KR20170011580A

KR20170011580A - Microneedle and microneedle manufacturing method for transdermal delivery

Info

Publication number: KR20170011580A
Application number: KR1020150104422A
Authority: KR
Inventors: 양성식
Original assignee: 주식회사 엔이케이
Priority date: 2015-07-23
Filing date: 2015-07-23
Publication date: 2017-02-02
Also published as: KR101744155B1

Abstract

A microneedle for transdermal delivery of the present invention comprises: a base film on an undersurface; a mold formed on the base film; a needle which is filled into and coated on molding grooves or on the top surface of the needle; a protective member attached on a top side of the needle. Moreover, the microneedle for transdermal delivery of the present invention has features of being cut into a roll product or a unit product. The microneedle for transdermal delivery comprises the following steps: coating the mold on the base film; molding the molding grooves of the needle on the mold while drying and hardening the mold; attaching the protective member after coating, drying and hardening materials of the needle on the molding grooves or on the top surface of the needle. The steps are processed in a continuous process, and the product is manufactured through cutting the product into the unit product or winding the product onto a winding roll after attaching the protective member.

Description

Technical Field [0001] The present invention relates to a transdermal delivery micro needle product and a method for manufacturing the same, and a microneedle delivery method,

The present invention relates to a transdermal delivery microneedle product and a method of manufacturing the same. More particularly, the present invention relates to a transdermal delivery microneedle product and a method of manufacturing the same, and more particularly, to an automated production line for manufacturing a needle, The present invention relates to a percutaneous delivery microneedle product and a method of manufacturing the same.

In general, the micro needle is a device for injecting a skin cosmetic substance or drug into the skin tissue or for extracting body fluids such as blood from the inside of the skin. Such a micro needle can be applied locally and continuously, It can be minimized. Therefore, it is a trend that the use in various fields is rapidly increasing recently. Representative examples include patches to prevent motion sickness and nicotine patches to aid smoking cessation, patches for pain relief, relatively recently developed dementia, and Parkinson ' s disease. Patches for treatment, and the like.

The transdermal drug delivery system using the microneedle has advantages such as easy usage, low cost, excellent drug release control, and the like compared with oral administration and subcutaneous injection.

Korean Patent Laid-open Publication No. 10-2011-0022664 discloses a prior art for a conventional micro needle manufacturing method. This prior art document includes a first step of forming a micro needle by applying a solution containing drug-containing nanoparticles to a mold having a micro needle pattern; And a second step of melting and removing the mold from the microneedles formed in the first step, wherein the mold has a melting point of 20 to 60 ° C.

In the prior art, a mold having a microneedle pattern is manufactured, a drug is injected into the mold to mold the needle, and the mold is melted and removed. However, this method has a problem in that it is difficult to melt and remove the mold, and after the mold is removed, only the microneedles are separated and packed.

On the other hand, in the micro needle molding, it is necessary to inject the drug into the needle-shaped groove of the mold to cure the drug. In the process of injecting the drug and forming the needle, bubbles remain in the micro- There is a problem that the tip of the formed needle may be blunt or defective needle may be formed.

Korean Patent No. 10-2011-0022664 (Mar. 07, 2011)

The present invention provides a percutaneous delivery microneedle product and a method of manufacturing the same which can improve the productivity by manufacturing a micro needle molding together with a mold as a mold in one automated production line.

In addition, the present invention is intended to produce a needle product with a basic packaging completed on a production line without attaching a protective material to the upper and lower surfaces of the micro needle production line.

Further, the present invention is to prevent defective molding of the needle by causing air to be sucked from the lower part of the mold so that bubbles are not generated in the needle-shaped groove of a minute size.

The transdermal delivery microneedle product according to the present invention comprises:

A base film formed on the bottom surface,

A mold formed on an upper surface of the base film and having a plurality of needle molding grooves formed along the needle pattern;

A needle-shaped needle on the needle molding groove of the mold and on the upper surface of the needle pattern region where the needle molding groove is formed;

And a micro needle product is formed by a top surface protection material attached to an upper surface of the needle.

Further, the micro needle product according to the present invention is characterized in that it is cut into a unit product according to a needle pattern region

The microneedle product according to the present invention is characterized by being formed of a roll of microneedle product wound on a take-up roll.

The method for producing a transdermal delivery microneedle according to the present invention comprises:

A mold coating process of supplying a base film and coating a mold material on the base film with a thin film;

A mold forming process for forming a needle molding groove on a mold by using a needle forming roll having needles formed according to a microneedle pattern and curing the mold material coated on the base film;

A needle material coating process for filling and coating a microneedle material at an upper portion of a needle molding groove formed in the mold molding process;

A protecting material coating process for attaching a protective film to the upper surface of the needle material while curing the coated needle material in the needle material coating process is performed in one automated production line.

The protective film is wound on a wind-up roll to wind the product with the needle-shaped product roll.

Alternatively, the cutting process may include cutting the product to which the protective film has been attached according to a predetermined product pattern without winding the product on the take-up roll with a needle product roll to complete the manufacture of the product as a single product.

The method may further include a unit packaging process of packing each single product cut into a single product or a plurality of individual products in a unit in the cutting process.

The mold-

A roll-to-roll or running press method, and curing the mold using UV or hot air.

The needle material coating process may include:

And a vacuum suction process for removing bubbles to fill the needle material into the needle molding groove while removing bubbles in the needle molding groove of the mold.

The base film is a porous base film for the vacuum suction process, and a needle molding groove is formed in the mold forming process so that the tip of the needle communicates with the lower surface of the mold.

Alternatively, for the vacuum suction process, a needle molding groove may be formed so that the tip end of the needle communicates with the lower surface of the mold in the mold molding process. After the base film is separated, the vacuum suction process is performed. And a base film is attached to the lower surface of the mold.

According to the method of manufacturing a microneedle according to the present invention, a mold is coated on a base film to be molded, the needle material is coated on the mold, the microneedles are molded, and a protective material is coated on the microneedle, As compared with the conventional needle manufacturing process in which molding and needle molding are separately performed, productivity is improved as a mass production facility, and the product is completed by attaching a protective material to the upper surface without separating the micro needle from the molding, . &Lt; / RTI > In addition, since the bubbles in the needle-forming groove of the mold are forcibly removed during the needle coating, the needle material can be filled into the needle-forming groove to fill the needle, thereby preventing needle defects. In addition, since the present invention is completed by coating a protective material on the top surface of a needle material after coating the needle material, the material is completed in a semi-finished state, wound on a winding roll and dried to complete an end product. It is possible to build an automated production line by solving the problem that the line can not be built.

BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a process flow diagram of a transdermal delivery micro needle preparation method according to the present invention. FIG.
2 is a systematic diagram of a percutaneous delivery microneedle manufacturing system according to the present invention.
3 is a schematic diagram of an embodiment of a percutaneous transmission microneedle manufacturing system according to the present invention.
Fig. 4 is an exemplary view of a mold forming unit according to the present invention; Fig.
5 is a sectional view of a microneedle product according to the present invention.

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

The transdermal delivery microneedle product according to the present invention, as shown in Fig. 5,

A base film (1) formed on the lower surface,

A mold 2 formed on an upper surface of the base film 1 and having a plurality of needle molding grooves 3 formed along a needle pattern;

A needle 4 coated on an upper surface of a needle pattern area formed with the needle molding groove 3 of the mold 2 and the needle molding groove 3;

And the upper surface protection material 5 attached to the upper surface of the needle 4 is a micro needle product.

That is, the percutaneous transmission microneedle product according to the present invention has a structure in which a base film 1, a mold 2 and a micro needle 4 are formed on a lower surface, and a protective material 5 is formed on an upper surface, .

This is because the conventional products are formed by integrally inserting the needles into the mold differently from the products made by separating the needles from the molds and wrapping them with separate packaging machines or packing materials, and protecting the upper and lower surfaces with a protective material and a film.

A method of manufacturing the microneedle product will now be described.

BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a process flow diagram of a transdermal delivery microneedle manufacturing method according to the present invention. As shown therein,

A mold coating process (S10) for supplying a base film (1) and coating a mold (2) material on the base film (1) with a thin film;

A mold forming step of forming a needle molding groove 3 on a mold 2 by using a needle forming roll having needles formed in accordance with a microneedle pattern and curing the mold 2 coated on the base film 1, (S20);

A needle material coating process S30 for filling and coating the material of the micro needle 4 at an upper portion of the needle molding groove 3 formed in the mold molding process S20;

The protecting material coating step S40 for adhering the protective film 5 to the upper surface of the needle 4 during the needle material coating step S30 is performed in one automated production line.

In the present invention, the mold 2 is coated on the base film 1 in the mold coating process S10, the needle molding groove 3 is formed on the mold 2 in the mold molding process S20, And the needle 4 is formed by filling the needle material on the upper surface of the mold 2 in which the needle molding groove 3 is formed in the needle coating process S30. In the protective material coating process (S40), the needle 4 is coated and formed, and the protective film 5 is coated thereon while being dried and cured. Therefore, the present invention can produce a micro needle product by a series of continuous processes, and such a series of continuous processes can be constructed as a single production line and constructed as an automated production equipment.

As the base film 1, a porous film such as a general nonwoven fabric can be used as a base film, and a protective material such as a commonly used PE film can be used as a base film. Preferably, a nonwoven fabric is used as a base film to perform the bubble removing process.

In the mold coating process (S20), the mold 2 is coated on the upper surface of the base film 1 and coated to a thickness of about 250 micrometers. This makes it possible to coat the mold with a thin thickness unlike the conventional mold so that the needle molding groove 3 can communicate with the base film 1 of the lower face. As the mold material, a silicon material having a flexible performance may be used, or an acrylic material may be used. Using a silicone-based material, the micro needle can easily be detached from the mold and adhered to the skin when the product is used.

Further, the present invention is characterized in that, in the protective material coating process (S40), the product with the top protective film 5 attached thereto is wound on a winding roll, and a winding process S50 is performed to complete the manufacture of the product with a needle product roll.

The reason why the winding process (S50) for winding the product on the winding roll is required is that it takes a long time to mold and dry-cure the needle 4, It can be dried and cured for a long time to complete the finished product. That is, the micro needle material of current microneedle products is used for medicines and cosmetics. In order to coat and dry-cure the materials of these medicines or cosmetics with needle products, it takes several hours to dry and cure .

Therefore, conventional methods have not been able to complete product production in a continuous production line due to a long drying and curing time after needle coating. Drying and curing are performed in a drying and curing chamber after needle coating molding. Then, only micro needles are separated, And a process of packaging the same in a separate manner.

Therefore, it was exposed to prolonged exposure to dry hardening of the needles, and contamination or needle damage due to transportation or contact with workers for separation and packaging was serious. The present invention solves the above-mentioned problems of the prior art, since it is completed with semi-finished products in a state that the protective film is adhered on the upper surface while properly drying and curing after the needle coating, and is wound and wound on a winding roll to complete drying and curing.

Alternatively, the cutting process may include cutting a product to which the protective film 5 is attached, according to a predetermined product pattern, without winding the product on the take-up roll with a needle roll, and completing the manufacture of the product as a single product.

The cutting process may be continuously performed in the post-process of the protective material coating process, or may be separated from the processes and wound on the take-up roll to perform the cutting process by the independent process. If the cutting process is performed by a continuous process, the product is cut into product units including a pattern region according to a needle pattern and stored in a container, so that a unit product can be produced in the form of a product for final sale in a continuous production process.

The mold forming process (S30)

Meanwhile, the needle material coating process (S30)

(S50) for removing bubbles to fill the needle material into the needle molding groove (3) while removing bubbles in the needle molding groove (3) of the mold (2).

The base film 1 is a porous base film for the vacuum suction process S50 and the needle molding groove 3 is formed so that the tip of the needle communicates with the lower surface of the mold 2 in the molding process S20 .

Alternatively, a needle molding groove 3 may be formed in the mold molding process (S20) so that the tip of the needle communicates with the lower surface of the mold 2 for the vacuum suction process (S50), and the base film The base film 1 is attached to the lower surface of the mold 2 immediately after the vacuum suction process S50.

The micro needle is formed with a small needle molding groove 3 each having a size of micro unit and it is difficult to fill the needle molding groove 3 in the process of filling and coating the needle material of the liquid state. This is because when the bubbles remain, the bubbles are not completely filled due to the bubbles, the bubbles are left, the defective needles are formed due to the bubbles, and the needles are damaged easily when used or stored.

Therefore, in the present invention, a vacuum inserting process (S50) is further carried out to completely fill the needle material so that the needle material can be completely filled by bubbling the bubble in the needle molding groove 3 at the bottom surface of the mold. For vacuum intake, the end of the needle-forming groove 3 must be communicated with the lower surface of the mold. This is because when the roll-to-roll method is used during molding, the lower roll is brought into close contact with the needle tip of the needle- The base film 1 on the lower surface may be a porous film (for example, nonwoven fabric), or a vacuum suction process may be performed with the base film removed.

FIG. 2 is a system diagram of a transdermal delivery microneedle manufacturing system according to the present invention, and FIG. 3 is a systematic diagram showing another embodiment of the transdermal delivery microneedle manufacturing system according to the present invention.

The transdermal delivery microneedle manufacturing system according to the present invention comprises:

A base film supply unit (10) for supplying the base film (1);

A mold coating unit 20 for thinly coating the mold 2 on the base film 1;

A mold forming unit 30 for forming a needle molding groove 3 on an upper surface of a mold material 2 coated on the base film 1 by using a needle molding roll having needles formed according to a micro needle pattern;

A mold hardening unit 40 for hardening the mold 2 to be molded by the mold forming unit 30;

A needle coating part 50 for filling and coating a needle material on an upper surface of the mold 2 that has passed through the mold hardening part 40;

A needle hardening portion 70 for dry-hardening the coated needle material in the needle coating portion 50;

And a protective material coating part (80) for coating an upper protective material (5) on the upper surface of the product passed through the needle hardening part (70).

The present invention also includes a product winding unit 90 for winding a product coated with the upper surface protection material 5 in the protective material coating unit 80.

A product cutting part for cutting the product coated with the top surface protection material 5 or the product supplied from the product winding part 90 in the protective material coating part 80 at an arbitrary interval determined according to the needle pattern, (100).

The product cut by the product cutting unit 100 may further include a packaging device for individually packaging each individual product or packaging a plurality of individual products in one packaging container.

In the present invention thus configured, when the base film 1 is supplied from the base film supply unit 10, the material of the mold 2 is coated on the upper surface of the base film 1 in the mold coating unit 20. At this time, a silicon material or an acrylic material is used as a mold material.

Molding is performed to form the needle molding groove 3 in the mold 2 in the mold forming section 30 when the base film 1 is transported while being coated with the material of the mold 2. [ The mold forming section 30 performs mold molding by a roll-to-roll method or a running-press method.

A mold forming roll 31 is disposed on the upper portion, and a driven roller is disposed on the lower portion to form a needle molding groove. At this time, the driven roller may use a pressing pattern roller 32 having a protruding surface corresponding to the needle pattern. This is because the needle molding groove 3 is formed so as to communicate with the outside of the lower surface of the mold 2.

Then, a mold hardening portion 50 is provided in the mold forming portion 30 to harden the mold 2 to be molded. It is dried and cured using a heat curing type or UV lamp. In the case of the thermosetting type, hot air may be blown from the outside, or the thermosetting may be performed by roller heating by providing a heating means inside the roller of the mold forming portion 30. [

The needle coating unit 50 further includes bubble removing means for removing bubbles in the needle molding groove 3 of the mold 2.

As the bubble removing means,

The base film 1 is formed using a porous film (e.g., nonwoven fabric)

The needle forming part (30)

A needle forming roller 31 having needles formed in accordance with a needle pattern and a pressing pattern corresponding to the needle pattern area are formed and interlocked with the needle forming roller 31 to press the material of the mold 2, And a pressing pattern roller (32) penetrating the material and communicating with the upper surface of the base film (1)

And a vacuum suction unit 60 installed at a lower portion of the needle coating unit 40 to remove bubbles by sucking bubbles in the needle molding groove 3 of the mold 2 by vacuum suction.

This is constituted by the upper mold forming roller 31 in the mold forming section 30 and the lower pressing pattern roller 32 formed with the pressing pattern which is the protruding face corresponding to the needle pattern, When the material is supplied to the mold forming unit 30 in a coated state, the mold is passed through the mold forming unit 30 while being in contact with the tip end of the needle by the pressing pattern turn, so that the needle pattern region is not yet cured The mold material of the state is pressed and pushed by the pressing pattern so that the tip end of the needle is brought into contact with the pressing pattern and the leading end of the needle molding groove is subjected to the mold molding with the mold passing therethrough.

Accordingly, when the base film 1 is a porous film, that is, a nonwoven fabric, when a vacuum inhaler is installed on the lower surface of the nonwoven fabric to draw in air, air bubbles in the needle molding groove 3 communicated with the nonwoven fabric are drawn in, do.

On the other hand, when the nonwoven fabric which is a porous film is not used as the base film 1, a base film separating section 11 for separating the base film as shown in Fig. 3, And a film attaching part 120. [

As the bubble removing means,

The needle forming part (30)

A base film separator 110 installed at a rear end of the pressing pattern roller 32 to separate the base film;

The base film separator 110 is provided at a lower portion of the needle coating unit 40 to remove air bubbles from the bottom surface of the mold. An intake part 60;

And a base film attaching part 120 installed at a rear end of the vacuum intake part 60 and supplying and attaching the base film 1 to the lower surface of the mold coated with the needle material in the needle coating part 40 .

This is because when the base film 1 is not used as a porous film such as a nonwoven fabric, the base film is separated by the base film separating section 110 and then the base film is separated by the vacuum suction section 60 The bubbles are removed and the base film 1 is supplied to the lower surface of the mold 2 by the base film attaching portion 120 and attached.

Therefore, it is possible to fill the needle material while surely removing the bubbles in the needle molding groove 3, so that the needle can be formed into a normal needle shape with a sharp end, and the defective needle forming rate can be reduced because there is no internal bubble.

The mold forming unit 30 is characterized in that a plurality of needles are formed by a roll-to-roll or running press method using a mold-forming roll formed in a predetermined needle pattern area in accordance with a product type .

The mold hardening unit 40 is characterized in that it is hardened by a heating method by means of a heating unit provided inside the mold forming unit 30.

The mold hardening unit 40 and the needle hardening unit 70 are cured by using a UV lamp or a hot air dryer.

1: base film 2: mold
3: Needle forming groove 4: Needle
5: Protection material 10: Base film supply part
20: Mold coating part 30: Mold forming part
31: Mold forming roller 32: Compression pattern roller
40: Mold hardening part 50: Needle coating part
60: Vacuum suction part 70: Needle hardening part
80: protective material coating part 90: product winding part
100: cutting portion 110: base film separating portion
120: base film attaching portion

Claims

A transdermal delivery microneedle manufacturing method comprising:
A mold coating process (S10) for supplying a base film (1) and coating a mold (2) material on the base film (1) with a thin film;
A mold forming step of forming a needle molding groove 3 on a mold 2 by using a needle forming roll having needles formed in accordance with a microneedle pattern and curing the mold 2 coated on the base film 1, (S20);
A needle material coating process S30 for filling and coating the material of the micro needle 4 at an upper portion of the needle molding groove 3 formed in the mold molding process S20;
Wherein the protecting material coating step (S40) is performed in which the protective film (5) is adhered to the upper surface while the coated needle (4) is cured in the needle material coating step (S30).

The method according to claim 1,
Further comprising a cutting step of cutting the product to which the protective film (5) is attached according to a predetermined product pattern to complete the manufacture of the product as a single product.

The method according to claim 1, wherein the mold forming process (S30)
Wherein the mold is formed by a roll-to-roll or running press method, and the mold is cured using UV or hot air.

The method of claim 1, wherein the needle material coating process (S30)
Further comprising a vacuum suction process (S50) for removing bubbles to fill the needle material into the needle molding groove (3) while removing bubbles in the needle molding groove (3) of the mold (2) Method of manufacturing micro needle.

5. The method of claim 4,
Wherein the base film (1) uses a porous base film and the needle molding groove (3) is formed so that the tip end portion of the needle communicates with the lower surface of the mold (2) in the mold molding step (S20) Method of manufacturing micro needle.

5. The method of claim 4,
The needle molding groove 3 is formed so that the tip end of the needle communicates with the lower surface of the mold 2 in the mold molding process S20 and the vacuum filming process S50 is performed after the base film 1 is separated , And the base film (1) is attached to the lower surface of the mold (2) immediately after the vacuum suction process (S50).

As a transdermal delivery micro needle product,
A base film (1) formed on the lower surface,
A mold 2 formed on an upper surface of the base film 1 and having a plurality of needle molding grooves 3 formed along a needle pattern;
A needle 4 coated on an upper surface of a needle pattern area formed with the needle molding groove 3 of the mold 2 and the needle molding groove 3;
Characterized in that the top surface protection material (5) attached to the top surface of the needle (4) is made of a micro needle product.

8. The transdermal delivery microneedle product according to claim 7,
A mold coating process S10 for coating the mold 2 with a thin film on the base film 1 and forming a needle molding groove 3 on the mold 2 while curing the coated mold 2 A needle material coating process S30 for filling and coating the material of the microneedles 4 at an upper portion of the needle molding groove 3, a needle material coating process S30 for coating the needle material coating process S30, (S40), in which a protective film (5) is adhered to the upper surface while curing the adhesive layer (4), is performed in a continuous process.

8. The transdermal delivery microneedle product according to claim 7,
Wherein the product comprising the base film, the mold, the needle and the protective material is cut into a unit product according to the area in which the needle patterns are formed.

8. The transdermal delivery microneedle product according to claim 7,
A product for transdermal delivery microneedle comprising: a micro-needle product roll formed by winding a product comprising a base film, a mold, a needle and a protective material on a take-up roll.