Microneedle patch and method for manufacturing microneedle patch

Abstract

The microneedle patch according to the present invention is characterized by comprising: an adhesive sheet that adheres to the skin; a needle support body provided on the adhesive sheet; and a needle body disposed on the needle support and having a tip portion, at least one of the needle support and the needle body comprising an expandable polymeric material that expands upon contact with bodily fluid.

Description

Technical Field

[0001] The present invention relates to a microneedle patch and a method for manufacturing the microneedle patch. Background Art

[0002] Although numerous drugs and bioactive substances have been developed for treating diseases, there are still some problems to be improved in delivering drugs and bioactive substances into the body, such as problems of penetrating biological barriers (e.g., skin, oral mucosa, and blood-brain barrier) and drug delivery efficiency.

[0003] Drugs and bioactive substances are usually administered orally in the form of tablets or capsules. However, due to drug digestion and absorption in the gastrointestinal tract or loss through liver mechanisms, many drugs cannot be effectively delivered solely by the above-mentioned administration method. In addition, some drugs cannot effectively diffuse through the intestinal mucosa. Moreover, patient compliance is also a problem (e.g., having to take medicine at specific intervals, or for critically ill patients who are unable to take medicine).

[0004] Another commonly used drug and bioactive substance delivery technique is the use of traditional needles. Although this method is more effective than oral administration, it has problems such as pain at the injection site, local skin damage, bleeding, and infection of injection site diseases.

[0005] To solve the above problems, various microneedle patches including microneedles have been developed. The microneedle patches developed so far are mainly used for in vivo drug administration, blood collection, and in vivo analyte detection.

[0006] Different from existing needles, microneedles are characterized by painless skin penetration and no trauma. Currently, microneedles must have the invasiveness to penetrate the skin and must penetrate the stratum corneum, the strongest skin barrier with a thickness of 10 - 20 micrometers, so they must have sufficient physical hardness. In addition, an appropriate length must also be considered to reach the capillaries, thereby improving drug delivery efficiency.

[0007] Due to limitations in manufacturing methods, traditional microneedles are limited to materials such as silica gel, polymers, metals, and glass, and have disadvantages such as drug denaturation due to complex and time-consuming manufacturing processes, insufficient hardness, and drug loss in manufacturing methods using molding techniques. Therefore, there is a continuous need for microneedles with a diameter thin enough to painlessly penetrate the skin, a length long enough to penetrate deep into the skin, while achieving sufficient hardness, not being limited by materials, and minimizing drug loss. Summary of the Invention

[0008] Technical Problems to be Solved by the Invention

[0009] In order to solve the above problems, the present invention aims to provide a microneedle patch including microneedles formed of an expandable polymer material that expands when contacting body fluid, and a manufacturing method thereof.

[0010] Furthermore, the present invention aims to provide a microneedle patch having invasiveness, sufficient hardness, and enhanced adhesiveness, and a manufacturing method thereof, for effectively injecting drugs.

[0011] Technical solutions for solving the problems

[0012] The above object of the present invention is achieved by a microneedle patch, which is characterized by including: an adhesive sheet that adheres closely to the skin; a needle support disposed on the adhesive sheet; and a needle body disposed on the needle support and having a tip portion, wherein at least one of the needle support and the needle body includes an expandable polymer material that expands when contacting body fluid.

[0013] Wherein, at least one of the needle support and the needle body may contain a drug, and at least one of the needle support and the needle body expands when contacting body fluid to supply the drug

[0014] Furthermore, at least one of the needle support and the needle body may be formed by curing a viscous composition in which an expandable polymer material and a drug are dissolved.

[0015] Furthermore, the needle body includes an expandable polymer material, and the shape of the needle body is such that the base diameter (D) corresponds to the diameter of the bottom surface in contact with the needle support, the needle height (H) corresponds to the vertical distance from the bottom surface to the upper end, and the needle diameter (N) corresponds to the diameter of the tip portion. When the needle body contacts body fluid, it can expand while maintaining its shape unchanged, causing at least one of the base diameter, the needle height, and the needle diameter to increase.

[0016] On the other hand, when contacting body fluid, the base diameter and the needle diameter can increase by more than 1.1 times and less than 2 times.

[0017] Furthermore, the needle body may include an expandable polymer material, and the shape of the needle body is such that the base diameter (D) corresponds to the diameter of the bottom surface in contact with the needle support, the needle height (H) corresponds to the vertical distance from the bottom surface to the upper end, and the needle diameter (N) corresponds to the diameter of the tip portion. When the needle body contacts body fluid, one of the base diameter, the needle height, and the needle diameter increases, and the other decreases.

[0018] Furthermore, the adhesive sheet and the needle support may form an adhesive surface, the needle support is inserted from the adhesive surface and arranged inside the adhesive sheet, and the needle body extends outward from the adhesive surface.

[0019] Furthermore, the needle support can be inserted into the inside of the adhesive sheet and arranged in a plurality of intaglio shapes spaced apart from each other, and the needle bodies are respectively provided on the plurality of needle supports.

[0020] In addition, the needle support can be inserted into the inside of the adhesive sheet and arranged in a layered manner extending in parallel, and the needle bodies are arranged on the needle support at intervals of each other.

[0021] On the other hand, the above object of the present invention is achieved by a method for manufacturing a microneedle patch, which is characterized by including the following steps: forming a needle support on a base resin; forming an adhesive sheet on the substrate to cover the needle support; forming a covering resin on the upper part of the adhesive sheet, turning over the needle support and the adhesive sheet so that the base resin is located on the upper part; removing the base resin; and forming a needle body on the needle support, and at least one of the needle support and the needle body includes an expandable polymer material that expands when contacting body fluid.

[0022] Wherein, at least one of the needle support and the needle body can be cured from a viscous composition in which an expandable polymer material and a drug are dissolved.

[0023] Furthermore, in the step of forming the needle body, a pair of structures for forming base needles on the needle support can be provided, and the pair of structures are relatively moved closer to each other so that a pair of base needles respectively formed on the pair of structures are in contact with each other, and the pair of structures are relatively moved away from each other so that the pair of base needles are adhered to each other and stretched and deformed, and the deformed base needles form the needle body.

[0024] On the other hand, the needle support may include a plurality of supports formed at intervals on the base resin, the adhesive sheet respectively covers the plurality of supports, and the needle bodies are respectively formed on the plurality of supports.

[0025] In addition, the needle bodies can be arranged on the needle support at intervals of each other.

[0026] Effects of the Invention

[0027] According to the microneedle patch and its manufacturing method of the present invention having the above structure, the advantage is that when contacting body fluid, the surface area and volume will expand, so as to effectively inject drugs. Description of the Drawings

[0028] Figure 1 The drawings briefly showing the manufacturing process of the thin sheet of the microneedle patch according to an embodiment of the present invention.

[0029] Figure 2 For Figure 1 A planar photograph of the manufactured thin sheet

[0030] Figure 3 To briefly show the drawings of the process of manufacturing a microneedle patch according to an embodiment of the present invention using a thin sheet according to Figure 1 the following,

[0031] Figure 4 For the side view photo of the microneedle patch manufactured according to the process shown in Figure 3 the following,

[0032] Figure 5 To briefly show the drawings of the manufacturing process of the thin sheet of the microneedle patch according to another embodiment of the present invention,

[0033] Figure 6 For the plan view photo of the thin sheet manufactured according to the process shown in Figure 5 the following,

[0034] Figure 7 To briefly show the drawings of the process of manufacturing a microneedle patch according to another embodiment of the present invention using the thin sheet shown in Figure 5 the following,

[0035] Figure 8 For the side view photo of the microneedle patch manufactured according to the process shown in Figure 7 the following,

[0036] Figure 9 To briefly show the drawings of the change of the needle body in the microneedle patch according to an embodiment of the present invention,

[0037] Figures 10 to 13 For the experimental graph of the change of the needle body in the microneedle patch according to an embodiment of the present invention,

[0038] Figure 14 To briefly show the drawings of the change of the needle body in the microneedle patch according to another embodiment of the present invention. Detailed Description of the Invention

[0039] Hereinafter, the microneedle patch according to an embodiment of the present invention and its manufacturing method will be described in detail with reference to the drawings.

[0040] Figure 1 To briefly show the drawings of the manufacturing process of the thin sheet 190 in the microneedle patch according to an embodiment of the present invention, Figure 3 To briefly show the drawings of the process of manufacturing a microneedle patch according to an embodiment of the present invention using the thin sheet 190 according to Figure 1 the following.

[0041] Through Figure 1 and Figure 3 the process of the following, a microneedle patch according to an embodiment of the present invention can be formed. That is to say, Figure 1 and Figure 3For the drawings showing the manufacturing process of the microneedle patch of the present invention, the shape shown in (c) corresponding to the last step can be understood as the microneedle patches 170, 170a. Figure 3 The shape shown in (c) can be understood as the microneedle patches 170, 170a.

[0042] First, as Figure 1 shown in (a), the needle support 110 can be formed by spotting the needle support 110 on the first base resin 100. The first base resin 100 corresponds to a thin sheet temporarily prepared for forming the needle support 110. That is, the first base resin 100 is omitted in the finally completed patch thin sheet 190.

[0043] The first base resin 100 can be made into a flat plate shape. For example, it can be a synthetic resin or a transparent PET film.

[0044] The needle support 110 can be formed by spotting multiple pieces on the upper part of the first base resin 100. For example, the needle support 110 can be composed of a plurality of first supports 1101, second supports 1102, and third supports 1103 spaced apart from each other. Each support 1101, 1102, 1103 can have the same shape and be arranged in sequence.

[0045] At this time, the needle support 110 can be formed by spotting and curing the first adhesive composition on the upper surface of the first base resin 100 at a predetermined interval. Therefore, due to the influence of adhesion or external wind, the shapes of the supports 1101, 1102, 1103 may be slightly different. The first adhesive composition for forming the needle support 110 will be described in detail later.

[0046] Moreover, the needle support 110 can be formed into various shapes on the first base resin 100 by various methods. In addition, the surfaces of the supports 1101, 1102, 1103 form an approximately circular, elliptical or curved surface due to surface tension, and a hemispherical shape (hereinafter referred to as "hemispherical") can be formed on the first base resin 100.

[0047] At this time, the arrangement, spacing or number of the supports 1101, 1102, 1103 can be formed differently as needed. For example, the supports 1101, 1102, 1103 can be regularly arranged to form a grid.

[0048] Meanwhile, as Figure 1As shown in (b) thereof, an adhesive sheet 120 can be formed on the upper part of the first base resin 100 and the needle support 110. That is to say, the adhesive sheet 120 can be formed on the upper part of the first base resin 100 to cover the needle support 110. Therefore, the needle support 110 is located between the adhesive sheet 120 and the first base resin 100.

[0049] The adhesive sheet 120 is formed above the needle support 110 to completely cover the needle support 110.

[0050] Next, in Figure 1 the state of (b), the first covering resin 130 is pasted onto the upper part of the adhesive sheet 120. After that, as Figure 1 shown in (c) thereof, the needle support 110 and the adhesive sheet 120 are turned over and placed so that the first base resin 100 is located above. That is to say, Figure 1 the shape shown in (b) thereof is reversed so that the first covering resin 130 is located below and the first base resin 100 is located above.

[0051] At this time, the first covering resin 130 corresponds to the bottom surface and the first base resin 100 corresponds to the top surface. The first covering resin 130 can be in the form of a flat plate like the first base resin 100 and can be in the form of, for example, a synthetic resin or a transparent PET film. That is to say, the first covering resin 130 and the first base resin 100 can have the same configuration or different configurations, and for the convenience of explanation, different names can be used.

[0052] As Figure 1 shown in (d) thereof, the first base resin 100 is removed, and the needle support 110 and the adhesive sheet 120 are arranged on the first covering resin 130 in a predetermined shape, thereby forming a thin sheet 190 of the microneedle patch.

[0053] Figure 2 is a plan view photograph of the thin sheet 190 manufactured according to the Figure 1 process shown.

[0054] Referring to Figure 1 and Figure 2 , the needle support 110 is in a state of being inserted into the adhesive sheet 120. For example, it can be said that the needle support 110 is inserted and placed in an engraved pattern that is recessed inward. In this case, the engraved shape can be formed into, for example, an approximate hemispherical shape, an arc shape or a semi-elliptical shape.

[0055] Here, taking the hemispherical shape of the needle support 110 as an example for illustration, in addition to the hemispherical shape, the needle support 110 can also be formed into various shapes, such as an arc shape, a semi-elliptical shape, etc.

[0056] In addition, the needle support 110 can be inserted into the adhesive sheet 120 to form one side of the adhesive sheet 120. As described above, since the first base resin 100 is flat, the needle support 110 and the adhesive sheet 120 adhered thereto form a flat surface. Then, when the first base resin 100 is removed, the surface formed by the needle support 110 and the adhesive sheet 120 will be exposed. Hereinafter, this surface will be referred to as the adhesive surface. For example, the adhesive surface can refer to the surface that contacts the skin.

[0057] And, as described above, the respective supports 1101, 1102, 1103 are spaced apart from each other, and the adhesive sheet 120 is exposed and placed between the respective supports 1101, 1102, 1103. Therefore, when the adhesive surface contacts the skin, the adhesive strength can be increased through the adhesive sheet 120 located between the respective supports 1101, 1102, 1103. In addition, the respective supports 1101, 1102, 1103 can be adhered more effectively, thereby improving the drug delivery efficiency.

[0058] Figure 3 For a brief display of the process of manufacturing the microneedle patches 170, 170a according to an embodiment of the present invention using the thin sheets according to Figure 1 The figures will be introduced in sequence below.

[0059] First, as shown in Figure 3 (a) of, in order to form the base needles 140 on the upper part of the needle support 110, the second adhesive composition is dot-coated. The second adhesive composition can be composed of the same or different materials as the first adhesive composition used to form the needle support 110. This will be described in detail later.

[0060] The number of the base needles 140 can correspond to the number of the needle supports 110. For example, the number of the base needles 140 can be composed of a plurality, including a first base 1401, a second base 1402, and a third base 1403 respectively formed on each of the supports 1101, 1102, 1103. Specifically, the first base 1401 is formed on the upper part of the first support 1101, the second base 1402 is formed on the upper part of the second support 1102, and the third base 1403 is formed on the upper part of the third support 1103.

[0061] Although not shown in the figure, a plurality of base pins 140 can also be dot-coated on the upper surface of the same needle support 110. In this case, the base pins 140 can be arranged at intervals from each other on the upper surface of the same needle support 100.

[0062] Meanwhile, for the convenience of explanation, each support 1101, 1102, 1103 or each base 1401, 1402, 1403 is named separately and corresponds to the same structure. In addition, since each support 1101, 1102, 1103 and each base 1401, 1402, 1403 are made of a viscous composition, their shapes may be slightly different, but this has nothing to do with the features of the present invention.

[0063] All in all, the base pins 140 are dot-coated on the upper surfaces of a plurality of supports 1101, 1102, 1103 that are spaced from each other, and the base pins 140 can protrude upward from the bonding surface formed by the needle support 110 and the adhesive sheet 120. Hereinafter, the shape shown in (a) of Figure 3 will be referred to as the structure 150.

[0064] Next, as shown in (b) of Figure 3 , a pair of structures 150, 150a are arranged opposite to each other. At this time, the formation methods of the respective structures 150, 150a are the same as those in (a) of the above Figure 3 and correspond to the same structure.

[0065] Therefore, the first structure 150 includes a first needle support 110, a first adhesive sheet 120, and a first base pin 140, and the second structure 150a includes a second needle support 110a, a second adhesive sheet 120a, and a second base pin 140a.

[0066] Specifically, the first structure 150 and the second structure 150a are arranged such that the first base pin 140 and the second base pin 140a face each other. That is to say, the bonding surfaces of the first structure 150 and the second structure 150a face each other. And, the first structure 150 and the second structure 150a are relatively moved so that the first base pin 140 and the second base pin 140a come into contact.

[0067] For example, the second structure 150a is arranged such that its bonding surface faces upward. And, the first structure 150 is located above the second structure 150a such that the bonding surface faces the bottom surface. And, the first structure 150 is lowered so that the first base pin 140 and the second base pin 140a come into contact.

[0068] At this time, the first needle support 110 and the second needle support 110a, the first adhesive sheet 120 and the second adhesive sheet 120a are arranged not to contact each other. In addition, each of the needle supports 110, 110a and the adhesive sheets 120, 120a is completely cured and will not deform even if they come into contact with each other.

[0069] On the other hand, the first base needle 140 and the second base needle 140a are in a state where the viscous composition is not cured, so they will deform when they come into contact with each other. That is, the structures 150, 150a come into contact with each other while the base needles 140, 140a are not completely cured.

[0070] Next, as shown in (c) of Figure 3 , the structures 150, 150a move relative to each other in a direction away from each other. As a result, the base needles 140, 140a are stretched and cured with each other.

[0071] The mutually adhered base needles 140, 140a undergo a stretching and curing step to form the needle bodies 160, 160a. Thus, the microneedle patches 170, 170a of the present invention can be manufactured. That is, the microneedle patches 170, 170a include the needle supports 110, 110a, the adhesive sheets 120, 120a, and the needle bodies 160, 160a.

[0072] The formation process of the needle bodies 160, 160a will be described in more detail below.

[0073] As described above, the first base needle 140 and the second base needle 140a are provided in a mutually adhered state. And, the first needle support 110 and the first adhesive sheet 120 move relative to each other in a direction away from the second needle support 110a and the second adhesive sheet 120a.

[0074] Therefore, the adhered base needles 140, 140a move apart, and their ends extend under the action of the adhesive force, and the radius decreases. Finally, they can be separated into a pair to form the needle bodies 160, 160a, which are formed with cutting edges.

[0075] For example, as shown in Figure 3 , the adhered ends of the approximately hemispherical base needles 140, 140a are stretched and deformed into approximately conical needle bodies 160, 160a.

[0076] That is to say, the bonded base needles 140 and 140a can be stretched to a desired length at a predetermined speed to form the needle bodies 160 and 160a. For example, for the bonded base needles 140 and 140a, 1) stretch to a first length at a first speed (first stretching), 2) wait for a predetermined time in a state where stretching is stopped (waiting), 3) stretch to a second length at a second speed (second stretching), 4) separate them from each other (cutting). In addition, in the separation or cutting step, it can be cut by quickly moving in a fully cured state or using a cutting device such as a laser to cut.

[0077] For example, the mutually bonded base needles 140 and 140a are stretched at a speed of 0.8 to 600000 μm / s for 10 to 5000 μm in a state where no air is blown, wait for 1 to 100 seconds in a state where stretching is stopped, and then stretch at a speed of 0.8 to 600000 μm / s for 10 to 5000 μm in a state where a viscous composition is blown in at a wind speed of 1 to 100 m / s, and then in a state where a viscous composition is blown in at a wind speed of 5 to 100 m / s, the viscous composition is cured and cut.

[0078] At this time, different first speeds, first lengths, waiting times, second speeds, second lengths, and whether to blow air can be set as needed and determined according to the required result values. Specifically, the longer the waiting time after the first stretching stops, the larger the diameter of the middle part and the relatively stronger the strength. The above method is described in detail in the applicant's registered patent number 10-1254240.

[0079] In summary, the forming steps of the micro-needle patches 170 and 170a are as follows: 1) form the needle support 110 on the upper part of the first base resin 100; 2) form the adhesive sheet 120 on the upper part of the first base resin 100 to cover the needle support 110; 3) invert and form the first covering resin 130 on the upper surface of the adhesive sheet 120; 4) remove the first base resin 100 to expose the bonding surface; 5) form a structure 150 having the base needle 140 on the bonding surface corresponding to the position of the needle support 110; 6) move a pair of structures 150 and 150a relatively closer to each other so that the base needles 140 and 140a are bonded to each other; 7) move the bonded base needles 140 and 140a relatively away from each other to stretch to form the needle bodies 160 and 160a.

[0080] In the above Figure 3 embodiment, the base needles 140 and 140a are shown to be formed by dot coating on the upper and lower structures 150 and 150a, but it is not limited thereto.

[0081] For example, although not shown in the figures, the second base needle 140a may be spot-coated only on the underlying second structure 150a. That is, the base needle may not be spot-coated on the first needle support 110 of the upper first structure 150. In this case, when the first structure 150 and the second structure 150a move relative to each other in a direction approaching each other, the surface of the first needle support 110 of the first structure 150 may move and contact the second base needle 140a of the second structure 150a. After the surface of the first needle support 110 of the first structure 150 contacts the second base needle 140a of the second structure 150a, the method of stretching the second base needle 140a by moving the first structure 150 and the second structure 150a away from each other is similar to the above-described embodiment, and thus repeated description is omitted.

[0082] Figure 4 Side view of a microneedle patch fabricated according to the Figure 3 process shown.

[0083] As Figure 4 shown, it can be seen that the needle bodies 160 have been formed. At the same time, in Figure 4 , the needle bodies 160 are formed from a viscous composition containing chitosan as the swellable polymer material. This swellable polymer material will be described in detail later.

[0084] On the other hand, the shapes of the above-described microneedle patches 170, 170a are merely exemplary, and the microneedles of the present invention can be made in various shapes. Microneedles having different shaped needle structures will be described below. However, the following microneedle patches 270, 270a can be fabricated by the same process as the above-described microneedle patches 170, 170a. Therefore, for the same process, the above description is incorporated by reference and detailed description is omitted, and the corresponding structures are designated by the same reference numerals and distinguished by the drawing reference numerals.

[0085] Figure 5 A drawing for briefly showing the formation of a sheet 290 of a microneedle patch according to another embodiment of the present invention, Figure 7 A drawing for briefly showing the process of fabricating microneedle patches 270, 270a according to another embodiment of the present invention using the Figure 5 sheet 290 shown.

[0086] By the Figure 5 and Figure 7 processes, microneedle patches 270, 270a according to another embodiment of the present invention can be fabricated. That is, Figure 5 and Figure 7 respectively show the manufacturing processes of the microneedle patches 270, 270a of the present invention, corresponding to the last step of Figure 7The shape shown in (c) can be understood as the microneedle patches 270, 270a.

[0087] As shown in Figure 5 (a), a third needle support 210 can be formed in the second base resin 200. The third needle support 210 can be formed to extend along the upper part of the second base resin 200. At this time, the third needle support 210 can be formed by coating a first viscosity composition on the upper part of the second base resin 200.

[0088] Next, as shown in Figure 5 (b), an adhesive sheet 220 can be formed on the upper parts of the second base resin 200 and the third needle support 210. That is to say, the adhesive sheet 220 can be formed on the upper part of the second base resin 200 to cover the third needle support 210. Therefore, the third needle support 210 is located between the adhesive sheet 220 and the second base resin 200.

[0089] Next, in the state of Figure 5 (b), a second cover resin 230 is provided on the upper part of the adhesive sheet 220, and then, as shown in Figure 5 (c), the second base resin 200 is turned over so that it is located on the upper part. That is to say, the upper and lower positions of the third needle support 210 and the adhesive sheet 220 are interchanged.

[0090] Next, as shown in Figure 5 (d), the upper second base resin 200 is removed, and the third needle support 210 and the adhesive sheet 220 are set in a predetermined shape.

[0091] Figure 6 Is a plan view photograph of the sheet 290 manufactured according to Figure 5 .

[0092] Referring to Figure 5 and Figure 6 , the third needle support 210 is inserted inside the adhesive sheet 220 and is set in the form of a single layer (i.e., a layer extending in parallel). In other words, the third needle support 210 is in a state of being completely inserted inside the adhesive sheet 220. For example, the third needle support 210 can be set in the adhesive sheet 220 in a recessed form to be flat. In this case, the adhesive sheet 220 can be exposed along the edge of the third needle support 210.

[0093] Further, the third needle support 210 is inserted into and adhered to the adhesive sheet 220 to form one surface of the adhesive sheet 220. As described above, since the second base resin 200 is flat, the adhered third needle support 210 and the adhesive sheet 220 can form a flat surface. Hereinafter, this surface will be referred to as the adhesive surface. For example, the adhesive surface refers to the surface that contacts the affected area.

[0094] Figure 7 To briefly show the use Figure 5 The attached drawing shows the process of manufacturing the microneedle patches 270 and 270a according to an embodiment of the present invention using the thin sheet 290 shown below. The following will be introduced in sequence.

[0095] First, as Figure 7 (a) shown, in order to form the base needles 240 on the upper part of the third needle support 210, the second adhesive composition is dot-coated. The second adhesive composition may be composed of the same or different materials as the first adhesive composition used to form the third needle support 210. This will be described later.

[0096] A plurality of the base needles 240 may be formed on the third needle support 210. For example, the base needles 240 may include a first base 2401, a second base 2402, and a third base 2403 that are spaced apart from each other. Each base 2401, 2402, 2403 may be formed in slightly different shapes, but this is not related to the features of the present invention.

[0097] Different from the above-mentioned needle support 110, the third needle support 210 is formed by extending in a flat plate shape. Therefore, a plurality of base needles 240 can be formed on one third needle support 210. This shape is easier to manufacture and can more effectively support the needle bodies 260 and 260a described later.

[0098] In summary, a plurality of base needles 240 are spaced apart from each other and dot-coated on the upper surface of the third needle support 210, and the base needles 240 can be formed by protruding above the adhesive surface formed by the third needle support 210 and the adhesive sheet 220. Hereinafter, the shape shown in Figure 7 (a) will be referred to as the structure 250.

[0099] Next, as Figure 7 (b) shown, a pair of structures 250 and 250a are arranged opposite to each other. At this time, the formation method of each of the structures 250 and 250a is the same as that of Figure 7 (a) described above, and corresponds to the same structure.

[0100] Therefore, the third structure 250 includes a third needle support 210, a third adhesive sheet 220, and a third base needle 240, and the fourth structure 250a includes a fourth needle support 210a, a fourth adhesive sheet 220a, and a fourth base needle 240a.

[0101] Specifically, the third structure 250 and the fourth structure 250a are arranged such that the third base needle 240 and the fourth base needle 240a face each other. That is, the adhesive surfaces of the third structure 250 and the fourth structure 250a face each other. And, the third structure 250 and the fourth structure 250a move relative to each other such that the third base needle 240 and the fourth base needle 240a come into contact.

[0102] For example, the fourth structure 250a is arranged such that its adhesive surface faces upward. And, the third structure 250 is located above the fourth structure 250a such that the adhesive surface faces the bottom surface. And, the third structure 250 is lowered such that the third base needle 240 and the fourth base needle 240a come into contact.

[0103] At this time, the third needle support 210, the second needle support 210a, the first adhesive sheet 220, and the second adhesive sheet 220a are arranged such that they do not contact each other. In addition, each of the needle supports 210, 210a and the adhesive sheets 220, 220a is completely cured, and even if they come into contact with each other, their shapes will not change.

[0104] On the other hand, the third base needle 240 and the fourth base needle 240a are in a state where the viscous composition is not cured, so they will deform when they come into contact with each other. That is, the structures 250, 250a come into contact with each other when the base needles 240, 240a are not completely cured.

[0105] Next, as shown in (c) of Figure 7 , the structures 250, 250a move relative to each other in a direction away from each other. As a result, the base needles 240, 240a are stretched and cured with each other.

[0106] The mutually adhered base needles 240, 240a undergo a stretching and curing step to form needle bodies 260, 260a. Thus, the microneedle patches 270, 270a of the present invention can be manufactured. That is, the microneedle patches 270, 270a include the needle supports 210, 210a, the adhesive sheets 220, 220a, and the needle bodies 260, 260a.

[0107] The formation process of the needle bodies 260, 260a will be described in more detail below.

[0108] Accordingly, the microneedle patches 270, 270a may form needle supports 210, 210a having a shape different from that of the microneedle patches 170, 170a described above. In addition, the microneedle patches 270, 270a may form needles 260, 260a having the same shape as the microneedle patches 170, 170a described above. The needles 160, 160a, 260, 260a will be described in detail below.

[0109] Figure 8 Side photograph of a microneedle patch manufactured according to the Figure 7 process shown.

[0110] As Figure 8 shown, it can be seen that the needle 260 has been formed. At the same time, in Figure 8 (a) of, the needle 260 is formed of a viscous composition containing chitosan as a swellable polymer material, and in Figure 8 (b) of, the needle 260 is formed of a viscous composition containing polyvinyl alcohol (PVA) as a swellable polymer material. This swellable polymer material will be described in detail later.

[0111] Figure 9 Brief view showing the change in the needle of a microneedle patch according to an embodiment of the present invention. Figure 9 (a) and (b) of only show the needles 160, 160a, 260, 260a in the microneedle patches 170, 170a, 270, 270a described above. One needle 160 will be described in detail below and described with reference thereto.

[0112] As Figure 9 shown, the needle 160 may be designed to have a shape of a substantially circular cone. That is, the needle 160 may be designed to have a substantially circular bottom surface, and the diameter gradually narrows toward the top to form a needle tip shape. Hereinafter, the bottom diameter of the needle 160 is referred to as the bottom surface diameter D, and the vertical distance from the bottom surface to the upper end is referred to as the needle height H. At this time, the bottom surface diameter D may be understood as the cross-sectional diameter of the portion in contact with the needle support 110, and the needle height H may be understood as the vertical distance from the needle support 110 or the bonding surface.

[0113] At this time, as described above, the needle 160 corresponds to a structure solidified from a viscous composition. Therefore, the bottom surface of the needle 160 may not be a perfect circle, and the bottom surface diameter D may be approximately calculated. The needle height H may be set as needed, but there may be a predetermined error in the separation or cutting step.

[0114] Meanwhile, the shape of the needle body 160 corresponds to the shape formed by stretch cutting. Therefore, a predetermined tensile fracture surface is formed instead of a point, and the generatrix is formed as a curve. At this time, the curvature of the generatrix can be determined by the stretching speed during the formation process of the needle body 160 described above.

[0115] As described above, the needle body 160 can be formed by stretching at a first speed and then at a second speed. At this time, the second speed can be faster than the first speed. Therefore, as Figure 9 shown, the needle body 160 can form a tip portion that becomes thinner and longer as it extends upward. At this time, the diameter of the portion stretched at the second speed is called the needle diameter N. Specifically, the needle diameter N corresponds to the diameter of the tip portion of the needle body 160 and can be calculated as its average value or median value.

[0116] Moreover, since a fracture surface is formed at the upper end of the needle body 160, a complete shape may not be formed within a certain range. Therefore, the upper end diameter of the needle body 160 can be replaced by the needle diameter N.

[0117] On the other hand, at least one of the above-mentioned needle body 160 and needle support 110 may contain a drug to be injected into the human body. That is, when the microneedle patch 170 of the present invention is attached to the human body, the drug contained in at least one of the needle body 160 and needle support 110 can be injected and delivered into the human body.

[0118] For this purpose, at least one of the needle body 160 and needle support 110 may contain swellable hydrophilic polymers that swell when in contact with body fluid.

[0119] When the microneedle patch 170 of the present invention is attached to the human body, the needle body 160 or needle support 110 swells after coming into contact with body fluid, and the drug inside the needle body 160 or needle support 110 can be delivered into the human body. In this case, even after coming into contact with body fluid, the needle body 160 or needle support 110 can maintain its shape or form without decomposition. That is, even if the needle body 160 or needle support 110 swells, its basic shape or form can be maintained.

[0120] Specifically, at least one of the needle body 160 and the needle support 110 may contain swellable polymer materials such as polyvinyl alcohol (PVA) or chitosan. PVA and chitosan are merely examples of swellable polymer materials, and the swellable polymer materials are not limited thereto.

[0121] Accordingly, at least one of the first adhesive composition for the needle support 110 and the second adhesive composition for the needle body 160 may include a drug and a swellable polymer material. In this case, the first adhesive composition and the second adhesive composition may include the same swellable polymer material or different swellable polymer materials.

[0122] The drug-containing adhesive composition for forming the needle body 160 or the needle support 110 will be described below.

[0123] First, a case where distilled water (Di water) is used as a solvent and PVA is used as a polymer material will be described. 1) Add distilled water (Di water 50 to 80 wt%) to a stirrer and heat it to 50 to 100 °C. 2) Add PVA (5 to 30 wt%) and stir at a speed of 200 to 800 RPM until completely dissolved. 3) After complete dissolution, add a water-soluble polymer, such as HPMC (hydroxypropyl methylcellulose) (2 to 20 wt%) or CMC (carboxymethyl cellulose) (2 to 20 wt%), heat to 50 to 100 °C, and stir at a speed of 200 to 800 RPM. 4) Then, while maintaining the temperature at 50 to 100 °C, add a drug (API: Active Pharmaceutical Ingredient), such as Donepezil (5 to 30 wt%), and stir at a speed of 200 to 800 RPM. 5) After complete dissolution, add glycerin (0.3 to 10 wt%) at 30 to 80 °C and stir at a speed of 100 to 600 RPM until completely dissolved.

[0124] Next, the case of using an aqueous acetic acid solution as a solvent and chitosan as a polymer material will be described. 1) Add an aqueous acetic acid solution (50 to 80 wt%) to a stirrer and heat it to 30 to 80 °C; 2) Add chitosan (5 to 30 wt%) and stir at a speed of 200 to 800 RPM until completely dissolved. 3) After complete dissolution, add a water-soluble polymer, such as HPMC (hydroxypropyl methylcellulose) (2 to 20 wt%) or CMC (carboxymethyl cellulose) (2 to 20 wt%), heat to 30 to 80 °C, and stir at a speed of 200 to 800 RPM. 4) Then, while maintaining the temperature at 50 to 100 °C, add a drug (API: Active Pharmaceutical Ingredient), such as donepezil (5 to 30 wt%), and stir at a speed of 200 to 800 RPM. 5) After complete dissolution, add glycerin (0.3 to 10 wt%) at 30 to 80 °C and stir at a speed of 100 to 600 RPM until completely dissolved.

[0125] Donepezil corresponding to the above drug is merely a drug for experimenting with the microneedle patch 170 of the present invention, and the present invention is not limited to the drug. For example, the type of drug that can be contained in the needle body 160 or the needle support 110 is not particularly limited.

[0126] Meanwhile, as described above, the needle support 110 or the base needle can be formed using the viscous composition formed as described above through the above process, and the needle body 160 can be formed by deforming it. At least one of the needle support 110 or the needle body 160 formed in this way has the property of swelling or swelling by binding to body fluid.

[0127] For example, the needle support 110 and the needle body 160 can be formed using the same viscous composition or different viscous compositions. Among them, the same viscous composition can be defined as a composition containing the same swellable polymer material, and both contain drugs.

[0128] And different viscous compositions can be defined as only one of the needle support 110 and the needle body 160 contains a swellable polymer material, or the swellable polymer materials contained in the two compositions are different from each other, or whether drugs are contained is different.

[0129] For example, the needle support 110 may comprise PVA, while the needle body 160 may comprise chitosan, and vice versa. In addition, at least one of the needle support 110 and the needle body 160 may comprise a drug.

[0130] A case where the needle body 160 comprises an expandable polymer material will be described in detail below. The above Figure 9 (a) of shows the original state of the needle body 160, Figure 9 (b) of shows the state where the needle body 160 contacts body fluid and expands.

[0131] The needle body 160 can combine with body fluid, thereby changing the base diameter D, the needle height H, and the needle diameter N. Specifically, at least one of the base diameter D, the needle height H, and the needle diameter N can increase in the range of 1% to 200%. Thereby, the surface area and volume of the needle body 160 can be increased.

[0132] For example, the base diameter D of the needle body 160 may be about 807 μm, the needle height H may be about 413 μm, and the needle diameter N may be about 90 μm. When combined with body fluid, the base diameter D' of the needle body 160 becomes about 1048 μm, the needle height H' becomes about 426 μm, and the needle diameter N becomes about 158 μm. Therefore, the base diameter D increases by about 30%, and the needle diameter N increases by about 76%. Although the needle height H hardly changes, it can be seen that the volume and surface area of the needle body 160 increase accordingly.

[0133] Figures 10 to 13 It is an experimental diagram of the change of the needle body in the microneedle patch according to an embodiment of the present invention.

[0134] Figure 10 and Figure 11 corresponds to the case where the needle body 160 comprises chitosan in the expandable polymer material. Figure 10 shows the original state of the needle body 160, Figure 11 shows the state after contacting with the body fluid simulation solution PBS (Phosphate Buffer Saline).

[0135] For Figure 10 and Figure 11 For the needle body shown on the left side of and, the base diameter changes from 809.15 μm to 1029.4 μm, the needle height H changes from 404.91 μm to 407.84 μm, and the needle diameter N changes from 96.13 μm to 171.90 μm. In addition, for Figure 10 and Figure 11The needle body shown on the right has a base diameter that changes from 806.33 μm to 1068.94 μm, a needle height H that changes from 423.85 μm to 445.7 μm, and a needle diameter N that changes from 84.53 μm to 145.65 μm.

[0136] Figure 12 and 13 corresponds to the case where the needle body 160 contains PVA in an expandable polymer material. Figure 12 shows the original state of the needle body 160, Figure 13 shows the state after contact with the body fluid simulation solution PBS (Phosphate Buffer Saline).

[0137] For Figure 12 and 13 the needle body shown on the left, its base diameter changes from 873.61 μm to 1002.10 μm, the needle height H changes from 614.74 μm to 614.67 μm, and the needle diameter N changes from 123.8 μm to 155.85 μm. Additionally, for Figure 12 and Figure 13 the needle body shown on the right, its base diameter changes from 888.55 μm to 1044.70 μm, the needle height H changes from 611.85 μm to 607.46 μm, and the needle diameter N changes from 123.84 μm to 167.5 μm.

[0138] From these experimental values, it can be confirmed that when the needle body contacts body fluid, the surface area and volume increase. At this time, it can be confirmed that the needle height H remains basically unchanged, but the base diameter D and the needle diameter N increase, thus extending laterally in the needle body. In summary, when contacting body fluid, the base diameter D and the needle diameter N increase by more than 1.1 times and less than 2 times, while the needle height H changes relatively little.

[0139] In addition, as described above, at least one of the needle support 110 and the needle body 160 may contain a drug. That is to say, the microneedle patch 170 of the present invention may include the following situations: 1) the needle body 160 contains a drug, 2) the needle support 110 contains a drug, or 3) both the needle body 160 and the needle support 110 contain a drug.

[0140] Table 1 below lists the experimental values of the actually measured drug content when the drug is contained in the needle support or the needle body.

[0141] Table 1

[0142]

[0143] In the cases of A and B, 4 mg of the drug was contained only in the viscous composition for forming the needle support, and the amount of the drug was measured again after the needle support was actually formed. In addition, experiments were also conducted on A containing chitosan and B containing PVA. The results showed that the measured value of A was 3.88 mg, which was 97.0% of the theoretical value; the measured value of B was 3.97 mg, which was 99.2% of the theoretical value. In other words, even if the drug is contained only in the needle support, the drug can be effectively contained.

[0144] In the cases of C and D, 4 mg of the drug was contained only in the viscous composition for forming the needle body, and the amount of the drug was measured again after the needle body was actually formed. In addition, experiments were also conducted on C containing chitosan and D containing PVA. As a result, the measured value of C was 3.95 mg, which was 98.7% of the theoretical value; the measured value of D was 3.96 mg, which was 99.0% of the theoretical value. In other words, even if the drug is contained only in the needle body, the drug can be effectively contained.

[0145] In the cases of E and F, 4.75 mg of the drug was contained in the viscous composition for forming the needle body and the needle support, and the amount of the drug was measured again after the needle body and the needle support were actually formed. In addition, experiments were also conducted on E containing chitosan and F containing PVA. As a result, the measured value of E was 4.68 mg, which was 98.5% of the theoretical value; the measured value of F was 4.68 mg, which was 98.6% of the theoretical value. That is to say, even if both the needle support and the needle body contain the drug, the drug can be effectively contained.

[0146] On the other hand, Figure 14 Schematic diagram of the change of the needle body in the microneedle patch according to another embodiment of the present invention.

[0147] Reference Figure 14 , according to the experiments of the present applicant, when the needle body comes into contact with body fluid, it can be deformed such that one of the base diameter D, the needle height H, and the needle diameter N increases while the other decreases.

[0148] For example, in Figure 14 the shape shown in (a), when in contact with body fluid, the needle body can be deformed into Figure 14 the shape shown in (b). Figure 14 Compared with the shape shown in (a) of Figure 14 the needle body shown in (b), the base diameter D" relatively increases while the needle height H" decreases. In this case, the needle diameter N" can be substantially the same or larger.

[0149] And, in Figure 14 the shape shown in (a), when in contact with body fluid, the needle body can be deformed into Figure 14 the shape shown in (c). Figure 14 Compared with the shape shown in (a) ofFigure 14 Compared with the shape shown in (a), the base diameter D''' is relatively reduced, while the needle height H''' is increased. In this case, the needle diameter N''' can be substantially the same or smaller.

[0150] In the needle body shown in (b) and (c) according to Figure 14 When in contact with body fluid, one of the base diameter D, the needle height H, and the needle diameter N increases and expands, so that the drug contained in the needle body can be injected into the human body.

[0151] In summary, at least one of the needle support and the needle body of the invention may contain an expandable polymer material or a drug. At this time, the needle support and the needle body can be understood as a "microneedle". The microneedle refers to a structure in which at least a part of the microneedle is inserted into the skin to inject a drug.

[0152] For example, if the needle support and the needle body are made of the same viscous composition, they are each formed by the above manufacturing process. In addition, the needle support and the needle body can form an integral microneedle.

[0153] Although the above has been described in conjunction with the preferred embodiments of the present invention, those skilled in the art can make various modifications and changes to the present invention without departing from the spirit and scope described in the claims of the present invention. Therefore, if the modified embodiment basically covers the elements described in the claims of the present invention, it should be regarded as being entirely included in the technical scope of the present invention.

Claims

1. A microneedle patch, characterized in that, Comprising: An adhesive sheet, which is closely attached to the skin; A needle support, which is arranged on the adhesive sheet; and A needle body, which is arranged on the needle support and has a tip end, At least one of the needle support and the needle body contains an expandable polymer material that expands when contacting body fluid.

2. The microneedle patch according to claim 1, characterized in that, At least one of the needle support and the needle body contains a drug, At least one of the needle support and the needle body expands when contacting body fluid to supply the drug.

3. The microneedle patch according to claim 1, characterized in that, At least one of the needle support and the needle body is formed by curing a viscous composition in which an expandable polymer material and a drug are dissolved.

4. The microneedle patch according to claim 1, characterized in that, The needle body contains an expandable polymer material, and the shape of the needle body is: the base diameter (D) corresponds to the diameter of the bottom surface in contact with the needle support, the needle height (H) corresponds to the vertical distance from the bottom surface to the upper end, and the needle diameter (N) corresponds to the diameter of the tip end, When the needle body contacts body fluid, at least one of the base diameter, the needle height, and the needle diameter increases.

5. The microneedle patch according to claim 4, characterized in that, When contacting body fluid, the base diameter and the needle diameter increase by more than 1.1 times and less than 2 times.

6. The microneedle patch according to claim 1, characterized in that, The needle body contains an expandable polymer material, and the shape of the needle body is: the base diameter (D) corresponds to the diameter of the bottom surface in contact with the needle support, the needle height (H) corresponds to the vertical distance from the bottom surface to the upper end, and the needle diameter (N) corresponds to the diameter of the tip end, When the needle body contacts body fluid, one of the base diameter, the needle height, and the needle diameter increases, and the other decreases.

7. The microneedle patch according to claim 1, characterized in that, The adhesive sheet and the needle support form an adhesive surface, The needle support is inserted from the adhesive surface and arranged inside the adhesive sheet, and the needle body extends outward from the adhesive surface.

8. The microneedle patch according to claim 7, characterized in that, The needle support is inserted into the inside of the adhesive sheet and arranged in a plurality of engraved shapes spaced apart from each other, The needle bodies are respectively arranged on a plurality of the needle supports.

9. The microneedle patch according to claim 7, characterized in that, The needle support is inserted into the inside of the adhesive sheet and arranged in a parallel extending layered manner, The needle bodies are arranged on the needle support at intervals of each other.

10. A manufacturing method of a microneedle patch, characterized in that, Comprising the following steps: Forming a needle support on a base resin; Forming an adhesive sheet on the substrate to cover the needle support; Forming a covering resin on the upper part of the adhesive sheet, turning over the needle support and the adhesive sheet so that the base resin is located on the upper part; Removing the base resin; And Forming a needle body on the needle support, At least one of the needle support and the needle body includes an expandable polymer material that expands when contacting body fluid.

11. The method for manufacturing a microneedle patch according to claim 10, wherein at least one of the needle support and the needle body is formed by curing a viscous composition in which an expandable polymer material and a drug are dissolved.

12. The method for manufacturing a microneedle patch according to claim 10, wherein in the step of forming the needle body, a pair of structures for forming base needles on the needle support are provided, the pair of structures are relatively moved closer to each other so that a pair of base needles respectively formed on the pair of structures contact each other, the pair of structures are relatively moved away from each other so that the pair of base needles adhere to each other and are stretched and deformed, the deformed base needles form the needle body.

13. The method for manufacturing a microneedle patch according to claim 10, wherein the needle support includes a plurality of supports formed at intervals on the base resin, the adhesive sheets respectively cover the plurality of supports, the needle bodies are respectively formed on the plurality of supports.

14. The method for manufacturing a microneedle patch according to claim 10, wherein the needle bodies are arranged on the needle support at intervals from each other.

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