Self-electric generating skin patch containing biodegradable metals

Abstract

The self-current-generating skin-applied patch includes a first region that contacts the user's skin and a second region that is spaced apart from the first region and contacts the adjacent skin that the first region contacts. The first region or the second region contains a biodegradable metal that contacts the user's skin or reacts with moisture in tissue to be decomposed and absorbed. The first region or the second region is provided as a thin sheet-like structure integral with the first region that directly contacts the user's skin and has at least one penetration that allows fluid delivery from the side opposite to the skin contact; a second electrode layer made of a different material that has a different standard reduction potential from the material that makes up the first electrode layer, located on the side opposite to the skin contact of the first electrode layer while being insulated from the first electrode layer, and at least a portion of the second electrode layer extends to be electrically connected to the second region; and a carrier layer that is a thick sheet-like layer located on the side opposite to the skin contact of the first electrode layer and is made of a hydrophilic material that can carry an ionic solution. The self-generated microcurrent can provide sufficient iontophoresis of active ingredients and other microcurrent effects even without a separate power source such as a battery.

Description

[Technical Field]

[0001] The present invention relates to a skin application patch for delivering cosmetic or pharmaceutical active ingredients into the body, and more particularly to a self-current generating skin application patch containing biodegradable metals, configured such that a minute current is generated simply by applying it to the skin due to the oxidation-reduction potential difference between dissimilar metals by an ionic solution consisting of or mixed with the active ingredients, thereby providing beneficial effects through the decomposition of biodegradable metals at the contact site. [Background technology]

[0002] Generally, in transdermal methods of supplying active ingredients into the body through the skin, the most common method is to apply cream or gel-type products containing the active ingredients to the surface of the skin. However, a considerable amount of the active ingredient is wasted because it cannot penetrate into the tissue compared to the amount applied. In particular, when the three-dimensional size of the active ingredient is large, such as with high molecular weight materials, there is a problem that most of it cannot pass through not only the epidermis but also the stratum corneum of the skin.

[0003] The most direct percutaneous method to address this is to inject the active ingredient via injection. While this method has the advantage of rapid absorption and immediate effects in the tissues because a needle is inserted through the skin and the drug is injected directly into the body, it has the inconvenience of having to be administered only by a specialist (making self-administration difficult), and because it usually uses a needle that is several millimeters long and several millimeters in diameter, patient compliance is poor due to injection pain.

[0004] There is active development of transdermal drug delivery systems to minimize the aforementioned side effects and drawbacks.

[0005] As mentioned above, active ingredients that are usually absorbed through the skin are formulated in the form of liquids, creams, gels, etc. However, due to the characteristics of these formulations, liquids, creams, and gels are difficult to adjust in volume and have problems such as stickiness and staining of the skin.

[0006] Therefore, a method is used in which a patch containing the active ingredient is applied to the skin, allowing the active ingredient to be absorbed through the skin.

[0007] The method of administering active ingredients such as drugs using patches allows the drug to be absorbed through the skin, thus preventing side effects associated with oral medication, such as gastrointestinal disorders and the effects of food. It also eliminates the pain and inconvenience of injections. Due to its convenience, its use has been gradually increasing recently.

[0008] Broadly speaking, a patch can be composed of a drug-impermeable backing layer that prevents the drug as the active ingredient from passing through, a drug-permeable membrane, and an adhesive layer that adheres the patch to the skin. The storage space for the drug is provided between the backing layer and the drug-permeable membrane.

[0009] A major drawback of such patches is that the absorption rate of the active ingredient through the skin is low, which means that the skin's function as a barrier to permeability must be reduced. Generally, the absorption rate through patches is known to be around 20%.

[0010] Various methods are used to increase the skin absorption rate of active ingredients in drugs and other substances. For example, chemical methods such as the use of skin absorption enhancers and prodrugs, and physical methods such as iontophoresis and electrophoresis are known.

[0011] However, even with these known methods, there are still limitations to improving the absorption rate of the active ingredient to a satisfactory level. Therefore, in order to expect an effect, it is unavoidable to use an excessive amount of the active ingredient, taking absorption into consideration, compared to the actual required amount.

[0012] In particular, the type of skin absorption enhancer is determined by the design of the formulation to be used or the physicochemical properties of its components. A certain level of concentration is required to exhibit its effect, but when skin absorption enhancers are added, it is not easy to prevent crystal formation over time, and the adhesive properties such as adhesion and cohesiveness change to the point where they are unsuitable for use.

[0013] Furthermore, technologies that utilize electricity have drawbacks, including the fact that patches must contain batteries, electrodes, circuits, and other components, resulting in complex product configurations, large size, high cost, and the generation of large amounts of waste after use.

[0014] The applicant has been continuously researching and developing technologies for microneedle patches made of biodegradable metals as a transdermal active ingredient delivery system, and has disclosed technologies that enhance the transdermal active ingredient delivery efficiency and have advantageous effects that occur during the degradation process itself, through Patent Document 1: Korean Patent Registration No. 2114472, "Microneedle using biodegradable metal", Patent Document 2: Korean Patent Registration No. 2291392, "Multi-type microneedle", etc.

[0015] These technologies already provide an excellent transdermal drug delivery method through microneedles that effectively penetrate the stratum corneum and epidermis without stimulating the pain nerves of the human body, and through characteristic structures such as the arrangement of numerous microneedles around the holes. However, the applicant has not stopped there, but has further researched and developed a method that can deliver active ingredients deep into the skin in a short time, leading to the present invention.

[0016] Therefore, the applicant has proposed the present invention to solve the above-mentioned problems. Related prior art documents include Patent Document 3: Korean Registered Patent No. 10-1423241, "Microcurrent Generating Patch," and Patent Document 4: Korean Registered Patent No. 10-2390735, "Microcurrent Generating Patch for Transdermal Drug Delivery and Method for Manufacturing the Same." However, Korean Registered Patent No. 10-1423241 only describes the structure and effect of promoting metabolism and blood circulation in the affected area by microcurrents generated by metals of different materials and a gel-like adhesive layer. Korean Registered Patent No. 10-2390735 only discloses a drug penetration structure using the ion topolesis method, but does not go beyond presenting a conceptual structure of an ion topolesis patch and does not present any concrete alternatives to whether a sufficient ion topolesis effect can be achieved with only self-generated power without a separate power source. Nor does it present optimized configurations such as microneedles made of biodegradable metals that can be decomposed in the body, or any synergistic effects resulting therefrom. [Prior art documents] [Patent Documents]

[0017] [Patent Document 1] Korean Patent Registration No. 10-2114472 [Patent Document 2] Korean Patent Registration No. 10-2291392 [Patent Document 3] Korean Registered Patent No. 10-1423241 [Patent Document 4] Korean Registered Patent No. 10-2390735 [Non-patent literature]

[0018] [Non-Patent Document 1] YOON, K. S. et al., Histological study on the effect of electrolyzed reduced water-bathing on UVB radiation-induced skin injury in hairless mice, Biological and Pharmaceutical Bulletin 34, 1671-7, 2011

Non-Patent Document 2

Summary of the Invention

Problems to be Solved by the Invention

[0019] The present invention is for solving such problems, and its object is to generate a minute current without a separate power supply device such as a battery and maximize the in-vivo delivery effect of an active ingredient by iontophoresis, and at the same time obtain the minute current effect known to relieve pain while recovering nerve, muscle, and tissue damage, and to provide a self-current generating skin-applicable patch containing a biodegradable metal.

[0020] Another object of the present invention is to provide a self-current generating skin-applicable patch having a skin improvement effect and a drug delivery enhancer effect by decomposition products, hydrogen gas, etc. released during decomposition by applying an electrode and a skin contact portion with a biodegradable metal having a specific composition according to the present invention.

[0021] Another objective of the present invention is to provide a self-current generating skin patch that not only increases the stratum corneum permeability by microneedles in the user's skin contact area, but also lowers the skin resistance value of the application site, thereby greatly enhancing the effect of delivering active ingredients into the body by ion electrophoresis. [Means for solving the problem]

[0022] To achieve the above objectives, the self-current generating skin application patch according to the present invention includes a first region that contacts the user's skin, and a second region that is separated from the first region and contacts the adjacent skin to which the first region has contact, wherein the first region or the second region contains a biodegradable metal that can be decomposed and absorbed by reacting with moisture in the tissue, and is provided in the form of a thin sheet that directly contacts the user's skin and has a structure integral with the first region, and includes a first electrode layer having at least one through-hole that allows fluid delivery from the opposite side of the skin contact, a second electrode layer made of a different material with a different standard reduction potential from the material making up the first electrode layer, located on the opposite side of the first electrode layer to the skin contact in an insulated state from the first electrode layer, and at least a portion of which extends and is electrically connected to the second region, and a support layer located on the opposite side of the first electrode layer to the skin contact in a sheet having thickness, and is made of a hydrophilic material that can carry an ionic solution.

[0023] In this case, the first region or the second region may include at least one microneedle protruding in the direction of contact with the user's skin.

[0024] In this case, the biodegradable metal is represented by the following chemical formula 1.

[0025] [Chemical formula 1] Mg a Zn b Ca c X d

[0026] (In the formula, a, b, c, and d are weight percent of each component, where a + b + c + d = 100 weight percent, a is the largest, 0 ≤ b ≤ 5, 0 ≤ c ≤ 1, 0 ≤ d ≤ 1, and X is one or more impurities composed of elements other than Mg, Zn, and Ca.)

[0027] In this case, the first region and the first electrode layer may be biodegradable metals according to the chemical formula 1, and the second electrode layer may contain a different substance with a higher standard reduction potential than the first electrode layer.

[0028] On the other hand, the second electrode layer can be composed of one or more substances selected from copper, zinc, silver, silver chloride, iron, and stainless steel.

[0029] In this case, the second region may be a biodegradable metal according to chemical formula 1 and may be configured to be electrically connected to the portion extending from the second electrode layer.

[0030] On the other hand, the second electrode layer may be a biodegradable metal according to the chemical formula 1, and the first electrode layer may be configured to contain a different substance with a higher standard reduction potential than the second electrode layer.

[0031] In this case, it is preferable that the microneedle has a length of 0.02 mm or more.

[0032] On the other hand, the support layer may be interposed between the first electrode layer and the second electrode layer in a laminated configuration.

[0033] The first electrode layer and the second electrode layer are laminated in a manner that they are mutually insulated by an insulating layer, the second electrode layer has an opening that exposes at least a portion of the through-hole of the first electrode layer, and the support layer can be configured to cover at least a portion of the opening on the side of the first electrode layer opposite to the skin contact.

[0034] In this case, the through-hole formed in the first electrode layer is hole-shaped, and the microneedle may be formed by bending at least one along the edge of the hole in the direction of contact with the user's skin.

[0035] On the other hand, the second electrode layer can be applied in the form of a flexible cloth manufactured including conductive fibers.

[0036] On the other hand, the ionic solution may contain one or more selected from phosphate-buffered saline and sodium chloride aqueous solution, and may further contain at least one active ingredient from functional cosmetics and pharmaceuticals.

[0037] In this case, the active ingredient can be composed of ionic components.

[0038] On the other hand, the support layer may be one or more materials selected from among dry fabric-type materials such as pure cotton sheets, natural pulp sheets, and rayon sheets.

[0039] Furthermore, the device may further include a capsule that dispenses the ionic solution into the support layer upon user initiation.

[0040] On the other hand, it is preferable that the area of ​​the first region is at least twice the area of ​​the second region.

[0041] On the other hand, the first region formed integrally with the first electrode layer is in the form of a thin sheet and can have a thickness of 0.07 to 0.7 mm. [Effects of the Invention]

[0042] The self-current-generating skin patch containing biodegradable metal according to the present invention has the following effects due to the configuration described above.

[0043] Firstly, even in configurations without a separate power source such as a battery, sufficient ion electrophoresis of active ingredients and other effects of microcurrents can be provided by the self-generated microcurrent.

[0044] Secondly, by applying the magnesium-based biodegradable metal according to Chemical Formula 1 of the present invention, which can be degraded in contact with the skin or within tissue, as a material for skin-contact electrodes, the active ingredient delivery effect can be further enhanced by the degradation products that act as drug delivery enhancers.

[0045] Thirdly, by-products and hydrogen gas generated during the decomposition process can incidentally provide benefits such as wrinkle improvement, reduction of skin erythema caused by inflammation, and prevention of skin damage caused by the sun.

[0046] Fourthly, by equipping the user's skin contact area with micro-scale microneedles, not only can the delivery of active ingredients into the tissue be made even smoother by penetrating the stratum corneum, but the reduction in skin resistance due to the microneedles increases power, thereby further enhancing the effectiveness of drug delivery by ion electrophoresis.

[0047] Fifth, by appropriately arranging dissimilar metal materials with different mutual standard reduction potentials that are electrically connected to the first and second regions that come into contact with the skin, it is possible to provide a product that can be used appropriately depending on the negative or positive ionic nature of the active ingredient.

[0048] Sixth, biodegradable metals that come into contact with or are inserted into the skin undergo electrochemical reactions that release even more biodegradable metal ions, further accelerating the repair of damaged skin barriers. [Brief explanation of the drawing]

[0049] [Figure 1] This is a schematic side view of a skin application patch according to a preferred first embodiment of the present invention. [Figure 2] This is a schematic side view of a skin application patch according to a preferred second embodiment of the present invention. [Figure 3] This is a schematic side view of a skin application patch according to a third embodiment, which is a modified example of the first embodiment shown in Figure 1. [Figure 4]This is a schematic side view of a skin application patch according to a preferred fourth embodiment of the present invention, incorporating a pre-filled capsule. [Figure 5] This is a schematic side view showing the overall configuration in which the skin application patch according to the present invention is attached to the skin by an adhesive sheet. [Figure 6a] This diagram shows test specimens corresponding to the biodegradable metal compositions applicable to the present invention, on an alloy phase diagram. [Figure 6b] This diagram shows test specimens corresponding to the biodegradable metal compositions applicable to the present invention, on an alloy phase diagram. [Figure 6c] This diagram shows test specimens corresponding to the biodegradable metal composition applicable to the present invention, on an alloy phase diagram. [Figure 6d] This diagram shows test specimens corresponding to the biodegradable metal composition applicable to the present invention, on an alloy phase diagram. [Figure 6e] This diagram shows test specimens corresponding to the biodegradable metal compositions applicable to the present invention, on an alloy phase diagram. [Figure 6f] This diagram shows test specimens corresponding to the biodegradable metal compositions applicable to the present invention, on an alloy phase diagram. [Figure 6g] This diagram shows test specimens corresponding to the biodegradable metal compositions applicable to the present invention, on an alloy phase diagram. [Figure 6h] This diagram shows test specimens corresponding to the biodegradable metal compositions applicable to the present invention, on an alloy phase diagram. [Figure 7] This figure schematically shows an experiment using the electrodes used in the experiment of the present invention. [Figure 8] This figure shows the experimental conditions compared when copper and SUS301 were used as the positive electrode in a PBS solution. [Figure 9] This figure shows the experimental conditions compared when copper and SUS301 were used as the positive electrode in an NaCl solution. [Figure 10] This is a perspective view showing the shape of a microneedle and a through-hole applicable to the first area of ​​the present invention. [Figure 11]Figures 11(a) to (c) are photographs of prototype skin application patches according to the present invention, showing the case without microneedles, with 100 μm long needles, and with 230 μm long needles, respectively. [Figure 12] This is a perspective view of a skin application patch according to the present invention, in a product form in which an adhesive sheet and a release liner are provided together. [Figure 13] This is a magnified view of the patch product at the bottom of Figure 12. [Figure 14] This is an exploded perspective view of a skin application patch according to a preferred sixth embodiment of the present invention. [Figure 15] This is a photograph showing the skin adhesion state of a prototype product that realizes the skin application patch according to the embodiment in Figure 14. [Figure 16] These are photographs of patch samples, from left to right, with a copper thin plate, a 65 μm thick Ag / AgCl coating layer on a PET film, and a 130 μm thick Ag / AgCl coating layer on a PET film applied as the second electrode plate. [Modes for carrying out the invention]

[0050] The advantages and features of the present invention as described above, as well as methods for achieving them, will become clear with reference to the embodiments described later in detail with the accompanying drawings.

[0051] However, the present invention is not limited to the embodiments disclosed below, but can be realized in a variety of different forms, and these embodiments are provided merely to complete the disclosure of the present invention and to fully inform those who are ordinary skill in the art to which the present invention pertains, and the present invention is defined only by the scope of the claims.

[0052] The present invention is based on a structure in which a small current is generated due to the potential difference between two regions, as the part that comes into contact with the user's skin is made of a conductive metal material or other conductive material, and these are composed of two or more regions that are separated from each other.

[0053] For this purpose, the patch according to the present invention has the configuration of a voltaic cell, which is the most basic battery configuration.

[0054] In other words, a metal material with a high ionization tendency and a tendency to become a positive ion (a material with a low standard reduction potential) can be used as the negative electrode (-). In this invention, it is basically a magnesium-based material, and the details will be described later.

[0055] On the other hand, the positive electrode (+) can be a conductive material with a low ionization tendency (a material with a high standard reduction potential), and the structure allows for an electrolyte capable of ion exchange to be interposed between them.

[0056] In this invention, the solution that plays the role of the electrolyte is referred to as an "ionic solution," and can be provided to be supported on a support layer made of a dry fabric material such as a pure cotton sheet, a natural pulp sheet, or a rayon sheet that can support the solution.

[0057] In other words, the ionic solution supported on the support layer ionizes the metal of the negative electrode plate into positive ions, releasing electrons. Simultaneously, a small current is generated as these released electrons travel through human tissue to the positive electrode plate. This current acts as an electrolyte, simultaneously enabling the rapid and deep transmission of the active ingredients in the ionic solution into the subcutaneous tissue.

[0058] The active ingredient may penetrate and diffuse into the subcutaneous tissue along with the ionic solution during the penetration and diffusion process, or, because it itself possesses negative or positive ionic properties, its movement may be promoted by direct electrical forces.

[0059] In other words, when an active ingredient having negative ionic properties is supplied while the negative electrode metal is in contact with the skin, or when an active ingredient having positive ionic properties is supplied while the negative electrode metal is in contact with the skin, the delivery and diffusion effects of the active ingredient by electrical force can be maximized. For this reason, the present invention illustrates two main embodiments and their variations, and proposes additional embodiments.

[0060] Figure 1 is a schematic side view of a self-current generating skin application patch containing a biodegradable metal according to a preferred first embodiment of the present invention, wherein the first electrode layer 11, which constitutes a first region 10 that contacts the user's skin and acts as a negative electrode, has a magnesium-based composition represented by chemical formula 1 according to the present invention, as described later, and the second electrode layer 22, which has a support layer 30 interposed between it and the first electrode layer 11, can be made of a material that has a lower ionization tendency and a higher standard reduction potential than the first electrode layer 11, such as copper, zinc, silver, silver chloride, iron, stainless steel, etc.

[0061] In this state, the first region 10 and the second region 20 extending from the second electrode layer 22 come into contact with the user's skin, and when an ionic solution acting as an electrolyte is supported on the support layer 30, which is interposed between the first electrode layer 11 and the second electrode layer 22, which were electrically insulated by the support layer 30, ionization of the metal of the first electrode layer occurs, and electrons move through the skin, i.e., an electric current is generated.

[0062] In this case, if the active ingredient contained in the ionic solution supported on the support layer 30 has negative ionic properties, the delivery and diffusion of the active ingredient supplied to the skin below the first region 10 via the penetration portion 16 can occur more effectively due to ion electrophoresis.

[0063] Conversely, when the active ingredient contained in the ionic solution has positive ionic properties, it is preferable that the configuration be such that the difference in standard reduction potential between the first electrode layer 11 and the second electrode layer 22 is opposite to that of the first embodiment.

[0064] In other words, Figure 2 is a schematic side view of a self-current generating skin application patch containing a biodegradable metal according to a preferred second embodiment of the present invention. Unlike the first embodiment, the first electrode layer 11 constituting the first region 10 that contacts the user's skin acts as a positive electrode and can be made of a material that has a lower ionization tendency and a higher standard reduction transition than the second electrode layer 22 having a magnesium-based composition represented by chemical formula 1 according to the present invention, which will be described later. For example, it can be made of copper, zinc, silver, silver chloride, iron, stainless steel, etc.

[0065] In this state, if the active ingredient contained in the ionic solution supported on the support layer 30 has positive ionic properties, the delivery and diffusion of the active ingredient by ion electrophoresis supplied to the skin below the first region 10 via the penetration portion 16 can occur more effectively than when the active ingredient is electrically neutral or has negative ionic properties.

[0066] To clearly distinguish between these two types, the present invention names the first embodiment as the basic type and the second embodiment as the reverse type.

[0067] As a variation of the first embodiment, a patch like the one shown in Figure 3 may be provided.

[0068] In the first embodiment, which is the basic type, the second region 20 is structured such that the portion extending from the second electrode layer 22 is in direct contact with the skin. Therefore, in this embodiment, the second region 20 serves only as an electrode for ion electrophoresis and microcurrent.

[0069] However, even though it is a basic type, as in the third embodiment shown in Figure 3, when a biodegradable metal having a magnesium-based composition according to chemical formula 1 described later is bonded to the second region 20 in the direction of skin contact of the second electrode layer 22 which plays the role of the positive electrode, there is an advantage in that the favorable effects obtained during the metal decomposition process can be obtained over the entire area of ​​the patch.

[0070] On the other hand, the structure of a self-current generating skin patch containing biodegradable metal according to the fourth embodiment of the present invention, as shown in Figure 4, will be described.

[0071] As described above, the present invention may be provided such that an ionic solution containing the active ingredient is supplied to the supporting layer 30 without any ionic solution being supported on it, via the through-hole 16 or side portion of the first region 10.

[0072] In other words, in this case, the patch according to the present invention and an ampoule containing the active ingredient can be provided separately as a set, allowing the user to absorb the solution in the ampoule into the support layer 30 immediately before applying it to the skin.

[0073] However, in order to eliminate such inconveniences in use, the patch according to the fourth embodiment, which is a modification of the third embodiment which is the basic type, may include a separate capsule 40 that is contained within or adjacent to the volume of the support layer 30, and the capsule 40 may have a structure in which an ionic solution containing the active ingredient is stored.

[0074] In such a case, the user can pull the handle 41 connected to the capsule 40 to cause the ionic solution inside the capsule 40 to be dispensed into the support layer 30.

[0075] The patches according to the present invention, as illustrated in the first to fourth embodiments, can be attached to the user's skin in close contact with the adhesive sheet 50, as shown in Figure 5, and can be provided in a commercial form in which the adhesive sheet 50 and release paper are provided together, as shown in Figures 12 and 13.

[0076] Figure 13 is a magnified view of the patch product at the lower end of Figure 12, and is shown in a transparent state so that the positional relationships between each component can be confirmed. It can be confirmed that the structure is composed of a first electrode layer 11 formed by numerous through-holes 16 and a first region 10 formed over a large area, a second electrode layer 22 which is positioned between the first electrode layer 11 with a support layer 30 interposed between it and the second electrode layer 22, which extends to the right from a position overlapping with the first region 10, and the extended portion is joined to a microneedle thin plate corresponding to the second region 20 which has a smaller area than the first region 10.

[0077] Here, we will describe in detail the biodegradable metal according to the present invention that can be applied to the first electrode layer 11 and the first region 10 in Embodiment 1, the second electrode layer 22 and the second region 10 in Embodiment 2, and the first electrode layer 11, the first region 10 and the second region 20 in Embodiment 3.

[0078] The biodegradable metal according to the present invention can be defined by the following chemical formula 1.

[0079] [Chemical formula 1] Mg a Zn b Ca c X d

[0080] In the formula, a, b, c, and d are weight percent of each component, where a + b + c + d = 100 weight percent, a is the largest and therefore has a value of 0 or greater and a value of 100 or less, while 0 ≤ b ≤ 5, 0 ≤ c ≤ 1, and 0 ≤ d ≤ 1, and X can consist of one or more impurities composed of elements other than Mg, Zn, and Ca.

[0081] In other words, the biodegradable metal according to the present invention encompasses metals that decompose by reacting with water in the body, but specifically, it has magnesium as its main component, with zinc and calcium mixed in appropriate proportions to provide harmless and beneficial effects to the human body, and can be selected from compositions having various alloy phases and decomposition rates.

[0082] Figures 6a to 6h show the internal phases of alloys at specific temperatures depending on the magnesium, zinc, and calcium content. Depending on the content of these elements, they exist in states such as alpha-magnesium phase (HCP), ternary phase (Ca2Mg6Zn3), Mg2Ca(C14_b), and MgZn. Of these, the Mg2Ca phase increases the strength of the alloy but also increases the decomposition rate by forming a galvanic circuit, and the MgZn phase is also known to increase the decomposition rate by inducing fine galvanics within the alloy. In other words, an increase in the decomposition rate means that the degree of ionization is even higher than that of pure Mg, so it is expected that the electromotive force due to the difference in standard reduction potential with the positive electrode layer will also increase.

[0083] To illustrate using specimen 3 in Figure 6c as an example, when an alloy that exists in a liquid state at a casting temperature of approximately 650°C or higher is cooled, it goes through three stages: "a region where the alpha magnesium phase (HCP) and the liquid phase coexist," "a region where the alpha magnesium phase (HCP) is formed," and "a region where the alpha magnesium phase (HCP) and the ternary phase (Ca2Mg6Zn3) are formed." At this time, the structure of the alloy is determined by the formed alpha magnesium phase (HCP) and ternary phase (Ca2Mg6Zn3), and the formation of the MgZn phase at its lower end can be prevented. If one were to intentionally try to form the MgZn phase with the composition of specimen 3, the manufactured alloy would have to be heat-treated for a long time at a temperature of approximately 120°C or lower. However, in a typical casting furnace, the specimen is removed from the furnace and rapidly cooled before it cools to the temperature at which the MgZn phase is formed, so the MgZn phase is not formed.

[0084] On the other hand, the impurities mentioned above are those that flow in from a crucible or the like during the manufacturing process, such as Ce, Mn, Al, Pb, Fe, Ni, Zr, Cu, Th, Be, Cd, Sn, P, Si, La, Sr, Pr, Na, and Y, and it is preferable that the total amount is 1% by weight or less.

[0085] In the present invention, the biodegradable metal can be produced by melting and mixing magnesium, calcium, and zinc, as is commonly known, and then molding the mixture.

[0086] The melting can be carried out in an inert gas atmosphere such as argon (Ar), which does not react with magnesium, calcium, and zinc, or in a vacuum atmosphere. Various methods can be used, such as a resistance heating method in which electricity is applied to a resistor to generate heat, an induction heating method in which current is passed through an induction coil, or a method using a laser or focused light.

[0087] The molding process can be exemplified by, but is not limited to, cooling methods, extrusion methods, and metalworking methods. The cooling method can be used to improve the mechanical strength of the magnesium alloy. More specifically, a method can be used in which a crucible containing molten magnesium is immersed in water. Alternatively, a cooling method can be used in which the molten magnesium is sprayed using an inert gas such as argon. This spray cooling method cools the magnesium at a much higher rate, resulting in a very fine structure. However, when casting magnesium to a small size, care should be taken as numerous pores may form inside.

[0088] By utilizing this processing method, magnesium-based alloys can be manufactured in a form containing a composition and crystalline phase suitable for generating a desired level of electromotive force. For example, a galvanic circuit can be configured to increase the decomposition rate as a way to further increase the electromotive force while using the same electrode, resulting in the formation of an alloy containing a high-strength Mg2Ca phase.

[0089] <Examples> [Manufacturing of biodegradable metal test specimens]

[0090] Calcium, zinc, and magnesium were placed in a crucible with an internal diameter of 50 mm, made of stainless steel (SUS410) (or a crucible made of carbon), according to the composition shown in Table 1 below. Next, while argon gas was flowed around the crucible to prevent contact between the calcium, zinc, and magnesium in the crucible and air, the crucible temperature was raised to approximately 700°C to 750°C using a resistance heating furnace to melt the calcium, zinc, and magnesium. The materials in the crucible were stirred to ensure thorough mixing of the molten calcium, zinc, and magnesium. The completely molten magnesium alloy was then cooled to produce a solid magnesium alloy. Furthermore, during cooling, the crucible was immersed in water to rapidly cool the molten magnesium alloy in order to improve the mechanical strength of the magnesium.

[0091] Test specimens were manufactured by extruding the solid magnesium alloy described above at an extrusion temperature of 400°C, with an extrusion ratio of 40:1 for the reduction in cross-sectional area before and after extrusion. The composition of the manufactured test specimens was evaluated using a metal composition analyzer (SPECTRO MAXx), and the results are shown in Figures 6(a) to (h) and Table 1.

[0092] [Table 1]

[0093] Subsequently, the manufactured test specimens were placed in a heating furnace and subjected to further heat treatment at a temperature of 450°C for 24 hours to produce heat-treated biodegradable metal test specimens.

[0094] [Evaluation of the decomposition characteristics of biodegradable metals]

[0095] As described above, we selected some samples of heat-treated biodegradable metal test pieces and evaluated their decomposition characteristics. To evaluate the decomposition characteristics, considering the characteristic of alkaline earth metals to release hydrogen gas when they decompose, we measured the amount of hydrogen gas released during decomposition using an eudiometer in a PBS solution set at 37°C, and the results are shown in Table 4.

[0096] [Table 2]

[0097] Table 2 shows that by comparing the commercially available biodegradable alloy material used as a comparative example with the test specimens produced in the examples, it can be confirmed that test specimens with high and low degradation rates exist in a diverse spectrum relative to the commercially available biodegradable alloy material. This allows for the selective application of magnesium-based alloy compositions with appropriate degradation rates depending on the active ingredients and application period of the skin application patch provided by the present invention.

[0098] Because it is manufactured from a biodegradable metal with the composition of the aforementioned chemical formula 1, the microneedle 15 formed in the first region 10 or second region 20, which is the user's skin contact area according to the present invention, differs from ordinary microneedles in that, after being inserted subcutaneously or into the epithelium for the injection of active ingredients, it acts as an electrode, and is also characterized by being absorbed and decomposed, releasing metal ions and decomposition products into the body.

[0099] The magnesium (Mg), calcium (Ca), zinc (Zn), etc., used as materials for the microneedles of the present invention are biodegradable metals of the alkaline earth metal type, and have a mechanism that reacts with water to release hydrogen gas as shown in the following formula. Therefore, when the aforementioned metal microneedles are absorbed and decomposed subcutaneously, they release ions and decomposition products, and the hydrogen gas generated by the by-products provides a swelling effect subcutaneously, inducing a wrinkle-improving effect. They can also reduce skin erythema caused by inflammation and prevent skin damage caused by the sun (Non-patent Literature 1-2: YOON, KS et al., Histological study on the effect of electrolyzed reduced water-bathing on UVB radiation-induced skin injury in hairless mice, Biological and Pharmaceutical Bulletin 34, 1671-7, 2011; IGNACIO, RM, et al., The balneotherapy effect of hydrogen reduced water on UVB-mediated skin injury in hairless mice, Molecular & Cellular Toxicology 9, 15-21, 2013).

[0100] Mg + 2H2O → Mg(OH)2 + H2(gas)

[0101] Zn + 2H2O → Zn(OH)2 + H2(gas)

[0102] Ca + 2H2O → Ca(OH)2 + H2(gas)

[0103] Furthermore, ZnO and MgCl, byproducts generated when magnesium (Mg) and zinc (Zn) are inserted into the body, can act as drug delivery enhancers, improving drug absorption even if they do not penetrate subcutaneously and remain only on the skin surface. Therefore, needles composed of biodegradable metals can further enhance the delivery effect of the active ingredient supported on the patch according to the present invention.

[0104] Therefore, as described above, by applying the biodegradable metal to the skin contact area of ​​the skin application patch according to the present invention, synergistic effects such as beneficial effects from degradation products and effects as drug delivery enhancers can be obtained.

[0105] [Electromotive force generation experiment based on electrolyte type and negative electrode metal type]

[0106] Prior to this experiment, a preliminary experiment was conducted comparing the generation of electromotive force using PBS and commercially available acne ampoule solutions. In the case of the acne ampoule solutions, the electromotive force did not reach the standard for any of the negative electrode metals. Therefore, it was confirmed that the ionic solution applicable to the present invention must be either a solution with a high degree of ionization as an electrolyte mixed with the active ingredient, or an aqueous solution of the active ingredient with a high degree of ionization itself.

[0107] As shown in Figure 7, a pure water Mg electrode containing unavoidable impurities was used as the negative electrode. Commercial phosphate-buffered saline (PBS) and an artificially produced 0.9% NaCl aqueous solution were prepared as electrolytes applicable as the ionic solution of the present invention, and experiments were conducted using SUS301, a type of stainless steel, and copper as the positive electrode metals.

[0108] These experiments were carried out as shown in the photographs in Figures 8 and 9.

[0109] FIG. 8 shows the experimental states in which copper and SUS301 were respectively used as the positive electrode in PBS solution,

[0110] FIG. 9 shows the experimental states in which copper and SUS301 were respectively used as the positive electrode in NaCl solution.

[0111] The results thereof are shown in Table 3 below.

[0112]

Table 3

[0113] Open circuit voltage V oc For the measurement of the operating voltage and current together with this, a 500 Ω resistor was used. As a result, it was confirmed that as the electrolyte contained in the ionic solution, a 0.9% NaCl aqueous solution artificially manufactured rather than PBS was more advantageous. This is presumably because there are even fewer factors hindering ion movement in the aqueous solution.

[0114] On the other hand, regarding the matching as the positive electrode, it was confirmed that the Mg-SUS301 combination was generally more advantageous in terms of electromotive force. However, the Mg-Cu combination was also predicted to be sufficient for application to the patch of the present invention. In the human application experiment described later, copper has a more advantageous aspect in terms of ductility related to skin adhesion and adhesiveness, so it can be appropriately selected according to the structure of the patch to be manufactured.

[0115] From the above experiments, it was confirmed that the ionic solution according to the present invention preferably includes, in addition to the NaCl aqueous solution, other ionic aqueous solutions having a degree of ionization similar thereto. Therefore, an effective component solution having an ionization degree comparable thereto, or the ionic solution according to the present invention can be provided by mixing the effective component with the good electrolyte solution.

[0116] As for the active ingredient, there are no restrictions as long as it is an ingredient that can produce the effect of a functional cosmetic or pharmaceutical, and it is even more preferable if the active ingredient has ionic properties.

[0117] For example, functional cosmetics are defined as follows:

[0118] - Functional cosmetics that help whiten the skin

[0119] - Functional cosmetics that help improve skin wrinkles

[0120] - Functional cosmetics that help protect the skin from ultraviolet rays

[0121] - Functional cosmetics that help change hair color (including desalting and bleaching).

[0122] - Functional cosmetics that help remove body hair

[0123] - Functional cosmetics that help soothe acne-prone skin

[0124] In particular, with regard to skin whitening (brightening skin tone), wrinkle improvement, and acne-fighting effects, the applicant of the present invention has already disclosed through publications such as Korean Patent Registration No. 2194089, "Flexible Metal Patch Having Antioxidant Activity and Whitening Effect and Method of Use Thereof," and Korean Patent Registration No. 2310566, "Acne Relief and Prevention Patch," that the biodegradable metal according to the present invention exhibits the aforementioned functional effects on its own without the need for additional active ingredients. Therefore, a higher synergistic effect can be expected compared to when the biodegradable metal skin application patch according to the present invention is used together with an active ingredient intended for this purpose.

[0125] On the other hand, as shown in Figure 10, the microneedles 15 and through-holes 16 applied to the first region 10 according to the present invention may have a configuration in which the through-holes 16 are polygonal or closed curved hole shapes, and at least one microneedle 15 is arranged on the edge of the through-holes 16.

[0126] The advantages of this structure are that, in the manufacturing of microneedle patches, after simultaneously forming the microneedles and penetrations on a flat surface, a patch with a large number of needles can be easily provided by bending the microneedles using a jig or the like. Furthermore, in use, the structure is formed with needles arranged around a wide penetration, allowing the active ingredient supplied from above the penetration 16 to be easily delivered downwards through the penetration 15, and simultaneously delivered to the inside of the skin along the insertion path of the microneedles.

[0127] In other words, in the case of the patch according to the present invention, the active ingredient in the ionic solution supported on the support layer is delivered to the inside of the skin through the process described above, and then can be rapidly diffused by electrical force, so the structure of the microneedle 15 and the penetration portion 16 can be applied in a structure further optimized for the present invention.

[0128] On the other hand, in addition to the aforementioned beneficial effects that occur when the microneedle 15 according to the present invention is inserted into the skin and decomposed, it plays a crucial role in generating a higher electromotive force according to the main objective of the present invention, enabling the ion electrophoresis of the active ingredient to be provided not merely as a concept but as a practical product.

[0129] [Electromotive force experiments with microneedles in skin contact, varying in presence and length]

[0130] Figures 11(a) to (c) are photographs of prototype self-current generating skin application patches containing biodegradable metal according to the present invention, in the case without microneedles, with needles of 100 μm in length, and with needles of 230 μm in length, respectively.

[0131] As shown in the photograph, a 0.07 mm thick magnesium metal sheet with numerous hole-shaped perforations was used as the first electrode layer, which has its entire surface in contact with the skin; a 0.07 mm thick copper metal sheet was used as the second electrode layer, which has a portion in contact with the skin; and a 0.28 mm thick pure cotton sheet was used as the support layer for the ionic solution.

[0132] The first electrode layer and the second electrode layer were electrically isolated by a pure cotton sheet, with no direct electrical connection between them. A 0.9% NaCl aqueous solution was used as the electrolyte for the ionic solution.

[0133] In this state, the patches shown in Figure 11 were applied to the user's skin, and the operating voltage and operating current were measured. The results are shown in Table 4 below.

[0134] [Table 4]

[0135] In other words, it can be confirmed that patches (b) and (c) show a significant increase in electromotive force with increasing current compared to patch (a) which has no microneedles, and in particular, patch (c) shows an increase in electromotive force of nearly six times compared to patch (b). As a result, it is estimated that when the needle length is 100 μm or more and penetrates the stratum corneum and epidermis of the skin to reach the dermis, a dramatic reduction in skin resistance can be obtained, so it is preferable that the thickness of the microneedles be at least 50 μm, which is the normal thickness of the epidermis.

[0136] Furthermore, as demonstrated in the patch manufacturing experiment, the thinner the sheet thickness of the first or second region, the better the adhesion and bonding to the skin. Therefore, it is preferable that the thickness be within an appropriate range. However, in the case of biodegradable metals according to the present invention, thin sheet processing to less than 0.07 mm is not easy, and if the thickness is 0.7 mm or more, a lifting phenomenon on the skin is observed despite its ductility. Therefore, the range is preferably 0.07 to 0.7 mm.

[0137] On the other hand, various experiments have confirmed that the larger the volume of the support layer 30 carrying the ionic solution, that is, the larger the amount of electrolyte solution, the greater the increase in electrical and physical quantities. However, in the case of a patch product with a structure in which the support layer is interposed between the first electrode layer and the second electrode layer according to the above-described embodiment of the present invention, there is a limit to how much the thickness of the support layer can be increased. Therefore, it is preferable to maximize its area, and thereby it is preferable that the area of ​​the first region 10 corresponding to the area of ​​the support layer 30 is more than twice that of the second region 20.

[0138] In this regard, a sixth embodiment, shown in Figure 14, will be described as another modification of the third embodiment, which is the basic type.

[0139] Figure 14 is an exploded perspective view showing a structure in which the first region 10 and the second region 20, which are the skin contact surfaces, are placed at the top of the drawing, and the second electrode layer 22, the support layer 30, and other components are sequentially placed at the bottom according to the stacking order.

[0140] In other words, the first region 10 and the second region 20 can be composed of biodegradable metals having a magnesium-based composition according to chemical formula 1, which will be described later. The second region 20 is joined so as to be electrically connected to the material forming the second electrode layer 22, while the first region is joined via an insulating layer 60 so as not to be in direct electrical contact with the second electrode layer 22.

[0141] In other words, such an integrated structure of insulating layer 60 and second electrode layer 22 can be manufactured by coating a conductive material on one surface of an insulating film (such as PET film) to form the second electrode layer 22, and then removing the insulating film in a portion of the area, or by manufacturing it including conductive fibers (such as copper fibers or silver fibers), so that the first region 10 can be laminated onto the insulating layer 60 formed by bonding insulating snow sculpture means to a portion of one surface of a conductive cloth.

[0142] In other words, the structure shown in Figure 14 can be realized by cutting a silver cloth woven from silver fibers into the desired shape as the material for the second electrode layer 22, then applying an insulating adhesive to a portion of the surface of the cloth, or by attaching insulating tape to it, to form the insulating layer 60 shown in white in Figure 15. Biodegradable metal corresponding to the second region 20 is bonded to the black portion where the surface of the material of the second electrode layer 22 is exposed, and biodegradable metal as the first electrode layer 11 corresponding to the first region 10 is bonded to the white portion where the second electrode layer 22 is insulated.

[0143] On the other hand, unlike the above embodiment in which the support layer 30 is interposed between the first electrode layer 11 and the second electrode layer 22, in the embodiment illustrated in Figure 14, the support layer 30 is located outside the second electrode layer 22 (on the lower side in the drawing, opposite the skin contact surface), so that when the device is attached to the skin, the support layer 30 is located on the outermost surface.

[0144] The advantages of this structure are that, compared to structures that sandwich a support layer 30 such as a pure cotton sheet, natural pulp sheet, or rayon sheet, the first electrode layer 11 and second electrode layer 22 are laminated in the form of thin films first, and then the support layer is bonded to the outside. This makes manufacturing easier, is advantageous in securing the area of ​​the support layer 30, and results in superior rigidity in the finished product.

[0145] Furthermore, in a structure like the one described, where there is no internal ionic solution support layer between the first electrode layer 11 and the second electrode layer 22, the second electrode layer 22 must also be open upwards with an opening 65 or the like in order to disclose the generation of self-current when the patch is applied without prior supply of the ionic solution. For this reason, it is preferable that the second electrode layer 22 has an opening 65, which allows the ionic solution to be easily and continuously supplied to the first region 10 and the skin below it, without any restrictions on the amount supplied.

[0146] At this time, by further bonding the support layer 30 in a manner that covers at least a part (as much as possible) of the opening 65, the ionic solution supplied from above instantly diffuses over the entire surface area of ​​the support layer 30, allowing the electrochemical reaction to proceed more smoothly, and the supported ionic solution can be supplied gradually and steadily to the inside of the patch. As a result, ion exchange can occur between the exposed portion of the electrically insulated second electrode layer 22 and the first electrode layer 11 by the electrolytic solution of the ionic solution.

[0147] With this configuration, problems such as the limited area of ​​the support layer 30, the weakening of skin adhesion due to moisture leaking from the support layer because the support layer 30 is located on the inside of the patch, and the difficulty of the ionic solution easily diffusing across the entire surface of the first electrode layer 11 are resolved, and additional advantages such as the ability to filter out foreign matter mixed in the ionic solution can be expected.

[0148] Figure 15 shows a photograph of the patch of the sixth embodiment actually implemented and applied to the skin. This configuration confirms that the self-current-generating skin application patch containing biodegradable metal according to the present invention can be realized in a structure that allows for the smooth and continuous supply of an ionic solution containing the active ingredient via the uppermost support layer 30 even when attached to the skin.

[0149] [Characterization of patches containing Ag / AgCl mixed electrode material]

[0150] Following electromotive force experiments with magnesium metal as the first electrode layer and Cu or SUS301 as the second electrode layer, as previously confirmed, and in order to evaluate the characteristics of a patch structure that is easily realized with the structure described in Embodiment 6 above, two types of electrode layers were prepared: a 0.07 mm thick magnesium metal sheet containing unavoidable impurities as the first electrode layer, and a 0.05 mm thick PET film coated with a paste-like Ag / AgCl mixture as the second electrode layer. A 0.03 mm thick Cu sheet was also prepared as a comparison sample. Thus, three types of samples were prepared in which the first and second electrode layers were laminated and bonded in an insulated state. The morphology of these samples is shown in Figure 16, and it was confirmed that they had the characteristics shown in Table 5 below, sequentially from left to right.

[0151] [Table 5]

[0152] The paste-like Ag / AgCl mixture used in the experiment was product SC141 sold by KT Corporation, which hardens when heated at 120°C for 30 minutes. The experiment was conducted by coating a 50 μm PET film with the Ag / AgCl mixture at varying thicknesses as follows. The results of the experiment with the above samples under a load resistance of 500 Ω are summarized in Table 6 below. The electrolyte solution used was a 0.9% NaCl aqueous solution.

[0153] [Table 6]

[0154] Compared to Sample 1, which was an experimental result using a thin Cu plate, the Ag / AgCl ratio in Sample 2 and Sample 3 showed a clear and further increase. From the results of Sample 2 and Sample 3, it can be confirmed that the operating voltage, operating current, and electromotive force increase proportionally with increasing Ag / AgCl coating layer thickness. When the structure of the second electrode layer + insulating layer is realized in the form of a coating layer on a film, it was confirmed that there is an appropriate thickness in terms of aspects such as deformation and flexibility. In conclusion, we were able to confirm the electrical advantages of using Ag as the material for the second electrode layer compared to Cu, and we also confirmed that it is possible to manufacture products with advantages in terms of patch flexibility and adhesion by using silver cloth woven from silver fibers as the second electrode layer instead of a coating method.

[0155] Although specific embodiments of the present invention have been described above, it goes without saying that various modifications are possible without departing from the scope of the present invention.

[0156] Therefore, the scope of the present invention should not be limited to the embodiments described, but should be defined not only by the claims described below, but also by equivalent claims.

Claims

1. It includes a first region (10) that contacts the user's skin, and a second region (20) that is separated from the first region (10) and contacts the adjacent skin that the first region (10) has contacted. The first region (10) or the second region (20) contains biodegradable metals that come into contact with the user's skin or react with moisture in the tissue to decompose and be absorbed. A first electrode layer (11) is provided in the form of a thin sheet that directly contacts the user's skin and has a structure integral with the first region (10), and has at least one through-hole that allows fluid delivery from the side opposite to the skin contact, A second electrode layer (22) is made of a different material with a different standard reduction potential from the material forming the first electrode layer (11), is located on the opposite side of the first electrode layer (11) from the skin contact, and at least a portion of it extends and is electrically connected to the second region (20), The device comprises a support layer (30) which is located on the opposite side of the first electrode layer (11) from the skin contact surface in a sheet-like form having thickness, and is made of a hydrophilic material capable of supporting an ionic solution. A self-current generating skin patch containing biodegradable metals, characterized by its features.

2. The self-current generating skin application patch containing a biodegradable metal according to claim 1, characterized in that the first region (10) or the second region (20) includes at least one microneedle (15) protruding in the direction of contact with the user's skin.

3. The biodegradable metal is given by the following chemical formula 1: [Chemical formula 1] Mg ａ Zn ｂ Ca ｃ X ｄ (In the formula, a, b, c, and d are weight percent of each component, where a + b + c + d = 100 weight percent, a is the largest, 0 ≤ b ≤ 5, 0 ≤ c ≤ 1, 0 ≤ d ≤ 1, and X is one or more impurities other than Mg, Zn, and Ca.) It is represented A self-current generating skin patch containing a biodegradable metal as described in claim 1 or 2.

4. The first region (10) and the first electrode layer (11) are biodegradable metals according to the chemical formula 1, and the second electrode layer (22) contains a different substance with a higher standard reduction potential than the first electrode layer (11). A self-current generating skin patch containing a biodegradable metal as described in claim 3.

5. The second electrode layer (22) is composed of one or more substances selected from copper, zinc, silver, silver chloride, iron, and stainless steel. A self-current generating skin patch containing a biodegradable metal as described in claim 4.

6. The second region (20) is a biodegradable metal according to chemical formula 1 and is electrically connected to the portion extending from the second electrode layer (22). A self-current generating skin patch containing a biodegradable metal as described in claim 5.

7. The second electrode layer (22) is a biodegradable metal according to the chemical formula 1, and the first electrode layer (11) contains a different substance with a higher standard reduction potential than the second electrode layer (22). A self-current generating skin patch containing a biodegradable metal as described in claim 3.

8. The microneedle (15) has a length of 0.02 mm or more. A self-current generating skin patch containing a biodegradable metal as described in claim 2.

9. The support layer (30) is interposed between the first electrode layer (11) and the second electrode layer (22) and is positioned in a stacked configuration. A self-current generating skin patch containing a biodegradable metal as described in claim 1.

10. The first electrode layer (11) and the second electrode layer (22) are laminated in a state where they are mutually insulated by an insulating layer (60). The second electrode layer (22) has an opening (65) that exposes at least a portion of the through-hole of the first electrode layer (11), The support layer (30) is positioned to cover at least a portion of the opening (65) on the side of the first electrode layer (11) opposite to the skin contact. A self-current generating skin patch containing a biodegradable metal as described in claim 1.

11. The through-hole formed in the first electrode layer (11) is hole-shaped, and at least one of the microneedles (15) is formed by bending along the edge of the hole in the direction of contact with the user's skin. A self-current generating skin patch containing a biodegradable metal as described in claim 2.

12. The second electrode layer (22) is applied in the form of a flexible cloth manufactured including conductive fibers. A self-current generating skin patch containing a biodegradable metal as described in claim 4.

13. The aforementioned ionic solution contains one or more selected from phosphate-buffered saline and sodium chloride aqueous solution. A self-current generating skin patch containing a biodegradable metal as described in claim 1.

14. The ionic solution further comprises at least one active ingredient from among functional cosmetics and pharmaceuticals. A self-current generating skin patch containing a biodegradable metal as described in claim 1 or 13.

15. The aforementioned active ingredient is ionic. A self-current generating skin patch containing a biodegradable metal as described in claim 14.

16. The support layer (30) is one or more materials selected from among pure cotton sheets, natural pulp sheets, and rayon sheets, which are materials in the form of dried fabric. A self-current generating skin patch containing a biodegradable metal as described in claim 1.

17. The invention further includes a capsule (40) that dispenses the ionic solution into the support layer (30) upon user initiation. A self-current generating skin patch containing a biodegradable metal as described in claim 1 or 16.

18. The area of ​​the first region (10) is at least twice the area of ​​the second region (20). A self-current generating skin patch containing a biodegradable metal as described in claim 9.

19. The first region (10), which is formed integrally with the first electrode layer (11), is in the form of a thin sheet and has a thickness of 0.07 to 0.7 mm. A self-current generating skin patch containing a biodegradable metal as described in claim 1.

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