DE102015223901A1 - preparation - Google Patents

Abstract

A composition, wherein the preparation is a substantially aqueous solution comprising an aldehyde component, a surfactant and a water-miscible solvent for use in the local treatment of nail fungus.

Description

The invention relates to a preparation, in particular for use in the treatment of nail fungus.

BACKGROUND OF THE INVENTION

Fungal toenail or fingernail (onychomycosis) infection is estimated to be diagnosed in about 8-10% of European and American populations. The frequency of infection increases with the age of the considered group of people, as well as health and occupational exposures are responsible for an increased infection rate. Even people who do intensive sports are often affected by nail fungus infections. The infestation is caused by different species, the most important groups being the dermatophytes of the genus Trichophyton spp. (eg Trichophyton rubrum, T. mentagrophytes), Epidermophyton floccosum, but also yeasts (Candida species) may be responsible for microbial infestation of the nail plate.

As a result of the infection, the nail plate is weakened and damaged, which leads to optical and structural changes, so that yellowish, white changes in the nail are observed, which can reach as far as the nail bed.

In most cases, the nail fungus infection is painless, therefore, in many cases, the infection is accepted as chronic after several unsuccessful treatment attempts. However, the altered appearance of the toenails leads to personal limitations in many individuals, e.g. when choosing footwear, as the affected toes are not readily visible. Also, persons who are required to work a lot with impermeable gloves (e.g., cleanroom personnel, medical professionals, etc.) are at an increased risk of infection, as well as those who exercise a high level of physical activity.

Treatments of nail fungus attack depend on the severity of the infestation (severity of infection, number of nails affected) and can be locally by application of appropriate active substances, by complete removal of the nail or systemically by administration of appropriate drugs, e.g. done in oral form.

• – Verschiebung der biologischen Lebensbedingungen im Bereich der befallenen Nagelbereiche: Hierzu gehören Methoden die durch Anwendung von organischen Säuren eine lokale Verschiebung des pH-Bereiches erreichen und so die Vermehrungsbedingungen für die Nagelpilze so stark verändern, dass ein weiteres Wachstum verhindert oder zumindest verlangsamt wird ( US 2014/0142177 , WO 2010/019777 ). Die Verwendung von Salizylsäure wird beispielsweise in US 2011/0160166 offenbart.
• – Einsatz von Desinfektionsmittel aus der Gruppe der Oxidationsmittel (Peroxide oder halogenhältige Oxidationsmittel) wird von WO 2010/125398 zur oberflächlichen Behandlung von Pilzinfektionen vorgeschlagen.
• – Die lokale Behandlung von Pilzinfektionen durch in situ Freisetzung von Stickoxiden durch Reaktion von Nitrit-Salzen mit Säure wird in WO 2011/155887 vorgeschlagen.
• – Behandlungen durch Laserstrahlen können zur lokalen Entfernung der befallenen Bereiche eingesetzt werden. Durch Temperaturerhöhungen werden die befallenen Bereiche entfernt.
• – Verwendung von Fungizid wirkenden Substanzen: Hierzu gehören Substanzen die eine hohe Toxizität für Pilze aufweisen. Beispiel sind Bifonazol, Clotrimazol, Ciclopirox, Amorolfin oder Metall-Pyrithion ( US 2009/0298805 ). Diese werden lokal beispielsweise als Nagellack aufgetragen. Die Verwendung von Formaldehyd als Bestandteil von pilzbekämpfenden Nagellacken wurde in FR 2805745 als mögliche Behandlungstechnik beschrieben.
• – Auch eine Behandlung mit ätherischen Ölen (z.B. Lavendelöl, Teebaumöl ( US 2006/0251593 )) und Pflanzenextrakten in unterschiedlicher Zubereitungsform wird zur Behandlung von Nagelpilzinfektionen vorgeschlagen.
• – Pulverförmige Zubereitungen welche Pflanzenextrakte, Calziumhydroxid und Bleioxid enthalten werden in IN 2011/MU03010 vorgeschlagen. Fluorid freisetzende Zubereitungen werden ebenfalls in der Literatur vorgeschlagen ( US 2002/0102223 ).

Relevant to the present invention are topically applied strategies for the treatment of nail fungus:

• - Shifting of the biological living conditions in the affected nail areas: These include methods that achieve a local shift of the pH range by the application of organic acids and so change the propagation conditions for the toenails so that further growth is prevented or at least slowed down ( US 2014/0142177 . WO 2010/019777 ). Salicylic acid is used for example in US 2011/0160166 disclosed.
• - Use of disinfectant from the group of oxidants (peroxides or halogenated oxidants) is from WO 2010/125398 proposed for the superficial treatment of fungal infections.
• - The local treatment of fungal infections by in situ release of nitrogen oxides by reaction of nitrite salts with acid is in WO 2011/155887 proposed.
• - Treatments by laser beams can be used for local removal of the affected areas. Due to temperature increases, the affected areas are removed.
• - Use of fungicidal substances: These include substances that have high toxicity to fungi. Examples are bifonazole, clotrimazole, ciclopirox, amorolfine or metal pyrithione ( US 2009/0298805 ). These are applied locally, for example, as nail polish. The use of formaldehyde as an ingredient of antifungal nail varnishes has been reported in FR 2805745 described as a possible treatment technique.
• - Also a treatment with essential oils (eg lavender oil, tea tree oil ( US 2006/0251593 )) and plant extracts in various formulations is proposed for the treatment of fungal nail infections.
• - Powdered preparations which plant extracts, calcium hydroxide and lead oxide are contained in IN 2011 / MU03010 proposed. Fluoride-releasing preparations are also proposed in the literature ( US 2002/0102223 ).

In the formulation of corresponding preparations, other additives, such as, for example, solvents, film formers, thickeners and swelling agents (permeation enhancers) are also used ( WO 2009/148794 ). The swelling agents are substances containing mercaptan groups, which are able to soften the nail structure by swelling ( US 6,123,690 and US 5,696,164 ).

The use of surface-active substances has already been described in the prior art for the formulation of antifungal preparations WO 2010/014070 proposed, wherein the task disclosed therein is in the stabilization of the preparation containing lipid structures. Therefore, no specific requirements are placed on the surfactants, in one preferred embodiment are exemplified nonionic surfactants used.

The high number of infections of nail fungi which are still present today in economically highly developed countries confirms the hitherto unsatisfactory suitability and effect of the proposed solutions, which have numerous disadvantages.

In systemic treatment, oral antifungals such as griseofulvin, itraconazole, terbinafine ( WO 2010/010470 ) or fluconazole for a prolonged period. These treatments require long periods of time as the antimycotics must be incorporated into the nail structure, which can reduce the infection. The health side effects of this long-term medication are considerable.

Local fungicidal substances such as bifonazole, clotrimazole, ciclopirox, amorolfine have only a limited effect. This is mainly due to two systematic causes: The substances are high molecular weight and insoluble in water substances. As a result, the formulations are often systems with solubilizers or emulsions, which can only penetrate poorly into the branched and deep growth areas in affected nails. However, a much more critical disadvantage is to be seen in the increasing resistance of fungi, which are becoming less sensitive to the active ingredients.

Concepts for shifting the pH have only a low temporal stability. Due to the body's own ability to buffer pH, sweat and also the body cleansing, the mechanisms of action are neutralized and thus a discontinuation of the treatment effectiveness. This applies analogously to the systems based on the action of oxidants. After disintegration / degradation of the oxidizing agent, there is no antifungal activity in the affected areas. This is also the case with active principles which use the release of NO gases.

Formulations containing the sometimes extremely toxic solid substances such as lead or mercury salts, are disadvantageous because of the high toxicity of the substances.

The use of lacquer polymers to strengthen the nail structure has been described in the literature ( DE 20 2013 009 976 ). If antifungal substances are incorporated into the paint formulation, an antifungal nail polish is produced ( DE 20 2013 009 988 ) wherein the use of formaldehyde in the in DE 20 2013 009 988 claimed formulation is explicitly excluded.

Formaldehyde is found in the human body as an intermediate of metabolism in a daily amount of about 50 g, as well as up to 0.01 mg / m ^{3 of} formaldehyde in the exhaled breath. The use of formaldehyde (methanal) as a preservative in preparations of surfactants for liquid detergents and also for the preservation of cosmetic products is known in the art and is approved in accordance with the Cosmetics Regulation of EU 1223/2009 for cosmetic products Annex III for the preservation of products , the application is also approved as a nail hardener.

Due to its high chemical reactivity, formaldehyde has a strong disinfectant effect and is still an important disinfectant in medical cleaning agents today. Due to the chemical reactivity and the biocompatibility, or the presence in the metabolism, chemical resistances of microorganisms to formaldehyde and other aldehydes or aldehyde-releasing substances are not to be expected. Formaldehyde is usually used as an aqueous solution (formalin) or in gaseous form.

Although the antimicrobial effect of formaldehyde is known, so far no optimal preparations for the treatment of nail fungus are known. It is known from the prior art, the application of aqueous solution of formaldehyde as a nail hardener ( US 3,382,151 ) and nearly anhydrous antifungal paint formulations with formaldehyde ( FR 2 805 745 ).

Due to the ability of formaldehyde to react with the nail keratin crosslinking reactions, this substance was used to harden the nail structure in brittle or mechanically weak nails. US 3,382,151 describes a combination of formaldehyde, garlic oil and surfactants and other vegetable oils as a recipe for curing the nail structure. To emulsify the otherwise insoluble oil components Kokosfettsäureethanolamide be proposed. The task of greater penetration of the nail substance is achieved by the addition of surfactant, as well as a formaldehyde known to be given aseptic and antifungal effect was called as a side effect. In the US 3,382,151 However, said ingredients diminish the required access of the active ingredients to the affected areas in a repeated application disadvantageously.

The usual preparations according to the prior art leave on and in the affected Nail area Residues which, in a subsequent repeated application, adversely affect the effect of the newly applied active ingredients in the course of an application for the treatment of nail fungus.

DESCRIPTION OF THE INVENTION

Thus, it is the task of providing a preparation that is suitable for the local treatment of nail fungus, is easy to handle and reaches the intrusion into the affected nail structure.

The object is achieved by a substance mixture comprising an aqueous solution comprising an aldehyde component and a surfactant and a water-miscible solvent.

The object is also achieved by a preparation for the local treatment of nail fungus, which is characterized in that the preparation is a substantially aqueous solution comprising an aldehyde component and a surfactant and a water-miscible solvent.

The mixture of substances or the preparation according to the invention provides a surprisingly simple solution which is suitable for the local treatment of nail fungus, is practical in its handling and achieves penetration into the affected nail structure. Although the use of formaldehyde, ie an aldehyde component for the treatment of nail fungus, is known, the present invention differs from the prior art in that it is a substantially aqueous solution and, in addition to the aldehyde component, a surfactant and another solvent are added are.

The preparation according to the invention is intended for the direct local treatment of nail fungus and can be provided as a cosmetic or pharmaceutical preparation.

The substance mixture can serve for the preparation of such a preparation or be used as such preparation itself.

An aldehyde component according to the invention may be an aldehyde or a compound which releases an aldehyde. The antimicrobial effect is attributed to the free aldehyde or the aldehyde releasing compound. Aldehydes are known for their ability to undergo reversible addition products with compounds such as water or alcohols. Thus, formaldehyde in aqueous solution is at least partially present as hydrate (methanediol). An addition product may also be formed with alcohols which may be included in the composition (see below for solvent). The term aldehyde component includes substances which themselves contain aldehyde groups, ie aldehydes or chemical compounds which are able to cleave off aldehydes. These include, for example, acetals such as dimethylformal, hemiacetals and aminals. A preferred aldehyde component is formaldehyde.

A surfactant is a substance that lowers the interfacial tension of the aqueous solution. According to the invention, this means that the surface tension of the substance mixtures or preparations according to the invention is lower than it would be without a surfactant.

A water-miscible solvent according to the invention is to be understood as meaning that a solvent other than water is added. Miscible with water are those solvents which are soluble in water, resulting in a homogeneous mixture. According to the invention, water-miscible solvents are soluble in water at room temperature at least to a level of up to about 30% by weight.

The composition according to the invention has, inter alia, the effect of reducing the viscosity of the mixture compared with other preparations with aldehyde component. By reducing the surface tension and the low viscosity, the deep penetration of the preparation is facilitated in the damaged nail areas. It has surprisingly been found that a very high antimycotic effect can be achieved by the addition of water-miscible solvent and surfactant. This effect is explained by the fact that the particular penetration depth of a preparation according to the invention containing an aldehyde into the damaged nail areas can be increased so much that complete elimination of the undesired fungal attack succeeds.

Due to the reduced surface tension of the preparation according to the invention, the treatment solution can penetrate sufficiently deep into the very fine growth channels in the affected nail areas. Due to the high penetration depth, complete treatment of the affected areas is achieved. It seems that the invention also enables treatment and elimination of fungal spores. The reaction of the formaldehyde with the Nagelkeratin a superficial sealing of the horn structure is achieved and a renewed infestation is hampered by the depot effect.

In addition, the preparation according to the invention is provided as a substantially aqueous solution, ie as a homogeneous mixture. For the mixture, this results in an advantageous physical and chemical stability. In contrast to the prior art, the one described here Preparation free of solid or oily components, which can lead to instabilities and may adversely affect the penetration and penetration of the nail structure.

In one embodiment, it is provided that the aldehyde component has at least one free aldehyde group.

Preferred aldehydes disclosed herein have good water solubility. Due to the low molecular weight, they can penetrate deep into the nail structure. For example, in a preferred embodiment, the aldehyde moiety having at least one free aldehyde group is formaldehyde, glutaraldehyde or glyoxal.

In alternative embodiments, an aldehyde is releasable from the aldehyde component. As already mentioned, addition products may form with other components of the composition or preparation from which the aldehyde is releasable. According to the invention, the person skilled in the art can also use aldehyde components which are per se so constructed that an aldehyde can be released. For example, those skilled in the art are aware of a number of so-called formaldehyde releasers from which formaldehyde can be released, such as, for example, acetals.

Of course, mixtures of aldehydes and components which release aldehydes are also conceivable in the composition according to the invention.

In embodiments, the surfactant is selected from the group of anionic surfactants, preferably alkyl sulfates, alkyl sulfonates, alkyl ether sulfates, alkyl phosphonates or alkyl phosphates, most preferably alkyl sulfates.

For the choice of surfactants, it should be noted that no irreversible reactions occur between the components of the invention, so that all components fulfill their function. The selection of the surfactants takes place after the requirement that they are not inactivated by chemical reaction with the aldehyde molecules or the solvent. For example, beneficial formulations have been formulated with fatty alcohol sulfates.

In embodiments, the water-miscible solvent is selected from the group of alcohols, polyethylene glycols or ketones, preferably alcohols.

The skilled worker is aware of a large number of solvents from these chemical groups, which have a sufficient polarity and are suitable as carriers for cosmetic or pharmaceutical preparation. These embodiments disclose suitable solvent additives that are water miscible.

Alcohols are preferred according to the invention. In the case of the low molecular weight alcohols, advantageous representatives are primary and secondary alcohols having a carbon number of up to 6 carbons, in particular methanol, ethanol, propanol or isopropanol, ethanol and isopropanol being particularly advantageous additives. It is important to ensure that an acetal / hemiacetal compound which may be formed can decompose reversibly again to the aldehyde components and thus the effect according to the invention of the preparation is not lost. Hemiacetals are addition products of alcohols and free aldehydes, which are in aqueous solution in equilibrium with the starting materials. The balance between free aldehydes and the hemiacetals formed depends on various parameters. Depending on the concentration conditions in the preparation and hemiacetals are formed by reaction with formaldehyde, which also develop an antifungal effect. In the literature, for example, the product of ethanol and formaldehyde is described as a very effective antimicrobial agent ( Sapozhok 74, in Sheklakov, ND; Tarasov, VP; Leshchenko, VM; Nikolaev, GM; Fedotova, TM; Mikhailov, NP, Vestnik Dermatologii i Venerologii (1979), (8), 17-19 ). Instead of alcohols can be used according to the invention as other solvents water-miscible solvents such as acetone, butanone, as a representative of low molecular weight ketones.

In a particular embodiment, the water-miscible solvent has an evaporation number <80, preferably <35, particularly preferably ≦ 10.

The evaporation rate of the water-miscible solvent is after DIN 53170 certainly. The evaporation number is defined as the relative indication of the evaporation time of the solvent compared to diethyl ether. According to the invention, solvents are used which are more volatile than water, ie which have an evaporation number <80. Preference is given to medium-volatile solvents, ie solvents having an evaporation number of from 10 to 35, even more preferred are volatile solvents ie solvents having an evaporation number <10. For example, ethanol having an evaporation number of 8.3 or acetone having an evaporation number of 2 is classified as readily volatile. For isopropanol, evaporation numbers are given as 10 or 11. According to the invention, compounds are preferred which, at temperatures in the range of room or body temperature, have sufficient vapor pressure to dry in a reasonable time. Advantageously, preparations with these compounds do not leave on drying Residues. One skilled in the art can select such compounds from the water-miscible solvent additives via physicochemical properties. In the course of the invention, for example, solvents are considered to be volatile and therefore preferred, which are selected from the group comprising alcohols having 1 to 6 carbon atoms, acetone or butanone.

By formulating the formulation of predominantly volatile components, a further positive effect is achieved. After application, virtually complete evaporation of all components, with the exception of the surfactant component, takes place, which in turn allows repeated and rapid application of the active substances into the treatment area. The volatility of the low molecular weight compounds in the preparation supports and improves the achievement of all affected areas, because locally, inside the nail, high concentrations of disinfectant can be generated. The rapid evaporation of the volatile solvent causes a local increase in the active concentration of antifungal aldehydes.

The composition of the preparation according to the invention should be understood to mean the inclusion of "a" component here in the sense of at least one component of the respective category. In particular, it is within the meaning of the invention to use various solvent additives, e.g. various representatives of the alcohols. The invention therefore also includes a mixture of substances or a preparation which comprises a further solvent selected from the group of water-miscible solvents, preferably from the group of alcohols, polyethylene glycols or acetone, more preferably alcohols.

• – einen Anteil von 0,1 und 30 Gew.%, bevorzugt zwischen 0,5 und 15 Gew.%, besonders bevorzugt zwischen 1 und 5 Gew.% an Aldehydkomponente und
• – einen Anteil von 0,05 und 80 Gew.%, bevorzugt zwischen 0,05 und 5 Gew.%, besonders bevorzugt zwischen 0,1 und 3 Gew.% an Tensid und
• – einen Anteil von 5 bis 80 Gew.%, bevorzugt von 10 bis 45 Gew.% an Lösungsmittel und
• – einen Rest auf 100% an Wasser.

With regard to the recipe, the substance mixture or the preparation is characterized by

• - A proportion of 0.1 and 30 wt.%, Preferably between 0.5 and 15 wt.%, Particularly preferably between 1 and 5 wt.% Of aldehyde component and
• - A proportion of 0.05 and 80 wt.%, Preferably between 0.05 and 5 wt.%, Particularly preferably between 0.1 and 3 wt.% Of surfactant and
• - A proportion of 5 to 80 wt.%, Preferably from 10 to 45 wt.% Of solvent and
• - a remainder to 100% of water.

The formulation of the substance mixture or of the preparation according to the invention can be compiled suitably by the person skilled in the art on the basis of the invention disclosed here or can be found in the examples. The person skilled in the art will adapt the selected concentrations of the individual constituents within the given ranges to the respective properties of the components used. For example, a surfactant is used in smaller amounts, the more active it is in the property of lowering the surface tension of solutions.

With regard to the possible production methods, the advantageous properties of the composition are also referred to here: As a homogeneous solution, the substance mixture can be prepared essentially by mixing, and the preparation as an essentially aqueous solution can take place according to classical pharmaceutical manufacturing processes. In a preferred embodiment, the preparation consists only of the ingredients disclosed herein. Alternatively, other additives such as color, fragrances can be incorporated into the formulation, provided that the function of the aldehyde component and the surfactant is not impaired.

• – täglich einmaliges Auftragen der Zubereitung vom Behandlungsbeginn bis zu Tag 2, 3, 4, 5, 6 oder 7 Tage nach Behandlungsbeginn, bevorzugt bis zu Tag 2 oder 3 nach Behandlungsbeginn,
• – anschließend wöchentlich einmaliges Auftragen der Zubereitung bis zu Woche 1, 2, 3, 4, 5, 6, 7, 8, 9 oder 10 nach Behandlungsbeginn, bevorzugt bis zu Woche 1, 2, 3, 4 oder 5 nach Behandlungsbeginn und
• – anschließend gegebenenfalls, monatlich einmaliges Auftragen der Zubereitung bis Monat 1, 2, 3, 4, 5, 6, 7, 8, 9 oder 10 nach Behandlungsbeginn, bevorzugt Monat 1, 2, 3, 4 oder 5 nach Behandlungsbeginn vorsieht.

In one embodiment, it is provided that the preparation according to the invention comprises the application by application to the affected, dry nail, wherein a treatment scheme

• - Daily single application of the preparation from the start of treatment up to day 2, 3, 4, 5, 6 or 7 days after the start of treatment, preferably up to day 2 or 3 after the start of treatment,
• - then weekly once a week, the preparation until week 1, 2, 3, 4, 5, 6, 7, 8, 9 or 10 after the start of treatment, preferably up to week 1, 2, 3, 4 or 5 after the start of treatment and
• - subsequently, if appropriate, monthly application of the preparation until month 1, 2, 3, 4, 5, 6, 7, 8, 9 or 10 after the start of treatment, preferably month 1, 2, 3, 4 or 5 after the start of treatment.

Such an application on the affected nail can be considered as topical or local application. It is obvious to a person skilled in the art that the preparation is advantageously provided in suitable form and packaging including a suitable applicator. It should be noted that the application is particularly practical to carry out thanks to the preparation according to the invention. The preparation can be spotted, for example. By the composition of the preparation, this is easy to use and dries quickly. In contrast to lacquer-forming or oily preparations, the progress of the drying process can be easily estimated by the user. The treatment regimen may be performed until the nail has regrown to ensure that the fungal infestation does not recur. Achievements according to the invention can be quickly recognized optically, whereby the application is positively received.

A corresponding substance mixture can be used in the local treatment of fungal infections of the nail or for the preparation of preparations for the local treatment of nail fungus. In one aspect, the invention thus relates to a substance mixture for use as a medicament. In particular, the invention relates to a preparation according to the invention for use as a medicament for the treatment of nail fungus.

EXAMPLES

Embodiment 1

A formaldehyde-containing preparation is prepared by preparing an aqueous solution containing 5% formaldehyde (by diluting a 20% formaldehyde solution), 10% ethanol and 0.25% fatty alcohol sulfate by weight.

The solution is dabbed on the dry nail area and penetrates through the lower surface tension in the nail. Then let the nail dry.

The treatment is repeated after one day, then after about 2-3 days after one week and then depending on the depth and severity of the infestation, the treatment is then repeated once a month until the affected nail area is fully grown.

In mild infestation, the infected nail area appears white and dry after the second application, indicating the killing of fungal infestation. The following treatments are then used to prevent re-infestation until complete regrowth of the healthy nail.

Embodiment 2

A formaldehyde-containing preparation is prepared by preparing an aqueous solution containing 5% formaldehyde (by diluting a 20% formaldehyde solution), 10% ethanol and 10% isopropanol and 0.25% fatty alcohol sulfate by weight.

The solution is dabbed on the dry nail area and penetrates through the lower surface tension in the nail. Then let the nail dry.

The treatment is first repeated daily, then after about 2-3 days after a week and then depending on the depth and severity of the infestation, the treatment is then repeated once a month until the affected nail area is fully grown.

In mild infestation, the infected nail area appears white and dry after the second application, indicating the killing of fungal infestation. The following treatments are then used to prevent re-infestation until complete regrowth of the healthy nail.

QUOTES INCLUDE IN THE DESCRIPTION

This list of the documents listed by the applicant has been generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Cited patent literature

• US 2014/0142177 [0006]
• WO 2010/019777 [0006]
• US 2011/0160166 [0006]
• WO 2010/125398 [0006]
• WO 2011/155887 [0006]
• US 2009/0298805 [0006]
• FR 2805745 [0006, 0017]
• US 2006/0251593 [0006]
• IN 2011/03010 [0006]
• US 2002/0102223 [0006]
• WO 2009/148794 [0007]
• US 6123690 [0007]
• US 5696164 [0007]
• WO 2010/014070 [0008]
• WO 2010/010470 [0010]
• DE 202013009976 [0014]
• DE 202013009988 [0014, 0014]
• US 3382151 [0017, 0018, 0018]

Cited non-patent literature

• Sapozhok 74, in Sheklakov, ND; Tarasov, VP; Leshchenko, VM; Nikolaev, GM; Fedotova, TM; Mikhailov, NP, Vestnik Dermatologii i Venerologii (1979), (8), 17-19 [0040]
• DIN 53170 [0042]

Claims (10)

 A composition, wherein the preparation is a substantially aqueous solution comprising an aldehyde component, a surfactant and a water-miscible solvent for use in the local treatment of nail fungus. A preparation according to claim 1, characterized in that the aldehyde component has at least one free aldehyde group, preferably the aldehyde component is formaldehyde, glutaraldehyde or glyoxal. Preparation according to claim 1, characterized in that from the aldehyde component, an aldehyde is releasable. Preparation according to one of claims 1 to 3, characterized in that the surfactant is an anionic surfactants, preferably selected from the group comprising alkyl sulfates, alkyl sulfonates, alkyl ether sulfates, alkyl phosphonates or alkyl phosphates, particularly preferably alkyl sulfates. Preparation according to one of claims 1 to 4, characterized in that the water-miscible solvent from the group of alcohols, polyethylene glycols or ketones, preferably alcohols is selected. Preparation according to one of claims 1 to 5, characterized in that the water-miscible solvent has an evaporation number <80, preferably <35, particularly preferably ≤ 10.  A preparation according to claim 6, characterized in that the water-miscible, volatile solvent is selected from the group comprising alcohols having 1 to 6 carbon atoms, acetone or butanone.  Preparation according to one of claims 1 to 7, characterized by another water-miscible solvent.  Preparation according to one of claims 1 to 8, characterized by - A proportion of 0.1 and 30 wt.%, Preferably between 0.5 and 15 wt.%, Particularly preferably between 1 and 5 wt.% Of aldehyde component and - A proportion of 5 to 80 wt.%, Preferably from 10 to 45 wt.% Of solvent and - A proportion of 0.05 and 80 wt.%, Preferably between 0.05 and 5 wt.%, Particularly preferably between 0.1 and 3 wt.% Of surfactant - a remaining share to 100% of water. Preparation according to one of claims 1 to 9, characterized in that it is applied to the affected, dry nail, wherein a treatment regimen - daily single application of the preparation from the start of treatment until day 2, 3, 4, 5, 6 or 7 days after Start of treatment, preferably up to day 2 or 3 after the start of treatment, then weekly application of the preparation once a week until 1, 2, 3, 4, 5, 6, 7, 8, 9 or 10 after the start of treatment, preferably up to week 1, 2, 3, 4 or 5 after the start of treatment and - then, if necessary, once a month applying the preparation to month 1, 2, 3, 4, 5, 6, 7, 8, 9 or 10 after the start of treatment, preferably month 1, 2, 3 , 4 or 5 after the start of treatment.