JP6980278B2 - Microneedle patch manufacturing equipment - Google Patents

Description

The present invention relates to a microneedle patch manufacturing apparatus, and relates to a microneedle patch manufacturing apparatus capable of removing fine bubbles generated in the microneedle patch manufacturing process.

There is a problem that fine bubbles are generated in the silicon mold during the manufacture of microneedle patches, and in order to solve this problem, there is a method of applying vacuum pressure to expand the bubbles and removing them by floating on the surface of the silicon mold. ..

However, such a method has a disadvantage that it takes a lot of time to drop due to buoyancy when the expanded bubbles are attached to the handle portion of the silicon mold when they are lifted.

In addition, as can be seen in FIG. 1, when a vacuum pressure is applied, a phenomenon in which molten oxygen is discharged from the drug appears, so that the product is dried with fine bubbles remaining. There is a point.

Then, air bubbles were removed by a method of pressurizing using an instrument such as a press or a roller, but even in such a case, there was a problem of secondary contamination due to contact of the drug with the pressurizing instrument. There is a problem that the cleanliness in the manufacturing process is also adversely affected.

US Registered Patent No. 8834423 (September 16, 2014) US Registered Patent No. 8353861 (2013.1.15)

The present invention is intended to solve the above-mentioned problems of the prior art, and relates to a microneedle patch manufacturing apparatus that may effectively remove fine bubbles generated in the microneedle patch manufacturing process. be.
The present invention relates to a microneedle patch manufacturing apparatus capable of further shortening the manufacturing time of the microneedle patch and increasing productivity.
It also relates to a microneedle patch manufacturing apparatus capable of minimizing drug contamination of the microneedle patch.

The technical problems to be addressed by the present invention are not limited to the technical problems mentioned above, and other technical problems not mentioned above are usually described below in the technical field to which the present invention belongs. It will be clearly understood by those who have the knowledge of.

In the microneedle patch manufacturing apparatus according to the present invention proposed as described above, the silicon mold is attached to the upper surface for molding the material for the microneedle patch, and the silicon mold is attached to the inside of the upper surface. And an upper block that is shaped with the carrier to form a chamber into which the material and silicon mold can be housed, and the upper block descends to be shaped with the carrier. Whether the air cylinder connected to the upper surface of the upper block to transmit power and the upper block and the carrier are shaped to each other to pressurize the chamber so as to rise to separate from the carrier. , Or a pressurizing section connected to the side surface of the upper block so that the pressurized chamber can be ventilated so that the upper block can descend to form the chamber with the carrier. In the combined state, after being pressurized and ventilated by the pressurizing portion, the upper block rises and separates from the carrier, and air bubbles flowing into the material during the molding process of the material are removed. As described above, the pressurization and ventilation by the pressurizing section are repeatedly performed a plurality of times.

As described above, according to the microneedle patch manufacturing apparatus according to the present invention, a plurality of pressurization and ventilation are performed by injecting a gas in a state where the material and the drug for manufacturing the microneedle patch are settled in the silicon mold. Since the material containing the drug is molded by a repeating method, there is an advantage that fine bubbles generated in the manufacturing process of the microneedle patch can be effectively removed in the repeated pressurizing and ventilation process. There is.

Further, as compared with the conventional method of removing air bubbles by vacuum pressure, according to the present invention, there is an advantage that the manufacturing time of the microneedle patch can be further shortened and the productivity can be improved.

Further, in contrast to the conventional method of directly pressurizing a material containing a drug with an instrument such as a press or a roller, in the present invention, the pressurization is performed by a gas such as air without direct contact by the instrument, so that the microneedle is used. There is an advantage that contamination of the patch with the drug can be minimized.

Photographs and explanatory diagrams showing how air bubbles are removed using conventional vacuum pressure. A perspective view showing a microneedle patch manufacturing apparatus according to the present invention. Front view showing a state in which the upper block is raised in the microneedle patch manufacturing apparatus according to the present invention. Front view showing a state in which the upper block is lowered in the microneedle patch manufacturing apparatus according to the present invention. Explanatory drawing which shows the state of the upper block in the manufacturing apparatus of the microneedle patch by this invention. Explanatory drawing which shows the process which pressurization and ventilation by a pressurizing part are repeated in the microneedle patch manufacturing apparatus by this invention. Explanatory drawing showing how a carrier, a silicon mold, and a sealing member are bonded in the microneedle patch manufacturing apparatus according to the present invention. Explanatory drawing showing how the carrier, the silicon mold and the sealing member are separated in the microneedle patch manufacturing apparatus according to the present invention. Explanatory drawing which shows detailed state of carrier in manufacturing apparatus of microneedle patch by this invention Explanatory drawing showing how a plurality of microneedle patch manufacturing apparatus according to the present invention are arranged and a continuous pressurizing step is performed.

Hereinafter, a detailed description will be given with reference to the drawings attached with an embodiment of the microneedle patch manufacturing apparatus according to the present invention.

FIG. 2 is a perspective view showing a microneedle patch manufacturing apparatus according to the present invention, and FIG. 3 is a front view showing a state in which the upper block is raised in the microneedle patch manufacturing apparatus according to the present invention. FIG. 4 is a front view showing a state in which the upper block is lowered in the microneedle patch manufacturing apparatus according to the present invention, and FIG. 5 is a drawing showing the state of the upper block in the microneedle patch manufacturing apparatus according to the present invention. 6 is a drawing showing a process in which pressurization and ventilation by a pressurizing section are repeated in the microneedle patch manufacturing apparatus according to the present invention. FIG. 7 is a drawing showing a state in which a carrier, a silicon mold and a sealing member are bonded in the microneedle patch manufacturing apparatus according to the present invention, and FIG. 8 is a drawing showing a carrier and silicon gold in the microneedle patch manufacturing apparatus according to the present invention. It is a drawing which shows the state which the mold and the sealing member were separated, FIG. 9 is a drawing which shows the detailed state of a carrier in the microneedle patch manufacturing apparatus by this invention, and FIG. 10 is a drawing which shows the microneedle patch manufacturing apparatus by this invention. It is a drawing which shows the state that the continuous pressurizing process is performed by arranging in a plurality of arrangements.

With reference to FIGS. 2 to 10, in the microneedle patch manufacturing apparatus 1 according to the present invention, a silicon mold 11 resting on the upper surface for forming the microneedle patch material 2 and the silicon on the inside of the upper surface. A carrier 12 to which the mold 11 is rested, an upper block 13 which is formed into a chamber 10 which is formed with the carrier 12 and can accommodate the material 2 and the silicon mold 11 inside, and the upper block. An air cylinder 14 connected to the upper surface of the upper block 13 to transmit power so that 13 descends to be shaped with the carrier 12 and rises to be separated from the carrier 12, and the upper portion. The block 13 and the carrier 12 are joined to the side surface of the upper block 13 so that the chamber 10 can be pressurized or the pressurized chamber 10 can be ventilated in a state where the block 13 and the carrier 12 are shaped to each other. The compression unit 15 and the like are included.

The carrier 12 is provided so as to be transferable so that the position can be changed. Pressurization and ventilation are performed by the pressurizing unit 15 in a state where the carrier 12 is transferred so as to be positioned immediately below the upper block 13 and the upper block 13 is lowered and shaped. .. Then, after the pressurization and ventilation are completed, the upper block 13 rises and separates from the carrier 12, and the carrier 12 can be transferred so as to separate from directly below the upper block 13. ..

Then, the microneedle patch manufacturing apparatus 1 is positioned so as to be separated above the base plate 171 from the base plate 171 to which the carrier 12 is transferred and rested, and the carrier 12 is placed between the base plate 171 and the base plate 171. And the separation plate 172 and the separation plate 172 so that the separation plate 172 can be fixed in a state of being separated from the base plate 171 so as to form a space in which the upper block 13 can be transferred. A support portion 173 connecting the 172 and a support portion 173 are provided so as to be able to move up and down along the guide hole 175 formed in the separation plate 172, and the lower end portion is provided on the upper surface of the upper block 13. It further includes a guide post 18 that is fixed and guides the elevating direction of the upper block 13.

The base plate 171 has a square flat plate shape and serves to support the remaining portion of the microneedle patch manufacturing apparatus 1. A heating plate 174 for heating the carrier 12 and the silicon mold 11 is installed at the center of the upper surface of the base plate 171, that is, at the fulcrum where the carrier 12 is located.

The separation plate 172 is also formed in the same square flat plate shape as the base plate 171 and serves to support the air cylinder 14, the guide post 18, the upper block 13, and the like.

Then, in the microneedle patch manufacturing apparatus 1, the carrier 12 is transferred directly below the upper block 13, and the upper block 13 is lowered so as to form the carrier 12 and the chamber 10. Then, after the pressurizing unit 15 pressurizes and ventilates the material, the upper block 13 rises and separates from the carrier 12, and the carrier 12 separates from directly below the upper block 13. 2 is molded. Further, the pressurization and ventilation by the pressurizing unit 15 are repeatedly performed a plurality of times so that the bubbles flowing into the material 2 are removed in the molding process of the material 2.

More specifically, the carrier 12 can be transferred and positioned on the upper surface of the base plate 171, i.e., the carrier 12 is transferred by a drive device and located on the upper surface of the base plate 171, for example, like a conveyor. Then, after the molding of the material 2 is completed, the material 2 can be transferred so as to be detached from the base plate 171.

The silicon mold 11 is attached to the upper surface of the carrier 12 transferred to the upper surface of the base plate 171, and the material 2 containing a chemical for manufacturing a microneedle patch is attached to the silicon mold 11. You will be calm.

The upper block 13 is located at the uppermost end while the carrier 12 is transferred, while the carrier 12 is located on the upper surface of the base plate 171, that is, at a corresponding fulcrum directly below the upper block 13. If so, it descends and is formed with the carrier 12 to form the chamber 10 together with the carrier 12.

At this time, a sealing member 19 is installed on the upper surface frame of the carrier 12 so that the chamber 10 can be tightly sealed while the carrier 12 is shaped with the upper block 13. To. The state in which the silicon mold 11 and the sealing member 19 are attached to the upper surface of the carrier 12 is as shown in FIGS. 7 to 8.

Further, as shown in FIG. 9, a mold installation groove 120 having a wide and shallow shape is formed in the center of the upper surface of the carrier 12 so that the silicon mold 11 can be rested. The upper frame of the carrier 12 is formed with a sealing groove 121 to which the sealing member 19 may be seated and press-fitted so that the airtightness can be reinforced. Then, a fixing protrusion 122 is formed in the mold setting groove 120 of the carrier 12 so that the silicon mold 11 can be more firmly fixed. That is, in the process of installing the silicon mold 11 on the upper surface of the carrier 12, the fixing protrusion 122 is inserted into the fixing hole 110 formed in the silicon mold 11, so that the silicon mold 11 is formed. It can be installed more firmly on the carrier 12.

Next, in a state where the upper block 13 and the carrier 12 are formed and the chamber 10 is shielded, a gas such as air is released in the chamber 10 by the pressurizing portion 15 connected to the upper block 13. By flowing in, the pressure inside the chamber 10 becomes high.

At this time, the upper block 13 is added to allow the pressurizing section 15 and the chamber 10 to communicate with each other so that the gas supplied for pressurization from the pressurizing section 15 can flow into the chamber 10. The pressure chamber 130 is formed. Further, the pressurizing flow path 130 extends from the side surface of the upper block 13 to the central portion of the upper block 13, and guides the gas flowing from the pressurizing portion 15 to the central portion of the upper block 13. It includes a passage 131 and a vertical flow path 132 that is formed so as to extend downward from the horizontal flow path 131 to the chamber 10 and guides the gas flowing into the horizontal flow path 131 to the chamber 10. Therefore, the gas that has flowed into the upper block 13 by the pressurizing unit 15 is supplied to the chamber 10 through the pressurizing flow path 130, and the pressure in the chamber 10 can be increased.

The pressurizing unit 15 is one of a pressurizing pipe 151 connected to the upper block 13 and serving to guide the gas to be supplied to the upper block 13 and the pressurizing pipe 151. Includes a valve 152 installed on the side to regulate the flow of gas through the pressurizing pipe 151.

When the pressure of the chamber 10 is increased by the pressurizing portion 15, the material 2 and the silicon mold 11 are pressured by the gas pressure inside the chamber 10, and the fine bubbles contained in the material 2 are released. It will be naturally removed while detaching from the material 2. After the fine bubbles of the material 2 are removed to some extent, the high-pressure gas inside the chamber 10 is exhausted to the outside by the pressurizing unit 15, that is, the internal pressure of the chamber 10 is lowered while the ventilation process is performed. become.

Such a pressurization and ventilation process by the pressurizing unit 15 is repeatedly performed in the order of primary pressurization, primary pressurization, secondary pressurization, secondary ventilation, and tertiary pressurization. At this time, at the time of the primary pressurization, the secondary pressurization and the tertiary pressurization, the internal pressure of the chamber 10 is pressurized so as to reach 2 to 3 bar.

The number of repetitions of the pressurization and ventilation process and the pressure value of the chamber 10 during pressurization are determined by how many times to search for an appropriate condition capable of effectively removing fine bubbles contained in the material 2. It was obtained from the experimental results, and therefore, it is seen as the optimum pressurizing condition in removing the fine bubbles contained in the material 2.

After all the pressurization and ventilation processes are completed, that is, after the molding for the material 2 is completed, the chamber 10 is opened while the upper block 13 is raised, and the carrier 12 is opened. Can be transferred and the molded material 2 can be discharged from the base plate 171.

On the other hand, as shown in FIG. 10, a plurality of the microneedle patch manufacturing devices 1 are arranged on a conveyor line to which the microneedle patch is continuously transferred, and the plurality of carriers 12 transferred along the conveyor. The pressurization and ventilation process can be repeated a larger number of times while sequentially passing through the microneedle patch manufacturing apparatus 1 of the above. This has the advantage that air bubbles remaining in the silicon mold 11 and the material 2 can be further completely removed.

According to the present invention as described above, the drug is subjected to a method in which a material 2 for manufacturing a microneedle patch and a drug are placed in a silicon mold 11 and a gas is introduced to repeat pressurization and ventilation a plurality of times. Since the material 2 containing the above-mentioned material 2 is formed, there is an advantage that fine bubbles generated in the manufacturing process of the microneedle patch can be effectively removed through the repeated pressurization and ventilation process.

In particular, the primary pressurization, the primary pressurization, the secondary pressurization, the secondary ventilation, and the tertiary pressurization are repeatedly performed in the order of the primary pressurization, the secondary pressurization, and the tertiary pressurization. Since the pressurization and ventilation process is carried out under optimum conditions so that the internal pressure of 10 reaches 2 to 3 bar, the effect of removing fine bubbles can be further maximized.

Further, as compared with the conventional method of removing air bubbles by vacuum pressure, according to the present invention, the manufacturing time of the microneedle patch can be further shortened, so that there is an advantage that productivity can be improved.

Further, in contrast to the conventional method of directly pressurizing the material 2 containing a drug with an instrument such as a press or a roller, in the present invention, the pressurization is performed by a gas such as air without direct contact by the instrument, so that the microneedle There is an advantage that contamination of the patch with the drug can be minimized.

As described above, within the scope of the basic technical idea of the present invention, it goes without saying that many other modifications are possible for a person having ordinary knowledge in the industry, and the scope of rights of the present invention is attached. Depends on the claims.

1 Microneedle patch manufacturing equipment 10 Chamber 11 Silicon mold 12 Carrier 13 Upper block 14 Air cylinder 15 Pressurizing part 18 Guide post 19 Sealing member 110 Fixed hole 120 Mold installation groove 121 Sealing groove 122 Fixed protrusion 130 Pressurized flow path 131 Horizontal flow path 132 Vertical flow path 151 Pressurized piping 152 Valve 171 Base plate 172 Separation plate 173 Support part 174 Heating plate 175 Guide hole

Claims (4)

A silicon mold that is settled on the upper surface to mold the material for the microneedle patch,
A carrier on which the silicon mold is settled on the inside of the upper surface,
An upper block that is shaped with the carrier to form a chamber in which the material and the silicone mold can be housed.
An air cylinder coupled to the top surface of the upper block to transmit power so that the upper block can descend to be shaped with the carrier and rise to separate from the carrier.
With a pressurizing section connected to the side surface of the upper block so that the chamber can be pressurized or the pressurized chamber can be ventilated with the upper block and carrier shaped to each other. , Including
After the upper block is lowered and shaped so that the chamber can be formed together with the carrier, the upper block rises and separates from the carrier after being pressurized and ventilated by the pressurizing portion. ,
Pressurization and ventilation by the pressurizing section are primary pressurization, primary pressurization, secondary pressurization, secondary ventilation, and 3 so that air bubbles that have flowed into the material are removed in the process of forming the material. It is performed in the order of secondary pressurization, and at the time of the primary pressurization, the secondary pressurization and the tertiary pressurization, the internal pressure of the chamber is pressurized so as to reach 2 to 3 bar.
In addition, the carrier is retractably provided so that its position can be varied.
The carrier is transferred so that it can be located directly below the upper block, and the upper block is lowered and shaped, and then pressure and ventilation are performed by the pressurizing portion.
After the pressurization and ventilation are completed, the microneedle patch is characterized in that the upper block rises and separates from the carrier, and the carrier is transferred so as to be detached from directly below the upper block. manufacturing device. To the chamber in a state in which the carrier is the upper block and the shape adjustment to be able to be firmly closed, shea-ring member is provided on an upper surface frame of the carrier, via the sealing member, The microneedle patch manufacturing apparatus according to claim 1, wherein the carrier and the upper block are sealed.
The upper block is formed with a pressurizing flow path that communicates the pressurizing section with the chamber so that the gas supplied for pressurization from the pressurizing section can flow into the chamber.
The pressurized flow path is
A horizontal flow path extending from the side surface of the upper block to the center of the upper block and guiding the gas flowing in from the pressurizing portion to the center of the upper block.
Includes a vertical flow path that is formed to extend downward from the horizontal flow path to the chamber and guides the gas flowing into the horizontal flow path to the chamber.
The microneedle patch manufacturing apparatus according to claim 2. The base plate to which the carrier is transferred and settled, and
A separation plate that is positioned above the base plate and forms a space between the base plate and the carrier, the lower block, and the upper block to which the carrier, the lower block, and the upper block can be transferred.
A support portion connecting the base plate and the separation plate so that the separation plate can be fixed in a state of being separated from the base plate.
It is provided so as to be able to move up and down through a guide hole formed in the separation plate, and the lower end portion is fixed to the upper surface of the upper block to guide the raising and lowering direction of the upper block. Including guide posts and more
The microneedle patch manufacturing apparatus according to claim 3.

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