DE102018115270B4 - Gel and patch preparation for topical treatment of skin and/or nail disorders - Google Patents

Abstract

Preparation (100) as a gel for the topical treatment of skin and/or nail diseases with at least the following ingredients: a) an apple cider vinegar; b) a vegetable oil and c) an emulsifier, the preparation having an apple cider vinegar content of from 3% to 18% Contains an emulsifier content of 2% to 15% and a vegetable oil content of 80% to 90%, and wherein the preparation (100) comprises no further ingredients apart from the apple cider vinegar, the vegetable oil and the emulsifier.

Description

technical field

The invention relates to a preparation in the form of a gel and a patch for the topical treatment of skin and/or nail diseases.

State of the art

In principle, skin or nail diseases that are easy to treat, such as herpes, eczema or nail fungus, are often treated by a specialized dermatologist, since no means are available for simple, safe and effective self-treatment by the affected patients. As a result, dermatologists are burdened with a large number of minor treatments, resulting in long waiting times and high costs for the healthcare system.

The external treatment of eczema and nail fungus with vinegar is known from the prior art. For example, the pamphlet describes CN102813703A a medication used to treat athlete's foot and nail fungus that contains vinegar, salt and eucalyptus leaf juice. Vinegar is said to have bacteriostatic and bactericidal effects, effectiveness against intestinal diseases, influenza and respiratory diseases, as well as germicidal, beautifying and antihypertensive effects when applied to skin or hair according to traditional Chinese medicine. The drug can be used as a hand or foot bath. However, this application is very impractical for the patient, since the bath first has to be prepared in a laborious manner, and the patient can practically do no other things during the application.

The pamphlet KR20100008400A discloses a formulation for treating atopic dermatitis with vinegar. In addition to persimmon vinegar, the formulation contains oil from the seeds of the fragrant evening primrose (Oenothera onorata), wax, tannin, ascorbic acid and vegetable oil, for example lavender oil, rice oil or carrot oil. Contains the dosage form of the formulation KR20100008400A no exact details.

The external treatment of eczema with vegetable oil is, for example, from the publication US8932656B1 known, which describes an oil mixture for the treatment of eczema. Coconut oil is the main ingredient because of its antifungal properties. The oil mixture is liquid, making it difficult for a practitioner to apply and hold it precisely at the treatment site.

The pamphlet DE2654743A1 describes a therapeutic agent for the external treatment of psoriasis, ringworm and eczema with coconut oil, palm kernel oil, laurel oil and an emulsifier, for example wool fat, wool wax alcohol, metal salts, mono- or diglycerides of aliphatic monocarboxylic acids. Contains the dosage form of the formulation DE2654743A1 no exact details.

The pamphlet CN105079214A discloses an emulsion containing sweet almond oil and extracts used in traditional Chinese medicine for the topical treatment of eczema. According to CN105079214A the sweet almond oil has an anti-allergenic, anti-inflammatory, decongestant and pain and irritation-relieving effect. Because the emulsion is liquid, it is difficult for a user to accurately apply and hold it at the treatment site.

The pamphlet DE60217880T2 describes a patch for treating nail fungus comprising a layer for contacting the nail and/or surrounding skin containing an adhesive, a skin and/or nail permeator and sertaconazole as an active ingredient. DE60217880T2 lists a large number of permeation enhancers that allow chemical substances to permeate through the nail. The patch can include additives such as other active ingredients, binders, crosslinkers, plasticizers, solvents, fillers or antioxidants. Due to the large number of ingredients, especially synthetic ones, there is a great risk of undesirable interactions, side effects or allergies when using the patch. These possible dangers are particularly problematic if the plaster is used for self-treatment without specialist medical supervision.

The pamphlets WO9940955A2 and US005753256A also disclose plasters for the treatment of nail fungus with an occlusive backing layer and a matrix layer for contact with the nail, the matrix layer containing an antifungal agent and an adhesive for fixing the matrix layer and optionally a permeation enhancer. The same potential problems arise as with the patch according to FIG DE60217880T2 .

US005464510A describes a patch for treating nail fungus comprising a patch formulation containing salicylic acid or a salt, an ester or a mixture thereof and a carrier. No other active ingredients are described, so the risk of undesirable interactions, side effects or allergies is lower here.

The pamphlet WO2017121831A1 describes a water-in-oil emulsion for the treatment of skin disorders. The emulsion comprises a water phase, an oil phase and an emulsifier system.

The pamphlet DE2654743A1 describes a spreadable therapeutic for the treatment of ringworm and eczema. The therapeutic agent contains coconut oil, palm kernel oil, laurel oil and an emulsifier.

The pamphlet EP1423102B1 describes a patch for the treatment of nail growth disorders having a layer for close contact with the nail comprising an adhesive, a permeation enhancer, an antifungal, and an additive.

The pamphlet US9468596B2 describes a versatile cosmetic composition of non-irritating and non-toxic components for application to the skin to improve health and beauty. The composition contains minerals, oils and emulsifiers as the main ingredients.

The pamphlet US9867774B1 describes a body lotion containing Dead Sea salt to treat dry skin. The lotion is based on organic aloe vera juice to which apple cider vinegar is added, among other things.

Technical task

The object of the invention is to create a preparation for the effective topical treatment, in particular for self-treatment, of skin and/or nail diseases that is easy to produce and easy to use, safe and reliable.

Technical solution

The subject of the present invention provides a preparation that solves the technical problem according to the features of claim 1. The object is also achieved by a plaster according to claim 6. Advantageous configurations emerge from the dependent claims.

Description of execution types

1. a) ein Apfelessig mit einem Anteil an der Zubereitung von 3 % bis 18 %;
2. b) ein Pflanzenöl, insbesondere ein Kokosöl und/oder Mandelöl, mit einem Anteil an der Zubereitung von 80 % bis 90 %, und
3. c) einen Emulgator, insbesondere ein Lecithin, mit einem Anteil an der Zubereitung von 2 % bis 15 %.

A preparation according to the invention is designed for the topical treatment of skin and/or nail diseases and comprises at least the following ingredients:

1. a) an apple cider vinegar with a share in the preparation of 3% to 18%;
2. b) a vegetable oil, in particular a coconut oil and/or almond oil, with a proportion of 80% to 90% in the preparation, and
3. c) an emulsifier, in particular a lecithin, with a proportion of 2% to 15% in the preparation.

The preparation is preferably in the form of a gel, in particular a cream. A gel within the meaning of the invention is a disperse system consisting of at least two components. A solid component forms a spongy, three-dimensional network whose pores are filled with the liquid component. The liquid component is thereby immobilized in the solid component. The liquid component of the preparation is, for example, apple cider vinegar and/or the solid component of the preparation is, for example, vegetable oil, which can be solid at the use temperature of the preparation. If necessary, the vegetable oil can be hardened.

The preparation as a gel has the advantage that it can be applied particularly easily and precisely to the surface to be treated without running beyond it. Furthermore, the gel can remain on the surface to be treated for a longer period of time and form a larger active substance depot there than, for example, a liquid. This enables a particularly safe and effective treatment.

In particular for use in a patch according to the invention, the preparation can be in the form of an emulsion. In a patch, the apple cider vinegar may be immobilized by means other than the solid component of a gel, such as in a reservoir. As an emulsion, the preparation can advantageously be easier to produce and process, in particular for integration into a patch.

The gel can be, for example, a cream, ie a mixture of roughly equal parts oil and apple cider vinegar, or an ointment, ie a mixture with a high proportion of oil and only a small amount of vinegar added. For many patients, creams are more pleasant than ointments because they are absorbed more quickly. In the case of very severe skin dryness, however, they can increase the skin dryness due to the high water content, so that an ointment is preferred in this case.

Experiments have shown that for an apple cider vinegar share of 3% to 18%, in particular 5% to 15%, an emulsifier share of 2% to 15%, especially 8% to 10%, and a vegetable oil share from 80% to 90% of the preparation is a consistency that is particularly advantageous for use tenz and a good effectiveness of the preparation result.

For example, the preparation can consist of 10% apple cider vinegar, 2% lecithin and 88% coconut oil. Such a preparation has a pH of 4.8; forms a homogeneous emulsion at room temperature (approx. 20 °C) and has a solid consistency and a white-yellowish color at refrigerator temperature (approx. 8 °C).

For example, the preparation can consist of 10% apple cider vinegar, 10% lecithin and 80% coconut oil. Such a preparation forms a very smooth emulsion at room temperature and has a firm consistency and a rather yellowish color at refrigerator temperature. A pleasant smell can be achieved by adding lavender oil.

According to the invention, a “nail” is understood to mean a fingernail or toenail of a mammal, in particular a human.

• - Alle Essigarten enthalten immunstärkende Bestandteile, Mineralsalze, Riboflavin, Vitamin B1, und Essigsäure.
• - Essig lindert Juckreiz und Trockenheit der Haut.
• - Apfelessig enthält Milchsäure, Essigsäure und Apfelsäure mit antibakteriellen und antimykotischen Eigenschaften, die trockene Haut und Hautinfektionen bekämpfen und Entzündungen, Juckreiz und Trockenheit lindern.
• - Apfelessig enthält eine Vielzahl essentieller Vitamine und Mineralien wie Pektin, Beta-Carotin und Natrium, Magnesium, Kalium, Kalzium, Eisen, Phosphor, Schwefel und Eisen, die das Immunsystem stärken.
• - Apfelessig enthält Antioxidantien wie Isoflavone und Beta-Carotin, die den Zellerneuerungsprozess der Haut verbessern.
• - Apfelessig ist reich an Kalium, das allergische Reaktionen lindert. Es wirkt auch als natürliches Adstringens, das den pH-Wert der Haut ausgleicht.

Apple cider vinegar has a variety of beneficial properties for treating skin and nail conditions:

• - All types of vinegar contain immune-boosting ingredients, mineral salts, riboflavin, vitamin B1, and acetic acid.
• - Vinegar relieves itching and dryness of the skin.
• - Apple cider vinegar contains lactic, acetic, and malic acids with antibacterial and antifungal properties that fight dry skin and skin infections, reducing inflammation, itching, and dryness.
• - Apple cider vinegar contains a variety of essential vitamins and minerals such as pectin, beta-carotene, and sodium, magnesium, potassium, calcium, iron, phosphorus, sulfur, and iron that help boost the immune system.
• - Apple cider vinegar contains antioxidants such as isoflavones and beta-carotene that improve the skin's cell renewal process.
• - Apple cider vinegar is rich in potassium, which reduces allergic reactions. It also acts as a natural astringent that balances the pH of the skin.

The vegetable oil can prevent possible dehydration of the skin from water contained in the apple cider vinegar and possible damage to the skin from acid contained in the apple cider vinegar. Furthermore, the vegetable oil can mask an odor of the apple cider vinegar that may be unpleasant for a user of the preparation.

In contrast to other antifungal, antibacterial or antiviral active ingredients, apple cider vinegar and vegetable oil are not harmful to health even if accidentally consumed, so they allow the preparation to be used particularly safely, especially for self-treatment.

The emulsifier allows stable mixing of apple cider vinegar and vegetable oil, so that the active ingredients contained in the preparation are evenly distributed, so that a predetermined dose of active ingredient can be reliably applied to the treatment site.

The skin and/or nail diseases can in particular include herpes, fungal diseases, for example skin fungus or nail fungus and/or eczema. Skin fungus is a disease caused by fungi growing on the skin of humans and animals. The most common are skin fungal diseases that affect the horny substance, they are referred to as dermatophytoses. In addition, fungal diseases occur that also affect the deeper layers of the skin. Nail fungus, also known as nail mycosis or onychomycosis, is an infection of the toenails or fingernails caused by dermatophytes, yeasts or molds. Nail fungus is not a serious condition, but it is a common condition. Five to twelve percent of Europeans carry dermatophytes in their nails, and the frequency increases with age.

Eczema is an inflammatory skin disease that manifests itself in a non-infectious inflammatory reaction of the skin. Eczema can be caused by a variety of triggers. They are characterized by a typical sequence of skin reactions (reddening of the skin, formation of blisters, weeping, formation of crusts, scaling).

The vegetable oil may include coconut oil and/or almond oil. Coconut oil has the advantage that it has an antibacterial, antifungal and antiviral effect, especially when combined with apple cider vinegar, and has a pleasant smell. The antibacterial and antiviral effect is based on the lauric acid contained in coconut oil, the antifungal effect on caprylic fatty acid. Furthermore, coconut oil is solid at room temperature, making it easy to create a gel with it. Coconut oil shows a moisturizing effect on the skin and has a cooling effect.

Almond oil has an anti-allergenic, anti-inflammatory, decongestant, pain-relieving and irritation-relieving effect. Almond oil is a very compatible and versatile base oil that is suitable for all skin types, especially sensitive, dry and baby skin. Incorporated into creams Almond oil produces soft, smooth and caring consistencies. Almond oil penetrates well into the skin and lubricates it. This is felt to be particularly soothing for dry skin. Almond oil is therefore considered to be soothing, moisturizing and intensively nourishing. Furthermore, almond oil has a pleasant smell and is solid at room temperature, so that it can be easily formed into a gel.

The vegetable oil can, in particular in addition to the coconut oil and/or almond oil, comprise a lavender oil which can impart a pleasant smell to the preparation.

The emulsifier can be a natural emulsifier and can include, for example, at least one phospholipid, in particular a lecithin. Using a natural emulsifier reduces the risk of allergic reactions. Phospholipids have a moisturizing effect on the skin. In this way, they prevent normal and especially dry skin from drying out after washing. They regulate the pH value of the skin and support the natural protective layer against aggressive environmental influences. Its high content of linoleic and linolenic acid has a positive effect on skin diseases. Lecithins are approved in the EU as a food additive for food with a maximum quantity restriction exclusively for baby food, so that they allow the preparation to be used particularly safely, especially for self-treatment.

According to the invention, the preparation contains no other ingredients apart from the apple cider vinegar, the vegetable oil and the emulsifier. Restricting yourself to these ingredients reduces the risk of unwanted side effects, interactions or allergic reactions, which is particularly beneficial for safe self-treatment.

The preparation advantageously has a weakly acidic to acidic pH. A weakly acidic pH value, in particular in the range from 4 to 6, for example at 4.8, supports the protective acid mantle from secretions of the skin glands, to which a bactericidal effect is ascribed.

A plaster according to the invention is designed for the topical treatment of skin and/or nail diseases, in particular nail fungus. The plaster comprises a reservoir with a contact surface for contact with the surface to be treated, in particular with a nail affected by nail fungus. The contact surface can constitute a physical boundary of the reservoir or at least comprise an opening so that direct contact between a content of the reservoir and the surface to be treated is possible. In the simplest case, the entire contact area is exactly one opening.

Advantageously, the contact surface is shaped in such a way that when the plaster is applied, the contact surface comes into contact only with the surface to be treated and not with an area of skin adjacent to the surface to be treated. In this way, for example, skin irritations caused by a component of the preparation are prevented. In particular, the shape and/or size of the contact surface can be adapted to a fingernail or toenail. The plaster, in particular the contact surface, can be cut to size, so that the user can cut it in shape and size to the surface to be treated, for example using household scissors.

1. a) einem Apfelessig;
2. b) einem Pflanzenöl und
3. c) einem Emulgator,

wobei die Zubereitung einen Apfelessig-Anteil an von 3 % bis 18 % einen Emulgator-Anteil von 2 % bis 15 % und einen Pflanzenöl-Anteil von 80 % bis 90 % enthält, und
wobei die Zubereitung (100) außer dem Apfelessig, dem Pflanzenöl und dem Emulgator keine weiteren Zutaten umfasst.According to the invention, the reservoir contains a preparation for the topical treatment of skin and/or nail diseases with at least the following ingredients:

1. a) an apple cider vinegar;
2. b) a vegetable oil and
3. c) an emulsifier,

wherein the preparation contains an apple cider vinegar content of 3% to 18%, an emulsifier content of 2% to 15% and a vegetable oil content of 80% to 90%, and
wherein the preparation (100) comprises no further ingredients apart from the apple cider vinegar, the vegetable oil and the emulsifier.

The preparation can in particular have one or more of the features of the preparation according to the invention described above, which results in the effects disclosed there.

The reservoir can include at least one cavity and/or at least one filler for receiving the preparation. The filler can advantageously be adhesive to the surface to be treated. As a result, the patch can be securely fixed to the surface to be treated, in particular without an additional adhesive being necessary for this purpose. The filler can, for example, a polymer matrix, in particular according to US5753256A (col. 2, lines 6 - 41: "adhesive matrix"), DE602117880T2 (Paragraph [0054][0056]: "Adhesive"), WO9940955A2 (p. 7, line 30 - p. 8, line 4: "pressure sensitive adhesives") or US5464610A (col. 3, lines 33-55: "plaster").

Since active ingredients can only penetrate the nail slowly in the treatment of nail fungus, it is particularly advantageous if an active substance depot, for example the preparation in the reservoir, is fixed on the nail affected by nail fungus over a longer period of time, for example several hours or a day.

The preparation in the patch can be designed as a gel, in particular as the preparation according to the invention designed as a gel. The preparation designed as a gel has the particular advantage that no filler is required to hold the preparation. In particular if direct contact of the preparation with the surface to be treated is possible, for example through a contact surface formed with at least one opening, this results in an unhindered and thus particularly accurately and reliably predictable release of active substance to the surface to be treated.

The patch may comprise an adhesive surface connected to the reservoir for sticking to the surface to be treated and/or an area of skin adjacent to the surface to be treated. In particular, when neither the preparation nor a filler is adhesive to the surface to be treated, the adhesive surface can securely fix the plaster. Since the surface to be treated may be sensitive to the adhesion of the patch, it may be advantageous if the adhesion surface is spaced from the contact surface. For example, the contact surface can be designed for contact with a nail and the adhesive surface for adhesion to the skin surrounding the nail.

The patch can comprise a protective layer encasing the reservoir at least on a side facing away from the surface to be treated and/or a side facing a skin area adjacent to the surface to be treated. The protective layer is impermeable at least for the preparation, in particular for the components of the preparation, at least for a typical period of use of the patch of, for example, a few hours or a day. The protective layer prevents an uncontrolled release of active ingredients to areas outside the surface to be treated. In particular, this avoids possible skin irritations outside the surface to be treated.

Advantageously, the protective layer is oxygen-tight for the typical period of use of the patch. As a result, oxygen necessary for the growth of aerobic fungi can be kept from the surface to be treated, so that the growth of the fungus is inhibited.

The protective layer can, for example, according to DE602117880T2 (Section [0014][0015]: “occlusive backing layer” or Section [0024]: “layer”).

The patch can comprise a covering of the contact surface that is detachable, in particular in sections, and impermeable to the preparation for a typical application period of, for example, a few hours or a day. The cover can, for example, comprise a film that is self-adhesive, in particular on both sides. The cover is advantageously divided into a number of sections, for example rectangular sections, which can be detached individually from the contact surface. As a result, a user can remove precisely those sections whose removal exposes an area of the contact surface which corresponds in shape and size to the surface to be treated, for example a nail. This ensures that active ingredients from the preparation reach the surface to be treated with pinpoint accuracy and not an adjacent skin area that may be sensitive to the active ingredients.

The reservoir can have a transport layer on the contact surface for the controlled transport of at least one component of the preparation from the reservoir to the surface to be treated. The transport layer can ensure an even release of the active substance, in particular over the typical period of use of the patch, so that an effective treatment takes place without overdosing or underdosing the active substance. The transport layer may comprise a material with a preset conductivity for the ingredient, for example apple cider vinegar. The conductivity can be set, for example, by a density of the material or a number of channels for the component.

All features disclosed in the application documents are claimed to be essential to the invention, provided they are new compared to the prior art, either individually or in combination.

character list

Further advantages, aims and properties of the invention are explained on the basis of the following description and attached drawings, in which objects according to the invention are shown by way of example. Features that at least essentially correspond in terms of their function in the figures can be identified with the same reference numbers, although these features do not have to be numbered and explained in all figures.

• [1] eine schematische Darstellung eines erfindungsgemäßen Pflasters und
• [2] eine schematische Darstellung eines weiteren erfindungsgemäßen Pflasters.

Show it:

• [ 1 ] a schematic representation of a patch according to the invention and
• [ 2 ] a schematic representation of a further plaster according to the invention.

Fig.1

[ 1 ] shows a schematic representation of a plaster 200 according to the invention. The plaster 200 shown comprises a reservoir 210 with a preparation 100 for the topical treatment of skin and/or nail diseases, for example nail fungus. The preparation 100 contains at least apple cider vinegar, a vegetable oil, for example coconut oil, and an emulsifier, for example a lecithin. The preparation 100 can be designed as a gel, for example, or immobilized in a polymer matrix (not shown) of the reservoir 210 .

The reservoir includes a contact surface 211, in the simplest case an opening, for contact with a surface to be treated O, for example a nail N. Active ingredients from the preparation can reach the surface to be treated O via the contact surface 211, in order to be there or in under the Surface O lying tissue, especially the nail N to act.

The contact surface 211 can serve as an adhesive surface for adhering the plaster 200 to the surface O to be treated. For this purpose, for example, the preparation 100 or the polymer matrix can be designed to be adhesive on the surface O.

Fig.2

[ 2 ] shows a schematic representation of another patch 200 according to the invention. In addition to the in 1 illustrated features, the plaster 200 can have the following features:

The reservoir 210 can be encased by a protective layer 230 that is impermeable to the preparation 100, in particular on its sides facing away from the surface O to be treated (top, right and left in the illustration).

The contact surface 211 can be covered by a cover 250, for example a self-adhesive film. The cover 250 can extend beyond the contact surface 211 , for example up to the protective layer 230 . The cover 250 can be detached from the contact surface 211, advantageously in sections, so that a region of the contact surface 211, which in particular corresponds in shape and size to the surface O to be treated, can be uncovered.

For example, an adhesive surface 220 for adhering the patch 200 to a skin area H surrounding the surface O to be treated can be provided on the protective layer 230 .

The reservoir 210 can comprise a transport layer 240 on the contact surface 211 for the controlled transport of at least one component of the preparation 100 to the surface O to be treated. The transport layer 240 may include a number of channels (not shown) with a preset fluid conductivity for the ingredient, such as apple cider vinegar.

Reference List

100

preparation

200

Pavement

210

reservoir

211

contact surface

220

adhesive surface

230

protective layer

240

transport layer

250

cover

H

skin area

N

nail

O

surface to be treated

Claims (10)

Preparation (100) as a gel for the topical treatment of skin and/or nail diseases with at least the following ingredients: a) an apple cider vinegar; b) a vegetable oil and c) an emulsifier, wherein the preparation contains an apple cider vinegar content of 3% to 18%, an emulsifier content of 2% to 15% and a vegetable oil content of 80% to 90%, and wherein the preparation (100) comprises no further ingredients apart from the apple cider vinegar, the vegetable oil and the emulsifier. Preparation (100) after claim 1 , characterized in that the skin and/or nail diseases include fungal diseases and/or eczema. Preparation (100) according to one of Claims 1 until 2 , characterized in that the vegetable oil comprises a coconut oil. Preparation (100) according to one of Claims 1 until 3 , characterized in that the emulsifier is a natural emulsifier. Preparation (100) according to one of Claims 1 until 4 , characterized in that the preparation (100) has a weakly acidic pH. Plaster (200) for the topical treatment of skin and/or nail diseases with a reservoir (210) with a contact surface (211) for contact with a surface (O) to be treated, characterized in that the reservoir (210) contains a preparation (100) for the topical treatment of skin and/or nail diseases with at least the following ingredients: a) an apple cider vinegar; b) a vegetable oil and c) an emulsifier, wherein the preparation contains an apple cider vinegar content of 3% to 18%, an emulsifier content of 2% to 15% and a vegetable oil content of 80% to 90%, and wherein the Preparation (100) does not include any ingredients other than apple cider vinegar, vegetable oil and emulsifier. Plaster (200) after claim 6 , characterized in that the preparation (100) as a gel according to one of Claims 1 until 6 is trained. Plaster (200) after one of the Claims 6 until 7 , characterized by a protective layer (H) enveloping the reservoir (210) at least on a side facing away from the surface (O) to be treated and/or facing a skin region (H) adjoining the surface (O) to be treated and impermeable to the preparation (100) 230). Plaster (200) after one of the Claims 6 until 8th , characterized by a detachable and for the preparation (100) impermeable cover (250) of the contact surface (211). Plaster (200) after one of the Claims 6 until 9 , characterized in that the reservoir (210) on the contact surface (211) comprises a transport layer (240) for the controlled transport of at least one component of the preparation from the reservoir (210) to the surface (O) to be treated.

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