KR20240055416A - Prefilled patch - Google Patents

Abstract

The present invention, an adhesive layer attached to the skin; A capsule provided on the adhesive layer and storing an active ingredient or drug; and a handle integrally connected to the capsule, wherein when the handle is pulled by a user, the capsule is cut so that the active ingredient or drug can be discharged.

Description

Prefilled Patch {PREFILLED PATCH}

The present invention relates to a prefilled patch attached to the skin and configured to deliver liquid active ingredients or drugs into the body.

Generally, methods for delivering active ingredients or drugs into the body include taking the drug, injecting the drug through injection, or absorbing the drug through the skin.

Among these methods, oral administration, that is, taking drugs, can cause central nervous system side effects such as headache, drowsiness, dizziness, and nervousness, as well as serious gastrointestinal side effects such as nausea, indigestion, diarrhea, peptic ulcer, gastrointestinal bleeding, and perforation. Therefore, its use is limited to short-term therapy.

In addition, the method of injecting drugs through injection involves inserting a needle through the skin and directly injecting the drug into the body, which allows rapid absorption, but is inconvenient as it must be administered only by a professional (self-administration is difficult), and the diameter is usually several millimeters. Because needles are used, patient compliance is poor due to pain during injection.

In order to eliminate the above-mentioned side effects and problems, the development of a drug delivery system by transdermal administration is being actively conducted.

Typically, drugs that are absorbed through the skin are formulated in the form of liquids, creams, gels, etc. However, due to the nature of the formulations, liquids, creams, and gels have problems such as difficulty in controlling the dosage, stickiness, or contamination of the coating.

Therefore, a method of attaching a patch containing a drug to the skin to absorb the drug through the skin is being used.

The drug administration method using a patch is convenient because the drug is absorbed through the skin, preventing side effects from taking the drug, such as gastrointestinal problems and effects on food, and eliminating pain and discomfort during injection. For this reason, its use has been gradually increasing recently.

The patch may be largely composed of a drug-impermeable backing layer that does not allow drugs to pass through, a drug-permeable membrane, and an adhesive layer that adheres the patch to the skin, and a storage area where the drug is stored. A conduit is provided between the backing layer and the drug permeable membrane.

The major disadvantage of these patches is that the drug absorption rate through the skin is low, so the skin's function as a permeation barrier must be reduced. Generally, the drug absorption rate through patches is known to be approximately 20%, and there are currently no methods to improve the absorption rate. Chemical methods such as the use of skin absorption accelerators and prodrugs, and physical methods such as iontophoresis and electrophoresis are known.

However, even if these known methods are used, there is still a limit to improving the drug absorption rate to a satisfactory level, so in order to expect drug efficacy, excessive use of the drug is inevitable, taking the absorption rate into consideration.

In particular, the type of skin absorption accelerator is determined by the design type of the preparation to be used or the physical and chemical properties of the ingredients, and a concentration above a certain level is required to be effective. When skin absorption accelerators are added, the type is determined by the physical and chemical properties of the ingredients. There are disadvantages in that it is not easy to prevent the formation of crystals, and adhesive properties such as adhesion and cohesion change unsuitably for use.

In addition, technology using electricity requires the patch to include batteries, electrodes, circuits, and other components, making the product more complex, increasing in size, making it more expensive, and generating a large amount of waste after use.

Accordingly, in order to increase the skin absorption rate of active ingredients or drugs, molten polymer microneedles carrying active ingredients or drugs have been developed. However, the amount of drug carried is small, the skin penetration efficiency of microneedles is low due to the strength of the polymer, and when attached to the skin, There is a limitation in that the microneedles break when attached in an inclined plane rather than a vertical direction, making it difficult to commercialize them for medical purposes.

Accordingly, the present applicant developed the present invention to solve the above problems, and related prior art documents include 'Phase-change skin care patch with increased absorption rate' of Republic of Korea Patent No. 10-0847222 .

The present invention is intended to solve the above problems, and its purpose is to provide a prefilled patch configured to prevent evaporation of liquid active ingredients or drugs, increase skin absorption rate, and store high doses of active ingredients or drugs.

In addition, the present invention aims to provide a prefilled patch configured to prevent liquid active ingredients or drugs from leaking to the outside of the patch due to the curvature of the skin when attached to the skin.

In addition, the purpose of the present invention is to provide a prefilled patch configured to allow liquid active ingredients or drugs to quickly penetrate the skin.

In addition, the purpose of the present invention is to provide a prefilled patch that allows the user to easily open the capsule containing the liquid active ingredient and drug to release the drug into the skin.

The present invention, an adhesive layer attached to the skin; A capsule provided on the adhesive layer and storing an active ingredient or drug; and a handle integrally connected to the capsule. When the handle is pulled by a user, the capsule may be cut so that the active ingredient or drug can be discharged.

Additionally, one longitudinal end of the handle may be integrally connected to the capsule, and the other longitudinal end of the handle may be exposed to the outside of the adhesive layer.

Additionally, a cutting line or perforation line may be formed on a portion of the capsule directly connected to one end in the longitudinal direction of the handle.

In addition, it may further include microneedles attached to the adhesive layer with a planar area larger than the planar area formed by the capsule and smaller than the planar area formed by the adhesive layer.

In addition, the microneedles include a substrate portion attached to the adhesive layer; a plurality of supporting holes formed in the substrate; and an insertion needle provided to protrude from a portion of the substrate portion dividing the support hole and inserted into the skin.

Additionally, a guide area may be formed on the substrate portion to guide the longitudinal end of the handle connected to the capsule so as not to interfere with the movement of the handle when the handle is torn off from the capsule.

Additionally, the microneedle may be made of a bioabsorbable metal, and the bioabsorbable metal may include at least one of magnesium, calcium, zinc, and iron.

The prefilled patch according to an embodiment of the present invention has a configuration in which the capsule discharges the active ingredient or drug from the inside of the adhesive layer attached to the skin, thereby preventing the active ingredient or drug from evaporating and continuously maintaining contact with the skin. By allowing it to come into contact, skin absorption rate can be increased.

In addition, the prefilled patch according to an embodiment of the present invention is provided with microneedles on the adhesive layer and the lower side of the capsule, so that the active ingredient or drug stored in the capsule is easily delivered subcutaneously through the microneedle and at the same time stimulates the skin. This can provide beneficial effects.

In addition, in the prefilled patch according to an embodiment of the present invention, the incision in the capsule created when the handle is separated serves as a discharge port for discharging the active ingredient or drug, so there is no need to form a separate discharge port in the capsule. Make sure there is no such thing.

In addition, in the prefilled patch according to an embodiment of the present invention, the handle is formed integrally during the capsule manufacturing process, so the process of manufacturing a separate handle and then bonding it to the capsule can be omitted.

1 is a perspective view showing the configuration of a pre-field patch according to an embodiment of the present invention.
Figure 2 is an exploded perspective view of a pre-field patch according to an embodiment of the present invention.
Figure 3 is a perspective view showing the handle shown in Figure 1 being pulled in the direction of the arrow.
Figure 4 is a perspective view showing the handle shown in Figure 1 completely separated from the capsule.
Figure 5 is a perspective view showing a state in which the release paper shown in Figure 4 has been removed.

The advantages and features of the present invention and methods for achieving them will become clear by referring to the embodiments described in detail below along with the accompanying drawings.

However, the present invention is not limited to the embodiments disclosed below and will be implemented in various different forms. The present embodiments only serve to ensure that the disclosure of the present invention is complete and are within the scope of common knowledge in the technical field to which the present invention pertains. It is provided to fully inform those who have the scope of the invention, and the present invention is only defined by the scope of the claims.

Hereinafter, with reference to FIGS. 1 to 5, a prefield patch according to an embodiment of the present invention will be described in detail. In describing the present invention, detailed descriptions of related well-known functions or configurations are omitted in order to make the gist of the invention unambiguous.

Figure 1 is a perspective view showing the configuration of a pre-filled patch according to an embodiment of the present invention, Figure 2 is an exploded perspective view of a pre-field patch according to an embodiment of the present invention, and Figure 3 is a handle shown in Figure 1. It is a perspective view showing the state of being pulled in the direction of the arrow, Figure 4 is a perspective view showing the handle shown in Figure 1 completely separated from the capsule, and Figure 5 is a perspective view showing the state in which the release paper shown in Figure 4 has been removed.

For reference, Figures 1 to 5 show the portion of the pre-field patch 100 facing the skin.

As shown in Figures 1 to 5, the prefilled patch 100 according to an embodiment of the present invention includes an adhesive layer 110 attached to the skin; A capsule 120 provided on the adhesive layer 110 and storing an active ingredient or drug; and a handle 130 integrally connected with the capsule 120.

As shown in FIGS. 2 and 5, the adhesive layer 110 may have a curvature around its circumference so that it can be attached to various parts of the body and may have various sizes and planar shapes. Additionally, the adhesive layer 110 can be made of a material that is harmless to the human body and has elasticity.

That is, since the user's skin to which the adhesive layer 110 is attached is not completely flat but has a curvature, it is desirable that the peripheral portion have a curved shape corresponding to this. In addition, because the adhesive layer 110 attached to the curvature of the skin receives pressure according to the user's movement, the active ingredient or drug can be naturally discharged from the capsule 120 storing the active ingredient or drug onto the skin due to the pressure. there is.

A known adhesive material may be coated or applied to one surface of the adhesive layer 110. For reference, one side of the adhesive layer 110 can be said to be in direct contact with the skin, and the other side of the adhesive layer can be said to be a side facing the outside.

As shown in FIGS. 1 and 2, the film F and the capsule 120 may be attached to one surface of the adhesive layer 110. Additionally, the substrate portion 210 of the microneedle 200, which will be described later, may also be attached. Additionally, release papers 141 and 142 may be attached to one edge of the adhesive layer 110.

The release papers 141 and 142 may be separated on one side of the adhesive layer 110 as shown in FIG. 5 when the prefilled patch 100 is used by a user. When the release papers 141 and 142 are separated from the adhesive layer 110, the user can attach the area of one side of the adhesive layer 110 to which the release papers 141 and 142 were attached to the skin.

The capsule 120 is disposed closer to the skin than the adhesive layer 110, and may be provided on one side of the adhesive layer 110 in a pouch shape.

Additionally, the capsule 120 provides an internal space where the active ingredient or drug can be stored, and may have a planar area smaller than that of the adhesive layer 110.

For reference, the adhesive layer 110 and the capsule 120 may be made of a flexible thin film or polymer material, and are preferably made of a transparent material so that the user can visually check the inside.

As described above, the handle 130 may be integrally connected to the capsule 120. That is, during the process of manufacturing the capsule 120, the handle 130 may be formed integrally.

As shown in Figures 3 to 5, when the handle 130 is pulled by the user, the capsule 120 is cut so that the active ingredient or drug can be discharged.

Meanwhile, one longitudinal end of the handle 130 is integrally connected to the area of the capsule 120 where the drug or active ingredient is stored. And, the other longitudinal end of the handle 130 is partially exposed to the outside of the adhesive layer 110.

Accordingly, as shown in FIGS. 1 and 3, the user can pull the handle 130 while holding the other longitudinal end portion exposed to the outside of the adhesive layer 110.

That is, when the user pulls the other longitudinal end of the handle 130 exposed to the outside of the adhesive layer 110, as shown in FIG. 4, one longitudinal end of the handle 130 is separated from the capsule 120 and the adhesive layer It may escape to the outside of (110). Then, the portion of the capsule 120 connected to the longitudinal end of the handle 130 is cut to form a passage through which the active ingredient or drug can be discharged. Then, the active ingredient or drug can be discharged through the passage.

In addition, the active ingredient or drug discharged from the internal space of the capsule 120 may spread throughout the skin area to which the adhesive layer 110 is attached and be absorbed into the skin.

For reference, the active ingredients or drugs stored in the capsule 120 include ingredients for disease prevention and treatment, but are not limited to genetic material or EGF (Epidermal Growth Factor) for skin care. ) or hyaluronic acid.

Meanwhile, when the handle 130 is pulled by a user, it is preferable that one end in the longitudinal direction is easily torn from the capsule 120. Accordingly, the portion of the capsule 120 that is directly connected to one longitudinal end of the handle 130 may have relatively lower strength than the remaining portions.

Alternatively, a cutting line or perforation line may be formed on a portion of the capsule 120 directly connected to one end in the longitudinal direction of the handle 130. Accordingly, when the user pulls the other longitudinal end of the handle 130, the longitudinal one end of the handle 130 can be easily torn off the capsule 120 by a cutting line or perforation line.

For reference, the cutting line or perforation line may be formed as a groove formed along the separation direction of the handle 130 at the portion of the capsule 120 directly connected to one end in the longitudinal direction of the handle 130. A single groove or multiple grooves may be formed at the connection portion of the handle 130 and the capsule 120.

In addition, the groove forming the cutting line or perforation line may be formed by a known semi-knife cutting process using a laser or a blade forming process.

In addition, the prefilled patch 100 according to an embodiment of the present invention, as shown in FIGS. 1 to 5, has a planar area that is larger than the planar area formed by the capsule 120 and smaller than the planar area formed by the adhesive layer 110. It may further include microneedles 200 attached to one surface of the adhesive layer 110.

The microneedle 200 includes a substrate portion 210 attached to an adhesive layer 110; A plurality of supporting holes 220 formed in the substrate 210; and an insertion needle 230 that protrudes from a portion of the substrate portion 210 that partitions the support hole 220 and is inserted into the skin.

The substrate portion 210 may have the form of a thin plate with a predetermined area and thickness, and as described above, may be provided on one side of the adhesive layer 110 coated or applied with an adhesive material.

The substrate portion 210 may be manufactured in various sizes and shapes to correspond to the skin area to which it is to be attached, and may be formed to have various curvatures so as to be in airtight contact with the curved skin. For reference, in one embodiment of the present invention, the substrate portion 210 is shown in the drawing as having the same shape as the adhesive layer 110.

The supporting holes 220 may be formed in the substrate 210 using a molding method using a press or a cutting device using a laser, and may be provided in plural numbers at intervals on the surface of the substrate 210. there is.

The support hole 220 may be provided in the substrate portion 110 in a circular or regular polygonal shape, and is preferably formed in a regular hexagonal shape in order to increase the structural durability of the substrate portion 110.

When the support hole 220 is formed in the shape of a regular hexagon, the substrate portion 210 may have a honeycomb structure.

The substrate portion 210 having a honeycomb structure has a plurality of bearing holes ( It is possible to prevent the portion of the substrate portion 210 disposed between 220) from being deformed or damaged by being affected by the pressure piece of the press.

To be more specific, in the process of inserting the press piece provided in the movable mold of the press into the support hole 220, the insertion needle 230 arranged in a lying state is pressed and bent in the vertical direction. At this time, a plurality of There is a risk that the portion of the substrate portion 210 disposed between the supporting holes 220 may be affected by the pressing piece and be deformed or torn.

However, since the microneedle 200 according to an embodiment of the present invention can form the substrate portion 210 into a honeycomb structure by providing the support hole 220 in the form of a regular hexagon, the substrate portion 210 By increasing the overall strength of the substrate 210, it is possible to prevent the substrate 210 from being deformed or damaged during a work process using a press.

The holding hole 220 configured as described above can store the active ingredient or drug discharged through the incision formed in the capsule 120 when one longitudinal end of the handle 130 is torn from the capsule 120. Provides space for That is, the active ingredient or drug discharged through the cut portion of the capsule 120 may spread along the planar area of the substrate portion 210 and be stored in the carrying hole 220.

In addition, the support hole 220 also serves to enable the substrate portion 210 and the attached adhesive layer 110 to further adhere to the skin. In other words, the adhesive layer 110 disposed at a position corresponding to the support hole 220 may be attached to the skin through the support hole 220.

When the substrate portion 210 is in close contact with the skin, only the peripheral area of the adhesive layer 110 that is not in contact with the substrate portion 210 is attached to the skin, so the substrate portion 210 may flow on the skin. However, since a plurality of supporting holes 220 are formed in the substrate portion 210, the adhesive surface of the adhesive layer 110 can be attached to the skin by passing through the supporting holes 220. Accordingly, even if the user moves his or her body, the substrate unit 210 can be fixedly placed at the initial attachment site.

Meanwhile, the substrate portion 210 is in close contact with the skin when the adhesive layer 110 is attached to the skin, so it is preferable that it does not interfere with the movement of the handle 130 during the process of separating the handle 130.

Therefore, as shown in FIGS. 1 to 5, the substrate portion 210 is preferably provided with a guide area 240 corresponding to the shape of the handle 130.

The guide area 240 is provided to prevent the movement of the handle 130 from interfering with the movement of the handle 130 when one longitudinal end of the handle 130 integrally connected with the capsule 120 is separated from the capsule 120. Provides a travel route. Therefore, when the user pulls the other longitudinal end of the handle 130 to discharge the active ingredient or drug stored in the capsule 120, the longitudinal end of the handle 130 is formed in the guide area 240 formed on the substrate 210. ), it can be easily moved without being disturbed by the substrate portion 210 and easily separated from the capsule 120.

For reference, the support hole 220 and the insertion needle 230 formed in the substrate portion 210 may be formed on the substrate portion 210 using a known lithography or etching technique.

Additionally, the substrate portion 210 and the insertion needle 230 may be made of a metal containing at least one of magnesium, calcium, zinc, and iron, which are used as bioabsorbable metals.

For reference, there are cases in which magnesium-based alloys have been manufactured and commercialized domestically and internationally for bioabsorbable metals to be used as orthopedic implants. The bioabsorbable metals applied to orthopedic implants decompose in the body for safe fracture fixation. The focus is on reducing speed as much as possible or improving corrosion resistance.

However, unlike the bioabsorbable metal used in orthopedics, the bioabsorbable metal forming the microneedle 200 according to an embodiment of the present invention accelerates the decomposition rate in the body, enabling drug release and mineral supply under the skin. Mechanisms can be applied.

For example, magnesium, calcium, and zinc, which are used as bioabsorbable metals, may have a mechanism for decomposing by reacting with water in the body and releasing hydrogen gas.

The substrate portion 210 and the insertion needle 230 made of the bioabsorbable metal as described above emit ions and decomposition products under the skin, and the hydrogen gas generated as a by-product provides a swelling effect under the skin, thereby improving wrinkles. can also be induced.

In addition, ZnO and MgCl, which are by-products produced when magnesium and zinc, which are components of bioabsorbable metal, are inserted into the body, stay subcutaneously and the active ingredients or drugs carried on the substrate portion 210 and the insertion needle 230 are absorbed subcutaneously. It can also act as a drug delivery enhancer that improves drug delivery. Therefore, the substrate portion 210 and the insertion needle 230 formed of bioabsorbable metal can effectively deliver the drug contained therein subcutaneously.

In the prefilled patch 100 according to an embodiment of the present invention, the incision in the capsule 120 created when the handle 130 is separated serves as a discharge port for discharging the active ingredient or drug, so the capsule 120 ) There is no need to form a separate discharge port. In addition, since the handle 130 is formed in the process of manufacturing the capsule 120, the process of separately manufacturing the handle 130 and then joining the handle 130 to the capsule 120 can be omitted.

Although specific embodiments according to the present invention have been described so far, it goes without saying that various modifications are possible without departing from the scope of the present invention.

For example, a component that changes the color of the substrate 210 or the insertion needle 230 by reacting with the microneedle 200 made of bioabsorbable metal may be stored in the internal space of the capsule 120.

Therefore, the user's physical condition can be checked according to the degree of discoloration of the microneedle 200, and it can also be used as a patch to diagnose the presence or absence of various viruses or disease infections using reagents.

Therefore, the scope of the present invention should not be limited to the described embodiments, but should be determined by the scope of the patent claims described below as well as equivalents to the claims of this patent.

100: Pre-field patch
110: Adhesive layer 120: Capsule
130: handle 200: micro needle
210: substrate portion 220: support hole
230: Insertion needle 240: Guide area

Claims (7)

An adhesive layer attached to the skin;
A capsule provided on the adhesive layer and storing an active ingredient or drug; and
Includes a handle integrally connected to the capsule,
A prefilled patch, wherein when the handle is pulled by a user, the capsule is cut so that the active ingredient or drug can be discharged.
According to claim 1,
A prefilled patch, wherein one longitudinal end of the handle is integrally connected to the capsule, and the other longitudinal end of the handle is exposed to the outside of the adhesive layer.
According to claim 2,
A prefilled patch, characterized in that a cutting line or perforation line is formed on a portion of the capsule directly connected to one end in the longitudinal direction of the handle.
According to claim 3,
A prefilled patch further comprising microneedles attached to the adhesive layer with a planar area larger than the planar area formed by the capsule and smaller than the planar area formed by the adhesive layer.
According to claim 4,
The microneedles are,
a substrate attached to the adhesive layer;
a plurality of supporting holes formed in the substrate; and
A prefilled patch comprising: an insertion needle provided to protrude from a portion of the substrate portion dividing the carrying hole and inserted into the skin.
According to claim 5,
In the substrate portion,
A prefilled patch, characterized in that when the longitudinal end of the handle connected to the capsule is torn and separated from the capsule, a guide area is formed to guide the movement of the handle so as not to interfere with it.
According to claim 5,
The microneedles include those formed of bioabsorbable metal,
The bioabsorbable metal is a prefilled patch characterized in that it contains at least one of magnesium, calcium, zinc, and iron.