WO2015186937A1

WO2015186937A1 - Microneedle patch and production method therefor

Info

Publication number: WO2015186937A1
Application number: PCT/KR2015/005464
Authority: WO
Inventors: 이재영
Original assignee: 주식회사 아모그린텍
Priority date: 2014-06-02
Filing date: 2015-06-01
Publication date: 2015-12-10
Also published as: KR101724654B1; KR20150138646A

Abstract

The present invention relates to a microneedle patch and a production method therefor, the microneedle patch being capable of: reducing production costs by forming a gel layer for supplying a skin care solution by electrospinning or electrospraying; and allowing a drug or the skin care solution to be smoothly absorbed into skin by evenly distributing same on the gel layer for supplying a substance to be delivered. The microneedle patch according to the present invention comprises: a support having a groove formed therein; a plurality of microneedles protruding from the underside of the groove; a gel layer for supplying a substance to be delivered, which consists of a mixture of the substance to be delivered and a biodegradable resin and is filled in a gel state in the groove; and a protective film, which covers the gel layer for supplying the substance to be delivered and is bonded to the support.

Description

Micro needle patch and its manufacturing method

The present invention relates to a micro-needle patch, and more particularly, to form a gel film for supplying the material to be delivered by electrospinning or electrospray, to reduce the manufacturing cost, the gel film for supplying the drug or skin cosmetic liquid The present invention relates to a microneedle patch and a method for manufacturing the same, which can be evenly distributed on the skin to smoothly penetrate the skin.

Micro-needle patch is a kind of drug delivery system (Drug Delivery System) that puts a micro-needle patch on the skin and injects drugs into the skin.

Microneedle patches are used in medical and cosmetic applications by puncturing the stratum corneum of the epidermis and delivering active ingredients into the skin.

Here, the microneedle is a fine needle that can make a passage directly through the epidermal and dermal layers of the skin.

As such, unlike the conventional injection form, the microneedle patch is able to administer the drug through the skin without pain, and is easy to use and simple to perform.

Korean Patent Publication No. 10-1392947 discloses micro-projections applicable to living skin and a polymer material constituting a common base of the micro-projections; And it is disclosed a micro-projection massage patch comprising fibers of linear structure of 0.1 ㎛ to 100 ㎛ thickness dispersed in the polymer material. This massage patch has the advantages of being free from distortion in the drying step during the manufacturing process, maintaining flexibility, freeing the shape change that does not break even after being manufactured and bent, and having excellent breathability.

However, the massage patch disclosed in Korean Patent Publication No. 10-1392947 includes a medicament in which the microprojections puncture the skin, and the microprojections are dissolved or melted and soaked into the skin to perform treatment and skin beauty. Therefore, the amount of the pharmaceutical injected into the skin depends on the size of the microprojections, so that the amount of the pharmaceutical injected into the skin cannot be increased, and there is a problem in that the manufacturing cost increases.

Accordingly, the present inventors continue to study the technology that can reduce the manufacturing cost of the microneedle patch to form a thin film by the electrospinning or electrospray to supply the material to be transferred to reduce the manufacturing cost, microneedle By inventing and inventing a structure and method characteristic that can be injected into the inner region of the skin along the sidewall of the to improve the effect of treatment and skin beauty, the present invention has completed a more economical and usable competitive invention.

The present invention has been made in view of the above, the object of the present invention is to penetrate the stratum corneum of the skin with microneedles to form micropores for drug delivery, and the drug or skin cosmetic liquid stored behind the microneedles through the micropores. The present invention provides a microneedle patch and a method of manufacturing the same, wherein the substance to be transferred is penetrated into the skin along the outer surface of the microneedle.

It is another object of the present invention to provide a microneedle patch and a method for manufacturing the same, which form a gel film for supplying a substance to be delivered by an electrospinning or electrospraying process to sufficiently reduce the amount of the substance to be delivered and to reduce the manufacturing cost. have.

In order to achieve the above object, an embodiment of the present invention, the support is formed groove; A plurality of microneedles protruding from the bottom surface of the groove; A gel film for supplying a to-be-transmitted substance made of a mixture of a to-be-transmitted substance and a biodegradable resin and filled in the groove in a gel state; And a protective film covering the gel film for supplying a substance to be transferred and adhered to the support part.

In addition, an embodiment of the present invention, the groove is formed on one surface, the step of preparing a support portion protruding a plurality of micro needles on the bottom surface of the groove; Preparing a spinning solution or spraying solution by mixing a substance to be transferred, a biodegradable resin, and a solvent; Forming a gel film for supplying a substance to be transferred by electrospinning the spinning solution or electrospraying the spraying solution into a groove of the support part; And adhering a protective film for protecting the gel film for supplying a substance to be transferred to the support unit.

As described above, in the present invention, a micropore formed in the skin by a microneedle, and a substance to be delivered such as a drug or a skin cosmetic liquid located on the outer surface of the microneedle is formed in a predetermined area inside the skin along the outer surface of the microneedle. By implementing a patch structure that can be injected, it is possible to inject a larger amount of drugs or skin cosmetics than the patches having the same size into the inner region of the skin has the effect of improving the treatment and skin cosmetic effects.

In addition, the present invention is filled with a biodegradable resin mixed with a drug or skin cosmetic liquid and a solvent in the groove of the support of the thin film form by electrospinning or electrospray to form a gel film for supplying the substance to be delivered in a thin film, thereby treating and skin care There is an advantage that can significantly reduce the manufacturing cost of the patch for.

In addition, the present invention forms a gel film for supplying a substance to be injected into the skin by electrospinning or electrospray, so that the drug or skin cosmetic is evenly distributed on the gel film for supplying the substance to be transmitted, thereby allowing the skin to penetrate smoothly. Technology can be provided.

1 is a schematic cross-sectional view of a microneedle patch according to the present invention,

Figure 2 is a schematic partial cross-sectional view for explaining a state in which the microneedle according to the present invention penetrated the skin,

3 is a schematic partial cross-sectional view for explaining the shape of the microneedle patch according to the present invention,

4 is a flowchart of a method of manufacturing a microneedle patch according to the present invention;

5A and 5B are schematic cross-sectional views for explaining a method of manufacturing microneedle patches by electrospinning according to the present invention;

6 is a schematic cross-sectional view for explaining a method for manufacturing a microneedle patch by electrospray according to the present invention;

7 is a schematic diagram of an electrospinning or electrospray apparatus applied to the present invention.

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

1 is a schematic cross-sectional view of a microneedle patch according to the present invention, Figure 2 is a schematic partial cross-sectional view for explaining a state in which the microneedle according to the present invention penetrated the skin, Figure 3 is a microneedle patch according to the present invention It is typical sectional drawing for demonstrating the shape of the.

Referring to FIG. 1, the microneedle patch 200 according to the present invention includes a support part 100 in which a groove 110 is formed; A plurality of micro needles 120 protruding from the bottom surface 111 of the groove 110; A gel film 130 for supplying a to-be-transmitted material formed in the groove 110 by being filled with a material or a biodegradable resin such as a drug or skin cosmetic liquid by electrospinning or electrospray; And a protective film 150 attached to the support part 100 by covering the gel film 130 for supplying the material to be transferred.

The support part 100 has a groove 110 that can be filled in the form of nanofibers or droplets made of a drug or skin cosmetic liquid and a biodegradable resin, and the groove 110 is electrospun or electrosprayed, such as a drug or skin cosmetic liquid. The biodegradable resin mixed with the carrier and the solvent is filled. The support part 100 includes a dam at an outer circumference thereof so that the groove 110 is formed therein.

At this time, since the microneedle patch of the present invention is attached to the skin and has a predetermined thickness, the microneedle patch protrudes from the skin. Therefore, the support portion 100 may be implemented in a thin film form because the degree of protrusion should be good.

Here, the groove 110 having a low depth is formed by the support 100 in the form of a thin film, thereby making it possible to reduce the filling capacity inside the groove 110. Therefore, even if a small amount of drug or skin cosmetic liquid and biodegradable resin are injected into the groove 110 of the support part 100, the manufacturing cost can be reduced.

The support 100 is preferably implemented with a polymer material that is harmless to the human body, and it is preferable to use ULTEM among the polymer materials. In addition, the support part 100 may implement a shape of a plurality of microneedles 120 protruding at a predetermined interval from the groove 110 and the bottom surface 111 of the groove 110 by an injection molding process.

The mold for molding the support part 100 may be precisely manufactured by MEMS (Micro Electro Mechanical Ssystem).

The protective film 150 has a function of preventing the damage of the gel state of the gel film 130 for supplying the substance to be transferred and a function of blocking the penetration of foreign substances from the outside, and the protective film 150 has a gel film for supplying the substance to be transferred ( 130 is bonded to the edge of the support 100.

Here, an adhesive (not shown) is formed in an adhesive region to which the protective film 150 and the support part 100 are adhered, and the protective film 150 is peeled off from the support part 100 to perform the microneedle patch 200. When removed, the adhesive component remains in the adhesive region of the support part 100 to which the protective film 150 is adhered, thereby allowing the microneedle patch 200 to adhere to the skin.

In addition, the protective film 150 is for safe storage and transport of the microneedle patch 200 performs a function similar to the release film.

When the user peels the protective film 150 from the support part 100 and presses the support part 100 while contacting the gel film 130 for supplying the substance to be delivered to the skin, the plurality of microneedles 120 punctures the skin. It penetrates into the skin.

At this time, as shown in Figure 2, the hole 11 is formed in the skin 10 by the microneedle 120, the gel drug or skin cosmetic liquid present on the side of the microneedle 120 is a microneedle Soak into the skin 10 along the outer surface of the 120 can be treated or skin care.

Referring to FIG. 3, the microneedle 130 may have a width W1 of the upper region narrower than a width W2 of the lower region based on the bottom surface 111 of the groove 110 to penetrate the skin. . Here, the ends of the plurality of micro needles 120 may be pointed or rounded.

Therefore, the microneedle 130 may penetrate the stratum corneum of the skin, and the drug or skin cosmetic liquid may be injected into a predetermined area inside the skin along the outer surface of the microneedle 120.

Here, since the bleeding should not occur when the plurality of microneedles 120 penetrates the stratum corneum of the skin and the drug or the cosmetic liquid is injected into a predetermined area inside the skin, the height H of the plurality of the microneedles 120 is 1000 μm. It is preferably less than and can be designed from several micros to several hundred micros.

In addition, the plurality of microneedles 120 may be formed of a material that may be biodegradable or dissolved by the body fluid inside the skin, such that the plurality of microneedles 120 may penetrate into the skin to prevent side effects. Here, biodegradation or dissolution of the plurality of microneedles 120 may be performed for a long time of several hours to a short time of several seconds. In addition, the material of the plurality of microneedles 120 may be harmless to the human body.

In the present invention, the support portion 100 is preferably formed integrally with a plurality of microneedles 120, in this case, the support portion 100, the groove 110 and the plurality of microneedles 120 are also formed in the body fluid It can be formed of a material that can be biodegradable or dissolved by.

Biodegradable or soluble materials include polyethylene glycol (PEG), polyvinylpyrrolidone (PVP), polyvinyl alcohol (PVA), cellulose, hydroxypropyl cellulose (HPC), hydroxyethyl cellulose (HEC), hydroxy Propyl methylcellulose (HPMC).

The gel film 130 for supplying a substance to be transferred includes nanofibers or droplets made of a biodegradable resin in which drugs or skin cosmetics and a solvent are mixed by electrospinning or electrospraying into the grooves 110 of the support part 100. It is a film that has accumulated and maintained a gel state.

Here, the solvent may be water-based spinning, it is possible to use alcohols harmless to the human body, an example of the biodegradable resin may be applied gelatin (gelatin) used as a medicine capsule processed collagen to be collected from cartilage tissues of animals.

In addition, the drug may be a single drug or a mixture of drugs, and in particular, anesthetics, anesthetic vaccines, immunoadjuvant, immunogens, immunomodulators, immune reactants, immune stimulants, analgesics, antibiotics, chitosan, collagen, It may be a single drug of gelatin, hyaluronic acid, polylactic acid, polyglycolic acid, or a combination thereof. As such, the drug may diffuse into the body tissue or blood flow of the patient through the skin, thereby imparting a therapeutic effect to the patient.

Skin cosmetic liquids consist of cosmetic ingredients for skin beauty, such as, for example, essences.

Therefore, in the present invention, by implementing a patch structure that can be injected into the dermis layer inside the skin along the outer surface of the microneedle, the drug or skin cosmetic liquid located on the outer surface of the microneedle as a hole formed in the skin by the microneedle, More drugs or skin cosmetics can be injected into the inner skin area than patches of the same size, thereby improving the therapeutic and skin cosmetic efficiency.

Figure 4 is a flow chart of a method for manufacturing a microneedle patch according to the present invention, Figures 5a and 5b is a schematic cross-sectional view for explaining a method for producing a microneedle patch by electrospinning according to the present invention, Figure 6 It is typical sectional drawing for demonstrating the method of manufacturing a microneedle patch by electrospray according to this invention.

In the present invention, a microneedle patch is manufactured by electrospinning or electrospraying a biodegradable resin mixed with a drug or skin cosmetic liquid and a solvent to a support.

That is, referring to Figure 4, in order to manufacture a microneedle patch, a groove is formed on one surface, and a support portion on which a plurality of micro needles protrude on the bottom surface of the groove is prepared (S100), and then a drug or Skin cosmetics are mixed with a solvent and a biodegradable resin to prepare a spinning solution or a spray solution (S110).

Thereafter, the spinning solution is electrospun into the spinning solution, or the injection solution is electrosprayed to form the gel film 130 for supplying the substance to be transferred (S120).

Subsequently, the gel film for supplying the substance to be transferred is wrapped with a protective film and bonded to the support unit (S130).

Referring to the process of performing the electrospinning, as shown in Figure 5a, when spinning the spinning solution made by mixing the drug or skin cosmetic liquid and the solvent with the biodegradable resin, the spinning nozzle 210, the nanofiber 300 It is radiated to and accumulated in the groove 110 of the support 100, thereby forming the gel film 130 for supplying the material to be transferred from the accumulated nanofibers (300).

When the nanofibers 300 are filled in the grooves 110 of the support part 100 and the formation of the gel film 130 for supplying the transferred material is completed, the electrospinning is terminated, or the spinning nozzles 210 are discharged. After leaving the support 100 from the region, as shown in FIG. 5B, the protective film 150 is adhered to the support 100 to surround the gel film 130 for supplying the material to be transferred.

In addition, in the process of performing the electrospray, as shown in Figure 6, the injection solution is made by the injection nozzle 211, the injection solution made by mixing the drug or skin cosmetic liquid and the solvent with the biodegradable resin. At this time, the droplet 310 is discharged from the injection nozzle 211, the droplet 310 is accumulated in the groove 110 of the support portion 100 to form a gel film 130 for supplying the substance to be transferred.

As described above, in the present invention, the electrospun or electrosprayed nanofibers or droplets are accumulated in the grooves 110 of the support part 100 to form the gel film 130 for supplying the substance to be delivered, thereby being manufactured by the method of the present invention. The microneedle patch has the following three structural features.

First, some of the plurality of micro needles 120 is completely wrapped by the gel film 130 for supplying the substance to be transferred, and the other end of the plurality of micro needles 120 is not wrapped in the gel film 130. The end may be in a structural state protruding from the surface of the gel film 130 for supplying a substance to be transferred.

Second, a state in which a plurality of microneedles 120 may not be visible on the surface of the gel film 130 for supplying material to be completely wrapped by the gel film 130 for supplying material to be delivered. Can be.

Third, the ends of all of the plurality of microneedles 120 cannot be wrapped by the gel film 130 for supplying the substance to be delivered so as to protrude from the surface of the gel film 130 for supplying the substance to be delivered. Can be.

Therefore, in the present invention, by filling the biodegradable resin mixed with the drug or skin cosmetic liquid and the solvent in the groove of the thin film form by electrospinning or electrospray to form a gel film for supplying the substance to be delivered, patches for treatment and skin beauty There is an advantage that can significantly reduce the manufacturing cost of.

In addition, the present invention forms a gel film for supplying a substance to be injected into the skin by electrospinning or electrospray, so that the drug or skin cosmetic is evenly distributed on the gel film for supplying the substance to be transmitted, thereby allowing the skin to penetrate smoothly. will be.

Referring to FIG. 7, the electrospinning or electrospraying apparatus of the present invention includes a solution tank 520 in which a spinning solution obtained by mixing a drug or skin cosmetic liquid and a solvent with a biodegradable resin is stored, and a nozzle connected to a high voltage generator (not shown). 550.

The nozzle 550 is disposed above the grounded collector 560 in the form of a conveyor moving at a constant speed, and a plurality of nozzles 550 are arranged along the traveling direction of the collector 560 (horizontal arrow direction), and the solution The tank 520 may include a stirrer 530 using the mixing motor 510 as a driving source.

When the spinning solution or spray solution sequentially discharged from the nozzle 550 passes through the nozzle 550 charged by the high voltage generator, the ultra-fine nanofibers or the droplets are discharged (in the direction of the vertical arrow) when the electrospinning is performed. It is sequentially accumulated in the groove (not shown) of the support part 100 on the grounded collector 560 in the form of a conveyor moving at a constant speed to form a gel film for supplying a substance to be transferred.

In the above, the present invention has been illustrated and described with reference to specific preferred embodiments, but the present invention is not limited to the above-described embodiments, and the present invention is not limited to the spirit of the present invention. Various changes and modifications will be possible by those who have the same.

The present invention relates to a drug delivery system (DDS), and can be applied to a microneedle patch that can effectively inject a drug or a substance such as skin cosmetic liquid into the skin at low cost.

Claims

A support in which grooves are formed;

A plurality of microneedles protruding from the bottom surface of the groove;

A gel film for supplying a to-be-transmitted substance made of a mixture of a to-be-transmitted substance and a biodegradable resin and filled in the groove in a gel state; And

And a protective film covering the gel film for supplying the substance to be transferred and adhered to the support part.
The method of claim 1,

The gel film for supplying the substance to be transferred is a microneedle patch in which a nanofiber made of a mixture of a drug or skin cosmetic liquid and a biodegradable resin is accumulated in the groove and formed in a gel state by electrospinning.
The method of claim 1,

The gel needle for supplying the substance to be transferred is a microneedle patch in which droplets made of a mixture of a drug or skin cosmetic liquid and a biodegradable resin are accumulated in the grooves and formed in a gel state by electrospraying.
The method of claim 1,

The material of the support is microneedle patch (ULTEM).
The method of claim 1, wherein the support portion is formed integrally with the plurality of microneedles,

The support is a microneedle patch formed of a material that can be biodegradable or dissolved by body fluids.
The method of claim 5, wherein the biodegradable or soluble material is polyethylene glycol (PEG), polyvinylpyrrolidone (PVP), polyvinyl alcohol (PVA), cellulose, hydroxypropyl cellulose (HPC), hydroxyethyl Microneedle patch, which is one of cellulose (HEC), hydroxypropyl methylcellulose (HPMC).
The microneedle patch of claim 1, wherein the width of the microneedle is smaller than the width of the lower area with respect to the bottom surface of the groove.
The microneedle patch of claim 1, wherein the microneedle is formed at a height capable of penetrating the stratum corneum of the skin, and the transfer material is injected into the skin along the outer surface of the microneedle.
The microneedle patch of claim 1, wherein the height of the microneedle is less than 1000 μm.
The method of claim 1, wherein the substance to be delivered comprises a drug,

The drug is an anesthetic, an anesthetic vaccine, an adjuvant, an immunogen, an immunomodulator, an immune reactant, an immune stimulant, an analgesic, an antibiotic, chitosan, collagen, gelatin, hyaluronic acid, A microneedle patch which is a single drug of one of polylactic acid, polyglycolic acid or a combination thereof.
The method of claim 1, wherein the substance to be delivered includes a skin cosmetic liquid,

The skin cosmetic liquid is a microneedle patch made of cosmetic ingredients for skin beauty.
The method of claim 1, wherein the ends of some of the plurality of microneedles protrude from the surface of the gel material for delivering the substance to be delivered, and the state in which all of the plurality of microneedles are present in the gel film for the substance to be delivered. And a microneedle patch in which the end of all of the plurality of microneedles is protruded from the surface of the gel material for supplying material to be delivered, and the gel film for delivery material is filled in the groove.
Preparing a support having a groove formed on one surface thereof, and having a plurality of microneedles protruding from the bottom surface of the groove;

Preparing a spinning solution or spraying solution by mixing a substance to be transferred, a biodegradable resin, and a solvent;

Forming a gel film for supplying a substance to be transferred by electrospinning the spinning solution or electrospraying the spraying solution into a groove of the support part; And

Adhering a protective film for protecting the gel film for supplying a substance to be transferred to the support unit.
The method of claim 13, wherein the substance to be delivered comprises a drug or skin cosmetic liquid,

The forming of the gel film for supplying the substance to be transferred includes electrospinning the spinning solution to accumulate nanofibers in which the drug or the skin cosmetic liquid and the biodegradable resin are mixed in the groove to form the gel material for supplying the substance to be transferred. Method for producing a microneedle patch to form.
The method of claim 13, wherein the substance to be delivered comprises a drug or skin cosmetic liquid,

The forming of the gel film for supplying the substance to be transferred may include forming a gel film for supplying the substance to be transferred in a gel state by accumulating droplets of the drug or skin cosmetic liquid and biodegradable resin in the grooves by electrospraying the spray solution. Method for producing a microneedle patch.