Micro-needle patch with ultra sonic wave and micro-needle particle patch with ultra sonic wave

Abstract

The present invention relates to an ultrasound-coupled microneedle patch and an ultrasound-coupled microneedle particle patch for enhancing transdermal absorption of the skin. More specifically, the invention relates to an ultrasound-coupled microneedle patch and an ultrasound-coupled microneedle particle patch for enhancing transdermal absorption of the skin, which allow an active substance to be directly absorbed into the skin by penetrating and dissolving into the skin. According to the present invention, by forming a layer of composition that performs skin soothing and regenerative functions on the surface of a microneedle patch that delivers drugs to the skin via transdermal absorption, it is possible to rapidly and directly treat wounds caused by the penetration of the needles into the skin.

Description

Technology Field

[0001] The present invention relates to an ultrasound-coupled microneedle patch for enhancing skin transdermal absorption and an ultrasound-coupled microneedle particle patch for enhancing skin transdermal absorption, and more specifically, to an ultrasound-coupled microneedle patch for enhancing skin transdermal absorption and an ultrasound-coupled microneedle particle patch for enhancing skin transdermal absorption that penetrates the skin and dissolves to allow an active substance to be directly absorbed into the skin. Background Technology

[0002] The skin is the gateway that protects our body from various intrusions, such as microorganisms, chemicals, and physical and chemical injuries. On average for an adult, the total surface area of ​​the skin is approximately 2 m², and its weight accounts for about 15% of body weight.

[0003] The skin, which makes up a significant portion of the body, has been used only as a primary defense mechanism of our body and has been utilized only partially as a means of delivering useful substances such as drugs.

[0004] Traditional methods for supplying moisture or delivering drugs through the skin involve applying liquid substances, ointments, creams, patches, etc., to the skin surface and allowing them to be delivered through the skin. However, due to the skin's inherent oil-soluble nature and the structure of the stratum corneum that prevents the intrusion of foreign substances, such conventional technologies either make delivery impossible at all or, even when delivery is possible, deliver only very small amounts.

[0005] Microneedles have been proposed as a new means to solve these problems. Microneedles are a method of delivering a desired substance by manufacturing multiple micro-needles of 250 µm or less, applying a desired substance to their surfaces or within their penetration holes, and then inserting the microneedles into the skin. The most significant feature of microneedles is that they deliver the desired substance through the skin without causing pain.

[0006] Unlike conventional injections, microneedles have the advantages of not causing pain or irritation, allowing for administration by non-professionals, eliminating the discomfort associated with needle insertion, being relatively inexpensive, and having few side effects.

[0007] In particular, technology using microneedles is being developed to produce cosmetic effects such as skin whitening, wrinkle removal, improved elasticity, and blemish removal, and has the advantage of being faster and more direct than oral administration or creams.

[0008] However, since microneedles must also penetrate the skin, they leave tiny abrasions in the process, and users with sensitive skin may experience pain or discomfort at the treatment site.

[0009] In addition, it causes inconvenience because regenerative creams or soothing substances must be applied additionally to treat micro-wounds on the skin after the microneedle procedure. Prior art literature

[0010] (Patent Document 0001) KR 10-2019-0123642 A(Patent Document 0002) KR 10-2023-0132131 A(Patent Document 0003) KR 10-2022-0004888 A The problem to be solved

[0011] The present invention, aimed at solving the aforementioned problems, provides an ultrasound-coupled microneedle patch for enhancing transdermal absorption by coating a layer containing a composition that soothes and regenerates the skin on the surface of the microneedle patch, thereby allowing the composition to act on the skin simultaneously with the penetration of the needles into the skin.

[0012] In addition, the invention aims to provide an ultrasound-coupled microneedle patch for enhancing transdermal absorption, wherein a composition comprising sucralfate and vitamin K as main ingredients is applied to the surface of a panel or needle to enable skin soothing and regenerative effects, thereby allowing it to be directly delivered into the dermis.

[0013] In addition, the purpose is to provide an ultrasound-coupled microneedle patch for enhancing transdermal absorption of drugs, which is equipped with an ultrasound application means for applying ultrasound to a microneedle structure to deliver ultrasound energy to the skin, thereby enabling homogeneous absorption of the drug. means of solving the problem

[0014] The present invention, devised to solve the aforementioned problems, is a microneedle patch that penetrates the skin and delivers an active substance into the skin, comprising: a panel (110) made of a soft material; a needle (120) formed as a protruding structure on one side of the panel (110) and penetrating the skin to dissolve; an ultrasonic application means (130) coupled to the other side of the panel (110) to apply ultrasonic vibration to the panel (110); and a composition layer formed on the surface of the panel (110) or on the surface of the needle (120).

[0015] The above composition layer is characterized by being composed of a first composition layer (140) formed on the surface of the panel (110).

[0016] The above composition layer is characterized by being composed of a second composition layer (150) formed on the surface of the needle (120).

[0017] The above composition layer is characterized by being a mixture of sucralfate and vitamin K mixed in a fat-soluble solvent.

[0018] The above composition layer is characterized by being manufactured by the steps of: introducing sucralfate powder into a container in which a fat-soluble solvent is stored; stirring the solution at a speed of 500 RPM to 2,000 RPM while maintaining the temperature of the solution at 50°C to 70°C; cooling the stirred solution to 30°C to 40°C; adding vitamin K to the solution to complete the composition consisting of the sucralfate mixture; and applying the composition to the surface of the panel (110) or the needle (120).

[0019] The above vitamin K is menadione, a synthetic vitamin, and is characterized by being added to the above solution in a state where its surface is liposomalized.

[0020] The above-mentioned ultrasonic application means is characterized by generating ultrasonic waves in the frequency band of 20 kHz to 40 kHz.

[0021] According to another embodiment, the present invention is a microneedle patch that penetrates the skin and delivers an active substance into the skin, comprising: a panel (110) made of a soft material; an adhesive layer (160) formed on one side of the panel (110); a particle (170) that has an irregular shape and is attached to the adhesive layer (160) to form a protruding structure, and penetrates the skin and dissolves; an ultrasonic application means (130) coupled to the other side of the panel (110) to apply ultrasonic vibration to the panel (110); and a composition layer formed on the surface of the panel (110) or on the surface of the particle (170). Effects of the invention

[0022] According to the present invention, by forming a layer of composition that soothes and regenerates the skin on the surface of a microneedle patch that delivers drugs to the skin via transdermal absorption, there is an effect of rapidly and directly treating wounds caused by the penetration of the needles into the skin.

[0023] In addition, by applying ultrasound in a frequency band where resonance with skin tissue or body fluids occurs most effectively, homogeneous absorption of the drug is achieved. Brief explanation of the drawing

[0024] FIG. 1 is a perspective view showing the structure of a microneedle patch according to one embodiment of the present invention. FIG. 2 is a cross-sectional view showing the state in which a first composition layer is formed. FIG. 3 is a cross-sectional view showing the state in which a second composition layer is formed. FIG. 4 is a conceptual diagram showing a process for preparing a sucralfate mixture. FIG. 5 is a flowchart showing a process for preparing a sucralfate mixture. FIG. 6 is a cross-sectional view showing the process of manufacturing microneedles in the first process. FIG. 7 is a cross-sectional view showing the process of manufacturing microneedles in the second process. FIG. 8 is a conceptual diagram showing the process of forming the structure of a microneedle particle patch according to another embodiment of the present invention. FIG. 9 is a cross-sectional view showing the structure of a microneedle particle patch. Specific details for implementing the invention

[0025] Hereinafter, with reference to the drawings, an "ultrasound-coupled microneedle patch for enhancing skin transdermal absorption" (hereinafter referred to as "microneedle patch") and an "ultrasound-coupled microneedle particle patch for enhancing skin transdermal absorption" (hereinafter referred to as "microneedle particle patch") according to an embodiment of the present invention will be described.

[0026] FIG. 1 is a perspective view showing the structure of a microneedle patch according to one embodiment of the present invention, FIG. 2 is a cross-sectional view showing the state in which a first composition layer is formed, and FIG. 3 is a cross-sectional view showing the state in which a second composition layer is formed.

[0027] The microneedle patch (100) of the present invention is configured to penetrate the surface of the skin and directly deliver a drug into the skin, and the needles (120) that penetrate into the skin are composed of a substance capable of producing effects such as wrinkle removal or whitening. Typically, the needles (120) are manufactured with hyaluronic acid as the main component, and may also include other substances effective for skin beauty.

[0028] The needle (120) is formed to protrude from one side of the flat panel (110). The panel (110) is mainly made of synthetic resin material, but various other materials may also be used. Preferably, it is made of a soft material so that it can adhere to curved body parts such as the face or neck.

[0029] A needle (120) having a pointed protruding structure is formed on the surface of the panel (110). The needle (120) may be formed by stacking a viscous medicinal substance in a cone shape or by dropping a liquid medicinal substance in a droplet shape and then turning the panel (110) upside down so that it becomes a pointed shape by gravity. Since the process of forming the structure of the needle (120) in the present invention can apply the same technology as the disclosed prior art for the method of forming the needle structure of a microneedle patch used for skin care, a detailed description is omitted.

[0030] An ultrasonic application means (130) is coupled to the opposite side of the panel (110) where the needle (120) is formed. The ultrasonic application means (130) includes a device that generates ultrasonic waves of a specific frequency and delivers ultrasonic energy to the skin for homogeneous absorption of a medicinal substance. In the present invention, ultrasonic waves in the frequency band of 20 kHz to 40 kHz are generated. Since frequencies in this band can cause maximum resonance or resonance phenomena with the skin or body fluids, the absorption efficiency of the drug can be maximized.

[0031] The technology of forming a needle (120) having a protruding structure on one surface of a panel (110) made of a soft material, allowing an active substance such as hyaluronic acid to be directly delivered into the skin as the needle (120) dissolves while penetrating the skin, and transmitting ultrasound to the panel (110) to achieve homogeneous diffusion of the active substance is the same as that used in conventional microneedles.

[0032] Meanwhile, the present invention is configured to help treat skin wounds by applying an additional medicinal substance to the microneedle patch (100). To this end, a first composition layer (140) and a second composition layer (150) are formed on the microneedle patch (100) either simultaneously or separately. For convenience of explanation, the layer formed on the surface of the panel (110) is referred to as the first composition layer (140), and the layer formed on the surface of the needle (120) is referred to as the second composition layer (150).

[0033] Since the first composition layer (140) is formed on the surface of the panel (110) which has a flat shape, it comes into contact with the outer skin when the needle (120) penetrates into the skin. The first composition layer (140) in contact with the outer skin is dissolved by moisture or oil, etc., on the outside of the skin and is delivered to the skin surface.

[0034] Since the second composition layer (150) is formed on the surface of the needle (120), it penetrates together with the needle (120) and dissolves inside the skin when the needle (120) penetrates into the skin. Therefore, it is directly delivered into the skin along with hyaluronic acid, etc., which form the structure of the needle (120).

[0035] The first composition layer (140) and the second composition layer (150) may be composed of the same component or may be composed of different components having different effects. Additionally, it is preferable that the first composition layer (140) and the second composition layer (150) be formed separately in each process.

[0036] In the present invention, sucralfate and vitamin K are used as the main components of the first composition layer (140) and the second composition layer (150).

[0037] Sucralfate was used as a pharmaceutical before it became known as a cosmetic ingredient. It is known to help protect the mucous membrane from stomach acid by forming a protective barrier, particularly in areas affected by gastritis and gastric ulcers, and is effective in treating hyperacidity, gastritis, gastric and duodenal ulcers, and reflux esophagitis.

[0038] Vitamin K plays an important role in blood coagulation, bone formation, and calcium metabolism, and is classified into Vitamin K1 (phylloquinone), Vitamin K2 (meniquinone), and Vitamin K3 (menadione). In this invention, synthetic Vitamin K3 is used, and it should be understood that all parts labeled as Vitamin K below refer to Vitamin K3. There is a difference in physical properties between Vitamin K1 and Vitamin K2, which are fat-soluble, and Vitamin K3, which is water-soluble. Since the raw material used in this invention is water-soluble Vitamin K3, a separate treatment is performed to dissolve it in sucralfate and a fat-soluble solvent.

[0039] When a composition containing sucralfate and vitamin K is applied to the skin, it can help treat micro-wounds on the skin caused by the penetration of the needle (120) and regenerate the skin. It can also reduce pain or redness by causing a soothing effect that alleviates irritation caused by the wounds on the skin.

[0040] Figure 4 is a conceptual diagram showing the process of preparing a sucralfate mixture, and Figure 5 is a flowchart showing the process of preparing a sucralfate mixture.

[0041] The composition used to form the composition layer in the present invention consists of sucralfate and vitamin K as main components. Sucralfate is dissolved by mixing with a fat-soluble solvent, and it is preferable to use a trihydric alcohol such as glycerol. Also, since vitamin K is water-soluble, it cannot be directly added and mixed into a fat-soluble solvent; therefore, it is preferable to add it by liposomalizing its surface to increase solubility.

[0042] Sucralfate is dissolved in a fat-soluble solvent, and vitamin K is added to produce a sucralfate mixture.

[0043] As shown in FIG. 5, sucralfate powder is first added to a container in which a lipid-soluble solvent is stored (S102). It is preferable that the lipid-soluble solvent does not contain water.

[0044] Then, the solution is stirred at a speed of 500 RPM to 2,000 RPM, preferably 1,000 RPM, while maintaining the temperature of the solution at 50°C to 70°C, preferably 60°C. (S104)

[0045] Once stirring is complete, the solution is cooled to 30°C to 40°C, preferably 35°C. (S106)

[0046] Then, vitamin K, which has been treated to be liposomalized so that it can be dissolved in a fat-soluble solvent, is added to the mixed solution to complete the composition of the sucralfate mixture. (S108)

[0047] A liposome refers to an intracellular microstructure composed of phospholipids, which are the main components of biological membranes. It forms a double lipid membrane and contains a hydrophilic space inside. In other words, it has a structure in which phospholipids, consisting of a hydrophilic head and a hydrophobic tail, form a double membrane while containing a hydrophilic substance inside. In this invention, liposomalization is defined as surrounding the surface of Vitamin K with phospholipid components. As the hydrophilic head of the phospholipid binds to the surface of Vitamin K, the hydrophobic (lipophilic) tail is exposed to the outside. Consequently, it can be dissolved or dispersed in a fat-soluble solvent.

[0048] In the present invention, phospholipids are coated on the surface of vitamin K to make it hydrophobic (lipophilic), thereby enabling it to dissolve well in a fat-soluble solvent together with sucralfate. For the liposomalization of vitamin K, emulsified hydrogenated lecithin is used in the present invention. This raw material is a component obtained by adding hydrogen to lecithin derived from soybeans, eggs, etc., and is a phospholipid containing glycerin and phosphoric acid, serving as one of the important components constituting biological membranes. Vitamin K coated with hydrogenated lecithin can be dispersed simultaneously in oil and water.

[0049] Then, the completed composition is applied to the microneedle patch (100). (S110) Depending on the application location of the composition, it is divided into a first composition layer (140) and a second composition layer (150), and if necessary, different components can be added to make the efficacy and properties of the two composition layers different.

[0050] Table 1 below shows the names of the ingredients and the mixing ratios of a composition containing sucralfate and vitamin K, and should be understood as one of various examples.

[0052] Ingredient name Mixing ratio Mineral Oil 24.5 Isopropyl Isostearate 14.5 C12-15 Alkyl Benzoate 11 PPG-15 Stearyl Ether 5 PEG-8 Caprylic / Capric Glycerides 10 Polyglyceryl-3 Diisostearate 5 Caprylic / Capric Triglyceride 7 Sorbitan Trioleate 5 PEG-6 Caprylic / Capric Glycerides 5.5 Polysorbate 80 7 Aluminum sucrose octasulfate (sucralfate) 2.5 Vitamin K 3 total 100

[0054] In the composition of this embodiment, sucralfate was added at 2.5%, but can be added in an amount of approximately 2% to 5%.

[0055] Meanwhile, FIG. 6 is a cross-sectional view showing the process of manufacturing microneedles in the first process, and FIG. 7 is a cross-sectional view showing the process of manufacturing microneedles in the second process.

[0056] The method of manufacturing the microneedle patch (100) of the present invention is broadly divided into two types.

[0057] First, as shown in FIG. 6, a first composition layer (140) is formed on the surface of a panel (110), then a needle (120) is formed thereon, and then a second composition layer (150) is formed on the surface of the needle (120).

[0058] A first composition layer (140) is formed by uniformly applying a composition to the surface of a flat panel (110). Then, a needle (120) is formed protruding in a conventional manner, and a second composition layer (150) is formed on the surface of the needle (120). To apply the composition only to the surface of the needle (120), a mask or the like with perforations at positions corresponding to the position of the needle (120) may be used.

[0059] By using this method, the process of applying the first composition layer (140) to the panel (110) becomes relatively simple.

[0060] Next, as illustrated in FIG. 7, a needle (120) is first formed on the surface of the panel (110). Then, a composition is applied only to the area on the surface of the panel (110) where the needle (120) is not formed to form a first composition layer (140). After the formation of the first composition layer (140) is finished, a composition is applied only to the location where the needle (120) is formed to form a second composition layer (150). To form the first composition layer (140) and the second composition layer (150), masks with perforations formed at the location where the needle (120) is not formed and at the location where it is formed may be used, respectively.

[0061] Through such a process, a microneedle patch (100) can be manufactured in which a first composition layer (140) and a second composition layer (150) are formed on the surface of the panel (110) or the surface of the needle (120), respectively. Then, an ultrasonic application means (130) is attached to the upper surface of the panel (110) on which the needle (120) is formed on the lower surface to complete the final product.

[0062] Meanwhile, instead of forming the needle (120) by dropping a liquid substance onto the surface of the panel (110), a structure having the same function as the needle (120) may be formed by adhering particles with an irregular shape to the panel (110). In the present invention, such a structure is described as a microneedle particle patch.

[0063] FIG. 8 is a conceptual diagram showing the process of forming the structure of a microneedle particle according to another embodiment of the present invention, and FIG. 9 is a cross-sectional view showing the structure of a microneedle particle.

[0064] As illustrated in FIG. 8, particles (170) having an irregular shape are placed on the surface of the jig (200). The particles (170) are made of a substance that produces a medicinal effect on the skin, similar to the needle (120), and may have hyaluronic acid as the main component, just like the needle (120). However, the particles (170) may contain other substances that produce pharmacological effects.

[0065] An adhesive layer (160) is formed on the bottom surface of the panel (110). The adhesive layer (160) can be formed by applying an adhesive or by attaching an adhesive tape. The panel (110) with the adhesive layer (160) formed thereon is brought into contact with the top surface of the jig (200), and through this process, particles (170) separated into individual particles are attached to the adhesive layer (160). Thus, microneedle particles in which particles (170) are irregularly attached to the bottom surface of the panel (110) can be manufactured.

[0066] When the molding of the microneedle particles is completed, a microneedle patch (100) can be manufactured by forming a first composition layer (140) on the surface of the panel (110) and forming a second composition layer (150) on the surface of the particles (170) using the method described above.

[0067] Although preferred embodiments of the present invention have been described above with reference to the attached drawings, those skilled in the art will understand that the technical configuration of the present invention described above may be implemented in other specific forms without altering the technical concept or essential features of the present invention. Therefore, the embodiments described above should be understood as illustrative in all respects and not restrictive, and the scope of the present invention is defined by the claims set forth below rather than by the detailed description above, and all modifications or variations derived from the meaning and scope of the claims and equivalent concepts thereof should be interpreted as being included within the scope of the present invention. Explanation of the symbols

[0068] 100: Microneedle patch 110: Panel 120: Needle 130: Ultrasonic application means 140 : First composition layer 150 : Second composition layer 160 : Adhesive layer 170 : Particles 200 : Jig

Claims

Claim 1 A microneedle patch that penetrates the skin and delivers an active substance into the skin, comprising: a panel (110) made of a soft material; a needle (120) formed as a protruding structure on one side of the panel (110) and penetrating the skin to dissolve; an ultrasonic application means (130) coupled to the other side of the panel (110) to apply ultrasonic vibration to the panel (110); and a composition layer formed on the surface of the panel (110) or on the surface of the needle (120); wherein the composition layer is a mixture in which sucralfate and vitamin K are mixed in a fat-soluble solvent, comprising the steps of: introducing sucralfate powder into a container in which the fat-soluble solvent is stored; stirring at a speed of 500 RPM to 2,000 RPM while maintaining the temperature of the solution at 50℃ to 70℃; cooling the stirred solution to 30℃ to 40℃; and adding vitamin K to the solution to form a sucralfate mixture. An ultrasound-coupled microneedle patch for enhancing transdermal absorption, characterized by being manufactured by the steps of: completing a composition; and applying the composition to the surface of the panel (110) or the needle (120). Claim 2 An ultrasound-coupled microneedle patch for enhancing transdermal absorption, characterized in that, in claim 1, the composition layer comprises a first composition layer (140) formed on the surface of the panel (110). Claim 3 An ultrasound-coupled microneedle patch for enhancing transdermal absorption, characterized in that, in claim 1, the composition layer is composed of a second composition layer (150) formed on the surface of the needle (120). Claim 4 delete Claim 5 delete Claim 6 An ultrasound-coupled microneedle patch for enhancing transdermal absorption, wherein, in claim 1, the vitamin K is menadione, a synthetic vitamin, and is added to the solution in a liposomal state. Claim 7 An ultrasound-coupled microneedle patch for enhancing transdermal absorption, wherein, in claim 1, the ultrasound application means generates ultrasound in a frequency band of 20 kHz to 40 kHz. Claim 8 A microneedle particle patch that penetrates the skin and delivers an active substance into the skin, comprising: a panel (110) made of a soft material; an adhesive layer (160) formed on one side of the panel (110); particles (170) that are formed as protruding structures by being adhered to the adhesive layer (160) in an irregular shape and penetrate the skin and dissolve; an ultrasonic application means (130) coupled to the other side of the panel (110) to apply ultrasonic vibrations to the panel (110); and a composition layer formed on the surface of the panel (110) or on the surface of the particles (170); wherein the composition layer is a mixture in which sucralfate and vitamin K are mixed in a fat-soluble solvent, comprising the steps of: introducing sucralfate powder into a container in which the fat-soluble solvent is stored; stirring at a speed of 500 RPM to 2,000 RPM while maintaining the temperature of the solution at 50℃ to 70℃; and the solution after stirring is completed An ultrasound-coupled microneedle particle patch for enhancing transdermal absorption, characterized by being manufactured by the steps of: cooling to 30°C to 40°C; adding vitamin K to a solution to complete a composition consisting of a sucralfate mixture; and applying the composition to the surface of the panel (110) or the particle (170).

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