Apparatus for manufacturing microneedle and method for manufacturing microneedle thereby

Abstract

Disclosed are an apparatus for manufacturing a microneedle and a method for manufacturing a microneedle thereby. The apparatus for manufacturing a microneedle according to an embodiment of the present invention comprises: a vacuum chamber for vacuum-processing a mold having an engraved shape of a microneedle formed thereon; an application device for applying a liquid medicine for manufacturing a microneedle to the vacuum-processed mold; and a drying device for drying the mold having the liquid medicine applied thereto.

Description

Microneedle manufacturing device and microneedle manufacturing method using the same

[0001] The present invention relates to a microneedle manufacturing device and a microneedle manufacturing method using the same, and more specifically, to a microneedle manufacturing device for manufacturing high-quality microneedles and a microneedle manufacturing method using the same.

[0002] Microneedles are tiny needles that pierce tiny holes in the skin to deliver drugs, vaccines, cosmetic ingredients, etc. Compared to conventional injection needles, they cause less pain, have high penetrability, and are easy to self-administer, so they are used in various fields.

[0003] Microneedles can directly act on the skin's surface, i.e., the dermis or transdermis, by using their formulation, and can thus have effects such as improving wrinkles, whitening, moisturizing, and nourishing the skin.

[0004] Microneedles consist of a needle portion and a base layer made of the same material mixed with the drug. Microneedles come in biodegradable and soluble types.

[0005] Biodegradable microneedles are made of biodegradable materials such as PDO (Polydioxanone), PLLA (Poly-L-Lactic Acid), and PCL (Polycaprolactone), and after being inserted into the skin, they naturally decompose over a long period of time (several weeks to several months) and are absorbed into the body.

[0006] Dissolvable microneedles are made of hyaluronic acid, collagen, peptides, gelatin, etc., and when inserted or attached to the skin, they dissolve in the skin within a short period of time (minutes to hours) compared to biodegradable types, releasing drugs.

[0007] Meanwhile, the conventional microneedle manufacturing method includes the process of applying a chemical solution to a mold in which the negative shape of the microneedle is formed, drying the mold, and then separating the microneedle from the mold.

[0008] Molds for microneedle manufacturing can be made of porous materials such as PDMS (Polydimethylsiloxane), which can stably inject the drug solution. During the microneedle manufacturing process, air pockets can form as the drug solution is applied to the mold. These air pockets prevent the drug solution from reaching the tip (also known as the tip) of the microneedle's negative surface. To address this issue, the drug-applied mold can be vacuum-treated, a process known as vacuum degassing.

[0009] Vacuum degassing technology is a microneedle manufacturing method in which a chemical solution is applied to a mold and then a vacuum is applied, and the air pockets inside the mold rise due to the external vacuum, filling the chemical solution up to the negative shape attachment of the mold.

[0010] However, this vacuum degassing technology has the problem that not only does it remove air bubbles due to air pockets existing on the mold, but the air saturation within the chemical solution decreases, and the air saturated within the chemical solution moves to the surface of the microneedles during vacuum treatment, causing bubbles.

[0011] The purpose of the present invention is to solve such conventional problems, and to provide a microneedle manufacturing device and a microneedle manufacturing method using the same for manufacturing high-quality microneedles by vacuum-treating a mold prior to applying a chemical solution to the mold having a microneedle engraved shape of a porous material.

[0012] The tasks of the present invention are not limited to the tasks mentioned above, and other tasks not mentioned will be clearly understood by those skilled in the art from the description below.

[0013] In order to solve the above-described problem, a microneedle manufacturing device according to one aspect of the present invention includes a vacuum chamber for vacuum-treating a mold in which a negative shape of a microneedle is formed, a coating device for applying a chemical solution for manufacturing microneedles to the vacuum-treated mold, and a drying device for drying the mold to which the chemical solution has been applied.

[0014] The vacuum chamber further includes an impermeable film adhered to the bottom of the mold, and the vacuum chamber can perform vacuum treatment while the impermeable film is adhered to the bottom of the mold.

[0015] The impermeable film may be characterized as having a single structure or a multilayer structure comprising at least one of polyethylene terephthalate (PET), polyethylene (PE), silicone, polyurethane (PU), and parylene.

[0016] The opaque film can form a plurality of holes at set intervals.

[0017] The hole can have a smaller size from the center to the edge.

[0018] A method for manufacturing microneedles according to another aspect of the present invention includes a vacuum treatment step of vacuum-treating a mold in which a negative shape of a microneedle is formed, a coating step of applying a chemical solution for manufacturing microneedles to the mold, a drying step of drying the mold, and a separation step of separating the microneedles from the mold.

[0019] Before the vacuum treatment step, an impermeable film can be attached to the lower surface of the mold, and vacuum treatment can be performed on the mold with the impermeable film attached to the lower surface.

[0020] The opaque film may have multiple holes formed at set intervals.

[0021] The hole can have a smaller size from the center to the edge.

[0022] According to the microneedle manufacturing device of the present invention and the microneedle manufacturing method using the same, the following effects are achieved.

[0023] First, by vacuum-treating the mold before applying the chemical solution to the mold in which the negative shape of the microneedle is formed, air is removed from the negative shape of the microneedle in the mold, thereby enabling the chemical solution to be effectively filled into the mold in the subsequent process.

[0024] Second, the vacuum treatment effect can be continuously maintained by performing vacuum treatment while an impermeable film is adhered to the bottom of the mold, thereby blocking atmospheric air from being absorbed into the inside of the mold through the bottom of the mold.

[0025] The effects of the present invention are not limited to the effects mentioned above, and other effects not mentioned will be clearly understood by those skilled in the art from the description of the claims.

[0026] Figure 1 illustrates a microneedle manufacturing device according to one embodiment of the present invention.

[0027] Figure 2 is a table showing the duration of the vacuum treatment effect when an impermeable film is adhered to the bottom of the mold of Figure 1.

[0028] Figures 3 and 4 illustrate the formation of multiple holes in the impermeable film illustrated in Figure 1.

[0029] Figure 5 is a flowchart showing a method for manufacturing microneedles using the microneedle manufacturing device of Figure 1.

[0030] Figure 6 illustrates a microneedle manufactured by the microneedle manufacturing method of Figure 5.

[0031] The advantages and features of the present invention, and the methods for achieving them, will become clearer with reference to the embodiments described in detail below together with the accompanying drawings. However, the present invention is not limited to the embodiments disclosed below and may be implemented in various different forms. These embodiments are provided only to ensure that the disclosure of the present invention is complete and to fully inform those skilled in the art of the scope of the invention, and the present invention is defined only by the scope of the claims. Like reference numerals designate like elements throughout the specification.

[0032] The sizes and shapes of components depicted in the drawings attached to this specification may be exaggerated for clarity and convenience of explanation. It should be noted that identical components are sometimes depicted with the same reference numerals in each drawing. Furthermore, detailed descriptions of functions and structures of known technologies that may unnecessarily obscure the gist of the present invention may be omitted.

[0033] The terminology used herein is used to describe specific embodiments and is not intended to limit the present invention. As used herein, the singular form may include the plural form unless the context clearly dictates otherwise. Furthermore, whenever a part of this specification is referred to as "comprising" a component, this means that it may also include other components, unless otherwise specifically stated.

[0034] When a component is referred to as being "connected" or "connected" to another component, it should be understood that it may be directly connected or connected to that other component, but that there may be other components in between. Conversely, when a component is referred to as being "directly connected" or "connected" to another component, it should be understood that there are no other components in between. Other expressions used to describe the relationship between components should be interpreted similarly.

[0035] The terms "top," "bottom," "upper surface," "lower surface," or "upper" and "lower surface" as used herein are used to distinguish the relative positions of components. For example, for convenience, the upper surface in a drawing may be referred to as "upper surface" and the lower surface in the drawing as "lower surface." In practice, the upper surface may be referred to as "lower surface" and the lower surface as "upper surface" without departing from the scope of the present invention.

[0036] Terms containing ordinal numbers, such as "first," "second," etc., described herein may be used to describe various components; however, these components are not limited by these terms. These terms are merely used to distinguish each component from another, and are not limited by the manufacturing order. Furthermore, the names may not be consistent between the detailed description of the invention and the claims.

[0037] All terms, including technical or scientific terms, used herein, unless otherwise defined, have the same meaning as commonly understood by those of ordinary skill in the art to which this invention pertains. Terms defined in commonly used dictionaries should be interpreted as having a meaning consistent with their meaning in the context of the relevant technology, and shall not be interpreted in an idealized or overly formal sense unless explicitly defined herein.

[0038] The symbols attached to each step are used to identify each step and do not indicate the order of the steps, and the steps may be performed in a different order than stated unless the context clearly indicates a specific order.

[0039] Hereinafter, embodiments of the present invention will be described with reference to the attached drawings.

[0040] Figure 1 illustrates a microneedle manufacturing device according to one embodiment of the present invention.

[0041] Referring to FIG. 1, a microneedle manufacturing device (100) according to an embodiment of the present invention includes a vacuum chamber (110) for vacuum-treating a mold (101) in which a negative shape of a microneedle is formed, an impermeable film (120) adhered to the lower surface of the mold (101), a coating device (130) for applying a chemical solution for manufacturing microneedles to the mold (101), and a drying device (140) for drying the mold (101) to which the chemical solution has been applied.

[0042] The mold (101) may have a negative shape of a microneedle and may be formed (manufactured) from one or more materials selected from the group consisting of porous PDMS (Poly dimethyl siloxane), porous PMHS (Polymethyl hydrosiloxane), porous silicon, porous polyurethane, and porous PMMA (Polymethyl methacrylate).

[0043] Conventionally, a chemical solution for microneedle manufacturing was applied to a mold and then vacuumed in a vacuum chamber. This allowed air pockets within the mold to rise due to the external vacuum, allowing the chemical solution to fill the mold up to its tip (also known as the tip). However, the air saturation within the chemical solution decreased, and air saturated within the chemical solution could migrate to the surface of the microneedles during vacuuming, creating bubbles.

[0044] Accordingly, the microneedle manufacturing device (100) according to an embodiment of the present invention vacuum-treats the mold (101) in which the negative shape of the microneedle is formed by a vacuum chamber (110) before applying the chemical solution to the mold (101).

[0045] Although not shown, the vacuum chamber (110) can be made into a vacuum state lower than atmospheric pressure by a vacuum pump, and the mold (101) can be stored within the vacuum chamber (110) for a set period of time. For example, under conditions of a mold thickness of 2 mm and a temperature within the vacuum chamber (110) of 25°C, the mold (101) can be vacuum-treated by being maintained within the vacuum chamber (110) maintained in a vacuum state 1 bar lower than atmospheric pressure for at least 10 minutes or 30 minutes. Such environmental conditions for mold vacuum treatment can be changed based on experimental results for optimal vacuum treatment.

[0046] By vacuum-treating the mold (101) in advance using a vacuum chamber (110) before applying the chemical solution to the mold (101) of the porous material, the air existing inside the mold (101) can be removed, and the pressure inside the mold (101) is lowered.

[0047] Since the mold (101) is a porous material, it may contain a small amount of air. As it is vacuum-stored in a vacuum chamber (110), the air inside the mold (101) can be removed from the edges, and changes in air concentration can be observed. As the mold (101) is vacuum-stored in a vacuum chamber (110), the air is completely removed, and the overall air concentration can converge to zero.

[0048] An impermeable film (120) is adhered to the lower surface of the mold (101). The impermeable film (120) may be adhered to the lower surface of the mold (101) by an adhesive (122). The adhesive (122) may include, for example, an adhesive silicone that is not air permeable.

[0049] The mold (101) can be degassed by a vacuum chamber (110) while an impermeable film (120) is adhered to the lower surface.

[0050] In this way, the mold (101) that has been vacuum-treated by the vacuum chamber (110) while the impermeable film (120) is adhered to the lower surface can block atmospheric air from being absorbed into the mold (101) through the lower surface of the mold (101) by the impermeable film (120) adhered to the lower surface of the mold (101), even if it is left in the atmosphere thereafter, so that the vacuum treatment effect can be continuously maintained.

[0051] The duration of the vacuum treatment effect of this mold (101) may be proportional to the volume of the microneedle mold (101) and inversely proportional to the surface area. In an embodiment of the present invention, in order to increase the duration of the vacuum treatment effect of the mold (101), as described above, the vacuum treatment may be performed in a state where an impermeable film (120) is laminated (attached) to the lower surface of the mold (101).

[0052] The impermeable film (120) can prevent the reintroduction of air when the microneedle mold (101) is exposed to air after vacuum treatment due to its impermeability, and can reduce the difference in position at which air is introduced.

[0053] Figure 2 is a table showing the duration of the vacuum treatment effect when an impermeable film is adhered to the bottom of the mold of Figure 1.

[0054] The impermeable film (120) may be a single structure or a multi-layer structure including one or more of polyethylene terephthalate (PET), polyethylene (PE), silicone, polyurethane (PU), and parylene.

[0055] Referring to Fig. 2, for both the thermosetting mold and the Sylgard 184 mold, the duration of the vacuum treatment effect increased when a parylene film or silicone film was coated (adhesive) on the lower surface of the mold compared to when it was not. In this case, the coating thickness may be 5 μm.

[0056] Specifically, when vacuum treatment is performed on a thermosetting mold having a thickness of 3 mm and an impermeable film (120) is not attached to the lower surface (no film coating), the duration of the vacuum treatment effect is only about 10 minutes.

[0057] On the other hand, when a parylene film or silicone film coating (adhesion) was performed on the lower surface of the mold, the duration of the vacuum treatment effect increased by 40 minutes and 20 minutes, respectively, compared to when the film coating was not performed. Therefore, the chemical solution for manufacturing microneedles can be applied to the mold (101) within the duration of the vacuum treatment effect.

[0058] When the above-described vacuum treatment was performed on a Sylgard 184 mold with a thickness of 5 mm and the impermeable film (120) was not attached to the lower surface (no film coating), the duration of the vacuum treatment effect was approximately 50 minutes.

[0059] On the other hand, when parylene film coating (adhesion) was performed on the bottom of the mold, the duration of the vacuum treatment effect increased by 20 minutes.

[0060] In this way, the impermeable film (120) according to the embodiment of the present invention seals the lower surface of the mold (101) to delay the re-inflow of external air, thereby stably maintaining the vacuum treatment effect for a longer period of time.

[0061] Figures 3 and 4 illustrate the formation of multiple holes in the impermeable film illustrated in Figure 1.

[0062] Referring to FIGS. 3 and 4, the above-described impermeable film (120) in another example can form a plurality of holes (121) at set intervals.

[0063] Here, the hole (121) formed in the impermeable film (120) may have a smaller size from the center to the edge of the impermeable film (120) corresponding to the mold (101). Through this, the pressure inside the mold (101) can be evenly distributed, thereby alleviating the pressure imbalance between the center and edge of the mold (101).

[0064] This allows for even distribution of the chemical liquid by controlling the pressure difference during the process of the chemical liquid seeping into the negative-shaped portion of the mold (101) when applying the chemical liquid for manufacturing microneedles to the mold (101) by the application device (130). Consequently, the chemical liquid is uniformly filled and hardened throughout the entire mold (101), thereby improving the quality of the microneedles.

[0065] Figure 5 is a flowchart illustrating a method for manufacturing microneedles using the microneedle manufacturing device of Figure 1. In the following, any duplicate content described above will be omitted as much as possible.

[0066] Referring to Fig. 5, a vacuum treatment step is performed (S501) in which a mold (101) in which a negative shape of a microneedle is formed by a vacuum chamber (110) is vacuum-treated.

[0067] By vacuum-treating the mold (101) before applying the chemical liquid to the mold (101) in which the negative shape of the microneedle is formed, air is removed from the negative shape of the microneedle of the mold (101), so that the chemical liquid can be effectively filled into the mold in the subsequent process.

[0068] Here, before the vacuum treatment step (S501), a process of adhering an impermeable film (120) to the bottom of the mold (101) can be performed.

[0069] Accordingly, the vacuum treatment described above can be performed on the mold (101) to which the impermeable film (120) is adhered on the lower surface.

[0070] The impermeable film (120) can prevent the reintroduction of air when the microneedle mold (101) is exposed to air after vacuum treatment due to its impermeability, and can increase the duration of the vacuum treatment effect.

[0071] In another example, a plurality of holes (121) may be formed at set intervals in the impermeable film (120). The size of the holes (121) may decrease from the center to the edges of the impermeable film (120). This allows the pressure within the mold (101) to be evenly distributed, thereby alleviating the pressure imbalance between the center and edges of the mold (101).

[0072] Next, a coating step of applying a chemical solution for manufacturing microneedles to a mold (101) by a coating device (130) is performed (S511).

[0073] As in the embodiment of the present invention, when a vacuum treatment is performed on a mold (101) to which an impermeable film (120) is adhered, and a chemical solution is applied (filled) to the mold (101) by a coating device (130) while the vacuum treatment effect is maintained, the chemical solution is evenly filled up to the tip (also called the tip) of the microneedle engraved shape of the mold (101), and no empty space is created. This is useful for producing high-quality microneedles.

[0074] Next, a drying step of drying the mold (101) by a drying device (140) is performed (S521).

[0075] Afterwards, a separation step is performed to separate the microneedles from the mold (101) (S531).

[0076] Figure 6 illustrates a microneedle manufactured by the microneedle manufacturing method of Figure 5.

[0077] Conventional vacuum degassing technology vacuum-treats the mold while the chemical solution is applied, which can cause large and small bubbles to form on the surface of the chemical solution. These bubbles remain on the microneedle sheet even after the mold is dried, which not only reduces the quality of the product but also causes the sheet surface to be uneven, which can have a negative impact on the subsequent process (hydrocolloid lamination process).

[0078] In contrast, the microneedle manufacturing process of the present invention, unlike conventional vacuum degassing techniques, first vacuum-treats the mold and then applies the chemical solution. Furthermore, to ensure that the chemical solution can be applied while maintaining the vacuum treatment effect, an impermeable film (120) is adhered to the bottom of the mold (101), and then vacuum treatment is performed and the chemical solution is applied.

[0079] This can remove bubbles on the surface of the microneedle sheet to make the surface flat, improve the quality of the microneedle sheet, and reduce the defect rate during the process.

[0080] Referring to Fig. 6, the liquid could be evenly filled up to the attachment portion of the microneedle engraved shape of the mold (101), and then, through the process of drying the mold (101) and separating the microneedle from the mold (101), a high-quality microneedle could be produced.

[0081] Although the preferred embodiments of the present invention have been illustrated and described with reference to the drawings as described above, the present invention is not limited to the specific embodiments described above, and various modifications may be made by a person skilled in the art to which the invention pertains without departing from the gist of the present invention as claimed in the claims. Furthermore, such modifications should not be understood individually from the technical idea or prospect of the present invention.

[0082] The present invention relates to a microneedle manufacturing device and a microneedle manufacturing method using the same, and can be used in industries such as the health care industry.

Claims

1. A vacuum chamber for vacuum-treating a mold in which the negative shape of microneedles is formed; A coating device for applying a chemical solution for manufacturing microneedles to the above vacuum-treated mold; and A microneedle manufacturing device including a drying device for drying a mold to which the above-mentioned chemical solution has been applied.

2. In paragraph 1, Further comprising an impermeable film adhered to the bottom of the mold, The above vacuum chamber A microneedle manufacturing device that performs the vacuum treatment while the above-mentioned impermeable film is adhered to the bottom surface of the mold.

3. In paragraph 2, The above impermeable film, A microneedle manufacturing device characterized by having a single structure or a multi-layer structure including at least one of polyethylene terephthalate (PET), polyethylene (PE), silicone, polyurethane (PU), and parylene.

4. Vacuum treatment step of vacuum-treating the mold in which the negative shape of the microneedle is formed; A coating step of applying a chemical solution for manufacturing microneedles to the mold; A drying step for drying the above mold; and A method for manufacturing microneedles, comprising a separation step of separating the microneedles from the mold.

5. In paragraph 4, Before the above vacuum treatment step, An impermeable film is adhered to the bottom of the above mold, A method for manufacturing microneedles, wherein the vacuum treatment is performed on a mold on which the above-mentioned impermeable film is adhered to the lower surface.

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