanide, which can be in particular in the form of a wound irrigation solution or a wound gel, is known from WO 03 / 004013 A1.

[0005] The subject of DE 102 05 883 A1 is an aqueous antiseptic based on bispyridinium alkanes.

[0006] WO 2007 / 031520 A2 relates to the use of octenidine dihydrochloride for the preparation of a pharmaceutical composition for, inter alia, the treatment of wounds.

[0007] EP 1 574 503 A1 discloses antibacterial dihydrotriazine compounds.

[0008] Thompson PE et al.: ("STUDIES ON A DIHYDROTRIAZINE AND A SULFONE, ALONE AND IN COMBINATION, AGAINST PLASMODIUM BERGHEI IN MICE", American Journal of Tropical Medicine & Hygiene, Vol. 14, March 1, 1965, pp. 198-206) discloses dihydrotriazine compounds for the treatment of malaria.

[0009] Conventional agents have the disadvantage that they have gaps in their effectiveness against fungi, especially yeasts.

[0010] An octenidine-containing preparation called Octenisept is available. While it has good mucosal tolerance, it can lead to intolerance and even necrosis when used in deeper wounds. This has been published, among other things, by the German Federal Institute for Drugs and Medical Devices: (https: / / www.bfarm.de / SharedDocs / Riskinformation / Pharmakovigilanz / DE / RHB / 201 1 / rhboctenisept.html ).

[0011] An octenidine-containing composition is known from EP 0 411 315 A1. TASK AND SOLUTION

[0012] The object of the invention is to provide a very well-tolerated composition which is suitable for treating mucous membranes and / or wounds and at the same time has improved effectiveness against fungi, in particular yeasts.

[0013] This object is achieved according to the invention by an aqueous composition having the features of independent claim 1. Preferred embodiments of the aqueous composition are the subject of the dependent claims and the description. The wording of all claims is hereby incorporated into the description by express reference.

[0014] The composition according to the invention is an aqueous composition, i.e., a water-containing composition. The aqueous composition is preferably in the form of an aqueous solution, i.e., a water-containing solution, or in the form of a hydrogel, i.e., a water-containing gel.

[0015] The aqueous composition has the following: a dihydrotriazine compound of the following general formula I: wherein R 1 represents (i) a phenyl group or a phenylalkyl group, each of which is optionally substituted by 1 to 3 substituents selected from the group consisting of C 1-6 alkoxy group, hydroxy group, a halogen atom, C 1-6 haloalkyl group, C 1-6 alkyl group, a sulfonamido group and C 1-6 haloalkoxy group, (ii) a naphthyl group or a naphthylalkyl group, (iii) a heterocyclic group, a heterocyclic alkyl group or a heterocyclic aminoalkyl group, (iv) an alkyl group having 1 to 16 carbon atoms or (v) a cycloalkyl group or a cycloalkylalkyl group, R 1 ' represents a hydrogen atom bonded to the nitrogen atom at position 1 or 3 of the dihydrotriazine ring, R 2 and R 3 independently represent a hydrogen atom or a methyl group, R 4 represents a alkyl group with 7 to 16 carbon atoms and the dashed line indicatesthat the position of a double bond lies either between positions 1 and 2 or between positions 2 and 3 of the dihydrotriazine ring, or a tautomer thereof, ie a tautomer of the dihydrotriazine compound of the general formula I, or a salt, in particular pharmacologically acceptable salt, thereof, ie a salt, in particular pharmacologically acceptable salt, of the dihydrotriazine compound of the general formula I, and a defoamer, for use in the prevention or treatment of infections and / or infectious diseases caused or co-caused by fungi.

[0016] The aqueous composition is particularly suitable for the prevention, i.e., prophylaxis, or treatment of mucous membranes and / or wounds, preferably acute or chronic wounds, and / or for the prevention, i.e., prophylaxis, or treatment of infections and / or for the prevention, i.e., prophylaxis, or treatment of infectious diseases, such as, for example, erysipelas or erysipelas. Therefore, within the meaning of the present invention, the aqueous composition can also be referred to as an aqueous wound treatment composition, in particular an aqueous antiseptic composition. The aqueous composition is preferably an aqueous wound irrigation solution.

[0017] For the purposes of the present invention, the term "dihydrotriazine compound" is to be understood as meaning a compound having a six-membered triazine ring having only two double bonds, i.e. a so-called dihydrotriazine ring, wherein the triazine ring or dihydrotriazine ring has a ring nitrogen atom at positions 1, 3 and 5 and a ring carbon atom at positions 2, 4 and 6, and wherein the position of one double bond is between positions 4 and 5 of the triazine or dihydrotriazine ring and the position of the other, i.e. second or remaining, double bond is either between positions 1 and 2 or between positions 2 and 3 of the triazine ring or dihydrotriazine ring.

[0018] For the purposes of the present invention, the term "defoamer" is understood to mean a compound which is capable of slowing down, attenuating, i.e. mitigating, reducing or avoiding foam formation.

[0019] For the purposes of the present invention, the term "surfactant" is to be understood as meaning a compound which reduces the surface tension of a liquid, in particular water or an aqueous liquid, and / or the interfacial tension between two phases and enables or supports the formation of dispersions and / or acts as a solubilizer.

[0020] For the purposes of the present invention, the term "emulsifier" is to be understood as a compound which is capable of mixing and, in particular, stabilising two immiscible liquids, such as oil and water, to form an emulsion.

[0021] The term "fungi" in the context of the present invention can mean unicellular or multicellular fungi.

[0022] For the purposes of the present invention, the term "yeasts" refers to single-celled fungi which reproduce by budding or division (splitting) (so-called yeast fungi).

[0023] For the purposes of the present invention, the term "phenyl group" is to be understood as meaning a benzene residue, i.e. the atomic group -C 6 H 5 .

[0024] For the purposes of the present invention, the term "benzyl group" is to be understood as meaning the phenylmethyl group -CH 2 -C 6 H 5 , formerly also referred to as α-tolyl group.

[0025] For the purposes of the present invention, the term "phenylalkyl group" means a group in which a linear, i.e., unbranched, or branched alkyl group or alkylene group, in particular having 1 to 6 carbon atoms, is bonded to a phenyl group. The alkyl group or alkylene group can be a substituted or unsubstituted alkyl group or alkylene group. The phenylalkyl group is preferably a benzyl group, methylbenzyl group, such as, in particular, 4-methylbenzyl group, 1-phenylethyl group, 2-phenylethyl group, 1-phenylpropyl group, 2-phenylpropyl group, or 3-phenylpropyl group.

[0026] A benzene ring of the phenyl group or phenylalkyl group may have one to three substituents, in particular selected from the group consisting of halogen atom, hydroxy group, C 1-6 alkyl group, C 1-6 haloalkyl group, C 1-6 alkoxy group, C 1-6 haloalkoxy group and sulfonamido group.

[0027] The term "halogen atom" in the context of the present invention may mean a fluorine atom, a chlorine atom, a bromine atom or an iodine atom.

[0028] For the purposes of the present invention, the term "C 1-6 alkyl group" can mean a corresponding linear or branched alkyl group, i.e., a linear or branched alkyl group having 1 to 6 carbon atoms. The alkyl group can be a substituted or unsubstituted alkyl group. For example, the C 1-6 alkyl group can be a methyl group, ethyl group, n-propyl group, isopropyl group, n-butyl group, isobutyl group, sec-butyl group, tert-butyl group, n-pentyl group, sec-pentyl group, isopentyl group, neopentyl group, n-hexyl group, or isohexyl group.

[0029] The term "C 1-6 haloalkyl group" in the sense of the present invention can mean in particular a chloromethyl group, bromomethyl group, 1-chloroethyl group or trifluoromethyl group.

[0030] The term "C 1-6 alkoxy group" in the sense of the present invention can mean in particular a methoxy group, ethoxy group, n-propoxy group, isopropoxy group, n-butoxy group or isobutoxy group.

[0031] The term "C 1-6 haloalkoxy group" in the sense of the present invention can mean in particular a trifluoromethoxy group.

[0032] The term "naphthyl group" in the context of the present invention may mean a 1-naphthyl group or a 2-naphthyl group.

[0033] For the purposes of the present invention, the term "naphthylalkyl group" means a group in which a linear, i.e., unbranched, or branched alkyl group, in particular having 1 to 6 carbon atoms, is bonded to a naphthyl group. The alkyl group can be a substituted or unsubstituted alkyl group. The naphthylalkyl group is preferably a 1-naphthylmethyl group, 2-naphthylmethyl group, 1-naphthylethyl group, or 2-naphthylethyl group.

[0034] The term "heterocyclic group" in the context of the present invention means a three- to six-membered heterocyclic group containing one to three atoms selected from the group consisting of nitrogen atom, oxygen atom and sulfur atom, wherein a benzene ring may be fused or condensed to the heterocyclic group. The heterocyclic group may, for example, be a pyridyl group, a pyrazinyl group, a thiazolyl group, a piperidyl group, a piperazyl group, a tetrahydrofuryl group, a thienyl group, a pyrrolyl group, a pyrrolidinyl group, an oxazolyl group, an imidazolyl group, an isooxazolyl group, an isothiazolyl group, a pyrazolyl group, a tetrahydropyranyl group, a 2-oxotetrahydropyranyl group, a pyrimidinyl group, a pyradizinyl group, a morpholinyl group, a 1,3,5-triazinyl group, a 1,2,4-triazinyl group, a quinolyl group or an isoquinolyl group.

[0035] In particular, the heterocyclic group in the sense of the present invention can be a 2-pyridyl group, a 3-pyridyl group, a 4-pyridyl group, a 2-furyl group, a 2-thiazolyl group, a 1-piperidyl group, a 1-piperazyl group, a 2-quinolyl group, a 3-quinolyl group, a 4-quinolyl group, a 5-quinolyl group, an 8-quinolyl group, a 1-isoquinolyl group, a 3-isoquinolyl group, a 4-isoquinolyl group or a 5-isoquinolyl group.

[0036] For the purposes of the present invention, the term "heterocyclic alkyl group" means a group in which a linear, i.e., unbranched, or branched alkyl group, in particular having 1 to 6 carbon atoms, is bonded to a heterocyclic group, in particular as defined or described in the preceding paragraphs. The alkyl group may be a substituted or unsubstituted alkyl group.The heterocyclic alkyl group is preferably a 2-pyridylmethyl group, 3-pyridylmethyl group, 4-pyridylmethyl group, 2-pyridylethyl group, 3-pyridylethyl group, 4-pyridylethyl group, pyrazinylmethyl group, pyrazinylethyl group, 2-furylmethyl group, 2-furylethyl group, 2-thiazolylmethyl group, 2-thiazolylethyl group, 4-piperidylmethyl group, 2-quinolylmethyl group, 3-quinolylmethyl group, 4-quinolylmethyl group, 5-quinolylmethyl group, 8-quinolylmethyl group, 1-isoquinolylmethyl group, 3-isoquinolylmethyl group, 4-isoquinolylmethyl group or 5-isoquinolylmethyl group.

[0037] For the purposes of the present invention, the term "heterocyclic aminoalkyl group" means a group in which a linear, i.e., unbranched, or branched alkyl group, in particular having 1 to 12 carbon atoms, is bonded to a heterocyclic amino group. The alkyl group can be a substituted or unsubstituted alkyl group. The heterocyclic aminoalkyl group is preferably a 4-amino-dihydro-1,3,5-triazin-2-yl-amino group, a 4-alkylamino-dihydro-1,3,5-triazin-2-yl-amino group, or a 4-phenylalkylamino-dihydro-1,3,5-triazin-2-yl-amino group.

[0038] For the purposes of the present invention, the term "alkyl group having 1 to 16 carbon atoms" means a linear, i.e., unbranched, or branched alkyl group having 1 to 16 carbon atoms. The alkyl group can be a substituted or unsubstituted alkyl group. The alkyl group having 1 to 16 carbon atoms is preferably a methyl group, ethyl group, n-propyl group, isopropyl group, n-butyl group, isobutyl group, sec-butyl group, tert-butyl group, n-hexyl group, n-heptyl group, n-octyl group, tert-octyl group, n-nonyl group, n-decyl group, n-undecyl group, n-dodecyl group, n-tridecyl group, n-tetradecyl group, n-pentadecyl group, or n-hexadecyl group.

[0039] For the purposes of the present invention, the term "cycloalkyl group" refers in particular to a cycloalkyl group having 3 to 6 carbon atoms. For example, the cycloalkyl group can be a cyclopropyl group, cyclobutyl group, cyclopentyl group, or cyclohexyl group.

[0040] For the purposes of the present invention, the term "cycloalkylalkyl group" means, in particular, a group in which a linear, i.e., unbranched, or branched alkyl group, in particular having 1 to 6 carbon atoms, is bonded to a cycloalkyl group, in particular as defined or described in the previous paragraph. The alkyl group can be a substituted or unsubstituted alkyl group. The cycloalkylalkyl group is preferably a cyclohexylmethyl group, a 1-cyclohexylethyl group, or a 2-cyclohexylethyl group.

[0041] For the purposes of the present invention, the term "alkyl group having 7 to 16 carbon atoms" means a linear, i.e., unbranched, or branched alkyl group having 7 to 16 carbon atoms. The alkyl group can be a substituted or unsubstituted alkyl group. The alkyl group having 7 to 16 carbon atoms is preferably an n-heptyl group, n-octyl group, tert-octyl group, n-nonyl group, n-decyl group, n-undecyl group, n-dodecyl group, n-tridecyl group, n-tetradecyl group, n-pentadecyl group, or n-hexadecyl group.

[0042] The term "salt" used in connection with the dihydrotriazine compound of general formula I can, in the sense of the present invention, mean in particular a salt with an organic acid, such as formic acid, acetic acid, propionic acid, lactic acid, butyric acid, isobutyric acid, malic acid, maleic acid, malonic acid, fumaric acid, succinic acid, succinic acid monoamide, glutaric acid, tartaric acid, oxalic acid, citric acid, glycolic acid, glucuronic acid, ascorbic acid, aspartic acid, glutamic acid, benzoic acid, phthalic acid, salicylic acid, anthranilic acid, benzenesulfonic acid, p-toluenesulfonic acid or methanesulfonic acid.

[0043] The term "antiseptic composition" in the sense of the present invention is to be understood as a composition for the reduction of microorganisms on living surfaces, in particular on mucous membranes and / or wounds, and / or for the prevention, i.e. prophylaxis, or treatment of mucous membranes and / or wounds and / or for the prevention and / or treatment of infections and / or infectious diseases.

[0044] The present invention is based, firstly, on the surprising discovery that dihydrotriazine compounds of general formula I, or a tautomer thereof, or a salt thereof, exhibit improved efficacy against fungi, particularly yeasts, compared to generic antiseptics such as polyhexamethylene biguanide or octenidine hydrochloride. This enables, in a particularly advantageous manner, better prevention or treatment of wounds and / or infections and / or infectious diseases caused or co-caused, in particular, by fungi.

[0045] Furthermore, it was surprisingly found that by combining a dihydrotriazine compound of general formula I or a tautomer thereof or a salt thereof and a defoamer, a low-foam or foam-free composition can be obtained, thereby optimizing or even enabling the use of the dihydrotriazine compound, in particular for the prevention or treatment of mucous membranes and / or wounds and / or infections and / or infectious diseases. The use of dihydrotriazine compounds of general formula I or tautomers thereof or salts thereof for the treatment and / or rinsing of mucous membranes and / or wounds was not to be expected due to their (sometimes) extreme foaming behavior. In the embodiment of the invention,

[0046] R 1 is a phenyl group or a phenylalkyl group, each of which is optionally substituted by 1 to 3 substituents selected from the group consisting of fluorine atom, chlorine atom, hydroxy group, methyl group, tert-butyl group, trifluoromethyl group and methoxy group, R 1 ' is a hydrogen atom bonded to the nitrogen atom at position 1 or 3 of the dihydrotriazine ring, R 2 and R 3 are each a methyl group and R 4 is an n-octyl group, n-nonyl group or n-decyl group. Preferred means / means

[0047] R 1 is a phenyl group, a benzyl group or a 2-phenylethyl group, each of which is optionally substituted by 1 to 3 substituents selected from the group consisting of fluorine atom, chlorine atom, hydroxy group, methyl group, tert-butyl group, trifluoromethyl group and methoxy group, R 1 ' is a hydrogen atom bonded to the nitrogen atom at position 1 or 3 of the dihydrotriazine ring, R 2 and R 3 are each a methyl group and R 4 is an n-octyl group, n-nonyl group or n-decyl group. Particularly preferred means / means

[0048] R 1 is a benzyl group which is optionally substituted by 1 to 3 substituents selected from the group consisting of fluorine atom, chlorine atom, hydroxy group, methyl group, tert-butyl group, trifluoromethyl group and methoxy group, preferably by 1 to 3 methyl groups, particularly preferably by a methyl group, R 1 ' is a hydrogen atom which is bonded to the nitrogen atom at position 1 or 3 of the dihydrotriazine ring, R 2 and R 3 are each a methyl group and R 4 is an n-octyl group, n-nonyl group or n-decyl group. In a further embodiment of the invention,

[0049] R 1 is a phenyl group, 4-chlorophenyl group, 2,4-difluorophenyl group, 2,3,4-trifluorophenyl group, 4-tert-butylphenyl group, 4-methoxyphenyl group, 2-methoxy-4-tert-butylphenyl group, 4-trifluoromethoxyphenyl group, benzyl group, methylbenzyl group such as in particular 4-methylbenzyl group, 4-methoxybenzyl group, 3,4-dimethoxybenzyl group, 4-hydroxybenzyl group, 3,4-dichlorobenzyl group, 2,3,4-trichlorobenzyl group, 4-trifluoromethylbenzyl group, 1-phenylethyl group, 2-phenylethyl group, 1-phenylpropyl group, 2-phenylpropyl group or 3-phenylpropyl group, preferably a methylbenzyl group, particularly preferably a 4-methylbenzyl group, R 1 ' is a hydrogen atom, is bonded to the nitrogen atom at position 1 or 3 of the dihydrotriazine ring, R 2 and R 3 each represent a methyl group and R 4 represents an n-octyl group, n-nonyl group or n-decyl group.

[0050] In a further embodiment of the invention, R 1 represents a methylbenzyl group, preferably a 4-methylbenzyl group, and / or R 2 and R 3 each represent a methyl group and / or R 4 represents an n-octyl group. Preferably, R 1 represents a methylbenzyl group, preferably a 4-methylbenzyl group, R 2 and R 3 each represent a methyl group, and R 4 represents an n-octyl group.

[0051] In a further embodiment of the invention, R 1 is / are a methylbenzyl group, preferably 4-methylbenzyl group, R 1 ' is a hydrogen atom which is bonded to the nitrogen atom at position 1 or 3 of the dihydrotriazine ring, R 2 and R 3 are each a methyl group and R 4 is an n-octyl group

[0052] The dihydrotriazine compound particularly preferably has the following formula la:

[0053] Alternatively, the dihydrotriazine compound may have the following formula Ib:

[0054] In a further embodiment of the invention, the dihydrotriazine compound or the salt thereof is 4-octylamino-1,6-dihydro-6,6-dimethyl-2-(4'-methylbenzylamino)-1,3,5-triazine gluconate, which can also be referred to as 6,6-dimethyl-N 2< -(4-methylbenzyl)-N 4< -octyl-1,6-dihydro-[1,3,5]triazine-2,4-diamine gluconate, or a tautomer thereof. Preferably, the dihydrotriazine compound or salt thereof is 4-octylamino-1,6-dihydro-6,6-dimethyl-2-(4'-methylbenzylamino)-1,3,5-triazine-D-gluconate, which may also be referred to as 6,6-dimethyl-N 2 < -(4-methylbenzyl)-N 4 < -octyl-1,6-dihydro-[1,3,5]triazine-2,4-diamine-D-gluconate, or a tautomer thereof. The dihydrotriazine compound or salt thereof disclosed in this paragraph.The dihydrotriazine compound salt disclosed in this paragraph has been found to be particularly effective for the prevention or treatment of mucous membrane and / or wounds and / or infections and / or infectious diseases, in particular wounds and / or infections and / or infectious diseases caused or co-caused by fungi, in particular yeasts.

[0055] The dihydrotriazine compound or the dihydrotriazine compound salt 4-octylamino-1,6-dihydro-6,6-dimethyl-2-(4'-methylbenzylamino)-1,3,5-triazine-D-gluconate mentioned in the previous paragraph is commercially available under the name "Femotaxidine" and can be represented by the following formula Ia #<:

[0056] In a further embodiment of the invention, the dihydrotriazine compound of the general formula I or the salt thereof is 4-octylamino-3,6-dihydro-6,6-dimethyl-2-(4'-methylbenzylamino)-1,3,5-triazine gluconate, in particular 4-octylamino-3,6-dihydro-6,6-dimethyl-2-(4'-methylbenzylamino)-1,3,5-triazine D-gluconate, or a tautomer thereof.

[0057] In a further embodiment of the invention, the dihydrotriazine compound of general formula I or the tautomer thereof or the salt thereof has a proportion of 0.001 wt.% to 1.00 wt.%, in particular 0.01 wt.% to 0.50 wt.%, preferably 0.025 wt.% to 0.25 wt.%, based on the total weight of the aqueous composition. In particular, the proportions disclosed in this paragraph for the dihydrotriazine compound or the tautomer thereof or the salt thereof have proven particularly advantageous with regard to the prevention or treatment of mucous membranes and / or wounds and / or infections and / or infectious diseases, in particular wounds and / or infections and / or infectious diseases caused or co-caused by fungi, in particular yeasts.

[0058] In a further embodiment of the invention, the defoamer is selected from the group consisting of alkylamide, silicone, poloxamer and combinations, in particular mixtures, of at least two of the said defoamers.

[0059] The alkylamide can in particular be an alkylamide of the formula R 1 -NH-R 2, where R 1 is n-octyl, iso-octyl, or 2-ethylhexyl and R 2 is n- or iso-octane, n- or isononane, or n- or isodecane. According to the invention, the alkylamide can also be a combination, in particular a mixture, of at least two corresponding alkylamides.

[0060] The silicone may be a polydimethylsiloxane, polyether siloxane (siloxane-polyethylene glycol or siloxane-polypropylene glycol), 3D-modified siloxane, also called crosslink siloxane, or a combination, in particular a mixture, of at least two of the silicones mentioned.

[0061] The poloxamer preferably has 2 to 130 structural units -CH 2 -CH 2 -O- and / or 15 to 67 structural units -CHCH 3 -CH 2 -O- per molecule.

[0062] For the purposes of the present invention, the term "poloxamer" is understood to mean a block copolymer of ethylene oxide and propylene oxide.

[0063] In particular, the poloxamer may be poloxamer 407, poloxamer 188 or a combination, in particular a mixture, thereof.

[0064] Furthermore, the defoamer can be a combination, in particular a mixture, of an alkylamide and a silicone. Such a combination of defoamers is particularly advantageous with regard to suppressing or attenuating foam formation of the dihydrazine compound or the tautomer thereof or the salt thereof. In this case, the alkylamide can have a proportion, in particular active proportion, of 0.0001 wt.% to 0.1 wt.%, in particular 0.0005 wt.% to 0.05 wt.%, preferably 0.001 wt.% to 0.05 wt.%, based on the total weight of the aqueous composition, and the silicone can have a proportion, in particular active proportion, of 0.00001 wt.% to 0.01 wt.%, in particular 0.00002 wt.% to 0.005 wt.%, preferably 0.00005 wt.% to 0.005 wt.%, based on the total weight of the aqueous composition.

[0065] In a further embodiment of the invention, the defoamer has a proportion of 0.0001 wt.% to 2.0 wt.%, in particular 0.0005 wt.% to 1.5 wt.%, preferably 0.001 wt.% to 1.0 wt.%, based on the total weight of the aqueous composition. In particular, the defoamer proportions disclosed in this paragraph have proven particularly advantageous with regard to suppressing or reducing foam formation attributable to the dihydrotriazine compound of general formula I or the tautomer thereof or the salt thereof.

[0066] In a further embodiment of the invention, the aqueous composition further comprises a surfactant, in particular non-ionic surfactant and / or zwitterionic surfactant, with the proviso that the surfactant, in particular non-ionic surfactant and / or zwitterionic surfactant, and the defoamer are selected to be different from one another, ie they represent different compounds.

[0067] For the purposes of the present invention, the term "nonionic surfactant" refers to a surfactant which does not contain any dissociable functional groups and therefore does not separate into ions in water or an aqueous liquid.

[0068] A non-ionic or zwitterionic surfactant has the particular advantage that there are no or few interactions with the dihydrotriazine compound and that it is also very well tolerated by mucous membranes and wounds.

[0069] The nonionic surfactant is preferably selected from the group consisting of poloxamer, fatty alcohol alkoxylate such as fatty alcohol ethoxylate, polyvinylpyrrolidone, alkyl polyglucoside, and combinations, in particular mixtures, of at least two of the nonionic surfactants mentioned. The nonionic surfactants mentioned in this paragraph and described in more detail below have proven particularly suitable for reducing or avoiding the irritation potential of the dihydrotriazine compound of general formula I or the tautomer thereof or the salt thereof, which is detrimental from a wound therapy perspective.

[0070] The poloxamer preferably has 2 to 130 structural units -CH 2 -CH 2 -O- and / or 15 to 67 structural units -CHCH 3 -CH 2 -O- per molecule.

[0071] The poloxamer may in particular be poloxamer 407, poloxamer 188 or a combination, in particular a mixture, thereof.

[0072] The use of a poloxamer as a surfactant may be particularly preferred according to the invention, since poloxamers, in addition to surfactant properties, also possess foam-suppressing or foam-reducing properties and / or emulsifying properties. This particularly advantageously allows foam formation attributable to the dihydrotriazine compound of general formula I or the tautomer thereof or the salt thereof to be additionally suppressed, mitigated, or suppressed, and / or a homogeneous distribution of the defoamer within the aqueous composition to be achieved or improved.

[0073] The use of polyvinylpyrrolidone as a surfactant may also be particularly preferred according to the invention, since this surfactant possesses emulsifying properties in addition to its surfactant properties. The advantages mentioned in the previous paragraph apply accordingly.

[0074] In addition, the use of polyvinylpyrrolidone has the advantage that it can bind water and thus act as a viscosity regulator.

[0075] For the purposes of the present invention, the term "fatty alcohol alkoxylate" refers to a nonionic surfactant whose lipophilic moiety comprises or consists of a fatty alcohol and whose hydrophilic moiety comprises or consists of a polyalkylene glycol, in particular short-chain polyalkylene glycol. The fatty alcohol can be, in particular, an alcohol derived from caprylic, capric, lauric, palmitic, stearic, or oleic acid, or branched isononyl, isundecyl, isotridecyl, isopentadecyl, or isononadecyl alcohols. For the purposes of the present invention, the fatty alcohol alkoxylate can also be referred to as a polyalkylene glycol ether.

[0076] As already mentioned, the fatty alcohol alkoxylate can in particular be a fatty alcohol ethoxylate.

[0077] The fatty alcohol ethoxylate is preferably a polyoxyethylene ether of lauryl alcohol, a polyoxyethylene ether of myristyl alcohol, a polyoxyethylene ether of cetyl alcohol, a polyoxyethylene ether of cetylstearyl alcohol, a polyoxyethylene ether of stearyl alcohol, a polyoxyethylene ether of oleyl alcohol, a polyoxyethylene ether of isononane alcohol, a polyoxyethylene ether of isoundecane alcohol, a polyoxyethylene ether of isotridecane alcohol, a polyoxyethylene ether of isopentadecane alcohol, a polyoxyethylene ether of isoheptadecane alcohol, a polyoxyethylene ether of isononadecane alcohol or a combination, in particular a mixture, of at least two of the polyoxyethylene ethers mentioned.

[0078] The fatty alcohol ethoxylate can in particular be selected from the group consisting of polyoxyethylene (4) lauryl ether, polyoxyethylene (7) lauryl ether, polyoxyethylene (9) lauryl ether, polyoxyethylene (23) lauryl ether, polyoxyethylene (2) cetyl ether, polyoxyethylene (10) cetyl ether, polyoxyethylene (20) cetyl ether, polyoxyethylene (6) cetyl stearyl ether, polyoxyethylene (20) cetyl stearyl ether, polyoxyethylene (25) cetyl stearyl ether, polyoxyethylene (2) stearyl ether, polyoxyethylene (10) stearyl ether, polyoxyethylene (20) stearyl ether, polyoxyethylene (2) oleyl ether, polyoxyethylene (10) oleyl ether, polyoxyethylene (20) oleyl ether, polyoxyethylene (10) monodecyl ether, Polyoxyethylene (10) tridecyl ether and combinations, in particular mixtures, of at least two of the fatty alcohol ethoxylates mentioned.

[0079] In other words, the fatty alcohol ethoxylate can in particular be selected from the group consisting of Laureth-4, Laureth-7, Laureth-9, Laureth-23, Ceteth-2, Ceteth-10, Ceteth-20, Ceteareth-6, Ceteareth-20, Ceteareth-25, Steareth-2, Steareth-10, Steareth-20, Oleth-2, Oleth-10, Oleth-20, Deceth-10, Trideceth-10 and combinations, in particular mixtures, of at least two of the fatty alcohol ethoxylates mentioned.

[0080] Fatty alcohol alkoxylates, especially fatty alcohol ethoxylates, have the advantage that they not only have surfactant properties but also have emulsifying properties.

[0081] For the purposes of the present invention, the term "alkyl polyglucoside" refers to a nonionic sugar surfactant that contains one or more glucose units and an alkyl radical, particularly a long-chain alkyl radical, or consists of one or more glucose units and an alkyl radical, particularly a long-chain alkyl radical. The glucose unit(s) act as the hydrophilic component, while the alkyl radical represents the hydrophobic group.

[0082] The alkyl polyglucoside preferably has 1 to 5 glucose building blocks and / or an alkyl radical having 6 to 20 carbon atoms, in particular 6 to 16 carbon atoms, preferably 8 to 14 carbon atoms.

[0083] The alkyl polyglucoside is preferably a C 8 to C 20 alkyl polyglucose, in particular a C 8 to C 16 alkyl polyglucose.

[0084] The alkyl polyglucoside is particularly preferably lauryl polyglucose, decyl polyglucose, cocoyl polyglucose, or a mixture of at least two of the above-mentioned alkyl polyglucosides. The alkyl radical of decyl polyglucose preferably has 8 to 16 carbon atoms, in particular 10 carbon atoms. The alkyl radical of lauryl polyglucose preferably has 12 to 16 carbon atoms, in particular 12 carbon atoms. The alkyl radical of cocoyl polyglucose preferably has 8 to 16 carbon atoms.

[0085] Alkyl polyglucosides also have the advantage that they not only have surfactant properties, but also represent emulsifying compounds.

[0086] In a further embodiment of the invention, the surfactant is a zwitterionic surfactant.

[0087] For the purposes of the present invention, the term "zwitterionic surfactant" refers to a surfactant which has both a negatively and a positively charged functional group (so-called amphoteric surfactant).

[0088] The zwitterionic surfactant is preferably an alkylamidoalkylbetaine, in particular an alkylamidoethylbetaine, alkylamidopropylbetaine or a combination, in particular a mixture, thereof.

[0089] The alkylamidoalkyl betaine is particularly preferably an alkylamidoalkyl betaine of a fatty acid. The fatty acid preferably has 8 to 18 carbon atoms. The fatty acid can be a saturated or unsaturated fatty acid. The fatty acid is preferably caprylic acid, capric acid, undecylenic acid (undec-10-enoic acid), undecylic acid (n-undecanoic acid), lauric acid, stearic acid, ricinoleic acid, or coconut fatty acid.

[0090] Preferably, the alkylamidoalkylbetaine is selected from the group consisting of caprylamidoalkylbetaine, caprimidoalkylbetaine, undecylenamidoalkylbetaine, undecylamidoalkylbetaine, lauramidoalkylbetaine, lauryldimethylaminoacetic acid betaine, stearinamidoalkylbetaine, ricinolamidoalkylbetaine, cocamidoalkylbetaine and combinations, in particular mixtures, of at least two of the alkylamidoalkylbetaines mentioned.

[0091] The alkylamidoethylbetaine is preferably an alkylamidoethylbetaine based on a fatty acid, in particular a fatty acid with 8 to 18 carbon atoms. The fatty acid can be a saturated or unsaturated fatty acid. The fatty acid is preferably caprylic acid, capric acid, undecylenic acid (undec-10-enoic acid), undecylic acid (n-undecanoic acid), lauric acid, stearic acid, ricinoleic acid, or coconut fatty acid.

[0092] The alkylamidoethylbetaine is particularly preferably selected from the group consisting of caprylamidoethylbetaine, caprimidoethylbetaine, undecylenamidoethylbetaine, undecylamidoethylbetaine, lauramidoethylbetaine, cocamidoethylbetaine, stearinamidoethylbetaine, ricinolamidoethylbetaine and combinations, in particular mixtures, of at least two of the alkylamidoethylbetaines mentioned.

[0093] The alkylamidopropyl betaine is preferably an alkylamidopropyl betaine based on a fatty acid, in particular a fatty acid with 8 to 18 carbon atoms. The fatty acid can be a saturated or unsaturated fatty acid. The fatty acid is preferably caprylic acid, capric acid, undecylenic acid (undec-10-enoic acid), undecylic acid (n-undecanoic acid), lauric acid, stearic acid, ricinoleic acid, or coconut fatty acid.

[0094] The alkylamidopropyl betaine is particularly preferably selected from the group consisting of caprylamidopropyl betaine, caprimidopropyl betaine, undecylenamidopropyl betaine, undecylamidopropyl betaine, cocamidopropyl betaine, stearinamidopropyl betaine, ricinolamidopropyl betaine and combinations, in particular mixtures, of at least two of the alkylamidopropyl betaines mentioned.

[0095] The optionally provided surfactant may also be a combination, in particular a mixture, of the surfactants described in the previous paragraphs, in particular a combination, in particular a mixture, of a nonionic surfactant and a zwitterionic surfactant. In this respect, reference is made entirely to the surfactants described in the previous paragraphs.

[0096] Furthermore, the surfactant can be a poloxamer, wherein the aqueous composition contains no defoaming compound and / or no emulsifying compound apart from the surfactant. Due to the already mentioned defoaming and / or emulsifying properties of a poloxamer, the additional use of a defoamer and / or emulsifier can be particularly advantageously dispensed with. Regarding further features and advantages of the poloxamer, reference is made in full to the previous description.

[0097] Furthermore, the surfactant can be polyvinylpyrrolidone, wherein the aqueous composition, apart from the surfactant, contains no defoaming compound and / or no emulsifying compound and / or no water-binding compound. Due to the already mentioned defoaming and / or emulsifying and / or thickening, i.e., water-binding, properties of polyvinylpyrrolidone, the additional use of a defoamer and / or emulsifier and / or thickener can, with particular advantage, be dispensed with. With regard to further features and advantages of polyvinylpyrrolidone, reference is made in full to the previous description.

[0098] Furthermore, the surfactant can be a fatty alcohol alkoxylate, in particular fatty alcohol ethoxylate, and / or alkyl polyglucoside, wherein the aqueous composition contains no emulsifying compound apart from the surfactant. Due to the already mentioned emulsifying properties of a fatty alcohol alkoxylate, in particular fatty alcohol ethoxylate, and / or alkyl polyglucoside, the additional use of an emulsifier can be particularly advantageously dispensed with. With regard to further features and advantages of the fatty alcohol alkoxylate, in particular fatty alcohol ethoxylate, and / or alkyl polyglucoside, reference is made in full to the previous description.

[0099] In a further embodiment of the invention, the surfactant has a proportion, in particular active proportion, of 0.01 wt.% to 10.0 wt.%, in particular 0.05 wt.% to 2.0 wt.%, preferably 0.1 wt.% to 1.0 wt.%, based on the total weight of the aqueous composition. In particular, the surfactant proportions disclosed in this paragraph are particularly suitable for significantly reducing the irritating effect of the dihydrotriazine compound of general formula I or the tautomer thereof or the salt thereof.

[0100] In a further embodiment of the invention, the aqueous composition further comprises an emulsifier, with the proviso that the emulsifier and an optionally present surfactant are selected to be different from one another, i.e., they represent different compounds. The emulsifier is preferably selected from the group consisting of alcohol ethoxylate, alkyl polyglucoside, polysorbate, ethoxylated castor oil, and combinations, in particular mixtures, of at least two of the aforementioned emulsifiers. Regarding further features and advantages of the surfactant, reference is made in full to the previous description.

[0101] The alcohol ethoxylate is preferably a fatty alcohol ethoxylate.

[0102] The fatty alcohol ethoxylate may in particular be a polyoxyethylene ether of lauryl alcohol, a polyoxyethylene ether of myristyl alcohol, a polyoxyethylene ether of isononyl alcohol, a polyoxyethylene ether of isundecyl alcohol, a polyoxyethylene ether of isotridecylyl alcohol, a polyoxyethylene ether of cetyl alcohol, a polyoxyethylene ether of cetylstearyl alcohol, a polyoxyethylene ether of stearyl alcohol, a polyoxyethylene ether of oleyl alcohol or a combination, in particular a mixture, of at least two of the polyoxyethylene ethers mentioned.

[0103] Preferably, the alcohol ethoxylate is selected from the group consisting of polyoxyethylene (4) lauryl ether, polyoxyethylene (7) lauryl ether, polyoxyethylene (9) lauryl ether, polyoxyethylene (23) lauryl ether, polyoxyethylene (2) cetyl ether, polyoxyethylene (10) cetyl ether, polyoxyethylene (20) cetyl ether, polyoxyethylene (6) cetyl stearyl ether, polyoxyethylene (20) cetyl stearyl ether, polyoxyethylene (25) cetyl stearyl ether, polyoxyethylene (2) stearyl ether, polyoxyethylene (10) stearyl ether, polyoxyethylene (20) stearyl ether, polyoxyethylene (2) oleyl ether, polyoxyethylene (10) oleyl ether, polyoxyethylene (20) oleyl ether, polyoxyethylene (10) monodecyl ether, Polyoxyethylene (10) tridecyl ether and combinations, in particular mixtures, of at least two of the fatty alcohol ethoxylates mentioned.

[0104] In other words, the alcohol ethoxylate can preferably be selected from the group consisting of Laureth-4, Laureth-7, Laureth-9, Laureth-23, Ceteth-2, Ceteth-10, Ceteth-20, Ceteareth-6, Ceteareth-20, Ceteareth-25, Steareth-2, Steareth-10, Steareth-20, Oleth-2, Oleth-10, Oleth-20, Deceth-10, Trideceth-10 and combinations, in particular mixtures, of at least two of the fatty alcohol ethoxylates mentioned.

[0105] The alkyl polyglucoside preferably has 1 to 5 glucose building blocks and / or an alkyl radical having 8 carbon atoms to 20 carbon atoms, in particular 8 carbon atoms to 16 carbon atoms, preferably 8 carbon atoms to 14 carbon atoms.

[0106] The alkyl polyglucoside is preferably a C 8 to C 20 alkyl polyglucose, in particular a C 8 to C 16 alkyl polyglucose.

[0107] The alkyl polyglucoside is particularly preferably lauryl polyglucose, decyl polyglucose, cocoyl polyglucose, or a mixture of at least two of the above-mentioned alkyl polyglucosides. The alkyl radical of decyl polyglucose preferably has 8 to 16 carbon atoms, in particular 10 carbon atoms. The alkyl radical of lauryl polyglucose preferably has 12 to 16 carbon atoms, in particular 12 carbon atoms. The alkyl radical of cocoyl polyglucose preferably has 8 to 16 carbon atoms.

[0108] For the purposes of the present invention, the term "polysorbate" is understood to mean an ethoxylated sorbitan acid fatty acid ester.

[0109] The polysorbate can in particular be selected from the group consisting of polyoxyethylene (20) sorbitan monolaurate, polyoxyethylene (4) sorbitan monolaurate, polyoxyethylene (20) sorbitan monopalmitate, polyoxyethylene (20) sorbitan monostearate, polyoxyethylene (4) sorbitan monostearate, polyoxyethylene (20) sorbitan tristearate, polyoxyethylene (20) sorbitan monooleate, polyoxyethylene (5) sorbitan monooleate, polyoxyethylene (20) sorbitan trioleate, polyoxyethylene (20) sorbitan monoisostearate and combinations, in particular mixtures, of at least two of the polysorbates mentioned.

[0110] In other words, the polysorbate can in particular be selected from the group consisting of polysorbate 20, polysorbate 21, polysorbate 40, polysorbate 60, polysorbate 61, polysorbate 65, polysorbate 80, polysorbate 81, polysorbate 85, polysorbate 120 and combinations, in particular mixtures, of at least two of the polysorbates mentioned.

[0111] In a further embodiment of the invention, the emulsifier has a proportion of 0.001 wt.% to 1.5 wt.%, in particular 0.01 wt.% to 1.5 wt.%, in particular 0.02 wt.% to 1.0 wt.%, preferably 0.05 wt.% to 0.5 wt.%, based on the total weight of the aqueous composition. In particular, the emulsifier proportions disclosed in this paragraph have proven particularly advantageous with regard to a homogeneous distribution of the defoamer within the aqueous composition.

[0112] In a further embodiment of the invention, the aqueous composition further comprises an additive which is selected from the group consisting of complexing agent, humectant, acid, alkali, organic solvent and combinations, in particular mixtures, of at least two of the additives mentioned.

[0113] The complexing agent can in particular be selected from the group consisting of citric acid, tartaric acid, succinic acid, methylglycine diacetate, ethyldiaminetetraacetate, N,N'-bis-(carboxymethyl)-L-glutamate, polyaspartic acid, iminodisuccinate, salts of the complexing agents mentioned and combinations, in particular mixtures, of at least two of the complexing agents mentioned.

[0114] Furthermore, the complexing agent can have a proportion of 0.01 wt.% to 10.0 wt.%, in particular 0.02 wt.% to 2.0 wt.%, preferably 0.05 wt.% to 1.0 wt.%, based on the total weight of the aqueous composition.

[0115] The humectant can be selected from the group consisting of glycerin, polydextrose, sorbitol, ethylene glycol, polyethylene glycol, propylene glycol, butylene glycol, pentylene glycol, hexanediol, octanediol, glucose, fructose, glucuronic acid, lactose, lactic acid, lactate, lactulose, sucrose, hyaluronic acid, xylitol, xylose and combinations, in particular mixtures, of at least two of the said humectants.

[0116] Furthermore, the humectant can have a proportion of 0.05 wt.% to 10.0 wt.%, in particular 0.1 wt.% to 7.5 wt.%, preferably 0.5 wt.% to 5 wt.%, based on the total weight of the aqueous composition.

[0117] The acid can be selected from the group consisting of formic acid, acetic acid, propionic acid, lactic acid, butyric acid, isobutyric acid, malic acid, maleic acid, malonic acid, fumaric acid, succinic acid, succinic acid monoamide, glutaric acid, tartaric acid, oxalic acid, citric acid, glycolic acid, glucuronic acid, ascorbic acid, aspartic acid, glutamic acid, benzoic acid, phthalic acid, salicylic acid, anthranilic acid, benzenesulfonic acid, p-toluenesulfonic acid, methanesulfonic acid and combinations, in particular mixtures, of at least two of the acids mentioned.

[0118] Furthermore, the acid can have a proportion of 0.01 wt.% to 10.0 wt.%, in particular 0.1 wt.% to 6.0 wt.%, preferably 0.1 wt.% to 5.0 wt.%, based on the total weight of the aqueous composition.

[0119] The alkalis may be selected from the group consisting of sodium hydroxide, potassium hydroxide, calcium hydroxide and magnesium hydroxide and combinations, in particular mixtures, of at least two of the alkalis mentioned.

[0120] Furthermore, the alkalis can have a proportion of 0.01 wt.% to 10.0 wt.%, in particular 0.1 wt.% to 6.0 wt.%, preferably 0.1 wt.% to 5.0 wt.%, based on the total weight of the aqueous composition.

[0121] The organic solvent may be selected from the group consisting of ethanol, propan-1-ol, propan-2-ol and combinations, in particular mixtures, of at least two of said organic solvents.

[0122] Furthermore, the organic solvent can have a proportion of 0.1 wt.% to 10.0 wt.%, in particular 0.5 wt.% to 10.0 wt.%, preferably 1.0 wt.% to 10.0 wt.%, based on the total weight of the aqueous composition.

[0123] The aqueous composition preferably has a water content of > 80 wt.%, in particular > 90 wt.%, based on the total weight of the aqueous composition.

[0124] In a further embodiment of the invention, the aqueous composition is an aqueous composition for application or use in the prevention or treatment of mucous membranes and / or wounds, in particular acute or chronic wounds, and / or for application or use in the prevention or treatment of infections, in particular infections caused or co-caused by fungi, in particular yeasts, and / or for application or use in the prevention or treatment of infectious diseases, in particular infectious diseases caused or co-caused by fungi, in particular yeasts. The infectious diseases can be, for example, candidiasis, erysipelas, or erysipelas.

[0125] Further features and advantages of the invention will become apparent from the following description of preferred embodiments. Individual features may be implemented individually or in combination with one another. The described embodiments merely serve to further explain the invention without limiting it thereto. EXAMPLE PART 1. Preparation of a wound irrigation solution according to the invention

[0126] 9912.5 g of water were placed in a suitable mixing reactor. A stirrer was then adjusted so that a slight torus formed on the water surface. 25.00 g of Tween 20 (Polysorbate 20) and 2.50 g of N-(2-Ethylhexyl)-Isononanamide were then added. 50.00 g of Cocamidopropyl Betaine (50%) were then added. 10.00 g of Femotaxidine were then added. The mixture was then stirred for one hour. The resulting solution had the following composition, shown in Table 1: Table 1: Example of a wound irrigation solution according to the invention Femotaxidine 0.100 wt.% Purified water 99.125 wt.% Cocamidopropyl betaine (50%) 0.500 wt.% Tween 20 0.250 wt.% Alkylamide 0.025 wt% 2. Preparation of another wound irrigation solution according to the invention

[0127] 9889.0 g of water were placed in a suitable mixing reactor. A stirrer was then adjusted so that a slight torus formed on the water surface. 40.00 g of Tween 20 and 1.00 g of polyether siloxane were then added. 50.00 g of cocamidopropyl betaine (50%) were then added. Finally, 20.00 g of femotaxidine were added. The mixture was stirred for one hour. The resulting solution had the following composition, shown in Table 2: Table 2: Example of a wound irrigation solution according to the invention Femotaxidine 0.200 wt.% Purified water 98,890 wt.% Cocamidopropyl betaine (50%) 0.500 wt.% Tween 20 0.400 wt.% silicone 0.010 wt.% 3. Preparation of another wound irrigation solution according to the invention

[0128] 9885.0 g of water were placed in a suitable mixing reactor. A stirrer was then adjusted so that a slight torus formed on the water surface. 17.50 g of Laureth-7 and 2.50 g of N-(2-ethylhexyl)-isononanamide were then added. 90.00 g of undecylenamidopropyl betaine (35%) were then added. Finally, 5.00 g of femotaxidine were added. The mixture was stirred for one hour. The resulting solution had the following composition, shown in Table 3: Table 3: Example of another wound irrigation solution according to the invention Femotaxidine 0.050 wt.% Purified water 98,850 wt.% Undecylenamidopropyl betaine (35%) 0.900 wt% Laureth-7 0.175 wt% Alkylamide 0.025 wt% 4. Preparation of another wound irrigation solution according to the invention

[0129] 9833.0 g of water were placed in a suitable mixing reactor. A stirrer was then adjusted so that a slight torus formed on the water surface. 15.00 g of Laureth-7 and 2.00 g of polyether siloxane were then added. Following this, 125.0 g of undecylenamidopropyl betaine (35%) were added. Finally, 25.00 g of femotaxidine were added. The mixture was stirred for one hour. The resulting solution had the following composition, shown in Table 4: Table 4: Example of another wound irrigation solution according to the invention Femotaxidine 0.250 wt.% Purified water 98,330 wt.% Undecylenamidopropyl betaine (35%) 1,250 wt.% Laureth-7 0.150 wt.% silicone 0.020 wt.% 5. Preparation of another wound irrigation solution according to the invention

[0130] 9904.4 g of water were placed in a suitable mixing reactor. A stirrer was then adjusted so that a slight torus formed on the water surface. 15.00 g of Laureth-7, 0.50 g of N-(2-ethylhexyl)-isononanamide, and 0.10 g of 3D-modified crosslink siloxanes were then added. 70.00 g of caprylamidopropyl betaine (35%) were then added. Finally, 10.00 g of femotaxidine were added. The mixture was stirred for one hour. The resulting solution had the following composition, shown in Table 5: Table 5: Example of another wound irrigation solution according to the invention Femotaxidine 0.100 wt.% Purified water 99.044 wt.% Alkylamidopropyl betaine (35%) 0.700 wt% Laureth-7 0.150 wt.% Alkylamide 0.005 wt% silicone 0.001 wt.% 6. Preparation of another wound irrigation solution according to the invention

[0131] 9889.5 g of water were placed in a suitable mixing reactor. A stirrer was then adjusted so that a slight torus formed on the water surface. 20.00 g of Poloxamer 188 and 0.50 g of 3D-modified crosslinked siloxanes were then added. 50.00 g of cocamidopropyl betaine (50%) were then added. Finally, 10.00 g of femotaxidine were added. The mixture was stirred for one hour. The resulting solution had the following composition, shown in Table 6: Table 6: Example of another wound irrigation solution according to the invention Femotaxidine 0.100 wt.% Purified water 98.895 wt% Cocamidopropyl betaine (50%) 0.800 wt.% Poloxamer 0.200 wt.% silicone 0.005 wt% 7. Preparation of another wound irrigation solution according to the invention

[0132] 9958.0 g of water were placed in a suitable mixing reactor. A stirrer was then adjusted so that a slight torus formed on the water surface. 30.00 g of Tween 20 and 2.00 g of N-(2-ethylhexyl)-isononanamide were then added. 10.00 g of femotaxidine were then added. The mixture was then stirred for one hour. The resulting solution had the following composition, shown in Table 7: Table 7: Example of another wound irrigation solution according to the invention Femotaxidine 0.100 wt.% Purified water 99,580 wt.% Tween 20 0.300 wt.% Alkylamide 0.020 wt.% 8. Preparation of another wound irrigation solution according to the invention

[0133] 9966.4 g of water were placed in a suitable mixing reactor. A stirrer was then adjusted so that a slight torus formed on the water surface. 12.50 g of Laureth-7, 1.00 g of N-(2-ethylhexyl)-isononanamide, and 0.10 g of 3D-modified crosslink siloxanes were then added. 20.00 g of femotaxidine were then added. The mixture was stirred for one hour. The resulting solution had the following composition, shown in Table 8: Table 8: Example of another wound irrigation solution according to the invention Femotaxidine 0.200 wt.% Purified water 99.664 wt% Laureth-7 0.125 wt% Alkylamide 0.010 wt.% silicone 0.001 wt.% 9. Preparation of another wound irrigation solution according to the invention

[0134] 9820.0 g of water were placed in a suitable mixing reactor. A stirrer was then adjusted so that a slight torus formed on the water surface. 500.00 g of polyvinylpyrrolidone were then added. 70.00 g of undecylenamidopropyl betaine (35%) were then added. 10.00 g of femotaxidine were then added. The mixture was then stirred for one hour. The resulting solution had the following composition, shown in Table 9: Table 9: Example of another wound irrigation solution according to the invention Femotaxidine 0.100 wt.% Purified water 98,200 wt.% Polyvinylpyrrolidone 5,000 wt.% Undecylenamidopropyl betaine (35%) 0.700 wt.% 10. Preparation of another wound irrigation solution according to the invention

[0135] 9890.0 g of water were placed in a suitable mixing reactor. A stirrer was then adjusted so that a slight torus formed on the water surface. 100.00 g of Poloxamer 188 were then added. 10.00 g of Femotaxidine were then added. The mixture was then stirred for one hour. The resulting solution had the following composition, shown in Table 10: Table 10: Example of another wound irrigation solution according to the invention Femotaxidine 0.100 wt.% Purified water 98,900 wt.% Poloxamer 1,000 wt.% 11. Preparation of a wound irrigation solution not according to the invention

[0136] 9980.0 g of water were placed in a suitable mixing reactor. A stirrer was then adjusted so that a slight torus formed on the water surface. 20.00 g of femotaxidine were then added. The mixture was stirred for one hour. The resulting solution had the following composition, shown in Table 11: Table 11: Example of a wound irrigation solution not according to the invention Femotaxidine 0.200 wt.% Purified water 99,800 wt.%

[0137] The wound irrigation solutions according to the invention prepared under steps 1 to 10 exhibited significant differences in foaming behavior compared to an aqueous femotaxidine solution (0.1 wt.% or 0.2 wt.% [Solution 11]). While the foam in the wound irrigation solutions according to the invention required much more energy to form and then disintegrated within a very short period of time, particularly within a few minutes, the foam in the aqueous femotaxidine solution used for comparison purposes formed very easily and persisted for a period of over 10 hours. Formulations 5 and 8, in particular, showed very rapid foam degradation.

[0138] Formula 9, as well as formula 11, showed significantly faster effectiveness against yeasts according to EN13624 compared to the commercial preparation Octenisept and were also convincing in the HET-CAM test with significantly lower irritation potential. Bacterial count reduction in log 10 ; criterion to pass the test according to EN13624 is > 4. EN 13624 Dirt conditions C. albicans 60 s C. albicans 90 s C. albicans 120 s HET-CAM Recipe 9 4.5 > 4.5 > 4.5 1 Recipe 11 4.5 > 4.5 > 4.5 2 Octenisept - - 3.0 6

[0139] The HET-CAM (Chicken Egg Test on the Chorion-Allantoic Membrane) is a method for testing the mucosal tolerance of chemicals. The CAM is the choroid of the egg. For the test, the substance to be tested is applied to the CAM. The membrane reactions (bleeding, changes in the blood vessels, or the egg white) are observed, compared with a reference (e.g., sodium dodecyl sulfate), and evaluated. The test is recognized as an official preliminary test for mucosal tolerance testing.

[0140] In the HET-CAM, a 6 means moderate irritation, while values ​​from 1-5 are considered mild irritation.

Claims

1. An aqueous composition, especially in the form of an aqueous solution or a hydrogel, comprising - a dihydrotriazine compound of the general formula I below: wherein - R1 means (i) a phenyl group or a phenylalkyl group, each of which is optionally substituted with 1 to 3 substituents selected from the group consisting of C1-6-alkoxy group, hydroxy group, a halogen atom, C1-6-haloalkyl group, C1-6-alkyl group, a sulfonamido group and C1-6-haloalkoxy group, (ii) a naphthyl group or a naphthylalkyl group, (iii) a heterocyclic group, a heterocyclic alkyl group or a heterocyclic aminoalkyl group, (iv) an alkyl group having 1 to 16 carbon atoms or (v) a cycloalkyl group or a cycloalkylalkyl group, - R1' means a hydrogen atom which is bonded to the nitrogen atom at position 1 or 3 of the dihydrotriazine ring, - R2 and R3 independently of one another mean a hydrogen atom or a methyl group, - R4 means an alkyl group having 7 to 16 carbon atoms and - the dashed line indicates that the position of a double bond is either between positions 1 and 2 or between positions 2 and 3 of the dihydrotriazine ring, or a tautomer thereof or a salt thereof and - a defoamer for use in the prevention or treatment of infections and / or infectious diseases caused or partly caused by fungi.

2. The aqueous composition for use as claimed in claim 1, characterized in that R1 means a phenyl group or a phenylalkyl group, especially benzyl group, each of which is optionally substituted by 1 to 3 substituents selected from the group consisting of fluorine atom, chlorine atom, hydroxy group, methyl group, tert-butyl group, trifluoromethyl group and methoxy group, R1' means a hydrogen atom which is bonded to the nitrogen atom at position 1 or 3 of the dihydrotriazine ring, R2 and R3 both mean a methyl group and R4 means an n-octyl group, n-nonyl group or n-decyl group.

3. The aqueous composition for use as claimed in claim 1 or 2, characterized in that R1 means a phenyl group, 4-chlorophenyl group, 2,4-difluorophenyl group, 2,3,4-trifluorophenyl group, 4-tert-butylphenyl group, 4-methoxyphenyl group, 2-methoxy-4-tert-butylphenyl group, 4-trifluoromethoxyphenyl group, benzyl group, methylbenzyl group, 4-methylbenzyl group, 4-methoxybenzyl group, 3,4-dimethoxybenzyl group, 4-hydroxybenzyl group, 3,4-dichlorobenzyl group, 2,3,4-trichlorobenzyl group, 4-trifluoromethylbenzyl group, 1-phenylethyl group, 2-phenylethyl group, 1-phenylpropyl group, 2-phenylpropyl group or 3-phenylpropyl group, preferably a 4-methylbenzyl group, R1' means a hydrogen atom which is bonded to the nitrogen atom at position 1 or 3 of the dihydrotriazine ring, R2 and R3 both mean a methyl group and R4 means an n-octyl group, n-nonyl group or n-decyl group.

4. The aqueous composition for use as claimed in any of the preceding claims, characterized in that R1 means a methylbenzyl group, preferably 4-methylbenzyl group, and / or R2 and R3 both mean a methyl group and / or R4 means an n-octyl group.

5. The aqueous composition for use as claimed in any of the preceding claims, characterized in that R1 means a methylbenzyl group, preferably 4-methylbenzyl group, R1' means a hydrogen atom which is bonded to the nitrogen atom at position 1 or 3 of the dihydrotriazine ring, R2 and R3 both mean a methyl group and R4 means an n-octyl group.

6. The aqueous composition for use as claimed in any of the preceding claims, characterized in that the dihydrotriazine compound is 4-octylamino-1,6-dihydro-6,6-dimethyl-2-(4'-methylbenzylamino)-1,3,5-triazine gluconate, 4-octylamino-3,6-dihydro-6,6-dimethyl-2-(4'-methylbenzylamino)-1,3,5-triazine gluconate, or a tautomer thereof.

7. The aqueous composition for use as claimed in any of the preceding claims, characterized in that the dihydrotriazine compound has a proportion of of 0.001% by weight to 1.00% by weight, especially 0.01% by weight to 0.50% by weight, preferably 0.025% by weight to 0.25% by weight, based on the total weight of the aqueous composition.

8. The aqueous composition for use as claimed in any of the preceding claims, characterized in that the defoamer is selected from the group consisting of alkyl amide, silicone, poloxamer and combinations of at least two of the defoamers mentioned.

9. The aqueous composition for use as claimed in any of the preceding claims, characterized in that the defoamer has a proportion of 0.0001% by weight to 2.0% by weight, especially 0.0005% by weight to 1.5% by weight, preferably 0.001% by weight to 1.0% by weight, based on the total weight of the aqueous composition.

10. The aqueous composition for use as claimed in any of the preceding claims, characterized in that the aqueous composition further comprises a surfactant, especially a nonionic surfactant, with the proviso that the defoamer and the surfactant are chosen such that they are different from one another, wherein the nonionic surfactant is preferably selected from the group consisting of poloxamer, fatty alcohol alkoxylate such as fatty alcohol ethoxylate, polyvinylpyrrolidone, alkyl polyglucoside and combinations of at least two of the nonionic surfactants mentioned.

11. The aqueous composition for use as claimed in any of the preceding claims, characterized in that the surfactant is a zwitterionic surfactant, especially an alkylamidoalkyl betaine, preferably an alkylamidoethyl betaine, alkylamidopropyl betaine or a combinations thereof.

12. The aqueous composition for use as claimed in any of the preceding claims, characterized in that the aqueous composition further comprises an emulsifier, with the proviso that the emulsifier and an optionally present surfactant are chosen such that they are different from one another, wherein the surfactant is preferably selected from the group consisting of alcohol ethoxylate, alkyl polyglucoside, polysorbate, ethoxylated castor oil and combinations of at least two of the emulsifiers mentioned.

13. The aqueous composition for use as claimed in any of claims 10 to 12, characterized in that the surfactant has an active proportion of 0.01% by weight to 10.0% by weight, especially 0.05% by weight to 2.0% by weight, preferably 0.1% by weight to 1.0% by weight, based on the total weight of the aqueous composition, and / or the emulsifier has a proportion of 0.001% by weight to 1.5% by weight, especially 0.02% by weight to 1.0% by weight, preferably 0.05% by weight to 0.5% by weight, based on the total weight of the aqueous composition.

14. The aqueous composition for use as claimed in any of the preceding claims, characterized in that the aqueous composition further comprises an additive selected from the group consisting of thickener, complexing agent, humectant, acid, alkali, organic solvent and combinations of at least two of the additives mentioned.