Integrated microstructure patch manufacturing equipment and microstructure patch manufacturing method

Abstract

Providing integrated microstructure patch manufacturing equipment that occupies minimal overall space. [Solution] An integrated microstructured patch manufacturing apparatus for applying a delivery component to a microstructured patch 91 having a patch layer 911 and a microstructured layer 912 provided on the patch layer 911, comprising a housing unit having a housing that defines a containment space, a carrier unit 2 having a holding table 21 disposed within the containment space, a coating device 3, and a processing device 6, wherein the holding table 21 has a carrier portion 211 capable of holding the microstructured patch 91, the coating device 3 is provided in the containment space and performs a coating process to apply the delivery component to the microstructured layer 912, and the processing device 6 is provided in the containment space and performs a first processing process to process the microstructured patch 91.

Description

Technical Field

[0001] The present invention relates to the manufacture of microneedle patches, and more particularly to an integrated microstructured patch manufacturing facility and a method for manufacturing microstructured patches.

Background Art

[0002] Microneedles (MNs) are formulations in which drugs and other active molecules penetrate the skin at a constant rate and are absorbed into the body circulation via capillaries. They have the characteristics of good patient compliance, avoiding the first-pass effect, having a stable and controllable blood concentration, and high safety. They also have advantages such as low invasiveness, painlessness, safety, and ease of use. By combining these characteristics, microneedles can be applied in a very wide range of fields such as skin care, drug delivery, vaccination, traditional Chinese acupuncture and moxibustion, and biosensors.

[0003] Conventional microneedle manufacturing processes mainly perform processes such as mold opening, material supply, drying, demolding, packaging, etc. Since each process is executed by independent equipment, semi-finished products will be exposed to the outside air when being transported between each equipment. Also, in such conventional manufacturing methods, due to the large batch size, there are drawbacks such as a long period for preparing molds and procuring materials for products with different specifications, high manufacturing costs, high space requirements, high contamination, and lack of flexible layout capabilities.

[0004] Meanwhile, with the growing demand for personalized skincare and precision medicine, conventional microneedle manufacturing methods are no longer sufficient to meet the customized production needs of local healthcare institutions and consumers. Several types of 3D printing-based microneedle manufacturing equipment are being attempted to address these needs. For example, drug care components are added to the microneedle material, and further technologies such as non-contact material deposition inkjet printing, stereolithography (SLA), and photopolymerization-based technologies using digital light processing (DLP), or fused deposition modeling (FDM) are being employed.

[0005] However, while these 3D printing methods have advantages such as low cost and minimal material waste, they have drawbacks, such as the inability of the materials available for 3D printing to meet requirements like the stability of active ingredients in different types of drug care components and compatibility with polymers. Furthermore, 3D printing methods cannot effectively verify the strength, stability, and viable cell count of microneedles, making it difficult to obtain approval under medical regulations and thus posing a problem in ensuring the safety of personalized medical institutions and consumers.

[0006] Considering the above issues, the current industry demands an integrated microneedle manufacturing system that can be manufactured at low cost, is space-efficient, minimizes contamination, allows for flexible placement, is compatible with various drug active ingredients, meets verifiable microneedle specifications, and addresses personalized medical and skincare needs. [Prior art documents] [Patent Documents]

[0007] [Patent Document 1] Chinese Patent Application Publication No. 105078880 Specification [Overview of the project] [Problems that the invention aims to solve]

[0008] In view of the above problems, the object of the present invention is to provide an integrated microstructured patch manufacturing apparatus and a method for manufacturing microstructured patches that improve upon at least one of the drawbacks of the prior art described above. [Means for solving the problem]

[0009] To achieve the above objective, the present invention provides an integrated microstructured patch manufacturing apparatus for applying a delivery component to a microstructured patch having a patch layer and a microstructured layer provided on the patch layer, comprising: a housing unit having a housing that defines a containment space; a carrier unit having a holding stand disposed within the containment space; a coating device; and a processing device, wherein the holding stand has a carrier portion capable of holding the microstructured patch; the coating device is provided in the containment space and performs a coating step to apply the delivery component to the microstructured layer; and the processing device is provided in the containment space and performs a first processing step to process the microstructured patch.

[0010] Furthermore, the present invention relates to a method for manufacturing a microstructured patch carried out by an integrated microstructured patch manufacturing facility, wherein the integrated microstructured patch manufacturing facility comprises a housing unit defining a containment space, a carrier unit installed in the containment space, a coating device, and a processing device, the carrier unit having a holding base having a carrier portion, and the containment space having a supply area, a first processing area, a coating area, and a second processing area arranged at angular intervals. A supply step comprising: rotating the holding base so that the carrier portion moves to the supply area, and placing a microstructured patch having a patch layer and a microstructured layer provided on the patch layer but not coated with a delivery component, onto the carrier portion; The holding base rotates so that the carrier unit moves to the first processing area, and the processing device performs a sterilization step to sterilize the microstructured patch, The coating process involves the holding base rotating to move the carrier to the coating area, and the coating apparatus applying the delivery component to the microstructured patch, The present invention also provides a method for manufacturing a microstructured patch, wherein the holding base rotates so that the carrier portion moves to a second processing area, and the processing apparatus performs a drying step in which the delivery component is dried on the microstructured patch. [Effects of the Invention]

[0011] The present invention constitutes an integrated microstructure patch manufacturing facility in which the carrier unit, the coating device, and the processing device are installed within the housing space defined by the housing unit. As a result, the overall space required is small, and the degree of installation flexibility is increased, making it suitable for small-scale manufacturing for personal and household use, as well as applicable to large-scale manufacturing. [Brief explanation of the drawing]

[0012] [Figure 1] This is a perspective view showing the configuration of a first embodiment of the integrated microstructure patch manufacturing equipment of the present invention. [Figure 2] This is a perspective view showing the configuration of the carrier unit, coating device, storage container, processing device, and packaging device located within the housing unit of the first embodiment. [Figure 3] This is a block diagram showing the configuration of the first embodiment. [Figure 4] This is a side view showing the configuration of the first embodiment. [Figure 5] This is a perspective view showing the configuration of the coating apparatus in the first embodiment. [Figure 6] This is a top view showing the configuration of the first embodiment. [Figure 7] This is a flowchart illustrating the method for manufacturing the microstructured patch of the present invention. [Figure 8]It is a top view showing how the supply process of the method for manufacturing the microstructured patch of the present invention is carried out. [Figure 9] Corresponding to FIG. 8, it is a top view showing how the sterilization unit in the first embodiment performs a sterilization process on the first patch unit. [Figure 10] Corresponding to FIG. 9, it is a top view showing how the coating device in the first embodiment executes a coating process on the first patch unit. [Figure 11] Corresponding to FIG. 10, it is a top view showing how the first drying unit in the first embodiment executes a drying process on the first patch unit. [Figure 12] It is a side view showing how the packaging device in the first embodiment executes a packaging process. [Figure 13] It is a graph showing the relationship between the strength and displacement of the microstructured patch under different drying conditions. [Figure 14] It is a graph showing the relationship between the strength and displacement of the microstructured patch at different astaxanthin component ratios. [Figure 15] It is a side view of the coating device in the second embodiment of the integrated microstructured patch manufacturing equipment of the present invention. [Figure 16] It is a perspective view of the third embodiment of the integrated microstructured patch manufacturing equipment of the present invention. [Figure 17] It is a cross-sectional view of the third embodiment of the integrated microstructured patch manufacturing equipment of the present invention. It is a cross-sectional view of the third embodiment. [Figure 18] It is a top view of the fourth embodiment of the integrated microstructured patch manufacturing equipment of the present invention.

Modes for Carrying Out the Invention

[0013] To more clearly illustrate the object, technical means, and advantages of the embodiments of the present invention, the technical means in the embodiments of the present invention will be described clearly and in detail below, in conjunction with the accompanying drawings of the embodiments of the present invention. It will be clear that the embodiments described are some embodiments of the present invention, and not all embodiments. Typically, the components of the embodiments of the present invention depicted and shown in the accompanying drawings can be arranged and designed in various different configurations. Therefore, the detailed description of the embodiments of the present invention provided below in the accompanying drawings does not constitute any limitation on the scope of protection of the present invention, but merely illustrates selected embodiments of the present invention.

[0014] Before explaining the present invention in detail, please note that in the following description, elements that perform the same role or function will be represented by the same number even if they do not have exactly the same configuration.

[0015] Furthermore, please note that in this specification, for the sake of explanation, terms such as "up," "down," "left," and "right," which indicate the relative positional relationships of each component, are used for explanatory purposes with reference to the examples in the drawings, and are not absolute terms that limit the configuration of the present invention.

[0016] Referring to Figures 1 and 2, a first embodiment of the integrated microstructured patch manufacturing apparatus of the present invention is used to apply a delivery component to a microstructured patch 91 or a plurality of microstructured patches 91. Each microstructured patch 91 has dimensions of 5 cm × 5 cm or less. Each microstructured patch 91 has a patch layer 911 and a microstructured layer 912 provided on the patch layer 911 to have a plurality of microneedles. The microneedles (not shown) of the microstructured layer 912 are arranged in a matrix and have a height of 100 μm to 1000 μm. In other modifications of this embodiment, the microstructured layer 912 may have microneedles formed hollow, a plurality of micropores formed, or other protrusion or recessed structures.

[0017] The microstructure layer 912 is composed of a biocompatible material (biomaterial), such as PEEK, PMMA, PC, PLA, ABS, PP, PVP, PVA, silicone, epoxy resin, other biocompatible thermoplastic or thermosetting polymer materials, or hydrogels. Regarding hydrogels, examples include glycosaminoglycans, polysaccharides, collagen, elastin, silk fibroin, starch, glucomannan, hyaluronic acid, cross-linked hyaluronic acid, hydrophobic modified hyaluronic acid, or a combination of one or more of these.

[0018] The delivery component contains either a drug care component or an active component. Examples of drug care components include drugs, biological products, herbal medicines, health foods, or cosmetics. Examples of active components include water-soluble drugs, lipid-soluble drugs, nucleic acid drugs, protein drugs, vaccines, exosomes, water-soluble herbal medicines, water-soluble vitamins, and natural phenolic antioxidants.

[0019] In this embodiment, the microstructure layer 912 is made of hydrogel, and its specifications before the application of the delivery component are summarized in Table 1 below.

[0020] [Table 1]

[0021] Referring to Figures 1 to 3, the integrated microstructure patch manufacturing equipment comprises a housing unit 1, a carrier unit 2, a coating device 3, a storage container 4, a recovery container 40, an imaging unit 5, a processing device 6, a temperature control device 60, a packaging device 7, and a control unit 8.

[0022] Housing unit 1 comprises a housing 11 defining a storage space 12, an operation panel 13 installed on the housing 11, and a ventilation pipe 130 installed on the housing 11 so as to communicate with the storage space 12. The housing 11 has a supply port 111 and an outlet port 112 that communicate with the storage space 12. Carrier unit 2, coating device 3, processing device 6, packaging device 7, and temperature control device 60 are installed in the storage space 12. Specifically, housing unit 1 has a height in the vertical direction Z of 683 mm, a length in the front-to-back direction X perpendicular to the vertical direction Z of 830 mm, and a width in the left-to-right direction Y perpendicular to the vertical direction Z and the front-to-back direction X of 690 mm.

[0023] Referring to Figures 1, 2, and 4, the carrier unit 2 includes a disc-shaped holder 21 that can rotate around an axis L extending along the vertical direction Z, and a moving structure 22 that rotates the holder 21.

[0024] The support base 21 has four carrier sections 211 spaced at 90-degree angles around the axis L. Each carrier section 211 is formed on the periphery of the upper surface of the support base 21 and is a roughly rectangular recess.

[0025] The moving structure 22 includes a shaft 221 fixed to the central bottom of the holding base 21, a motor 222, and a drive belt 223 connected between the motor 222 and the shaft 221.

[0026] The storage space 12 has a supply area 121, a first processing area 122, a coating area 123, and a second processing area 124 located above the holding base 21. The supply area 121, the first processing area 122, the coating area 123, and the second processing area 124 are arranged at 90-degree intervals clockwise around axis L when viewed from above.

[0027] Furthermore, the supply area 121 and the coating area 123 are spaced apart in the front-to-back direction X, and the supply port 111 is adjacent to the supply area 121 on the opposite side from the coating area 123. The first processing area 122 and the second processing area 124 are spaced apart in the left-to-right direction Y, and the discharge port 112 is adjacent to the second processing area 124 on the opposite side from the first processing area 122.

[0028] The motor 222 rotates the holder 21 via the drive belt 223, moving each carrier section 211 between the supply area 121, the first processing area 122, the coating area 123, and the second processing area 124.

[0029] The patch unit 9 is placed on one of the carrier sections 211 by hand or by a pick-and-place device (e.g., a robotic arm, not shown) via the supply port 111, and then the patch unit 9 is removed via the discharge port 112. Specifically, the patch unit 9 has a tray 92 and nine patch sets 93 arranged in a 3x3 grid on the tray 92. Each patch set 93 has an aluminum film 931 and four of the aforementioned microstructured patches 91 arranged in a 2x2 grid on the aluminum film 931. The aforementioned microstructured layers 912 of these microstructured patches 91 face upward. The shape of the tray 92 corresponds to that of the carrier section 211, and its position is fixed when the tray 92 is placed on any carrier section 211, preventing shaking or displacement of the microstructured patches 91 due to the rotation of the holding base 21. In other modifications, the microstructured patches 91 can also be placed directly on the holding base 21 for processing.

[0030] Referring to Figure 5, the coating apparatus 3 performs a coating process in which the delivery component is applied to the microstructure layer 912 of the microstructure patch 91. The coating apparatus 3 is positioned adjacent to the coating area 123 and has a base 31 and a pick-and-place unit 32. At least one storage tank 311 for containing the delivery component is formed on the upper surface of the base 31. Specifically, in this embodiment, twelve storage tanks 311 are formed on the base 31 and are positioned corresponding to the microstructure patches 91 of the patch set 93.

[0031] The pick-and-place unit 32 includes a horizontal linear rail structure 33 located above the coating area 123 and extending along the front-rear direction X, an actuator 34 installed on the horizontal linear rail structure 33, a gripping means 35 installed on the actuator 34, a lift linear rail structure 36 installed on the side of the base 31 so as to extend along the up-down direction Z, a frame 37 installed on the lift linear rail structure 36, a gripping holder 38 pivotally supported on the frame 37 so as to be located above the storage tank 311, and a motor 39 installed on the frame 37 so as to be able to rotate the gripping holder 38.

[0032] The horizontal linear rail structure 33 drives the gripping means 35 in the forward / backward direction X. The actuator 34 drives the gripping means 35 in the up / down direction Z. The gripping means 35 has multiple vacuum nozzles 351 that pick up three patch sets 93 on the tray 92. The lift linear rail structure 36 drives the frame 37 in the up / down direction Z. The gripping holder 38 has three upward-facing suction surfaces 381 that can vacuum-suction the three sets of patch sets 93 picked up by the gripping means 35. In other modifications, it is also possible to use a robot arm or other type of drive mechanism that can perform the functions of both the horizontal linear rail structure 33 and the actuator 34.

[0033] In this embodiment, two storage containers 4 are detachably mounted on a base 31, each storing either a delivery component or a cleaning solution. The two storage containers 4 are used to supply the delivery component and cleaning solution to the containment tank 311, respectively. A recovery container 40 is detachably positioned on the base 31 to recover the liquid in the containment tank 311. Therefore, when manufacturing microstructured patches 91 of different delivery components, the cleaning solution is discharged from the storage containers 4, diluting the delivery component in the containment tank 311. By then discharging the liquid from the containment tank 311 into the recovery container 40, the different delivery components can be filled into the storage containers 4 and output to the containment tank 311. Specifically, by repeating the procedure of discharging the cleaning solution from the storage containers 4 and discharging the liquid from the containment tank 311 into the recovery container 40, the containment tank 311 can be reliably cleaned. Thus, the application device 3 and storage containers 4 can accommodate various drug care active ingredients.

[0034] In this embodiment, the coating apparatus 3 is configured to apply the delivery component to the microstructure layer 912 of the microstructure patch 91 by dip coating. In other modifications, the delivery component can also be applied to the microstructure layer 912 of the microstructure patch 91 by employing a coating apparatus that performs inkjet printing, nozzle printing, jet drying, spray coating, piezoelectric inkjet printing, or a dispenser.

[0035] The imaging unit 5 is mounted on the gripping means 35 and can image the microstructure patch 91.

[0036] Referring to Figures 2 and 6, the processing apparatus 6 includes a sterilization unit 61 located adjacent to the first processing area 122 and a drying unit 62 located adjacent to the second processing area 124.

[0037] The sterilization unit 61 has two ultraviolet irradiation means 611 above the first processing area 122. The ultraviolet irradiation means 611 irradiate ultraviolet light onto the portion of the holding base 21 located in the first processing area 122. The sterilization unit 61 can perform a first processing step in which it sterilizes the microstructured patch 91 located in the first processing area 122 before coating by irradiating it with ultraviolet light. Specifically, the ultraviolet irradiation means 611 irradiate 185 μm ultraviolet light, and the ultraviolet light can be irradiated for 0 to 6 hours in the first processing step. In other variations, the first processing step can also be performed by other means that do not use ultraviolet light, such as gamma ray irradiation or sterilization using ethylene oxide gas (EOG sterilization).

[0038] The drying unit 62 has six spray heads 621 above the second processing area 124. These spray heads 621 can spray gas onto portions of the second processing area 124 located on the holding base 21. These spray heads 621 are connected to a gas source (not shown) via at least one vent pipe 130, which can provide filtered or heated dry air. The drying unit 62 can perform a second processing step to dry the delivered components on the microstructure layer 912 by spraying gas onto these microstructure patches 91 after coating in the second processing area 124.

[0039] In other variations, the drying unit 62 may be a device that performs drying using other methods such as convection, radiation drying, infrared drying, microwave drying, vacuum drying, or freeze drying, and for example, a fan device, electric heating tubes, or freeze dryer can be used. Specifically, the drying unit 62 can be a fan device installed on top of the housing unit 1 and having a 3000 rpm rotating fan and a filter of a high-efficiency particulate air filter (HEPA) or an air filtration membrane.

[0040] Furthermore, the first processing step in the present invention is not limited to sterilization or drying. In other variations, the processing apparatus 6 may perform processing on the microstructured patch 91 using only the sterilization unit 61, the drying unit 62, or any other device.

[0041] For example, the processing device 6 can use only the sterilization unit 61, and the coating device 3 can sterilize the microstructured patch 91 in a first processing step performed before the coating step, and then allow it to air dry after the coating step is performed.

[0042] Alternatively, the processing device 6 can utilize only the drying unit 62, and the coating device 3 can perform the coating process before drying the microstructured patch 91 in the drying unit 62 during the first processing step.

[0043] The temperature control device 60 controls the temperature of the containment space 12. Specifically, an air conditioner is used as the temperature control device 60 to maintain the containment space 12 at a set temperature between -80°C and 80°C. The set temperature may be -80°C, -60°C, -40°C, -20°C, 0°C, 20°C, 40°C, 60°C, or 80°C.

[0044] The packaging device 7 is located above the carrier unit 21 and includes a horizontal linear rail structure 71 extending between the first processing area 122 and the second processing area 124, an actuator 72 provided on the horizontal linear rail structure 71, and a suction means 73 provided on the actuator 72.

[0045] The horizontal linear rail structure 71 allows the suction means 73 to move between the first processing area 122 and the second processing area 124. The actuator 72 drives the suction means 73 along the vertical Z direction. The suction means 73 has a plurality of vacuum nozzles 731 and suctions the packaging sheet 10. The packaging sheet 10 is, for example, made of transparent PET material and is used to cover the patch unit 9 and can be heat-sealed with an aluminum film 931 to seal the microstructure patch 91. Specifically, the heat-sealing temperature is in the range of 30°C to 150°C and the maximum pressure is 80 kgf.

[0046] In addition, in the modified example, a vacuum-formed case that can engage with the packaging sheet 10 can be used instead of the aluminum film 931. In this case, heating is not required, and the packaging process is completed by engaging the packaging sheet 10 and the vacuum-formed case under pressure.

[0047] By connecting at least one of the ventilation pipes 130 to a vacuum pump, a vacuum suction force can be provided to the vacuum nozzle 351 of the gripping means 35, the suction surface 381 of the gripping holder 38, and the vacuum nozzle 731 of the suction means 73.

[0048] Referring to Figures 1 to 3, the control unit 8 is installed in the housing space 12 and is electrically connected to the operation panel 13, carrier unit 2, coating device 3, imaging unit 5, processing device 6, temperature control device 60, and packaging device 7. Based on control commands, the control unit 8 can control at least one of the carrier unit 2, coating device 3, imaging unit 5, processing device 6, temperature control device 60, and packaging device 7 to switch between an automated processing process (automatic processing mode) and a manual processing process (manual processing mode). Specifically, the user can use the operation panel 13 to set up an automated processing process or to manually execute individual work procedures. In the example of variation, the control unit 8 can also be operated by means other than the operation panel 13, for example, by receiving control commands from wireless communication. Based on the image of the microstructure patch 91 captured by the imaging unit 5, the control unit 8 can use AI image recognition to recognize the position of the microstructure patch 91 and the microstructure layer 912, and control the coating device 3 to perform a precise coating process.

[0049] Referring to Figure 7, the method for manufacturing the microstructured patch 91 of the present invention involves performing a supply step S1, a sterilization step S2, a coating step S3, a drying step S4, and a packaging step S5.

[0050] Referring to Figures 1 and 8, in this supply process S1, the holding base 21 rotates, and one of its carrier sections 211 moves to the supply area 121. Next, using manual labor or a robotic arm, the patch units 9 are placed on the carrier section 211 via the supply port 111. At this time, the microstructure layer 912 of these microstructure patches 91 is not coated with the delivery component.

[0051] Referring to Figure 9, in the sterilization process S2, the holding table 21 rotates and the patch unit 9 moves to the first processing area 122. Next, another patch unit 9 is placed in the carrier section 211 in the supply area 121. For the sake of explanation, the previous patch unit 9 will be referred to as the first patch unit 9A, and the subsequent patch unit 9 as the second patch unit 9B. The sterilization unit 61 performs the first processing step, and the ultraviolet irradiation means 611 irradiates the microstructured patch 91 on the first patch unit 9A with ultraviolet light to sterilize it.

[0052] Referring to Figures 5 and 10, in coating step S3, the holding table 21 rotates to move the first patch unit 9A to the coating area 123 and the second patch unit 9B to the first processing area 122. Next, the patch unit 9 covered with the packaging sheet 10 is placed in the carrier section 211 in the supply area 121. Here, the patch unit 9 covered with the packaging sheet 10 is defined as the third patch unit 9C. The coating apparatus 3 performs the coating step, and the control unit 8 controls the horizontal linear rail structure 33 and actuator 34 based on the image acquired by the imaging unit 5 from the first patch unit 9A, so that the gripping means 35 picks up three of the six patch sets 93 arranged horizontally on the tray 92 and places them on the suction surface 381 of the gripping holder 38. The suction surface 381 of the gripping holder 38 picks up the microstructured patch 91. Next, the motor 39 rotates the gripping holder 38 so that the microstructured layer 912 of the microstructured patch 91 faces downwards. The lift linear rail structure 36 lowers the frame 37 and gripping holder 38, immersing the microstructure layer 912 in the delivery component in the containment tank 311. Next, the gripping holder 38 rises and rotates, and the gripping means 35 returns the microstructure patch 91 immersed in the delivery component back to the tray 92. Then, the immersion of the microstructure patches 91 of the remaining six patch sets 93 is performed in a similar procedure. Similarly, the sterilization unit 61 performs the first processing step of sterilization on the second patch unit 9B.

[0053] Referring to Figure 11, in drying step S4, the holding stand 21 rotates and the first patch unit 9A moves to the second processing area 124. Next, another patch unit 9 covered with the packaging sheet 10 is placed in the carrier section 211 in the supply area 121. The drying unit 62 performs the second processing step, in which the spray head 621 blows air onto the microstructured patch 91 on the first patch unit 9A, drying the delivery components on the microstructured layer 912. Similarly, at this time, the coating device 3 performs the coating step on the second patch unit 9B, and the sterilization unit 61 performs the first processing step on the third patch unit 9C.

[0054] Referring to Figures 1, 11, and 12, in the packaging process S5, the adsorption means 73 of the packaging device 7 adsorbs the packaging sheet 10 on the third patch unit 9C onto the microstructured patch 91 on the first patch unit 9A. This prevents contamination of the newly dried microstructured patch 91. Next, the first patch unit 9A is removed from the discharge port 112, and the aluminum film 931 of the packaging sheet 10 and the first patch unit 9A are heat-pressed together to seal the microstructured patch 91 and maintain its cleanliness.

[0055] Specifically, the integrated microstructured patch manufacturing equipment of this embodiment can produce a total of 36 microstructured patches 91 per hour, which can be placed on one tray 92 (each of which consists of 9 patch sets 93 containing 4 microstructured patches 91). Furthermore, the production volume can be adjusted by changing the number of patch sets 93 that can be accommodated in one tray 92 or the number of microstructured patches 91 contained in one patch set 93.

[0056] Figure 13 shows the changes in mechanical strength of microstructured patches after different drying times for the comparative example, Test Example 1, Test Example 2, and Test Example 3. The horizontal axis represents the pressure displacement of the microneedles, and the vertical axis represents the mechanical strength per unit microneedle.

[0057] The strength test method for this microneedle involves placing the microstructure layer 912 in a universal material testing machine (model number 3343, manufactured by INSTRON), setting the displacement to 10 mm, and performing a compression test at a speed of 66 mm / min, simultaneously obtaining 500 compressive stress values ​​per second. The mechanical strength of the needle is represented by the stress measured when the height of the microneedle is compressed to approximately half (i.e., when the height of the needle is approximately 150 μm). Generally, if the mechanical strength measured when the height of the microneedle is compressed to approximately half is 0.058 N or higher, it is considered that the needle will not bend or break even when penetrating human skin.

[0058] The microstructure layer 912 of the comparative example and Test Examples 1 to 3 includes microneedles made of hydrogel material. The comparative example is a microstructure patch 91 without dye coating. Test Examples 1 to 3 are microstructure patches 91 coated with blue dye using the manufacturing method of the present invention, and differ in that after dye coating, Test Example 1 was dried at 30°C for 15 minutes, Test Example 2 was dried at 30°C for 60 minutes, and Test Example 3 was dried at 30°C for 75 minutes.

[0059] The test results show that the microneedles of Test Example 3, dried at 30°C for 75 minutes using the manufacturing method of the microstructured patch of the present invention, have the same mechanical strength as the microneedles of the comparative example that are not coated, and that the mechanical strength of the needle body is sufficient (i.e., 0.058 N / needle) to be considered not to bend or break when puncturing human skin (e.g., scalp).

[0060] It should be noted that if the delivered component is astaxanthin, astaxanthin microneedles can be manufactured using the method for manufacturing the microstructured patch of the present invention.

[0061] Figure 14 shows the change in mechanical strength of the microstructured patches 91 of Test Examples 1' to 4', which were manufactured by the method for manufacturing microstructured patches of the present invention. Here, the delivered component of Test Example 1' is astaxanthin with a content of 100 wt%. The delivered components of Test Examples 2' to 4' consist of astaxanthin and a buffer (phosphate-buffered saline, PBS). The ratio of astaxanthin to buffer in Test Example 2' is 3:1, the ratio of astaxanthin to buffer in Test Example 3' is 2:1, and the ratio of astaxanthin to buffer in Test Example 4' is 1:1.

[0062] The results of this test demonstrate that astaxanthin microneedles possess the necessary mechanical strength (i.e., 0.058 N / needle) to be considered as not bending or breaking when puncturing human skin (e.g., scalp).

[0063] Figure 15 shows a second embodiment of the integrated microstructure patch manufacturing equipment of the present invention. This coating apparatus 3 is a dispenser apparatus that performs the coating process using a dispenser method.

[0064] Referring to Figures 5 and 15, the coating apparatus 3 specifically includes a horizontal linear rail structure 33, an actuator 34, and a spray unit 30 installed on the actuator 34 and communicating with the storage container 4. Similar to the first embodiment, the control unit 8 controls the horizontal linear rail structure 33 and the actuator 34 to move the spray unit 30 based on the image of the microstructure patch 91 captured by the imaging unit 5, causing the spray unit 30 to discharge the delivery component from the storage container 4 onto the microstructure layer 912. When the storage container 4 is replaced, the spray unit 30 similarly cleans any remaining delivery component inside with a cleaning solution. Specifically, the spray unit 30 is a spray nozzle and is used for non-contact and spray application. In the modified example, a dispense head can also be used as the spray unit 30. The specifications of the second embodiment are summarized in Table 2 below.

[0065] [Table 2]

[0066] Figures 16 and 17 show a third embodiment of the integrated microstructure patch manufacturing equipment of the present invention. This third embodiment is similar to the first embodiment but differs in that it further includes partitions 14 fixed to the housing 11 so that the housing unit 1 is positioned in the accommodation space 12. These partitions 14 are positioned between the coating area 123 and the first processing area 122, between the coating area 123 and the second processing area 124, and between the second processing area 124 and the supply area 121. Specifically, the partitions 14 have two first partition plates 141 that extend along the front-to-back direction X and are located on both sides of the supply area 121 and the coating area 123 along the left-to-right direction Y, and two second partition plates 142 that are connected between these first partition plates 141 and spaced apart along the front-to-back direction X. The holder 21 is also rotatable relative to the partitions 14.

[0067] A notch 143 is formed in each first partition plate 141 at an intermediate position in the front-to-back direction X, passing through along the left-to-right direction Y. These notches 143 are located between the first processing area 122 and the second processing area 124 and serve as a path for the suction means 73 of the packaging device 7 to pass through. Two passages 144 are formed at the bottom of each first partition plate 141, adjacent to the supply area 121 and the coating area 123, respectively. These passages 144 are located on the movement path of the carrier section 211 and serve as a path for the patch unit 9 on the carrier section 211 or the patch unit 9 covered by the packaging sheet 10 to pass through. Specifically, one passage 144 is located between the supply area 121 and the first processing area 122, another passage 144 is located between the first processing area 122 and the coating area 123, another passage 144 is located between the coating area 123 and the second processing area 124, and another passage 144 is located between the second processing area 124 and the supply area 121.

[0068] These second partition plates 142 are adjacent to these notches 143 along the front-to-back direction X, with one of the second partition plates 142 working in cooperation with the first partition plate 141 to surround the supply area 121 in a roughly U-shape, and the other second partition plate 142 working in cooperation with the first partition plate 141 to surround the coating area 123 in a roughly U-shape.

[0069] Therefore, when the third embodiment of the integrated microstructured patch manufacturing equipment of the present invention manufactures a microstructured patch 91, the partition 14 can prevent cross-contamination between the supply area 121, the first processing area 122, the coating area 123, and the second processing area 124. Specifically, when the coating process is carried out in the coating area 123, it is possible to prevent the delivery components from reaching the first processing area 122, the supply area 121, or the second processing area 124. In particular, when the drying process is carried out in the second processing area 124, it is possible to prevent volatile delivery components applied to the microstructured patch 91 from diffusing into the first processing area 122, the supply area 121, or the coating area 123.

[0070] Figure 18 shows a fourth embodiment of the integrated microstructure patch manufacturing equipment of the present invention. In this fourth embodiment, the carrier unit 2 has a slide rail module 23 and a holder 24 installed on the slide rail module 23 and capable of supporting patch units 9. Specifically, the slide rail module 23 in this embodiment is a biaxial slide rail structure having two rail members along the mutually intersecting X and Y axes, each with a length of 60 cm and substantially orthogonal to each other, so that the holder 24 and the patch units 9 supported by the holder 24 can be moved between the supply area 121, the first processing area 122, and the supply area 121 and the second processing area 124.

[0071] In summary, the advantages and effects of the integrated microstructure patch manufacturing equipment of the present invention are as follows:

[0072] 1. The integrated microstructure patch manufacturing equipment of the present invention is constructed by installing a carrier unit 2, a coating device 3, and a processing device 6 within a housing space 12 enclosed by a housing unit 1. As such, the overall space occupied is small, and the degree of installation flexibility is increased, making it suitable for small-scale manufacturing for personal and household use, as well as applicable to large-scale manufacturing.

[0073] 2. By configuring the holding base 21 to be rotatable, the microstructured patch 91 held on the holding base 21 can be easily moved between the coating area 123, the first processing area 122, and the second processing area 124 by rotating the holding base 21. Since such a rotational movement structure is simple, it also has the advantage of saving manufacturing costs. In this way, the limited storage space 12 can be effectively utilized, and the overall size of the integrated microstructured patch manufacturing equipment of the present invention can be reduced.

[0074] 3. By using the replaceable storage container 4 and cleaning the internal piping of the application device 3 with the cleaning solution, different types of drug care components can be easily exchanged.

[0075] 4. By irradiating the microstructure layer 912 with ultraviolet light before application to sterilize it, the number of viable bacteria on the microstructure layer 912 can be effectively reduced, ensuring hygiene and safety.

[0076] 5. By performing a post-application drying treatment on multiple microneedles on the microstructure layer 912 using the drying unit 62, the delivery components are fixed and the mechanical strength of the microneedles is maintained, thereby restoring the microneedles to their strength state before application. This makes it possible to manufacture microneedles that are suitable for skin puncture and can be used repeatedly.

[0077] 6. The placement of the partition 14 prevents cross-contamination between the supply area 121, the first processing area 122, the coating area 123, and the second processing area 124, thereby maintaining cleanliness within the containment space 12.

[0078] 7. In the packaging step of the method for manufacturing the microstructured patch of the present invention, by covering the dried microstructured patch 91 with the packaging sheet 10, the microstructured patch 91 can be prevented from being contaminated by airborne particulate matter and volatile gases, and the cleanliness of the microstructured patch 91 can be maintained to the maximum extent.

[0079] Although embodiments of the present invention have been described above, the present invention is not limited thereto, and various modifications are possible without departing from its essence. [Explanation of symbols]

[0080] 1 Housing Unit 11 cabinets 111 Supply port 112 Outlet 12 Containment space 121 Supply Areas 122 First processing area 123 Application Area 124 Second processing area 13. Control Panel 14 dividers 141 First partition 143 Notches 144 Passage 142 Second partition 2 Carrier Units 21 Holding stand 211 Career Department 22 Mobile structure 221 Shaft 222 Motor 223 Drive belt 23 Slide rail modules 24 Holding stand 3. Coating device 31 Pedestal 311 Storage Tank 32 Pick-and-Place Units 33 Horizontal linear rail structure 34 Actuators 35. Grasping methods 351 Vacuum Nozzle 36. Lift linear rail structure 37 frames 38 Gripping holder 381 Adsorption surface 39 Motor 30 spray units 4. Storage containers 40 Collection containers 5. Shooting Unit 6 Processing equipment 60 Temperature control device 61 Sterilization Unit 611 Ultraviolet irradiation means 62 Drying Unit 621 Spray Head 7 Packaging equipment 71 Horizontal linear rail structure 72 Actuators 73 Adsorption means 731 Vacuum Nozzle 8 Control Unit 9 Patch Units 91 Microstructure Patches 911 Patch Layer 912 Microstructure Layers 92 trays 93 Patch Set 9A First Patch Unit 9B Second Patch Unit 9C Third Patch Unit 10 Packaging Sheets L axis Z vertical direction Y left / right direction X Anteroposterior direction

Claims

1. An integrated microstructure patch manufacturing apparatus for applying a delivery component to a microstructure patch having a patch layer and a microstructure layer provided on the patch layer, An integrated microstructured patch manufacturing apparatus comprising a housing unit having a casing that defines a containment space, a carrier unit having a holding base disposed within the containment space, a coating device, and a processing device, wherein the holding base has a carrier portion capable of holding the microstructured patch, the coating device is provided in the containment space and performs a coating process to coat the delivery component onto the microstructured layer, and the processing device is provided in the containment space and performs a first processing process to process the microstructured patch.

2. The integrated microstructured patch manufacturing apparatus according to claim 1, wherein the housing space comprises a coating area and a first processing area, the carrier unit further comprises a movable structure that can move the holding base between the coating area and the first processing area, the coating apparatus performs the coating process on the microstructured patch when the microstructured patch is in the coating area, and the processing apparatus performs the first processing process on the microstructured patch when the microstructured patch is in the first processing area.

3. The integrated microstructure patch manufacturing apparatus according to claim 2, wherein the housing unit further comprises a partition provided in the housing space so as to be interposed between the coating area and the first processing area.

4. The integrated microstructured patch manufacturing apparatus according to claim 3, wherein the partition has a passage that communicates with the coating area and the first processing area so that the microstructured patch can pass through.

5. The integrated microstructured patch manufacturing apparatus according to claim 2, wherein the housing space further comprises a second processing area, the moving structure can move the carrier portion of the holding base between the coating area, the first processing area, and the second processing area, and when the microstructured patch is in the second processing area, the processing apparatus performs a second processing step on the microstructured patch.

6. The integrated microstructure patch manufacturing apparatus according to claim 5, wherein the first processing step involves sterilizing the microstructure patch before coating, and the second processing step involves drying the delivery component coated on the microstructure layer of the microstructure patch.

7. The integrated microstructured patch manufacturing apparatus according to claim 6, wherein the processing apparatus comprises a sterilization unit that irradiates ultraviolet light to perform the first processing step and a drying unit that supplies gas to the microstructured patch to perform the second processing step.

8. The integrated microstructure patch manufacturing apparatus according to claim 6, wherein the housing unit further comprises a partition provided in the housing space so as to be interposed between the coating area and the first processing area.

9. The integrated microstructure patch manufacturing apparatus according to claim 2, wherein the coating area and the first processing area are arranged at an angular distance from each other with respect to an axis, and the moving structure moves the carrier portion between the coating area and the first processing area by rotating the holding base about the axis.

10. The integrated microstructure patch manufacturing apparatus according to claim 2, wherein the moving structure is a two-axis slide rail structure.

11. The integrated microstructured patch manufacturing apparatus according to claim 1, wherein the carrier portion has a recess formed therein that can accommodate a tray for holding the microstructured patch.

12. The integrated microstructured patch manufacturing apparatus according to claim 1, further comprising: an imaging unit installed in the coating apparatus for imaging the microstructured patch; and a control unit electrically connected to the coating apparatus and the imaging unit, which recognizes the position of the microstructured patch or the microstructured layer based on the image acquired by the imaging unit, and controls the coating apparatus to apply the delivery component to the microstructured layer of the microstructured patch.

13. The integrated microstructure patch manufacturing apparatus according to claim 1, further comprising a control unit electrically connected to the carrier unit, the coating device, and the processing device, wherein the control unit controls at least one of the carrier unit, the coating device, and the processing device based on received control commands, and can switch between an automated processing process and a manual processing process.

14. The integrated microstructured patch manufacturing apparatus according to claim 1, wherein the coating apparatus has a spray unit that moves within the containment space and sprays the delivery component onto the microstructured patch.

15. The integrated microstructured patch manufacturing apparatus according to claim 1, wherein the coating apparatus comprises a base and a pick-and-place unit, the base having a storage tank for containing the delivery component, and the pick-and-place unit is configured to grasp the microstructured patch and immerse the microstructured layer of the microstructured patch in the delivery component in the storage tank.

16. The integrated microstructure patch manufacturing apparatus according to claim 1, further comprising a storage container removablely installed on the coating apparatus for storing the delivery component.

17. The integrated microstructure patch manufacturing apparatus according to claim 1, comprising a storage container communicating with the coating apparatus, wherein the storage container is filled with the delivery component and a cleaning solution, and the coating apparatus can perform a cleaning step of dispensing the cleaning solution to clean the delivery component remaining in the coating apparatus.

18. The integrated microstructure patch manufacturing apparatus according to claim 1, wherein the first processing step involves irradiating the microstructure patch with ultraviolet light to sterilize it, or drying the delivery component applied on the microstructure patch.

19. The integrated microstructure patch manufacturing apparatus according to claim 1, further comprising a packaging device installed in the aforementioned containment space and capable of performing a packaging process in which the microstructure patch is covered with a packaging sheet.

20. A method for manufacturing a microstructured patch carried out by an integrated microstructured patch manufacturing facility, wherein the integrated microstructured patch manufacturing facility comprises a housing unit defining a containment space, a carrier unit installed in the containment space, a coating device, and a processing device, the carrier unit having a holding base having a carrier portion, and the containment space having a supply area, a first processing area, a coating area, and a second processing area arranged at angular intervals, A supply step comprising: rotating the holding base so that the carrier portion moves to the supply area, and placing a microstructured patch having a patch layer and a microstructured layer provided on the patch layer but not coated with a delivery component, onto the carrier portion; The holding base rotates so that the carrier unit moves to the first processing area, and the processing device performs a sterilization step to sterilize the microstructured patch, The coating process involves the holding base rotating to move the carrier to the coating area, and the coating apparatus applying the delivery component to the microstructured patch, A method for manufacturing a microstructured patch, comprising: a drying step in which the holding base rotates so that the carrier portion moves to a second processing area, and the processing apparatus dries the delivery component on the microstructured patch.

21. The integrated microstructured patch manufacturing equipment further comprises an imaging unit installed in the coating apparatus for imaging the microstructured patch, and a control unit electrically connected to the coating apparatus and the imaging unit, wherein in the coating step, the control unit recognizes the positions of the microstructured patch and the microstructured layer based on the image acquired by the imaging unit, and controls the coating apparatus to apply the delivery component to the microstructured layer of the microstructured patch, as described in claim 20.

22. The method for manufacturing a microstructured patch according to claim 20, wherein the integrated microstructured patch manufacturing equipment further comprises a packaging device, and after the drying step, a packaging step is performed in which the microstructured patch is covered with a packaging sheet.

Images