Magnesium salts composition

Abstract

The present invention relates to a composition, 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. The composition of the invention is intended for the treatment of skin inflammation conditions.

Description

[0001] DESCRIPTION

[0002] COMPOSITION OF MAGNESIUM SALTS

[0003] Technical field of the invention

[0004] The present invention relates to a composition characterized in that it comprises at least one magnesium salt, at least one salt that does not contain magnesium, at least one antioxidant, and at least one plant extract. The composition of the invention is intended for the treatment of inflammation, particularly inflammation of the skin, for example: dermatitis, atopic dermatitis, vitiligo, psoriasis, or pruritus, and combinations of the foregoing.

[0005] Background of the invention

[0006] Skin inflammation is a problem that can be caused by many factors, including environmental factors, allergies, irritants, medical conditions, stress, and genetics. It is a common condition characterized by redness, itching, swelling, and a burning sensation on the skin's surface. Furthermore, it is essential to take care of your skin and take measures to prevent autoimmune lesions at the cutaneous and systemic levels (such as psoriasis, atopic dermatitis, itching, vitiligo, and cancer prevention) and other processes.

[0007] Existing technology for treating skin inflammation includes creams, lotions, or ointments containing topical corticosteroids, antihistamines, and other active ingredients. However, these treatments often have unwanted side effects and are not effective for everyone. Some medications, such as certain antibiotics, nonsteroidal anti-inflammatory drugs, and blood pressure medications, can also trigger or aggravate the disease in certain individuals.

[0008] Furthermore, 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 may help reduce skin inflammation. However, these natural ingredients are often unstable and may lose their effectiveness during the manufacturing and / or application process. In summary, adequate prevention of skin inflammation at the systemic or local level and skin protection are crucial measures to avoid neoplastic lesions in the skin and oral cavity, as well as to prevent autoimmune disorders in the body. Consequently, there is an unmet need for an effective and safe composition to treat irritation that is free of unwanted side effects and contains stable and effective natural ingredients.

[0009] Various compositions comprising magnesium are known in the prior art. For example, document US2008 / 038219 A1 discloses a topical composition composed of carboxylic acids, chelating agents, dimethylsulfone, and magnesium sulfate, which serves as a base for the application of medicaments and active ingredients. Furthermore, document WO 2020 / 095099 discloses compositions comprising magnesium, as well as various plant salts and extracts. However, these compositions are intended for oral cosmetic use due to their remineralizing activity, which restores tooth enamel and reduces tooth sensitivity.

[0010] There are also cosmetic skin care products that contain magnesium salts, non-magnesium salts, plant extracts, and antioxidants, such as face masks. However, these products are not intended to treat skin inflammation and / or irritation, but rather for daily skin care.

[0011] The present invention meets this need by formulating an innovative composition that utilizes safe, natural active ingredients that have been proven effective in treating inflammation that occurs in the skin.

[0012] Summary description of the invention

[0013] The present invention solves the aforementioned drawbacks by means of a composition comprising at least one magnesium salt among other natural ingredients.

[0014] The first aspect of the invention relates to a composition characterized in that it comprises at least one magnesium salt, at least one salt that does not contain magnesium, at least one antioxidant, and at least one plant extract. The combination of compounds in the composition results in an increase in anti-inflammatory efficacy. Thus, in general, the formulations resulting from the present invention make it possible to eliminate aggressive substances such as corticosteroids and antibiotics from the composition, surprisingly enhancing, through a synergistic effect, the anti-inflammatory effect of the compounds in the composition at low concentrations.

[0015] The second aspect of the invention relates to the process for preparing the composition according to the first aspect.

[0016] The third aspect of the invention relates to the use of the composition of the first aspect in a treatment of skin inflammation, for example, in the treatment of dermatitis, atopic dermatitis, vitiligo, psoriasis or pruritus.

[0017] Brief description of the figures

[0018] Figure 1 shows the evolution in the affected skin area before (1A, 1C) and after (1B, 1D) treatment with the composition object of the invention.

[0019] Figure 2 shows a comparison of the SCORAD, DLQI, EASI, POEM, PRURITO, and VLG-AD values, measured on two occasions: the first before treatment and the second 15 days after applying the composition. These values ​​are compared between the compositions of the invention (white) and those known in the prior art (black).

[0020] Detailed description of the invention

[0021] The first aspect of the invention relates to a composition characterized in that it comprises at least one magnesium salt, at least one salt that does not comprise magnesium, at least one antioxidant, and at least one plant extract. Preferably, the composition of the invention is an aqueous composition, although it can 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 95% by weight of water, preferably at least 98% by weight of water relative to the composition, more preferably 99% by weight of water relative to the composition. The term "alcoholic composition" refers to a composition containing an alcohol as the solvent, for example, ethanol. In particular, the alcoholic compositions of the invention comprise at least 10% by weight of alcohol.Unless otherwise stated, all percentages refer to percentages by weight relative to the composition.

[0022] In a preferred embodiment of the first aspect of the invention, the at least one magnesium salt is selected from organic or inorganic magnesium salts, or mixtures thereof. The inorganic magnesium salts are selected from those salts that have high solubility in water, such as halides or sulfates. Preferably, it is selected from the group consisting of magnesium sulfate, magnesium chloride, magnesium bromide, magnesium oxide, or mixtures thereof. In a preferred embodiment, the magnesium salt is magnesium sulfate. In another preferred embodiment, the magnesium salt is a mixture of magnesium sulfate and magnesium chloride. The organic magnesium salts are selected from those salts that have high solubility in water, such as, for example, citrates, aspartates, or lactates.

[0023] In a preferred embodiment of the first aspect of the invention, the composition comprises between 0.01 and 3% by weight of at least one salt containing magnesium. Preferably, between 0.01 and 2% by weight of the composition.

[0024] In a preferred embodiment of the first aspect of the invention, the at least one salt that does not comprise magnesium is selected from the group of inorganic salts with high solubility comprising halides, borates, sulfates, carbonates and bicarbonates in combination with sodium, calcium, potassium, chlorine and sulfur. In particular, the salts are selected from the group of sodium chloride, sodium fluoride, potassium chloride, sodium sulfate, calcium chloride, sodium bicarbonate, sodium bromide, strontium chloride, sodium borate, ferric chloride or mixtures thereof. In a preferred embodiment, the salt that does not comprise magnesium is a mixture of sodium chloride, sodium fluoride and potassium chloride. In another preferred embodiment, the salt that does not comprise magnesium is a mixture of sodium chloride, sodium fluoride, potassium chloride and ferric chloride.

[0025] In a preferred embodiment of the first aspect of the invention, the composition comprises between 0.01 and 3% by weight relative to the composition of at least one salt that does not comprise magnesium. Preferably between 0.01 and 2.5% by weight relative 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 solvents based on propylene glycol or ethylene glycol are used to obtain the active compounds of the plants, that is, a solution of propylene glycol or ethylene glycol containing the active ingredients extracted from the plant.

[0026] In a preferred embodiment of the first aspect of the invention, the composition comprises between 0.01 and 0.1% by weight relative to the composition of at least one plant extract. Preferably, between 0.01 and 0.05% by weight relative to the composition.

[0027] In a preferred embodiment, the solid plant extract is selected from the group consisting of rosemary dry extract, fermented papaya extract, green tea extract, thyme dry extract, chamomile dry extract, lemon balm dry extract, witch hazel dry extract, ginkseng dry extract, ginkgo biloba dry extract, St. John's wort dry extract, turmeric dry extract, or mixtures thereof. The preferred solid plant extract is a mixture of rosemary dry extract, fermented papaya extract, and green tea extract. The term "dry extract" refers to a plant extract in powder or solid form.

[0028] In a preferred embodiment, the glycolic plant extract is selected from the group consisting of chamomile glycolic extract, oat glycolic extract, sage glycolic extract, centella asiatica glycolic extract, birch glycolic extract, flowering calendula glycolic extract, sweet clover glycolic extract, white nettle glycolic extract, green nettle glycolic extract, horse chestnut glycolic extract, or mixtures thereof. The preferred glycolic plant extract is a mixture of chamomile glycolic extract, oat glycolic extract, and sage glycolic extract.

[0029] In an even more preferred embodiment, the composition comprises rosemary dry extract, fermented papaya extract, green tea extract, chamomile glycolic extract, oat glycolic extract, and sage glycolic extract.

[0030] 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, iron 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.

[0031] Ferulic acid is a natural antioxidant found in various plants, especially grains such as rice, wheat, and oats, as well as 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. It helps protect the skin from free radical damage and contributes to the prevention of premature skin aging.

[0032] Nicotinamide, also known as vitamin B3 or niacinamide, is a water-soluble form of B vitamin. 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 minimize enlarged pores. It also helps maintain the skin's protective barrier and maintain proper hydration.

[0033] Zinc gluconate is a zinc salt frequently used as a nutritional supplement and also found in skin care products. Zinc is a trace mineral essential for body function, including maintaining the immune system and cell regeneration. In skin care, zinc gluconate can help regulate sebum production, reduce inflammation, and promote wound healing.

[0034] Melatonin, also known as N-acetyl-5-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 metabolizing free radicals and is also capable of oxidizing to eliminate them without producing a redox cycle, leading it to be called a "suicide antioxidant."

[0035] Resveratrol is a polyphenolic compound found in some plants, especially the skin of red grapes and also in red wine. It has antioxidant and anti-inflammatory properties that may be beneficial for cardiovascular and skin health. It has been studied for its potential effects on reducing cellular aging and protecting against damage caused by free radicals.

[0036] By combining different antioxidants, the synergistic effect of the composition is enhanced, thus achieving greater benefits for the skin or the body's antioxidant system.

[0037] In a preferred embodiment of the first aspect of the invention, the composition comprises between 0.01 and 1% by weight relative to the aqueous composition of at least one antioxidant. Preferably, between 0.01 and 0.1% by weight relative to the composition of at least one antioxidant. Even more preferably, between 0.01 and 0.05% by weight relative to the composition.

[0038] In the most preferred embodiment the composition comprises:

[0039] 0.1 and 1% by weight relative to the composition of magnesium sulfate;

[0040] 0.1 and 1% by weight relative to the composition of sodium chloride, sodium fluoride and potassium chloride;

[0041] 0.01 and 0.1% by weight relative to the composition of rosemary dry extract, fermented papaya extract, green tea extract and chamomile glycolic extract; and

[0042] 0.01 and 0.1% by weight relative to the composition of ferulic acid, nicotinamide, zinc gluconate, melatonin, and resveratrol.

[0043] In another more preferred embodiment the composition comprises:

[0044] 0.1 and 1% by weight relative to the composition of magnesium sulfate;

[0045] 0.1 and 1% by weight relative to the composition of sodium chloride, sodium fluoride and potassium chloride;

[0046] 0.01 and 0.1% by weight relative to the composition of rosemary dry extract, fermented papaya extract, green tea extract and chamomile glycolic extract; and

[0047] 0.01 and 0.1% by weight relative to the composition of ferulic acid, nicotinamide, zinc gluconate, melatonin, and resveratrol.

[0048] In another more preferred embodiment the composition comprises:

[0049] 0.1 to 3% by weight relative to the composition of magnesium sulfate and magnesium chloride; 0.1 to 3% by weight relative to the composition of sodium chloride, sodium fluoride, and potassium chloride;

[0050] 0.01 and 0.1% by weight relative to the composition of rosemary dry extract, fermented papaya extract, green tea extract, chamomile glycolic extract, oat glycolic extract and sage glycolic extract;

[0051] 0.01 and 0.1% by weight relative to the composition of ferulic acid, nicotinamide, zinc gluconate, melatonin, and resveratrol.

[0052] In another more preferred embodiment the composition comprises:

[0053] 0.1 and 3% by weight relative to the composition of magnesium sulfate and magnesium chloride;

[0054] 0.1 and 3% by weight relative to the composition of sodium chloride, sodium fluoride and potassium chloride;

[0055] 0.01 and 1% by weight relative to the composition of rosemary dry extract, fermented papaya extract, green tea extract, chamomile glycolic extract, oat glycolic extract and sage glycolic extract;

[0056] 0.01 and 1% by weight relative to the composition of ferulic acid, nicotinamide, zinc gluconate, melatonin, and resveratrol.

[0057] The compositions of the examples can be completed with varying amounts of other substances, such as, for example, preservatives, pigments, thickeners, flavorings or active ingredients, depending on the intended use of the composition.

[0058] In other preferred embodiments of the composition, it additionally comprises at least one element selected from rosehip oil, jojoba oil, calendula oil, shea butter, medium chain triglycerides (esters of medium chain fatty acids (between 8 and 12 carbon atoms) and glycerol (1,2,3-propanetriol)), dimethicone, glycerin, dexpentanol, urea, hyaluronic acid, enoxolone, lanolin or mixtures thereof. The inclusion of one or more of these components reinforces the anti-inflammatory, antiviral and antimicrobial properties of the composition. For example, jojoba oil or medium chain triglycerides provide these qualities, while dimethicone or glycerin improve their moisturizing and healing capabilities, among others.

[0059] In other preferred embodiments, the composition is in any pharmacologically acceptable form for topical application, for example, in the form of an aqueous composition, an alcoholic composition, a gel, a cream, a cream-gel, or a lotion. The second aspect of the invention relates to a method for preparing the composition of the first aspect of the invention.

[0060] In the preferred embodiment of the second aspect, the method for preparing a composition according to the first aspect comprises the following steps: a) Providing the desired amount of solvent; b) Adding at least one magnesium salt and at least one salt that does not comprise magnesium to the solvent of the previous step; c) Adding at least one antioxidant and at least one plant extract to the mixture of the previous step. d) Optionally, adding excipients such as preservatives, antioxidants, pigments, thickeners, flavorings or active ingredients, depending on the intended use of the composition.

[0061] The third aspect of the invention relates to the use of the composition of the first aspect for the treatment of inflammation.

[0062] In an embodiment of the third aspect of the invention, the use of the composition according to the first aspect of the invention is a therapeutic use for the treatment and / or prevention of inflammation in skin, for example, in the treatment of dermatitis, atopic dermatitis, vitiligo, psoriasis or pruritus.

[0063] In a preferred embodiment of the third aspect of the invention, 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 determined period of time.

[0064] In another preferred embodiment of the third aspect of the invention, the treatment of the affected area of ​​the skin is carried out by spraying the affected area with the composition of the first aspect.

[0065] In another preferred embodiment of the third aspect of the invention, 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 physician will assess—with the appropriate frequency—the possible presence and intensity of the pathologies, and will formulate the composition and its application based on each one. The compositions of the present invention control inflammation 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. Examples

[0066] Example 1: Preparation of the aqueous composition of the invention.

[0067] 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: a) Providing the necessary amount of water according to the area of ​​the skin to be treated; b) Adding magnesium sulfate, sodium chloride, sodium fluoride, potassium chloride, ferulic acid, nicotinamide, zinc gluconate, rosemary dry extract, fermented papaya extract, and green tea extract to the water from the previous step; c) Adding melatonin, resveratrol, and chamomile glycolic extract to the solution from the previous step.

[0068] As indicated, the amount of water may vary depending on the area to be treated: if total immersion is required, 100L (a bathtub) will be prepared; if partial immersion is required, 50L (a basin), 10L (a bidet) or 5 liters (a basin) of the composition of the invention will be prepared.

[0069] In addition to applying this composition in bathtubs and / or showers, it can also be applied via vaporizer spray.

[0070] Example 2: Preparation of the composition of the invention - qel, cream or qel-cream.

[0071] Other preferred embodiments of the invention are detailed below, by way of non-limiting example. In particular, Example 2.1 corresponds to a preparation in cream-gel format, Example 2.2 to a preparation in gel format, and Example 2.3 to a composition in cream format.

[0072] Example 3: Treatment of the skin by applying the composition of the invention.

[0073] The composition of the invention, particularly that prepared according to Example 1, is applied to patients by fully immersing the patient or the patient area for at least 20 minutes. The results of the treatment can be seen in Figures 1 and 2, where the before (1A, 1C) and after (1B, 1D) of treatment with the compositions of the invention can be seen. As can be seen in the figure, the decrease in inflammation is notable.

[0074] Alternatively, the compositions of the invention may be applied by spraying onto the area to be treated. Other forms of the composition, Examples 2.1-2.3, are formulated so that they can be applied directly to the desired area without the need to submerge the affected area. The results obtained are comparable to those obtained with the treatment of the composition of Example 1. of the invention

[0075] The effectiveness of the compositions known in the state of the art, see US2008 / 038219 A1 table 1, was compared against the compositions of the invention, with special emphasis on example 2.

[0076] The parameters compared were the following:

[0077] • SCORAD (Scoring Atopic Dermatitis): SCORAD is a clinical tool used to assess the severity of atopic dermatitis (eczema). It considers the extent and intensity of the rash, as well as other symptoms such as itching and sleep disturbances.

[0078] • DLQI (Dermatology Life Quality Index): DLQI is a questionnaire that measures the impact of skin conditions on a patient's quality of life.

[0079] • EASI (Eczema Area and Severity Index): EASI is another tool for assessing eczema severity. It evaluates the extent and intensity of erythema (redness), induration (swelling), excoriation (scratching), and lichenification (thickening) in different body areas affected by eczema.

[0080] • POEM (Patient-Oriented Eczema Measure): POEM is a patient-reported outcome measure used to assess the severity of eczema symptoms from the patient's perspective. It evaluates symptoms such as itching, sleep disturbances, bleeding, oozing, and the impact on daily activities over the past week.

[0081] • PRURITUS (Pruritus Severity Scale): PRURITUS is a scale used to assess the severity of pruritus (itching) experienced by patients with skin conditions. It evaluates the intensity and frequency of itching, as well as its impact on daily activities and quality of life.

[0082] • VLG-AD (Visual Analog Scale for Atopic Dermatitis): VLG-AD is a visual analog scale used to assess the severity of atopic dermatitis. Patients rate their disease severity on a scale ranging from "no symptoms" to "very severe symptoms."

[0083] The study was conducted with 10 volunteers, equally distributed between the two creams. For each sample, SCORAD, DLQI, EASI, POEM, PRURITUS, and VLG-AD scores were collected at two different time points: first before treatment and then again 15 days after cream application.

[0084] As can be seen in Figure 2, the compositions of the invention (white) show a superior and improved effect across all measured metrics compared to the prior art compositions (black), with particular emphasis on the SCORAD score. This clearly demonstrates the unexpectedly improved effect of the compositions of the invention.

Claims

CLAIMS 1. Topical anti-inflammatory composition for use in the treatment and / or prevention of skin inflammation, characterized in that it comprises at least one magnesium salt, at least one salt that does not comprise magnesium, at least one antioxidant, and at least one plant extract.

2. The composition according to claim 1, wherein the at least one salt comprising magnesium is selected from the group of magnesium sulfate, magnesium chloride, magnesium bromide, magnesium oxide or mixtures thereof.

3. The composition according to claim 2, wherein the at least one salt comprising magnesium is magnesium sulfate or a mixture of magnesium sulfate and magnesium chloride.

4. The composition according to any of the preceding claims, wherein the at least one salt comprising magnesium is present in a concentration of 0.1 to 3% by weight relative to the composition.

5. The composition according to claim 1, wherein the at least one salt not comprising magnesium is selected from the group of sodium chloride, sodium fluoride, potassium chloride, sodium sulfate, calcium chloride, sodium bicarbonate, sodium bromide, strontium chloride, sodium borate, ferric chloride or mixtures thereof.

6. The composition according to claim 5, wherein the at least one salt not comprising magnesium is a mixture of sodium chloride, sodium fluoride and potassium chloride or is a mixture of sodium chloride, sodium fluoride, potassium chloride and ferric chloride.

7. The composition according to any of claims 5 or 6, wherein the at least one salt not comprising magnesium is present in a concentration of 0.1 to 3% by weight relative to the composition.

8. The composition according to claim 1, wherein the at least one plant extract is a glycolic extract of chamomile, glycolic extract of oats, glycolic extract of Sage, Centella Asiatica glycolic extract, Birch glycolic extract, Calendula flower glycolic extract, Sweet clover glycolic extract, White nettle glycolic extract, Green nettle glycolic extract and Horse chestnut glycolic extract or mixtures thereof.

9. The composition according to claim 1, wherein the at least one plant extract is a solid extract selected from rosemary dry extract, fermented papaya extract, green tea extract, thyme dry extract, chamomile dry extract, lemon balm dry extract, witch hazel dry extract, ginkseng dry extract, ginkgo biloba dry extract and St. John's wort dry extract or mixtures thereof.

10. The composition according to claim 1, wherein the at least one plant extract is present in a concentration of 0.01 to 1% by weight in relation to the composition.

11. The composition according to claim 1, wherein the at least one antioxidant is selected from the group of ferulic acid, nicotinamide, zinc gluconate, iron gluconate, melatonin, resveratrol, vitamin C (ascorbic acid), dimethylethanolamine (DMAE), glycolic acid and coenzyme Q, lipoic acid, quercetin, curcumin, ascorbyl palmitate, taurine, isoflavones, lycopene, vitamin E, L-carnosine, or mixtures thereof.

12. The composition according to claim 11, wherein the at least one antioxidant is present in a concentration of 0.01 to 1% by weight relative to the composition.

13. The composition according to any of the preceding claims, wherein the composition is in the form of an aqueous composition, alcoholic composition, gel, cream, gel-cream or lotion.

14. A method for preparing a composition according to any of the preceding claims, characterized in that it comprises the following steps: a) Providing the desired amount of solvent; b) Adding at least one magnesium salt and at least one salt that does not contain magnesium to the solvent from the previous step; c) Adding at least one antioxidant and at least one plant extract to the mixture from the previous step.

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