Patent Description:
Skin inflammation is a problem that can be caused by various factors, such as environmental factors, allergies, irritants, medical conditions, stress, and genetics. It is a common condition characterised by redness, itching, swelling, and a burning sensation on the surface of the skin or mouth. Preventing oral inflammation is critical to maintaining oral health and avoiding oral problems such as lichen planus, an autoimmune disease that affects the lining of the mouth and can lead to painful lesions and discomfort. In addition, it is essential to take care of the skin and take measures to prevent autoimmune lesions at a cutaneous and systemic level (such as psoriasis, atopic dermatitis, itching, vitiligo and cancer prevention) and other processes.

Existing technology to treat inflammation in the skin includes creams, lotions, ointments or mouthwashes containing topical corticosteroids, antihistamines, mouthwashes with special solutions and other active ingredients. However, these treatments often have unwanted side effects and are not effective for everyone. Some medications, such as certain antibiotics, non-steroidal anti-inflammatory drugs, and hypertension medications, can also trigger or aggravate the disease in certain individuals.

In addition, the use of natural ingredients in the formulation of products to treat skin inflammation has been investigated. For example, aloe vera and calendula have been shown to have anti-inflammatory and soothing properties that can help reduce skin inflammation. However, these natural ingredients are often unstable and may lose their effectiveness in the manufacturing and/or application process.

In short, adequate prevention of skin inflammation at a systemic or local level in the mouth and skin protection are crucial measures to avoid neoplastic skin in addition to preventing autoimmune disorders in the body. Accordingly, there is an unmet need for an effective and safe composition for treating irritation that does not have unwanted side effects and that contains stable and effective natural ingredients.

Several compositions containing magnesium are known in the prior art. For example, <CIT> discloses a topical composition consisting of carboxylic acids, chelating agents, dimethyl sulfone, and magnesium sulphate, which serves as a base for the application of medications and active ingredients. Additionally, <CIT> discloses compositions that include magnesium, various non-magnesium salts, and plant extracts. However, these compositions are designed for oral cosmetic use due to their remineralizing properties, which restore tooth enamel and reduce tooth sensitivity.

Similarly, there are cosmetic products for skin care that contain magnesium salts, variousnon-magnesium salts, plant extracts, and antioxidants, such as GIGOT's facial mask "Instant mask mascarilla facial fango verde con alga espirulina. " However, these products are intended for daily skin care and not for the treatment of skin inflammation or irritation.

The present invention meets this need by the formulation of an innovative composition utilising safe, natural active ingredients that have been shown to be effective in treating inflammation occurring in the skin.

The present invention resolves the aforementioned drawbacks by means of a composition comprising at least one magnesium salt among other natural ingredients.

The first aspect of the invention relates to a topical anti-inflammatory composition for use in a treatment of skin inflammation characterised in that it comprises at least one magnesium salt, at least one salt not comprising magnesium, at least one antioxidant, and at least one plant extract, wherein the at least one salt not comprising magnesium is a mixture of sodium chloride, sodium fluoride and potassium chloride.

The combination of compounds of the composition results in an increase in anti-inflammatory efficacy. Thus, in general, the resulting formulations of the present invention allow eliminating from the composition the aggressive substances such as corticosteroids, antibiotics, enhancing, surprisingly, by a synergistic effect, the anti-inflammatory effect of the compounds of the composition at low concentrations.

<FIG> shows the evolution in the affected skin area before (1A, 1C) and after (1B, 1D) treatment with the composition object of the invention.

The first aspect of the invention relates to a topical anti-inflammatory composition for use in a treatment of skin inflammation characterised in that it comprises at least one magnesium salt, at least one salt not comprising magnesium, at least one antioxidant, and at least one plant extract, wherein the at least one salt not comprising magnesium is a mixture of sodium chloride, sodium fluoride and potassium chloride. Preferably, the composition of the invention is an aqueous composition, although it may also be formulated as an alcoholic composition. The term "aqueous composition" refers to a composition containing water as the main solvent. In particular, the compositions of the invention comprise at least <NUM>% by weight of water, preferably at least <NUM>% by weight of water in relation to the composition, more preferably <NUM>% by weight of water in relation to the composition. The term "alcoholic composition" relates to a composition containing an alcohol as a solvent, e.g., ethanol. In particular, the alcoholic compositions of the invention comprise at least <NUM>% by weight of alcohol. Unless otherwise indicated, all percentages refer to percentages by weight with respect to the composition.

In a preferred embodiment of the first aspect of the invention, the at least one magnesium salt is selected from organic, inorganic magnesium salts or mixtures thereof. The inorganic magnesium salts are selected from those salts having a high solubility in water, such as halides or sulphates. It is preferably selected from the group of magnesium sulphate, magnesium chloride, magnesium bromide or mixtures thereof. In a preferred embodiment the magnesium salt is magnesium sulphate. The organic magnesium salts are selected from those salts having a high solubility in water, such as, for example, citrates, aspartates or lactates.

In a preferred embodiment of the first aspect of the invention, the composition comprises between <NUM> and <NUM>% by weight with respect to the composition of at least one salt comprising magnesium. Preferably between <NUM> and <NUM>% by weight with respect to the composition.

In a preferred embodiment of the first aspect of the invention, the composition comprises between <NUM> and <NUM>% by weight with respect to the composition of at least one salt not comprising magnesium. Preferably between <NUM> and <NUM>% by weight with respect to the composition.

In a preferred embodiment of the first aspect of the invention, the composition comprises at least one plant extract selected from solid plant extracts or glycolic plant extracts, or a mixture thereof. The term "glycolic plant extract" refers to the form of botanical extract in which propylene glycol-based solvents are used to obtain the active compounds from plants.

In a preferred embodiment of the first aspect of the invention, the composition comprises between <NUM> and <NUM>% by weight in relation to the composition of at least one plant extract. Preferably between <NUM> and <NUM>% by weight in relation to the composition.

In a preferred embodiment, the solid plant extract is selected from the group of rosemary dry extract, fermented papaya extract, green tea extract, thyme dry extract, chamomile dry extract, lemon balm dry extract, witch hazel dry extract, ginseng dry extract, ginkgo biloba dry extract and hypericum dry extract or mixtures thereof. The preferred solid plant extract is a mixture of rosemary dry extract, fermented papaya extract, green tea extract.

In a preferred embodiment, the glycolic plant extract is selected from the group of chamomile glycolic extract, oat glycolic extract, sage glycolic extract, centella asiatica glycolic extract, birch glycolic extract, flowering calendula glycolic extract, melilot glycolic extract, white nettle glycolic extract, green nettle glycolic extract and horse chestnut glycolic extract or mixtures thereof. The preferred glycolic plant extract is a chamomile glycolic extract.

In an even more preferred embodiment, the composition comprises rosemary dry extract, fermented papaya extract, green tea extract, and chamomile glycolic extract.

In a preferred embodiment of the first aspect of the invention, the composition comprises at least one antioxidant selected from the group of ferulic acid, nicotinamide, zinc gluconate, melatonin, resveratrol, vitamin C (ascorbic acid), dimethylethanolamine (DMAE), glycolic acid and coenzyme Q, lipoic acid, quercetin, curcumin, ascorbic palmitate, taurine, isoflavones, lycopene, vitamin E, L-carnosine, or mixtures thereof. Preferably, the at least one antioxidant is a mixture of ferulic acid, nicotinamide, zinc gluconate, melatonin, and resveratrol.

Ferulic acid is a natural antioxidant found in various plants, especially in grains such as rice, wheat and oats, as well as in some fruits and vegetables. It is known for its antioxidant and anti-inflammatory properties, making it a valuable component in skin care products and dietary supplements. Helps protect the skin from damage caused by free radicals and contributes to the prevention of premature ageing of the skin
Nicotinamide, also known as vitamin B3 or niacinamide, is a form of water-soluble vitamin B. It plays an essential role in cellular metabolism and has anti-inflammatory properties and the ability to help improve skin tone, reduce the appearance of dark spots and minimise enlarged pores. In addition, it contributes to maintaining the protective barrier of the skin and adequate hydration.

Zinc gluconate is a zinc salt that is frequently used as a nutritional supplement and is also found in skin care products. Zinc is an essential trace element for the functioning of the body, including the maintenance of the immune system and cell regeneration. In skin care, zinc gluconate can help regulate sebum production, reduce inflammation, and promote wound healing.

Melatonin, also known as N-acetyl-<NUM>-methoxytryptamine, is a hormone found in higher animals and some algae. In the skin, melatonin plays a crucial role as a free radical scavenger. It increases the activity of enzymes responsible for metabolising free radicals and, in addition, is able to oxidise to eliminate them without producing a redox cycle, which has led it to be called a "suicide antioxidant".

Resveratrol is a polyphenolic compound found in some plants, especially in the skin of red grapes, and also in red wine. It has antioxidant and anti-inflammatory properties that may be beneficial for cardiovascular health and skin. It has been studied for its possible effects in reducing cellular ageing and in protecting against damage caused by free radicals.

By combining the different antioxidants, the synergistic effect of the composition is enhanced, thus achieving a greater benefit for the skin or the body's antioxidant system.

In a preferred embodiment of the first aspect of the invention, the composition comprises between <NUM> and <NUM>% by weight relative to the aqueous composition of at least one antioxidant. Preferably between <NUM> and <NUM>% by weight in relation to the composition.

In the most preferred embodiment the composition comprises:.

The compositions of the examples can be completed with variable amounts of other substances, such as, for example, preservatives, antioxidants, pigments, thickeners, or active ingredients, according to the intended use of the composition.

In other preferred embodiments of the composition, it is in the form of gel, cream, or lotion.

The method of preparing a composition for use in a treatment of skin according to the first aspect comprises the following steps:.

The use of the composition according to the first aspect of the invention is a therapeutic use for the treatment of inflammation in the skin, for example, in the treatment of dermatitis, atopic dermatitis, vitiligo, psoriasis or pruritus.

In a preferred embodiment, the treatment of the affected area of the skin is carried out by immersing the affected area in the composition of the first aspect for a certain period of time.

In another preferred embodiment, the treatment of the affected area of the skin is carried out by spraying the affected area with the composition of the first aspect.

In another preferred embodiment, the treatment of the affected area of the skin is carried out by applying the composition in gel, cream or cream-gel format of the first aspect to the affected area.

In each case and for each patient, the doctor will assess - with the appropriate periodicity - the possible presence and intensity of the pathologies, and will formulate the composition and its application depending on one or the other.

With the compositions of the present invention, inflammation is controlled without the need to abuse substances with side effects, such as antibiotics or corticosteroids, by surprisingly enhancing the effect of the components of the composition of the invention present at low concentrations.

The preferred embodiment of the invention is detailed below, by way of non-limiting example.

The process for preparing the aqueous composition of the invention comprises the following steps:.

As indicated, the amount of water may vary depending on the area to be treated: if total immersion is required, <NUM> (a bathtub) will be prepared, if partial immersion is required, <NUM> (a basin), <NUM> (a bidet) or <NUM> (a basin) of the composition of the invention will be prepared.

In addition to the application of this composition in bathtubs and/or showers, it can also be applied through a vaporiser spray.

Other preferred embodiments of the invention are detailed below, by way of non-limiting example. In particular, example <NUM> corresponds to a preparation in cream-gel format, example <NUM> to a preparation in gel format and <NUM> to a composition in cream format.

The composition of the invention, in particular that prepared according to example <NUM>, is applied to patients by total immersion of the patient or the patient's area for at least <NUM> minutes. The results of the treatment can be seen in <FIG> and <NUM> where the before (1A, 1C) and after (1B, 1D) treatment with the compositions of the invention can be observed. As can be seen in the figure, the decrease in inflammation is remarkable.

Claim 1:
A topical anti-inflammatory composition for use in a treatment of skin inflammation, characterised in that it comprises at least one magnesium salt, at least one salt not comprising magnesium, at least one antioxidant, and at least one plant extract, wherein the at least one salt not comprising magnesium is a mixture of sodium chloride, sodium fluoride, and potassium chloride.