ES2562985B1 - Pharmaceutical composition for the treatment of skin lesions - Google Patents

Abstract

The object of this invention patent is a pharmaceutical composition for the treatment of skin lesions containing a combination of 4 active substances, in particular Sodium Diclofenac, Clotrimazole, Sulfanilamide and Benzyl Alcohol, all of them in a topical administration formulation. on the skin, of semi-solid consistency in a hydrophilic gel structure, with a viscous and translucent texture, easily applicable on the skin and capable of being applied uniformly. The formulation contains per 1 gram (1,000 mg.) Diclofenac sodium in a proportion of between 10 mg. and 60 mg .; Clotrimazole in a proportion between 10 mg. and 60 mg .; Sulfanilamide in a proportion between 50 mg. and 150 mg. and Benzyl alcohol in a proportion of between 10 mg. and 80 mg., contained in the same formulation.

Description

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ES 2 562 985 A1

DESCRIPTION

The present invention relates to a pharmaceutical composition for the treatment of skin lesions.

Background of the invention

The skin, considered the largest organ of the human body, is also possibly one of the ones that suffers the most wear, continually renewing itself with the formation of new cells that replace dead cells and prone to suffer injuries. In reality, the skin acts as an effective defense that covers the entire organism, isolating it from everything that surrounds it and specifically from any external aggression. Structurally, the skin is not uniform throughout the body, its thickness varies depending on the needs of protection and its relationship with the environment, being thicker where there is greater contact and / or rubbing and therefore requires greater resistance, for example the feet and in particular the heels, and being thinner in other areas, such as the eyelids or the face, the skin structure comprising three parts or layers: epidermis, dermis and hypodermis, the epidermis being the most superficial and the hypodermis or subcutaneous tissue, the deepest.

Logically, being the skin the protective organ that covers the entire human body is continually exposed to multiple injuries, due to accidental circumstances such as bumps, friction, burns, etc. and also effects that may be consequences of other diseases such as ulcers derived from diabetes, vascular diseases or infections. In any case, an aggression in the skin that alters its structure should be considered as an injury that requires adequate medical treatment since any lesion of the skin or mucous membrane with loss of substance, that is, an ulcer, involves Considerable infection risks likely to affect other internal organs and / or not to heal and become chronic.

In addition to ulcerations, the skin is susceptible to multiple alterations in its structure, such as keratosis caused by sun exposure, epidermal tumors, acne, psoriasis, warts or pustules.

Any skin lesion requires medical treatment to relieve and treat its symptoms and recover its structure. There are surgical treatments,

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suitable for especially significant skin pathologies such as tumors or burns that require direct intervention to clean and treat the affected area, but most procedures are non-surgical with a treatment of less aggressiveness based on the use of ointments, Ointments, gels or the like of direct application on the skin to relieve and treat the symptoms that may occur.

One of the most dispensed pharmaceutical compositions is the combination of neomycin, polymyxin and bacitracin, especially suitable for burns, scrapes or cuts that result in an infection, being highly effective because of its content in antibiotics that work to stop the growth of bacteria. Also, diclofenac topic, of the non-steroidal anti-inflammatory type, is of effective use to treat actmic keratosis and osteoarthritis but is scarcely effective, in itself, in other types of skin lesions as they do not have antibacterial properties.

At the industrial property level there are many pharmaceutical patents that have formulations and compositions intended for the treatment of skin conditions such as for example US2010221245 for the treatment of acne and containing an antibacterial agent, for example, bacitracin, an anti-inflammatory agent, for example, benzoyl peroxide and an antioxidant agent, for example, omeprazole and sodium pantoprazole. For its part, WO2009158687 develops a formulation that covers a wide range of skin effects, such as psoriasis, skin infection, actic keratosis, eczematous dermatitis, Raynaud's phenomenon symptoms, lupus erythematosus smtoma and skin cancer, which includes active anti-seborrheic, dermatological, antipsoriasic, keratolrtic and vasotropic principles.

As for alternative treatments, it is advisable to apply on the skin, either in gel or cream format or by compresses in case of open lesions, certain combinations of herbs, vitamins and amino acids, corticosteroid creams, oral antihistammics (allergy) in sporadic circumstances , lotions and moisturizers etc. Among these natural remedies, cite Aloe Vera in gel format especially effective for pressure ulcers; the combination of curcuma root and Hazel, Agrimony (Agrimonia eupatoria) also popularly known as St. William's Wort, hypericum (Hypericum perforatum), Yarrow (Achillea millefolium) or aquilea or the combination of sugar and honey.

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Object of the invention

The present invention relates to a pharmaceutical composition for the treatment of skin lesions that occurs mainly in gel, ointment or ointment format.

In particular, the composition claimed is specially formulated to act against keratosis caused by sun exposure, wide-spectrum epidermal tumors, acne, warts and pustules, being equally effective in relieving ulcers and open skin wounds since it acts to inhibit the division and proliferation of fungi and microorganisms, reducing inflammation, sclerosis and hardening of the ulcer, leaving, after a continuous and correctly dosed application, a crust that by its desiccation is released from the skin and falls on its own alone.

In general, it is obvious that any formulation that claims to have an effective result against skin disorders must combine various active ingredients that mainly combine antibacterial and anti-inflammatory properties capable of acting against germs, bacteria, fungi or the like that proliferate especially in open wounds in the skin. skin and analgesic properties that reduce and relieve pain.

The claimed composition contains a combination of four active substances that meet the needs described, namely Diclofenac sodium, Clotrimazole, Sulfanilamide and Benzyl Alcohol, all of them in a topically administered administration formulation in the skin, of semi-solid consistency in a Hydrophilic gel structure, with a viscous and translucent texture, easily applicable to the skin and capable of being applied uniformly.

The formulation contains per 1 gram (1,000 mg.) Diclofenac sodium in a proportion of between 10 mg. and 60 mg .; Clotrimazole in a proportion between 10 mg. and 60 mg .; Sulfanilamide in a proportion between 50 mg. and 150 mg. and benzyl alcohol in a proportion of between 10 mg. and 80 mg., contained in the same formulation.

The four aforementioned active substances have, in particular, different properties that, added together, act in an effective manner against the aforementioned skin lesions.

Diclofenac sodium is a medicine that belongs to the family of non-steroidal anti-inflammatory drugs (NSAIDs), therefore with properties that act against

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inflammation and also of an analgesic nature, to which are added muscle relaxant properties that relieve muscle spasms.

Clotrimazole is an antomicomic or antifungal drug, it is dedr, capable of acting against certain fungi, preventing their growth or destroying them.

Sulfanilamide is an antibiotic that belongs to the group of sulfa drugs, effective in superficial infections of the skin of bacterial origin, acting on the wall of the bacteria, eliminating them and thus preventing the infection from spreading.

Bendic Alcohol is an antimicrobial preservative with certain disinfectant and anesthetic properties in a local application.

The sum of these substances reinforces the positive properties of each of them, which translates into a high effectiveness in the processes that involve skin lesions when acting together with antibacterial, anti-inflammatory and analgesic / anesthetic properties.

The pharmaceutical composition contains at least one of the following excipients: Coconut oil, Isopropyl Alcohol, Paraffin, Propylene Glycol, Carbitol, Stearates and Water in sufficient quantity

Depending on the percentage of water, the developed pharmaceutical formulation has a cream or ointment structure.

The preferred dosage is one application on the damaged skin every 24 hours.

The application guideline is as follows:

1. Apply a small amount of gel covering the area to be treated.

2. Cover the area to prevent evaporation and dryness of the gel. Keep covered for 12 hours.

a) It is usually sufficient to apply a small sheet of soft plastic (polyethylene or similar) or

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b) In case of open wounds or suppurating sores, apply a gauze instead of the plastic sheet.

3. At 12 hours, discover and wash with water and soap in a tablet, especially neutral.

4. Keep the area to be treated without covering, drying it in the open air for 12 hours.

5. At 12 o'clock, start a new application schedule, that is, apply a small amount of gel covering the area to be treated.

It is not considered necessary to make this description more extensive so that any person skilled in the art understands the scope of the invention and the advantages derived from this composition. The terms in which this report has been written should always be taken in a broad and non-limiting sense.

Claims (5)

5 10 fifteen twenty 25 30 35 1st Pharmaceutical Composition for the treatment of skin lesions characterized in that it contains a combination of four active substances, Diclofenac Sodium, Clotrimazole, Sulfanilamide and Benzyl Alcohol, contained, together with certain excipients, in the same formulation. 2nd Pharmaceutical composition for the treatment of skin lesions, according to the claim, essentially characterized in that the formulation contains 1 gram (1,000 mg.) Sodium diclofenac in a proportion of between 10 mg. and 60 mg. 3rd Pharmaceutical composition for the treatment of skin lesions, according to the claim, essentially characterized in that the formulation contains 1 gram (1,000 mg.) Clotrimazole in a proportion of between 10 mg. and 60 mg. 4th Pharmaceutical composition for the treatment of skin lesions, according to the 1st claim, essentially characterized in that the formulation contains per 1 gram (1,000 mg.) Sulfanilamide in a proportion of between 50 mg. and 150 mg. 5th Pharmaceutical composition for the treatment of skin lesions, according to the 1st claim, essentially characterized in that the formulation contains per 1 gram (1,000 mg.) Benzyl alcohol in a proportion of between 10 mg. and 80 mg., 6a Pharmaceutical composition for the treatment of skin lesions, according to the 1st claim, essentially characterized in that it contains at least one of the following excipients: Coconut oil, Isopropyl Alcohol, Paraffin, Propylene Glycol, Carbitol, Stearates and Water in sufficient quantity. 7a Pharmaceutical composition for the treatment of skin lesions, according to the preceding claims, characterized essentially in that the formulation is topically administered in the skin, of semi-solid consistency in a hydrophilic gel structure, with a viscous and translucent texture. 8a Pharmaceutical composition for the treatment of skin lesions, according to the 1st and 7th claims, essentially characterized in that the preferred dosage is an application on the damaged skin every 24 hours. 7 9th Pharmaceutical composition for the treatment of skin lesions, according to the 8th claim, essentially characterized in that the application pattern is as follows: 10 1. Apply a small amount of gel covering the area to be treated. 2. Cover the area to prevent evaporation and dryness of the gel. Keep covered for 12 hours. to. Cover with a small sheet of soft plastic (polyethylene or similar) or b. In case of open wounds or suppurating sores, apply gauze. 3. Discover and wash with water and soap in a tablet, especially neutral. 4. Keep the area to be treated without covering, drying it in the open air for 12 hours. 5. At 12 noon, start a new application guideline. 10th Pharmaceutical composition for the treatment of skin lesions, according to the 1st and 6th claims, characterized essentially because according to the percentage of water, the developed pharmaceutical formulation has a cream or ointment structure. 11a Pharmaceutical composition for the treatment of skin lesions, according to the preceding claims, essentially characterized in that it acts against keratosis 20 produced by sun exposure, wide-spectrum epidermal tumors, acne, warts and Pustules, being equally effective in relieving ulcers and open skin wounds.