WO2022102977A1

WO2022102977A1 - Microneedle array and method for manufacturing same

Info

Publication number: WO2022102977A1
Application number: PCT/KR2021/013760
Authority: WO
Inventors: 김동환; 박상한; 강복기; 이민석
Original assignee: 주식회사 대웅테라퓨틱스
Priority date: 2020-11-13
Filing date: 2021-10-07
Publication date: 2022-05-19
Also published as: KR20220065655A

Abstract

An embodiment of the present invention provides a method for manufacturing a microneedle array, the method comprising the steps of: (A) injection-molding a thermoplastic resin to prepare a mold for manufacturing a microneedle, wherein the mold includes one or more intaglio portions; and (B) injecting microneedle raw materials into the intaglio portions to mold the raw materials into one or more microneedles. In addition, another embodiment of the present invention provides a microneedle array comprising: a mold for manufacturing a microneedle, wherein the mold is prepared by injection-molding a thermoplastic plastic resin and includes one or more intaglio portions; and one or more microneedles which are molded by injecting microneedle raw materials into the intaglio portions.

Description

Microneedle array and manufacturing method thereof

The present invention relates to a microneedle array and a method for manufacturing the same, and more particularly, to a microneedle array manufactured using a mold manufactured by injection molding using a thermoplastic resin as a material and a method for manufacturing the same.

In general, microneedle formulations aim to deliver ingredients through the skin to achieve a desired efficacy. The microneedle formulation uses microneedles with diameters and heights of only tens to thousands of micrometers to penetrate the stratum corneum, which is the main barrier layer for ingredient delivery through the skin. By using the microneedle, the target component reaches the epidermal layer or the dermal layer, so that the microneedle is applied or the body's circulatory system exhibits efficacy throughout the body.

The material of the microneedle can be largely divided into a metal microneedle and a biodegradable material microneedle.

The metal microneedle has a hollow microneedle shape like a general injection needle with a path through which the component to be delivered can move, and a solid microneedle that delivers the component by coating it on the surface of the microneedle. there is a form

On the other hand, the biodegradable microneedle is mainly in the form of a solid microneedle, and the component is coated on the surface of the microneedle or the microneedle is formed like a biodegradable polymer and applied to the skin, and then the applied microneedle is decomposed to deliver the component. .

The microneedle is generally manufactured by injecting a material constituting the needle into a metal (iron, silicon, etc.) mold in which the shape of the microneedle is engraved.

In this method of forming the microneedle in the metal mold, since the metal mold is an accessory of the microneedle manufacturing equipment or is heavier than the non-metal, the process of separating the microneedle from the mold to cycle the manufacturing process after the formation of the microneedle is essential. .

Due to such a manufacturing method, when the microneedle is separated from the metal mold, or after the mold is separated, the shape of the microneedle may be deformed or lost during an additional manufacturing or distribution process. Such deformation or loss may result in non-uniformity in the content of individual microneedles, and as a result, may lead to imbalance in the total content of drugs loaded into the microneedle array. In addition, since the metal mold is an accessory of the manufacturing equipment, for mass production, the manufacturing equipment must be enlarged as the size of the metal mold increases, and the manufacturing cost also increases. There is a problem in that the production cost is lowered due to this.

Also, after separating the microneedles from the mold, a packaging material capable of protecting each of the microneedles is desperately needed, but there is no packaging material surrounding each of the microneedles.

선행기술문헌Prior art literature

(Patent Document 1) Korean Patent Publication No. 10-1694317 (2017.01.03)

SUMMARY OF THE INVENTION The present invention is to solve the problems of the prior art, and an object of the present invention is to provide a microneedle array manufactured using a mold manufactured by an injection molding method using a thermoplastic resin as a material and a method for manufacturing the same.

In order to achieve the above object, one aspect of the present invention comprises the steps of: (A) injection molding a thermoplastic resin to manufacture a mold for manufacturing a microneedle including at least one intaglio; And (B) injecting a microneedle raw material into the intaglio portion to mold one or more microneedles; it provides a method of manufacturing a microneedle array comprising a.

In one embodiment of the present invention, the thermoplastic resin is at least one selected from the group consisting of polyethylene terephthalate (PET), polyvinyl chloride (PVC), and polypropylene (PP). It may be a manufacturing method.

In one embodiment of the present invention, the mold may be a method of manufacturing a microneedle array, characterized in that the mold is a primary packaging container in full close contact with the microneedle and is removed immediately before application of the microneedle to the human body.

In one embodiment of the present invention, after step (B), (C) laminating the pressure-sensitive adhesive sheet on a flat surface including the top surface of the microneedle and one surface of the mold; characterized in that it further comprises It may be a method of manufacturing a microneedle array.

In one embodiment of the present invention, in the step (B), after the microneedle raw material is injected, the pressure is reduced to 0.5 atm or less, and then filled with a blade or pressurized to 2 atm or higher to fill the concave part of the mold. It may be a method of manufacturing a microneedle array, characterized in that.

In one embodiment of the present invention, in the step (B), the microneedle raw material containing the active ingredient to be delivered is filled in the concave part of the mold, and after primary drying, the base part raw material is filled in the upper part, Secondary drying may be a method of manufacturing a microneedle array, characterized in that the microneedle is molded.

In one embodiment of the present invention, the microneedle raw material may be a method of manufacturing a microneedle array, characterized in that at least one selected from the group consisting of metals, non-metals, biodegradable polymers, and pharmacological components.

In one embodiment of the present invention, the base raw material is carboxymethyl cellulose (CMC), hyaluronic acid (HA), polyvinyl alcohol (PVA), polylactic acid (PLA), polylacticcoglycolic acid (PLGA), It may be a method of manufacturing a microneedle array, characterized in that at least one selected from the group consisting of polyvinylpyrrolidone (PVP).

In order to achieve the above object, another aspect of the present invention, is manufactured by injection molding a thermoplastic resin, a mold for manufacturing a microneedle including one or more intaglio; and one or more microneedles molded by injecting a microneedle raw material into the intaglio portion; it provides a microneedle array comprising a.

In one embodiment of the present invention, the thermoplastic resin is at least one selected from the group consisting of polyethylene terephthalate (PET), polyvinyl chloride (PVC), polyvinylidene chloride (PVDC), and polypropylene (PP). Characterized in, it may be a microneedle array.

In one embodiment of the present invention, the mold may be a microneedle array, characterized in that it is removed immediately before application of the microneedle to the human body as a primary packaging material in full close contact with the microneedle.

In one embodiment of the present invention, it may be a microneedle array, characterized in that it further comprises a base on the upper surface of the microneedle.

In one embodiment of the present invention, the base portion is carboxymethyl cellulose (CMC), hyaluronic acid (HA), polyvinyl alcohol (PVA), polylactic acid (PLA), polylacticcoglycolic acid (PLGA), polyvinyl It may be a microneedle array, characterized in that at least one selected from the group consisting of pyrrolidone (PVP).

In one embodiment of the present invention, it may be a microneedle array, characterized in that the adhesive sheet is laminated on one surface of the microneedle.

In one embodiment of the present invention, it may be a microneedle array, characterized in that the adhesive sheet is laminated on one surface of the base.

According to one aspect of the present invention, the mold for manufacturing microneedles manufactured through injection molding does not shrink or warp even when stored for a long period of time compared to thermocompression molding, so that the shape of the product does not change, and the storage stability of the product can be improved. there is.

In addition, the mold for manufacturing microneedles manufactured through injection molding can be formed very precisely without deviation in height of individual intaglios compared to thermocompression molding, and many intaglios can be formed in a narrower area.

In addition, when a mold for manufacturing microneedles is manufactured by injection molding, production efficiency may be improved compared to thermocompression molding, and manufacturing cost may be reduced.

Then, the mold for manufacturing the microneedle manufactured through injection molding is used as a mold required for manufacturing the microneedle, and the mold for manufacturing the microneedle is present in the final product without being removed from the microneedle, so that the user applies the mold to the human body. Deformation, loss, contamination, etc. of the microneedle can be prevented by allowing the microneedle to be completely removed.

In addition, since a mold for manufacturing microneedles having a function of protecting the microneedle in the final product is used as a mold for forming the microneedle, the maximum production quantity can be adjusted according to the input amount of raw materials regardless of the size of the manufacturing apparatus, Accordingly, microneedles can be mass-produced within a short period of time.

In addition, thermoplastic plastic materials such as PET, PVC, and PP are cheaper than silicone materials, and molds for manufacturing microneedles made of these thermoplastic materials are free from the issues of Cleaning Validation (CV), durability and internal medicines. It has excellent protection against external contamination, and pre-sterilization is possible.

It should be understood that the effects of the present invention are not limited to the above-described effects, and include all effects that can be inferred from the configuration of the invention described in the detailed description or claims of the present invention.

1 is a schematic diagram of a step of manufacturing a mold for manufacturing a microneedle according to an embodiment of the present invention.

2 is a photograph of a mold for manufacturing a microneedle manufactured by an injection molding method.

Figure 3 is a schematic diagram of the step of molding the microneedle according to an embodiment of the present invention.

Figure 4 is a schematic diagram of the step of molding the microneedle according to an embodiment of the present invention by a two-stage molding method.

5 is a schematic view of the step of laminating the pressure-sensitive adhesive sheet according to an embodiment of the present invention.

6A and 6B are perspective and cross-sectional views, respectively, of a microneedle array including a microneedle manufacturing mold, a microneedle, and an adhesive sheet according to an embodiment of the present invention.

7 is a photograph in which the microneedle is removed from the mold for manufacturing the microneedle according to an embodiment of the present invention.

8 is a view showing the shape change of a mold for manufacturing a microneedle manufactured by an injection molding method and a mold for manufacturing a microneedle manufactured by a thermocompression molding method.

FIG. 9 is a diagram illustrating a distance between needles of a mold for manufacturing microneedles manufactured by an injection molding method and a mold for manufacturing microneedles manufactured by a thermocompression molding method.

Hereinafter, the present invention will be described with reference to the accompanying drawings. However, the present invention may be embodied in several different forms, and thus is not limited to the embodiments described herein. And in order to clearly explain the present invention in the drawings, parts irrelevant to the description are omitted, and similar reference numerals are attached to similar parts throughout the specification.

Throughout the specification, when a part is "connected" with another part, this includes not only the case where it is "directly connected" but also the case where it is "indirectly connected" with another member interposed therebetween. . In addition, when a part "includes" a certain component, this means that other components may be further provided without excluding other components unless otherwise stated.

Hereinafter, embodiments of the present invention will be described in detail with reference to the accompanying drawings.

One aspect of the present invention, (A) manufacturing a mold for manufacturing a microneedle including one or more intaglio parts by injection molding a thermoplastic resin; And (B) injecting a microneedle raw material into the intaglio portion to mold one or more microneedles; it provides a method of manufacturing a microneedle array comprising a.

In the step (A), the mold 10 for manufacturing a microneedle including the intaglio part 11 may be manufactured by melting, flowing, cooling, and demolding the thermoplastic resin using an injection device.

1 is a schematic diagram of a step of manufacturing a mold for manufacturing a microneedle according to an embodiment of the present invention, FIG. 2 shows a mold for manufacturing a microneedle manufactured by an injection molding method, and FIG. 8 is a microneedle manufactured by an injection molding method It is a view showing the shape change of a mold for manufacturing a needle and a mold for manufacturing a microneedle manufactured by a thermocompression molding method, and FIG. 9 is a needle of a mold for manufacturing a microneedle manufactured by an injection molding method and a mold for manufacturing a microneedle manufactured by a thermocompression molding method It is a diagram showing the interval between

1 and 2, when injection molding through a process of melting, flowing, cooling and demolding a thermoplastic resin using an injection device, the thermoplastic resin is a mold for manufacturing a microneedle including one or more intaglio parts (10) can be molded into At this time, one surface of the molded microneedle manufacturing mold 10 may include one or more intaglio portions 11, and the other surface may be flat.

The engraved part 11 serves as a mold for the microneedle 21 formed in a subsequent step, and has the same shape as the microneedle 21 , but may have an upside down phase reversed.

In this case, the engraved part 11 may be a tip engraved part. As used herein, the term “tip intaglio” refers to an intaglio recessed from the upper surface by reducing the cross-sectional area from the flat upper surface to the lower surface forming the tip to have the shape of a conventional microneedle 21 .

Meanwhile, one surface of the molded microneedle manufacturing mold 10 may include a flat intaglio portion 12 and one or more intaglio portions 11 formed on a lower surface of the flat intaglio portion 12 . As used herein, the term “flat intaglio” refers to an intaglio recessed with substantially the same cross-sectional area and a predetermined depth from a flat upper surface to a lower surface. A lower surface of the flat intaglio portion 12 may be substantially flat. In addition, the terms "upper surface" and/or "lower surface" used herein are for specifying the relative positional relationship of each component, and do not specify their absolute positions.

The intaglio portions 11 of the mold 10 for manufacturing a microneedle in which the flat intaglio portions 12 do not exist are not interconnected and exist independently. When the microneedle 21 is manufactured using the mold 10 for manufacturing the microneedle, the manufactured microneedle 21 also exists independently without being interconnected. 30), there is a problem in that it is difficult to adhere uniformly. For example, in the case of laminating 100 microneedles 21 that exist independently of each other in 10 * 10 (horizontal * vertical) with the adhesive sheet 30 in a subsequent step, a single Since the cross-sectional area of the upper surface of the microneedle 21 is insufficient, it may be easily separated from the adhesive sheet 30 and cause inconvenience to the user.

In contrast, the mold 10 for manufacturing a microneedle in which the flat intaglio portion 12 is present includes one or more intaglio portions 11 formed on the lower surface of the flat intaglio portion 12, and in a subsequent step, the microneedle raw material 20 ) is filled in not only the intaglio part 11 but also the flat intaglio part 12 so that the microneedle 21 formed by the intaglio part 11 and the support 22 formed by the flat intaglio part 12 are integrated Since it is formed as, it is possible to prevent the single microneedle 21 from arbitrarily falling from the pressure-sensitive adhesive sheet 30 as described above.

The thermoplastic resin may be at least one selected from the group consisting of polyethylene terephthalate (PET), polyvinyl chloride (PVC), and polypropylene (PP), but is not limited thereto.

Conventional silicone materials are expensive and difficult to use once, so reuse is required. In addition, in the case of silicone material, it is physically and chemically decomposed, and due to its relatively weak hardness, it is difficult to verify the generation of fragments during the manufacturing process or the washing process and the lifespan of the silicone mold.

In addition, in the mold manufacturing method using a silicone material, since silicone does not play a protective role against external air or foreign substances, the dried microneedle must be demolded from the silicone mold and then repackaged. In this process, since it is practically difficult to individually pack the microneedles in close contact with the microneedles, the microneedles must be packaged in a pouch exposed to air or packaged in a cap-shaped container.

The closure and stability of the packaging container is a factor that has a great influence on maintaining the quality of the internal medicine, and it must be completely protected from physicochemical deformation or deterioration of the internal microneedle medicine through the simulation of transport conditions and mechanical testing of the final product.

*Therefore, the microneedle manufacturing mold 10 may be configured to be removed immediately before application of the microneedle 21 to the human body as a primary packaging container in full close contact with the microneedle 21 .

That is, in the final product, the microneedle 21 is deformed, lost, contamination can be prevented.

Thermoplastic materials such as polyethylene terephthalate (PET), a release paper material that protects in direct contact with the drug layer, polyvinyl chloride (PVC) used for packaging pharmaceutical tablets, and polypropylene (PP) used for syringe manufacturing, are silicone materials. It is a low-cost material and can be used once. Therefore, the mold 10 for manufacturing microneedles made of thermoplastic plastic materials such as PET, PVC, and PP is free from cleaning validation (CV) issues, and has excellent durability and protection of internal medicines from external contamination sources. , which is advantageous in that it can be pre-sterilized.

In addition, the mold 10 for manufacturing the microneedle is a primary packaging material that is completely in close contact with the microneedle 21 without the need to demold and repack the microneedle 21 manufactured in the microneedle manufacturing process. It can be advantageous in maintaining the quality of the internal microneedle drug because it is configured to simplify the manufacturing process, and has excellent closure and stability as a packaging container.

Referring to FIG. 8 , the shape changes of a mold for manufacturing a microneedle manufactured by injection molding a thermoplastic resin and a mold for manufacturing a microneedle manufactured by thermocompression molding a thermoplastic resin are shown.

The mold 40 for manufacturing microneedles manufactured through thermocompression molding undergoes shrinkage, warpage, etc. over time during storage, thereby changing the shape of the product. On the other hand, the mold 10 for manufacturing microneedles manufactured through injection molding does not shrink or warp even after long-term storage, so that the shape of the product does not change, and the storage stability of the product can be improved.

In addition, thermocompression molding is to form a solid film, and since the mold 40 for manufacturing microneedles manufactured through thermocompression molding easily causes variations in the force received by position during thermal compression, the height of the intaglio is not constant. do. On the other hand, injection molding is a method of filling the inside of an injection mold by liquefying a plastic resin, and the mold 10 for manufacturing a microneedle manufactured through injection molding can be formed very precisely without deviation in the height of the intaglio.

Referring to FIG. 9 , the distance between individual intaglio parts of a mold for manufacturing microneedles manufactured by injection molding a thermoplastic resin and a mold for manufacturing microneedles manufactured by thermocompression molding a thermoplastic resin is shown.

The mold 40 for microneedle production manufactured by thermocompression molding including 100 intaglio parts 41 that exist independently of each other in 10 * 10 (horizontal * vertical) requires an area of 1.4 cm * 1.4 cm, but 10 * It can be seen that the mold 10 for manufacturing a microneedle manufactured by thermocompression molding including 100 intaglio portions 11 that exist independently of each other by 10 (horizontal * vertical) requires an area of 0.8 cm * 0.8 cm.

That is, thermocompression molding is to thermocompress a solid plastic resin film using a mold having several embossed parts. Between the points where the film is molded by the embossed parts, a gap required for deformation such as stretching of the film is required. On the other hand, injection molding is a method of filling the inside of an injection mold by liquefying a plastic resin, so that many engraved parts can be formed in a narrower area.

In addition, in thermocompression molding, the processes of mold heating, film pressurization, cooling and desorption are 1 cycle, and it takes about 1 to 2 hours per cycle. On the other hand, in injection molding, the process of melting, flowing, cooling and desorbing the plastic resin is 1 cycle, and it takes about 2 minutes per cycle. That is, when a mold for manufacturing microneedles is manufactured by the injection molding method, the production efficiency may be improved compared to the thermal compression molding method, and the manufacturing cost may be reduced.

Figure 3 is a schematic diagram of the step of molding the microneedle according to an embodiment of the present invention. 3(a) and 3(b) show the steps of forming the microneedle using a mold for manufacturing each microneedle molded through the method of FIG. 1, respectively.

In the step (B), the microneedle raw material 20 may be injected into the intaglio part 11 to form the microneedle 21 . The microneedle 21 of the present invention is a soluble microneedle, and the microneedle raw material 20 is made of metal, non-metal, biodegradable polymer, and active pharmaceutical ingredients according to the shape of the microneedle 21 . It may include one or more selected from the group. For example, the microneedle raw material 20 may be a composition including a pharmacological component, and may be a composition including a metal, a non-metal, a biodegradable polymer, or a combination of two or more thereof, but is not limited thereto.

Referring to FIG. 3 , the microneedle raw material 20 is supplied from the storage tank to the mold 10 for manufacturing the microneedle through a single discharge port, and the intaglio part 11 and/or the flat intaglio part 12 can be injected. However, the method of supplying and injecting the microneedle raw material 20 is not limited thereto, and, if necessary, the microneedle raw material 20 may be formed into a plurality of intaglio portions 11 and/or flat intaglio portions 12 . The microneedle raw material is directly injected into the intaglio part 11 and/or the flat intaglio part 12 through a plurality of outlets located adjacent to each other, or using a coating method such as roll coating, bar coating, or spray coating. (20) may be injected into the intaglio portion 11 and/or the flat intaglio portion 12.

At this time, after reducing the pressure to 0.5 atmosphere or less, preferably 0.1 atmosphere or less in the decompression chamber, the microneedle raw material 20 is put on the flat surface of the mold 10 for manufacturing the microneedle, and then using a blade It may be filled in the engraved part 11 and/or the flat engraved part 12 of the mold 10 for manufacturing the microneedle. As such, the filling method using a blade after decompression so that the inside of the decompression chamber is close to a vacuum state suppresses the generation of bubbles in the engraved part 11 of the mold 10 for microneedle production, so that the microneedle 21 is sophisticated for pharmaceutical use. It is possible to overcome the limitation of application to general cosmetics by having the same content as the shape. On the other hand, after injection of the raw material 20 of the microneedle, it may be filled by pressurizing at least 2 atm, preferably at least 2 atm and below 50 atm. The high pressure pressurizes the raw material and pushes the air, so it is possible to suppress the generation of bubbles in the intaglio portion 11 of the mold 10 for manufacturing the microneedle.

On the other hand, when the microneedle raw material 20 is supplied exceeding the depth of the intaglio part 11 and/or the flat intaglio part 12 , the intaglio part 11 and/or the flatness of the mold 10 for manufacturing a microneedle Since the microneedle raw material 20 remains in the region except for the engraved part 12, the adhesive sheet 30 cannot be smoothly laminated in a subsequent step, and as an excessive amount of the microneedle raw material 20 is used, economically also disadvantageous

On the other hand, after supplying the microneedle raw material 20, the intaglio part 11 and/or the flat intaglio part 12 of the mold 10 for manufacturing a microneedle using a method such as squeezing is excluded. The microneedle raw material 20 remaining in the area can be removed, and the area except for the intaglio part 11 and/or the flat intaglio part 12 of the microneedle manufacturing mold 10 and the upper surface of the microneedle 21 A problem that may occur in a subsequent step can be prevented by removing any step difference between the livers so that they form a substantially flat surface.

As such, in the method of manufacturing the array of microneedles 21 of the present invention, the mold 10 for manufacturing microneedles manufactured by injection molding the thermoplastic resin in step (A) is subjected to microneedle 21 in step (B). The microneedle 21 is used as a mold necessary for manufacturing the array, and the mold 10 for manufacturing the microneedle in the final product is removed from the microneedle 21 before being applied to the human body by the user in a state that is not removed from the microneedle 21. It can prevent deformation, loss, contamination, etc.

Figure 4 is a schematic diagram of the step of molding the microneedle according to an embodiment of the present invention by a two-stage molding method. 4(a) and 4(b) show the steps of molding the microneedles by a two-stage molding method using a mold for manufacturing each microneedle molded through the method of FIG. 1, respectively.

Referring to FIG. 4 , the microneedle 21 molding according to an embodiment may be performed in the following two steps. First, the microneedle raw material 20 containing active ingredients such as pharmacological ingredients to be delivered is filled in the concave part 11 of the mold 10 for microneedle production as described above, and then dried first. Then, the dried microneedle 21 is reduced in volume and exists only at the lower end of the intaglio part 11 . Then, the base raw material 23 is filled in the upper part of the microneedle 21 dried as described above, and then the secondary drying is performed.

Through this, it is possible to form a microneedle array in which the microneedles 21 and the base 24 are separately manufactured. At this time, the microneedle 21 and the base part 24 can be made of different materials, and preferably, the microneedle 21 and the base part 24 are carboxymethyl cellulose (CMC) and hyaluronic acid (HA), respectively. ), polyvinyl alcohol (PVA), polylactic acid (PLA), polylacticcoglycolic acid (PLGA), polyvinylpyrrolidone (PVP), etc.

In this way, the microneedle array manufactured by the two-stage molding method can be manufactured so that active ingredients, such as pharmacological ingredients, exist only at the lower end of the microneedle 21, if necessary, so that only a precisely controlled amount can be delivered to the user.

5 is a schematic view of the step of laminating the pressure-sensitive adhesive sheet according to an embodiment of the present invention. 5 (a) and 5 (b) show the step of laminating the pressure-sensitive adhesive sheet on one surface, that is, the flat surface of the microneedle array prepared in FIGS. 3 (a) and 3 (b), respectively.

The flat surface may include an upper surface of the microneedle 21 and one surface of the mold 10 for manufacturing the microneedle (FIG. 3(a)), and a support 22 integrally formed with the microneedle 21 may include an upper surface of the mold 10 and one surface of the mold 10 for manufacturing the microneedle (FIG. 3(b)).

The pressure-sensitive adhesive sheet 30 may be a sheet made of a thermoplastic substrate such as a metal, a polymer, or a fabric or a pressure-sensitive adhesive coated on one surface of the sheet. The pressure-sensitive adhesive may be a releasable pressure-sensitive adhesive that can be attached and peeled at least once.

One side of the pressure-sensitive adhesive sheet 30 on which the pressure-sensitive adhesive is applied is laminated to one side of the microneedle 21 array, that is, a flat surface to attach and fix the upper surface of the microneedle 21, and for manufacturing the microneedle One surface of the mold 10 and the attached region maintain adhesive force even after the mold 10 for manufacturing the microneedle is removed for skin application, so that the pharmacological component contained in the microneedle 21 is attached to the skin for a period necessary for delivery. can be

In the microneedle 21 array in which the adhesive sheet 30 is laminated, the bonding force between the side surface of the microneedle 21 and the mold 10 for manufacturing the microneedle is the adhesive sheet 30 and the microneedle 21 When the bonding force of the upper surface of ), and the required amount of drug cannot be administered. Accordingly, the composition of the pressure-sensitive adhesive and its adhesive force so that the bonding force between the pressure-sensitive adhesive sheet 30 and the upper surface of the microneedle 21 is greater than that of the side surface of the microneedle 21 and the microneedle manufacturing mold 10 . The microneedle by controlling and/or coating one surface in contact with the microneedle raw material 20 of the microneedle manufacturing mold 10 with a certain material and/or surface-treating to give a certain level of roughness By lowering the bonding force between the side surface of (21) and the mold 10 for manufacturing the microneedles, the mold 10 for manufacturing the microneedles can be easily removed.

6A and 6B are perspective and cross-sectional views, respectively, of a microneedle array including a microneedle manufacturing mold, a microneedle, and an adhesive sheet according to an embodiment of the present invention, and FIG. 7 is an embodiment of the present invention. It is a photograph in which the microneedle according to the example is removed from the mold for manufacturing the microneedle.

6 and 7, the microneedle array is manufactured by injection molding a thermoplastic resin, and a mold for manufacturing a microneedle including one or more intaglio parts, and one or more microneedles molded by injecting a microneedle raw material into the intaglio part may include needles.

The mold 10 for manufacturing the microneedle may be a mold of a plastic material for manufacturing the microneedle 21 , and at the same time may be a packaging container that is completely in close contact with the microneedle 21 . That is, the microneedle 21 by the mold 10 for manufacturing the microneedle is not exposed to the air until just before the manufacturing process and application to the human body, so that deformation, loss, contamination, etc. can be prevented.

The above description of the present invention is for illustration, and those of ordinary skill in the art to which the present invention pertains can understand that it can be easily modified into other specific forms without changing the technical spirit or essential features of the present invention. will be. Therefore, it should be understood that the embodiments described above are illustrative in all respects and not restrictive. For example, each component described as a single type may be implemented in a dispersed form, and likewise components described as distributed may be implemented in a combined form.

The scope of the present invention is indicated by the following claims, and all changes or modifications derived from the meaning and scope of the claims and their equivalents should be construed as being included in the scope of the present invention.

부호의 설명Explanation of symbols

10 Mold for manufacturing microneedle

11 engraving

12 flat engraving

20 microneedle raw material

21 microneedle

22 support

23 Base raw material

24 base

30 adhesive sheet

Claims

(A) manufacturing a mold for manufacturing a microneedle including one or more intaglio parts by injection molding a thermoplastic resin; and

(B) molding one or more microneedles by injecting a microneedle raw material into the intaglio portion; including, a method of manufacturing a microneedle array.
According to claim 1,

The method of manufacturing a microneedle array, characterized in that the thermoplastic resin is at least one selected from the group consisting of polyethylene terephthalate (PET), polyvinyl chloride (PVC), and polypropylene (PP).
According to claim 1,

The mold is a primary packaging container in full close contact with the microneedle, characterized in that the microneedle is removed immediately before application to the human body.
According to claim 1,

After step (B),

(C) laminating an adhesive sheet on a flat surface including the upper surface of the microneedle and one surface of the mold;
According to claim 1,

In the step (B), after the microneedle raw material is injected, the microneedle array, characterized in that the pressure is reduced to 0.5 atm or less and then filled in the concave part of the mold by using a blade or pressurized to 2 atm or more. manufacturing method.
According to claim 1,

In the step (B), the microneedle raw material containing the active ingredient to be delivered is filled in the engraved part of the mold, and after primary drying, the base part raw material is filled on the upper part and secondary drying to form the microneedle. A method of manufacturing a microneedle array, characterized in that.
According to claim 1,

The microneedle raw material is a method of manufacturing a microneedle array, characterized in that at least one selected from the group consisting of a metal, a non-metal, a biodegradable polymer, and a pharmacological component.
According to claim 1,

The base raw material is carboxymethylcellulose (CMC), hyaluronic acid (HA), polyvinyl alcohol (PVA), polylactic acid (PLA), polylacticcoglycolic acid (PLGA), polyvinylpyrrolidone (PVP). A method of manufacturing a microneedle array, characterized in that at least one selected from the group consisting of.
A mold for manufacturing a microneedle manufactured by injection molding a thermoplastic resin and including one or more engraved parts; and

One or more microneedles molded by injecting a microneedle raw material into the intaglio portion; including, a microneedle array.
10. The method of claim 9,

The thermoplastic resin is a microneedle array, characterized in that at least one selected from the group consisting of polyethylene terephthalate (PET), polyvinyl chloride (PVC), polyvinylidene chloride (PVDC), and polypropylene (PP).
10. The method of claim 9,

The mold is a primary packaging container in complete contact with the microneedle, characterized in that the microneedle is removed immediately before application to the human body.
10. The method of claim 9,

The microneedle raw material is a method of manufacturing a microneedle array, characterized in that at least one selected from the group consisting of a metal, a non-metal, a biodegradable polymer, and a pharmacological component.
10. The method of claim 9,

The microneedle array, characterized in that it further comprises a base on the upper surface of the microneedle.
14. The method of claim 13,

The base is carboxymethylcellulose (CMC), hyaluronic acid (HA), polyvinyl alcohol (PVA), polylactic acid (PLA), polylacticcoglycolic acid (PLGA), polyvinylpyrrolidone (PVP) A microneedle array, characterized in that at least one selected from.
10. The method of claim 9,

A microneedle array, characterized in that an adhesive sheet is laminated on one surface of the microneedle.
14. The method of claim 13,

A microneedle array, characterized in that the adhesive sheet is laminated on one surface of the base.