Two-component system composition for therapeutic treatment of skin lesion, and method for creating the same

Abstract

To provide a system for therapeutic treatment of skin lesion, and wound, burn injury, pressure sore, and ulcer.SOLUTION: A two-component system composition is made up of two components, where a first component is in the form of an aqueous gel, a second component called a cross-linker is in the form of an aqueous solution, the first component consists of at least one kind of biocompatible polymer, at least one kind of polyacid or salt thereof, and at least one kind of preserving material, and at least one kind of pharmacologically active substance can be present, and the second component consists of physiological saline containing calcium chloride, magnesium chloride, and zinc chloride, a method of use includes application in advance of the first component in the form of an aqueous gel of a viscous fluid state onto skin of a patient, and only after the application, the second component is sprayed in an aqueous solution causing in-situ formation of a film having rubber-like consistency, and the rubber-like film can be removed by washing the skin with water.SELECTED DRAWING: None

Description

Technical Field

[0001] The patent application of the present invention generally relates to the medical and health sector, and more specifically to the fields of dermatology, surgery and cardiac surgery. More specifically, the present invention is included in the field of treatment for skin or dermal injuries, as well as the prevention and treatment of infections caused by burns and accidental causes, long-term hospitalization and / or the healing of surgical sutures.

Background Art

[0002] As is known, any change on the skin surface caused by a pathological event, a traumatic event or an environmental event is called a skin lesion.

[0003] In the intact skin, a large number of bacterial species defined as the "resident flora" are established, which shows a competitive effect against other bacterial species attempting to colonize themselves. In most cases, skin lesions show a rapid course towards healing, but in some patients, despite medical care and nursing, the course is particularly long and complex and does not necessarily progress towards healing. In the case of wounds such as extensive surgical sutures and burns, the presence of a large amount of bacterial contamination can damage the patient's health and in extreme cases lead to death due to sepsis. As a result, these injuries have an adverse impact on physical and mental health, and more generally on the quality of life of the patient, causing the consumption of important resources that have an impact on the health system in both the long-term hospitalization, organizational and economic aspects.

[0004] The risk of infection of chronic skin lesions is related to the host's resistance and the characteristics, load, and pathogenicity of the bacteria. In fact, all skin lesions are contaminated, but this state is characterized by the presence of non-replicating or growth-declining microorganisms for which the healing process is easy. However, they tend to replicate more quickly when the host can no longer maintain the balance between the attacking and defensive factors, leading to an increase in the bacterial load that is characteristic of a successive stage causing the expansion of the lesions with an obvious delay in the healing process. Finally, an infectious state characterized by the blockade of strong cell replication and cell repair processes can be reached. In this case, even massive losses of body fluids accompanied by dehydration of the patient, which are complications that worsen the clinical picture, must be avoided. In the case of bedsores, the compression of the tissue prevents their normal physiology and causes necrosis over time. In this case, it is important to associate the local administration of factors that stimulate tissue regrowth and maintain its optimal hydration state.

[0005] Current techniques for assisting wound healing essentially consist of covering the wound itself with a bandage, which often requires replacement for both preventing bacterial contamination and for the periodic addition of contaminants, as well as drugs, disinfectants, and antibiotics. However, the use of bandages has the drawback of often being difficult and painful for the patient and having to be removed, which causes pain and, in some cases, exacerbates irritation and patient injury. In the case of bedsores, adhesion to the sheets or clothing can cause serious problems for similar reasons, and the application of creams has to be repeated very frequently when mechanically removed from the bandage.

[0006] Generally, in order to effectively treat a wound, it is first necessary to form an efficient barrier from the outside to maintain the humidity of the tissue, avoid excessive loss of fluid, and enable the exchange of gases such as oxygen and carbon dioxide. Therefore, the generation of the bacteriostatic and bioadhesive effects of the barrier to prevent the invasion of bacteria and the continuous and sustained release of disinfectants, anti-inflammatory agents, antibiotics and / or factors that stimulate tissue regrowth or coagulation factors is a basic condition for maintaining a state suitable for the healing of the same lesion. Another requirement is to have a barrier with good mechanical and elastic characteristics that can accommodate sensors and indicators for detecting the wound healing state or the onset of infection inside. It lies in having a barrier with good mechanical and elastic characteristics.

[0007] Finally, a further feature in the treatment of skin lesions is to form a non-sticky outer surface, a barrier with high resistance and good durability that can be easily removed. To overcome these and other drawbacks of currently marketed products, the inventors have provided a combination product for clinical use in dermatology, surgery and cardiac surgery, which is characterized by forming a stable elastic film with gas permeability and breathability in situ on the living body.

[0008] Another object of the present invention is to provide a system for dermatological use that can avoid tissue dehydration, accommodate body fluids, and can be easily removed by simple washing with water.

[0009] A more specific object is to provide a bioadhesive system for dermatological use that can release active ingredient molecules that can exert local or systemic effects in human or animal organisms over time. In particular, the object of the present invention is, strictly speaking, to release pharmacologically active substances such as disinfectants, anti-inflammatory agents, regrowth factors, coagulation factors, antibiotics, etc.

[0010] Other advantages of the present invention will become apparent from the detailed description of its embodiments provided as non-limiting examples below.

Summary of the Invention

[0011] This patent application for an industrial invention discloses and claims a two-component composition that forms a bioadhesive system for the treatment of skin lesions, as well as wounds, burns, bedsores, ulcers, etc., consisting of a first component in the form of an aqueous gel called a base gel and a second component called a cross-linking component in the form of physiological saline.

[0012] More specifically, the first component consists of a biocompatible polymer, a polyacid or its salt, as well as at least one disinfectant and one or more pharmacologically active substances, and a mixture of disinfectants, anti-inflammatory agents, proliferation factors, coagulation factors, and antibiotics for dermatological use in an aqueous solution. On the other hand, the second component consists of an aqueous solution of a salt of a divalent, trivalent, or polyvalent cation.

[0013] Regarding the clinical use of the two-component composition of the present invention, this includes its prophylactic application to the skin of patients requiring asepsis, as well as protection against bacterial infections from dirt fragments and / or injuries, and thus it must be reported that it evenly covers and conforms to the shape and affected body part. Only then is the second component in the form of an aqueous solution sprayed onto the aqueous gel present in a fluid viscous state, inducing the in vivo formation of the rubber-like film of the present invention. Once formed, the film of the present invention has a porosity of less than 10 microns, forms a barrier preventing the passage of bacteria and spores, allows the passage of gases such as oxygen, carbon dioxide, nitrogen, and water vapor, enables its transpiration while retaining moisture, has a shear modulus of more than 1,000,000 Newtons per square meter, and an elongation at break of more than 100%.

[0014] This solution according to the present invention constitutes an optimal compromise in that the rubber-like gel film can advantageously perform various functions.

[0015] The polymer adhesion process actually involves the formation of close contact between the surface of the lesion and the polymer chains of the bioadhesive system, particularly the dehydration of the mucosal surface or the exposed skin surface, followed by the formation of cross-linked secondary chemical bonds and hydrogen bonds between these two surfaces.

[0016] First of all, this situation, in combination with the bioadhesive action in the application area, forms a protective and bacteriostatic barrier action that prevents the infiltration of bacteria and dirt fragments.

[0017] For all of this, the mucoadhesion process enables the carried drug to remain in close contact with the action site or absorption site for a long time, resulting in an improvement in the pharmacokinetic profile of the active substance, and as a result, higher efficacy of the treatment and a reduction in the possibility of side effects.

[0018] It should also be emphasized that this inventive means of forming a film enables the film to fully conform to any body part and to perform its function easily and continuously.

[0019] Furthermore, the presence of polyvinyl alcohol imparts elasticity, rubber-like solidity (having strong resistance to elongation and stress), and adhesive properties to the resulting film, which enables the sealing action at the intervention site and protection from bacterial invasion, enables resistance to large stresses, and also exhibits anti-adhesive properties against external bandages.

[0020] A further basic aspect according to the invention runs parallel to all the technical solutions described so far and starts from the fact that, particularly in relation to the implementation of the invention, the wound environment is dynamic and the healing rate can be improved by administering the therapeutic agent at the appropriate time. Therefore, this approach requires real-time monitoring of the wound environment, which can always be related to the bioadhesive action of the film. In fact, as can be seen in the detailed description, the two-component composition functions as an actual support for the sensors and chemical indicators, enabling real-time monitoring of the wound state and an appropriate response at that specific moment.

[0021] Other features of the invention are described in the following detailed description of one or more specific embodiments thereof, which are protected by various dependent claims.

Embodiments for Carrying Out the Invention

[0022] With reference also to the production method described below, preferred embodiments of the invention will be described in detail.

[0023] The first aspect of the invention consists in that the two-component composition for the therapeutic treatment of skin lesions and wounds, burns, bedsores, ulcers consists of two components: a first component in the form of an aqueous gel and a second component in the form of an aqueous solution.

[0024] More specifically, the first component is composed of at least one biocompatible polymer, at least one polyacid or its salt, and one or more preservatives and pharmacologically active substances. The optimal concentration values for obtaining an effective system that can guarantee the formation of a resistant film, has good elasticity, and has sufficient porosity for the passage of gases, as well as oxygen and carbon dioxide, but prevents the passage of bacteria, are also reported below.

[0025] Specifically, in a preferred embodiment of the present invention, the biocompatible polymer is polyvinyl alcohol, having a concentration between 0.001 and 30% w / w, preferably between 1% and 10% w / w, with respect to the first component, and having a molecular weight in the range of 10 to 1,000,000, more preferably a molecular weight of more than 10,000.

[0026] As far as the polyacid is concerned, this is represented by polyacrylic acid and sodium alginate, which are taken alone or in combination, and the polyacrylic acid having a molecular weight between 10 and 5,000,000, preferably equal to 400,000, is present at a concentration between 0.01 and 10% w / w, more preferably between 2 and 4% w / w, with respect to the first component, and sodium alginate is included between 0 and 5% w / w, preferably present at a concentration equal to 1.5% w / w, with a viscosity in the range of 50 to 2000 cp at 20 °C.

[0027] As far as the pharmaceutically active molecules and preservatives present in the first compound of the present invention are concerned, these are diverse and, as specified below, they belong to various pharmaceutical categories.

[0028] In particular, a preferred embodiment of the present invention provides that the antibiotics for dermatological use are selected from the group consisting of metronidazole, metronidazole benzoate, any antibiotic belonging to the nitroimidazole family, doxycycline, any antibiotic belonging to the tetracycline family, amoxicillin in association with clavulanic acid and any antibiotic belonging to the penicillin family, rifaximin and any antibiotic belonging to the rifamycin family, neomycin, mupirocin and any combination thereof, and the concentration of the antibiotic with respect to the first component is included between 0.01 and 70% w / w, more preferably between 0.5 and 30% w / w.

[0029] In the preferred embodiment, the disinfectant is selected from the group consisting of chlorhexidine gluconate, iodine, silver ions, and any combination thereof, at a concentration of between 0.0001 and 10% w / w, more preferably between 0.002 and 4% w / w, based on the first component.

[0030] In the preferred embodiment, the anti-inflammatory agent is selected from the group consisting of acetylsalicylic acid and / or flurbiprofen and any combination thereof, at a concentration of between 0.001 and 30% w / w, more preferably between 0.5 and 10% w / w, based on the first component.

[0031] In the preferred embodiment, the tissue regeneration factor is hyaluronic acid at a concentration of between 0.001 and 30% w / w, more preferably between 0.01 and 2% w / w, based on the first component.

[0032] In the preferred embodiment, the regeneration factors included in the first component are selected from the group consisting of hyaluronic acid and / or its sodium salt, retinol, vitamin A, vitamin C, vitamin D, vitamin E, biotin, linoleic acid, arachidonic acid, coenzyme Q10, oxygen, hydrogen peroxide, or other oxygen-generating compounds, and any combination thereof.

[0033] In the preferred embodiment, the local coagulation factor is selected from the group consisting of vitamin K, protamine, fibrinogen, prothrombin, calcium, proaccelerin, accelerin, procovulentin, antihemophilic factor A, Christmas factor, tissue factor III, Stuart-Power factor, plasma precursor of thromboplastin, Hageman factor, fibrin stabilizing factor, or any combination thereof, at a concentration of between 0.001 and 4% w / w, more preferably between 0.2 and 2% w / w, based on the first component.

[0034] In the preferred embodiment, the first component comprises a disinfectant selected from the group consisting of members of the parabens class, or the group consisting of propyl paraoxybenzoate and methyl paraoxybenzoate, or any combination thereof.

[0035] Alternatively, with respect to the second component present in the foregoing preferred embodiment, this is constituted by a physiological saline solution in which the cation is divalent, trivalent or of a higher valence, and the salt is selected from the group consisting of chlorides, iodides, and preferably, the salt is calcium chloride, magnesium chloride and zinc chloride at a concentration included between 0.001 mol and the saturation concentration of the solution, and is selected from the group consisting of calcium chloride, magnesium chloride and zinc chloride.

[0036] As a non-limiting example, a particularly preferred composition according to the present invention consists of the presence of a first component in the form of a mixture in an aqueous solution of polyvinyl alcohol having a molecular weight of about 90,000 at a concentration of about 2% w / w, sodium alginate at a concentration of about 2% w / w, silver ions at a concentration of about 1% w / w and / or chlorhexidine gluconate at a concentration of about 2-4%, and flurbiprofen at a concentration of about 5% w / w, preferably consisting of the presence of a second component in the form of an aqueous saline solution of calcium chloride at a concentration included between 0.001 and 10 M.

[0037] However, heretofore, when a pharmaceutically active substance was included among the components in the first component, this has been considered, but this should not be regarded as limiting for the present invention since, in particular for assisting the tissue regeneration process, the treatment system of the present invention can also contain substances for cosmetic, nutraceutical use and micronutrients. Thus, the field of application of the release system of the present invention is the medical, pharmaceutical, cosmetic and pharmaceutical-cosmetic (cosmetics for therapeutic purposes) as well as nutraceutical fields. As already mentioned above, the approach for detecting the dynamic environment of skin lesions requires the presence of chemical, physical or biological sensors, as well as sensors for temperature, pH value, bacterial load value, etc. This situation is implemented by enabling the two-component composition of the present invention to integrate or function as a support for common chemical, physical or biological sensors and indicators, as specified below.

[0038] For this purpose, it is envisaged that the system of the present invention can function as a support for at least one device for detecting temperature, pH value, ion concentration, physiological saline concentration, oxygen concentration, oxygen perfusion in the tissue, carbon dioxide concentration or any combination thereof. Furthermore, in light of the above, in the composition of the first component of the present invention, the presence of a fluorescent substance selected from the group comprising green fluorescent protein (GFP), fluorescein, dichlorofluorescein, Dylight Fluor, or a combination thereof, for detecting bacterial strains is provided.

[0039] Another feature within the scope of the concepts described above is that the system of the present invention provides for the presence of a colorimetric indicator of the state of a skin lesion for indicating pH value, redox characteristics, salinity, redox activity, and dissolved gas within the composition of the first component, and such indicators are bromothymol blue, thymol blue, methyl violet, basic violet 3, methyl yellow, methyl orange, bromophenol blue, bromocresol green, methyl red, phenol red, cresol red, 1-naphthol phthalein, phenolphthalein, thymolphthalein, bromocresol violet, trinitrotoluene, ferroin, N-phenylanthranilic acid, naphthyl black, 2,2'-bipyridine (complex with Ru), nitrophenanthroline (complex with Fe), N-phenylanthranilic acid, 1,10-phenanthroline (complex with Fe), N-ethoxychrysoidine, 2,2'-(complex with Fe), 5,6-dimethylphenanthroline (complex with Fe), o-dianisidine, sodium diphenylamine sulfonate, diphenylbenzidine, diphenylamine, viologen, 2,6-dibromophenol-indophenol, o-cresol-indophenol, thionin (or "lauth's violet"), methylene blue, indigotetrasulfonic acid, indigotrisulfonic acid, carmine indigo (indigosulfonic acid), indigomonosulfonic acid, phenosafraninic acid, safranin T, basic red 5, or any combination thereof.

[0040] In a second aspect, the present invention relates to a method for producing the above preferred compositions. However, the following examples regarding the preparation, property evaluation, and use of the products according to the present invention are provided for illustrative purposes only and are not intended to limit the scope of the present invention as defined by the appended claims.

Examples

[0041] <Preparation> A base gel (first component) was obtained by dissolving polyvinyl alcohol with a molecular weight of 90,000 in water at a concentration of 4% w / w. The solution was stirred until a homogeneous solution was obtained, and then hyaluronic acid was added at a concentration of 0.5% w / w, flurbiprofen at a concentration of 5% w / w, and sodium alginate with a high molecular weight at a concentration of 2% w / w. Finally, silver chloride was added throughout at a concentration of 1% w / w, and chlorhexidine gluconate was added at a concentration of 2% w / w. The physiological saline consisted of an aqueous solution of 1 mole of calcium chloride.

Example

[0042] <Application> The gel prepared according to Example 1 was applied to the skin lesion, and then the calcium chloride prepared according to Example 1 was sprayed by a spray nebulizer.

Example

[0043] <Evaluation of the properties of the elastic film> The rubber-like film obtained by the method described in Example 1 was evaluated for its properties by the elasticity and release ability of flurbiprofen, silver ions, chlorhexidine gluconate, and hyaluronic acid contained therein. When the elastic breaking elongation of the gel sample was measured, it exceeded 100%. The release of flurbiprofen, silver ions, and hyaluronic acid was longer than 7 days.

Example

[0044] <Alternative preparation> A base gel (first component) was obtained by dissolving polyvinyl alcohol with a molecular weight of 90,000 in water at a concentration of 4% w / w. The solution was stirred until a homogeneous solution was obtained, and then hyaluronic acid was added at a concentration of 0.5% w / w, polyacrylic acid at a concentration of 0.5% w / w, and sodium alginate with a specific viscosity of 4,000 cp at a concentration of 1.5% w / w. Finally, silver chloride was added throughout at a concentration of 1% w / w, chlorhexidine gluconate was added at a concentration of 2% w / w, and acetylsalicylic acid was added at a concentration of 10% w / w.

[0045] The crosslinking agent (second component), which can convert the gel into a solid having the consistency of soft rubber, consists of an aqueous solution of 1 mole of calcium chloride.

Example

[0046] <Alternative preparation for inserting the physical sensor> A base gel (first component) was obtained by dissolving polyvinyl alcohol with a molecular weight of 90,000 in water at a concentration of 10% w / w. The solution was stirred until a homogeneous solution was obtained, and then polyacrylic acid was added at a concentration of 4% w / w and dissolved by also stirring the solution. After inserting and placing the temperature and oxygen sensors, the final homogeneous solution was dried in an oven at 40 °C for 24 hours in the presence of dehydrated salts. The final rubber-like film containing the sensors was crosslinked at 80 °C for 1 hour. The solid elastic film thus obtained was adhered to the skin above and around the wound or suture using the gel prepared according to Example 1 and applied according to Example 2 as an adhesive.

Claims

1. A two-component composition for the therapeutic treatment of skin lesions, characterized in that it is composed of two components, the first of which is in the form of an aqueous gel and the second, called crosslinker, in the form of an aqueous solution, said first component being composed of at least one biocompatible polymer with at least one polyacid or one salt thereof, and that at least one preservative substance can be present as well as at least one pharmacologically active substance, and that said second component is composed of a physiological saline solution in which the cations are divalent, trivalent or of higher valence.

2. The compound present in said first component is characterized in that said biocompatible polymer is polyvinyl alcohol, with a concentration between 0.001 and 30% w / w, preferably between 1% and 10% w / w, relative to said first component, and has a molecular weight comprised in the range of 10 to 1,000,000, more preferably a molecular weight greater than 10,000, said polyacid being represented by polyacrylic acid and sodium alginate, used by itself or in association, said polyacid having a molecular weight between 10 and 5,000,000, preferably equal to 400,000. acrylic acid is present in a concentration comprised between 0.01 and 10% w / w, more preferably between 2 and 4% w / w, relative to said first component, sodium alginate is present in a concentration comprised between 0 and 5% w / w, preferably equal to 1.5% w / w, relative to said first component, the viscosity being in the range of 50 to 2000 cp at 20° C., and the antibiotic for dermatological use belongs to the aforementioned pharma- ceutical active molecules, having a concentration comprised between 0.01 and 70% w / w, more preferably between 0.5 and 30% w / w, relative to said first component, said antibiotic being metronidazole, benzoin, metronidazole acid, any antibiotic belonging to the family of nitroimidazoles, doxycycline, any antibiotic belonging to the family of tetracyclines, amoxicillin, also related to clavulanic acid, any antibiotic belonging to the family of penicillins, rifaximin, any antibiotic belonging to the family of rifamycins, neomycin, mupirocin, and any combination thereof, characterized in that the disinfectant is present in an amount of between 0.0001 and 10% w / w, more preferably between 0.002 and 4% w / w, relative to said first component. % w / w, characterized in that the disinfectant is selected from the group comprising chlorhexidine gluconate, iodine, silver ions, and any combination thereof; the anti-inflammatory agent is selected from the group comprising acetylsalicylic acid and / or flurbiprofen, and any combination thereof, characterized in that the tissue regeneration factor isthe tissue regeneration factor is hyaluronic acid, the regeneration factor is selected from the group consisting of hyaluronic acid and / or its sodium salt, retinol, vitamin A, vitamin C, vitamin D, vitamin E, biotin, linoleic acid, arachidonic acid, coenzyme Q10, oxygen, oxygenated water or other compounds that generate oxygen and any combination thereof; and the local coagulation factor is present in a concentration of 0.001-4% w / w, more preferably 0.2-2% w / w, relative to the first component. / w, characterized in that said local coagulation factor is selected from the group comprising vitamin K, protamine, fibrinogen, prothrombin, calcium, proaccelerin, accelerin, proconvertin, antihemophilia A factor, Christmas factor, tissue III factor, Stuart Power factor, plasma precursor of thromboplastin, Hageman factor, fibrin stabilizing factor, or any one combination thereof, and finally, said preservative compound is selected from the group comprising those belonging to the class of parabens, or the group of propyl parahydroxybenzoate and methyl parahydroxybenzoate, or any combination thereof, The two-component composition according to claim 1 .

3. 3. A binary composition according to claim 1 or 2, characterized in that the second component is constituted by a saline solution in which the cation is of divalent, trivalent or higher valence, the salt being selected from the group comprising chloride, iodide and finally, the salt being selected from the group comprising calcium chloride, magnesium chloride and zinc chloride in concentrations comprised between 0.001 molar and the solution saturation concentration.

4. In the first component, at least one fluorescent substance is present for the detection of bacterial strains, such fluorescent substance being selected from the group comprising Green Fluorescent Protein (GFP), Fluorescein, Dichlorofluorescein, Dylight Fluor, or a combination thereof; and in the first component, at least one colorimetric indicator is present for indicating pH value, redox properties in the gel film, salinity, redox activity, and dissolved gases, such indicators being Bromothymol Blue, Thymol Blue, Methyl Violet, Basic Violet 3, Methyl Yellow, Methyl Orange, Bromophenol Blue, Bromocresol Green, Methyl Red, Phenol Red, Cresol Red, 1-Naphtholphthalein, Phenolphthalein, Thymolphthalein, Bromocresol Violet, Trinitrotoluene, Ferroin, N-Phenylanthranilic Acid, Naphthyl Black, 2,2′-Bipyridine (complex with Ru), Nitrophenanthroline (complex with Fe), N 4. The binary composition according to claim 1, characterized in that the active ingredient is selected from the group comprising: 1,2,3-phenylanthranilic acid, 1,10-phenanthroline (complex with Fe), N-ethoxychrysoidine, 2,2'- (complex with Fe), 5,6-dimethylphenanthroline (complex with Fe), o-dianisidine, sodium diphenylamine sulfonate, diphenylbenzidine, diphenylamine, viologen, 2,6-dibromophenol-indophenol, o-cresol-indophenol, thionine (or "lout violet"), methylene blue, indigo tetrasulfonic acid, indigo trisulfonic acid, carmine indigo (indigo sulfonic acid), indigo monosulfonic acid, phenosafranic acid, safranine T, basic red 5, or any combination thereof.

5. 5. The binary composition according to claim 1, characterized in that the system, in contact with the skin or mucous membrane, serves as a support for at least one device for detecting temperature, the pH value, ion concentration, saline concentration, oxygen concentration, oxygen perfusion in tissues, carbon dioxide concentration or any combination thereof.

6. 6. The two-component composition according to any one of claims 1 to 5, characterized in that it is used for the therapeutic treatment of common skin lesions, as well as wounds, burns, decubitus ulcers and ulcers in animals and humans, characterized in that the method of use comprises the prior application of the first component in the form of an aqueous gel in a viscous fluid state onto the skin of the patient, only after which the applied first component is sprayed with the second component in the form of an aqueous solution, inducing the in vivo formation of a film with a rubber-like consistency, and that the rubber-like film can be removed by washing the skin with water.

7. 7. The two-component composition of any one of claims 1 to 6, wherein the film having a rubber-like consistency, once formed, has a porosity of less than 10 microns, a shear modulus of greater than 1,000,000 Newtons per square meter, and an elongation at break of 100% or greater.

8. The film performs a bioadhesive activity, the bioadhesive process allows the delivered active ingredient to remain in intimate contact with the site of action or absorption for an extended period of time, and the active ingredient 8. A two-component composition according to any one of claims 1 to 7, characterized in that an improvement in the pharmacokinetic profile of the active component itself is obtained, and a water-impermeable barrier is achieved which prevents the passage of bacteria and spores and allows the passage of gases such as oxygen, carbon dioxide, nitrogen and water vapor.

9. 9. A two-component composition according to any one of claims 1 to 8, characterized in that among the constituents of the first component are included substances for cosmetic applications, nutraceutical applications and micronutrients, in particular for supporting tissue regeneration processes.

10. A method for producing and applying the two-component composition according to any one of claims 1 to 9, comprising the steps of: (i) preparing a first component by dissolving polyvinyl alcohol in room temperature water with stirring until a homogenous solution is obtained, then adding hyaluronic acid, polyacrylic acid, sodium alginate, silver chloride, chlorhexidine gluconate and acetylsalicylic acid; (ii) preparing a second component by dissolving calcium chloride in water at room temperature; wherein the first component is applied to a skin lesion and then the second component, calcium chloride, is sprayed with a spray nebulizer.

11. A method of producing and applying a two-component composition according to any one of claims 1 to 10, wherein the system is used to insert a sensor and comprises preparing a base component by dissolving polyvinyl alcohol in water at room temperature while stirring until a homogeneous solution is obtained, then adding polyacrylic acid and stirring the solution to dissolve also the polyacrylic acid until a homogeneous solution is obtained, and a temperature and oxygen sensor is inserted and placed in the final homogeneous solution, which is dried in an oven at 40°C for 24 hours in the presence of a dehydrating salt, characterized in that the final rubber-like film containing the sensor is crosslinked at 80°C for one hour and the solid elastic film thus obtained is adhered to the skin or mucosa above and around the wound or suture using the first component as adhesive and then the second component calcium chloride is applied using a spray nebulizer.