KR101832716B1 - Micro needle device and it's manufacturing method which can control drug quantity and dosing speed - Google Patents

Micro needle device and it's manufacturing method which can control drug quantity and dosing speed Download PDF

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Publication number
KR101832716B1
KR101832716B1 KR1020160067712A KR20160067712A KR101832716B1 KR 101832716 B1 KR101832716 B1 KR 101832716B1 KR 1020160067712 A KR1020160067712 A KR 1020160067712A KR 20160067712 A KR20160067712 A KR 20160067712A KR 101832716 B1 KR101832716 B1 KR 101832716B1
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South Korea
Prior art keywords
mold
drug
protrusion
sheet
solution
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KR1020160067712A
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Korean (ko)
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KR20170135575A (en
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이승욱
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이승욱
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0021—Intradermal administration, e.g. through microneedle arrays, needleless injectors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/0023—Drug applicators using microneedles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/0053—Methods for producing microneedles

Abstract

The present invention relates to a biodegradable medical device comprising a protruding sheet formed of a biodegradable material protruding from a contact surface in contact with the skin and inserted and dissolved in the skin and a biodegradable material attached to the supporting protrusion, Tips,
Wherein the support protrusion is a material having a relatively fast biodegradation rate and the drug tip is a material having a relatively low rate of biodegradation.

Description

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a microneedle structure and a manufacturing method thereof,

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a microneedle structure and a manufacturing method thereof, and more particularly, to a microneedle structure and a manufacturing method capable of performing a quantitative dose of a drug.

Generally, a method of delivering a drug to the dermal layer through the skin includes a method of applying a drug to the skin, and a method of injecting a drug through a very short injection needle through a shallow needle.

On the other hand, drugs applied to the skin are very difficult to transfer into the skin due to the thick, dry skin layer.

On the other hand, when the drug is injected through the injection needle, it is difficult to control the amount due to the drug remaining in the channel, and it is difficult to manufacture the drug, which results in a very expensive cost (see Korean Patent No. 10-0819648).

As an alternative to this, fine needle structures are densely formed to puncture the skin, and microneedle structures designed to allow the drug to enter through the holes made in the keratin are developed. In this case, the microneedle which is not dissolved in the body is significantly lowered in the production stage, but the quantity can not be controlled due to the drug remaining in the interface with the skin or in the injection channel, which limits the quantitative drug injection. 10-0869277)

On the other hand, the microneedles made of materials dissolving in the body merely puncture the skin and dissolve to form a passage through which the drug passes, or even when the drug is contained, It is impossible to control the exact dosage (dose) of the drug to be injected, and the depth to be injected can not be controlled, so that the exact position (depth) of the drug to be injected can not be controlled. (Korean Patent No. 10-1061975 )

As a result, the existing micropatterns of soluble micro-needles have not been administered quantitatively enough to control injections or to control the injection depth.

It is an object of the present invention to provide a microneedle structure capable of controlling the administration depth and dose of a drug.

It is another object of the present invention to provide a method of manufacturing a microneedle structure capable of controlling the depth and dosage of a drug and the rate of drug administration.

It is still another object of the present invention to provide a micro needle structure comprising a protrusion sheet having a support protrusion and a drug tip attached to the support protrusion, wherein the biodegradation rate of the support protrusion is faster than the biodegradation rate of the drug tip, Is applied to the skin for a relatively short time and then removed, so that the drug tip can remain in the skin.

The present invention relates to a biodegradable medical device comprising a protruding sheet formed of a biodegradable material protruding from a contact surface in contact with the skin and inserted and dissolved in the skin and a biodegradable material attached to the supporting protrusion, Tips,

Wherein the support protrusion is a material having a relatively fast biodegradation rate and the drug tip is a material having a relatively low rate of biodegradation.

At this time, the support protrusions and the drug tip include a hyaluronic acid polymer, and the hyaluronic acid polymer contained in the support protrusion has a relatively low molecular weight, and the hyaluronic acid polymer included in the drug tip may have a relatively high molecular weight .

More specifically, the hyaluronic acid polymer contained in the support protrusion has a molecular weight of less than 100,000, and the hyaluronic acid polymer included in the drug drug tip may have a molecular weight of 100,000 or more.

Meanwhile, it is preferable that the time for the support protrusion to be cut after insertion into the skin is in the range of 5 to 15 minutes.

As a method for manufacturing such a microneedle structure,

A mold preparing step of preparing a mold having the same shape as the outer shape of the microneedle structure; Forming a drug tip in a mold of the mold and injecting a drug solution as a biodegradable material solution and curing the drug solution to form a drug tip; Injecting a protrusion sheet solution, which is a biodegradable material solution having a relatively high biodegradation rate, into the template of the mold on which the drug tip is formed, and curing the protrusion sheet to form a protrusion sheet; And separating the microneedle structure from the mold,

Providing a first mold having an engraved mold corresponding to the shape of the drug tip and a second mold having a through hole corresponding to the shape of the support protrusion; Applying and curing a drug solution as a biodegradable material solution forming a drug tip on a mold of the first mold; Aligning and attaching a second mold to the first mold, applying and curing a projection sheet solution, which is a biodegradable material solution having a relatively fast biodegradation rate, on the second mold, And separating the microneedle structure from the mold,

Providing a squeeze mold having a mold having a mold having an engraved shape corresponding to the shape of the drug tip and the support protrusion and a squeeze protrusion corresponding to the shape of the support protrusion; Applying a drug solution, which is a biodegradable material solution forming a drug tip to a mold of the mold, and pressing the drug solution with the squeeze mold to adjust the application amount of the drug solution; Removing the squeeze mold, injecting a protrusion sheet solution, which is a biodegradable material solution having a relatively high biodegradation rate, into the mold of the mold, and curing the mold; And separating the microneedle structure from the mold.

At this time, the drug solution and the projection sheet solution may contain a hyaluronic acid polymer, and the hyaluronic acid polymer contained in the projection sheet solution has a molecular weight of less than 100,000, and the hyaluronic acid polymer contained in the drug solution has a molecular weight It can be over 100,000.

In addition, in the above methods, before the step of separating the microneedle structure from the mold, the step of attaching the pressure sensitive adhesive sheet to the back side of the projection sheet may be further included.

The present invention also provides a biodegradable biodegradable biodegradable biodegradable biodegradable biodegradable biodegradable biodegradable biodegradable biodegradable biodegradable biodegradable biodegradable biodegradable biodegradable biodegradable biodegradable biodegradable And a medicament tip made of a material, wherein the support protuberance provides a microneedle structure having a neck having a relatively small cross-sectional area.

The neck portion may have at least one recessed groove.

The support protrusions and the drug tip include a hyaluronic acid polymer, and the hyaluronic acid polymer contained in the support protrusion has a relatively low molecular weight, and the hyaluronic acid polymer contained in the drug tip is more preferably a relatively high molecular weight.

More specifically, the hyaluronic acid polymer contained in the support protrusion has a molecular weight of less than 100,000, and the hyaluronic acid polymer included in the drug drug tip may have a molecular weight of 100,000 or more.

It is preferable that the time for the support protrusion to be cut after insertion into the skin is in the range of 5 to 15 minutes.

The present invention also relates to a medical instrument comprising a protruding sheet formed of a biodegradable material protruding from a contact surface contacting skin and dissolving in the skin and having a relatively narrow cross section, A method for producing a microneedle structure comprising a drug tip comprising a biodegradable material inserted and dissolved in the skin,

A mold providing step of a mold having an embossed shape identical to an outer shape of the microneedle structure and made of an elastic material; Forming a drug tip in a mold of the mold and injecting a drug solution as a biodegradable material solution and curing the drug solution to form a drug tip; Injecting a protrusion sheet solution, which is a biodegradable material solution having a relatively high biodegradation rate, into the template of the mold on which the drug tip is formed, and curing the protrusion sheet to form a protrusion sheet; And separating the microneedle structure from the mold,

Providing a first mold having an engraved mold corresponding to the shape of the drug tip and a second mold having an elastic material and having a through hole corresponding to the shape of the support protrusion; Applying and curing a drug solution as a biodegradable material solution forming a drug tip on a mold of the first mold; Aligning and attaching a second mold to the first mold, applying and curing a projection sheet solution, which is a biodegradable material solution having a relatively fast biodegradation rate, on the second mold, And separating the microneedle structure from the mold,

Providing a squeeze mold having a mold having an engraved shape corresponding to the shape of the drug tip and the support protrusion and having a resilient material and a squeeze protrusion corresponding to the shape of the support protrusion; Applying a drug solution, which is a biodegradable material solution forming a drug tip to a mold of the mold, and pressing the drug solution with the squeeze mold to adjust the application amount of the drug solution; Removing the squeeze mold, injecting a protrusion sheet solution, which is a biodegradable material solution having a relatively high biodegradation rate, into the mold of the mold, and curing the mold; And separating the microneedle structure from the mold.

At this time, the mold may have a protrusion at a portion corresponding to the neck of the support protrusion, a shrinkage hole may be provided in the protrusion,

In the step of separating the micro-needle structure from the mold, it is preferable that negative pressure is applied to the shrinkage cavity so that the projection is contracted.

Meanwhile, the drug solution and the projection sheet solution may contain a hyaluronic acid polymer,

The hyaluronic acid polymer contained in the projection sheet solution has a molecular weight of less than 100,000, and the hyaluronic acid polymer contained in the drug solution preferably has a molecular weight of 100,000 or more.

Further, before the step of separating the microneedle structure from the mold, the step of attaching the pressure sensitive adhesive sheet to the back surface of the projection sheet may be further included.

The microneedle structure according to the present invention has a projection sheet having a support protrusion for adjusting the depth of insertion. By forming the drug tip on the support protrusion of the projection sheet, the effect that the drug tip can penetrate a desired depth accurately Bring it.

In addition, since the penetrated drug tip is entirely put into the skin tissue, the amount of drug to be injected can be accurately controlled.

Therefore, it is possible to utilize the microneedle structure for the administration of the pharmaceutical agent which requires a fixed dose.

The microneedle structure according to the present invention has the effect of gradually supplying the drug of the drug tip in the skin by making the drug tip consist of a component having a slow biodegradation rate.

In addition, the micro-needle structure of the present invention allows the micro-needle structure to have a relatively fast biodegradation rate than the drug tip, thereby allowing the drug tip to penetrate into the skin. There is an effect that can be made.

1 is a perspective view of a microneedle structure according to a first embodiment of the present invention.
2 is a cross-sectional view of a microneedle structure according to a first embodiment of the present invention.
3 is a perspective view of a microneedle structure according to a second embodiment of the present invention.
4 is a cross-sectional view of a microneedle structure according to a second embodiment of the present invention.
5 is a cross-sectional view of another embodiment of a microneedle structure according to an embodiment of the present invention.
6 is a process diagram showing a method of manufacturing a microneedle structure according to a first embodiment of the present invention.
7 is a process diagram showing a method of manufacturing a microneedle structure according to a second embodiment of the present invention.
8 is a process diagram illustrating a method of manufacturing a microneedle structure according to a third embodiment of the present invention.
9 is a photograph of a micro-needle structure according to the present invention.
10 is a perspective view of a microneedle structure according to a fourth embodiment of the present invention.
11 is a cross-sectional view of a microneedle structure according to a fourth embodiment of the present invention.
12 is a process diagram showing a method of manufacturing a microneedle structure according to a fourth embodiment of the present invention.
13 is a process diagram illustrating a method of manufacturing a microneedle structure according to a fifth embodiment of the present invention.
14 is a process diagram showing a method of manufacturing a microneedle structure according to a sixth embodiment of the present invention.

The terms and words used in the present specification and claims should not be construed as limited to ordinary or preliminary meaning and the inventor shall properly define the concept of the term in order to describe its invention in the best possible way It should be construed in accordance with the meaning and concept consistent with the technical idea of the present invention. It should be noted that the embodiments described in the present specification and the configurations shown in the drawings are only the most preferred embodiments of the present invention and do not represent all the technical ideas of the present invention, It should be understood that various equivalents and modifications are possible.

FIG. 1 is a perspective view of a microneedle structure according to a first embodiment of the present invention, and FIG. 2 is a sectional view of a microneedle structure according to a first embodiment of the present invention.

As shown, the microneedle structure 100 according to the first embodiment of the present invention includes a protrusion sheet 140 and a drug tip 160.

The protrusion sheet 140 serves to support the microneedle structure 100 and to penetrate the drug tip 160 to a desired depth in the skin.

The projection sheet 140 has a support projection 146 protruding from a contact surface 144 that contacts the skin. The support protrusion 146 forms a lower region of the microneedle, and the drug tip 160 is integrally formed on the upper end of the support protrusion 146.

The support protrusion 146 formed on the protrusion sheet 140 penetrates into the skin along with the drug tip 160 and the support protrusion 146 is made of a biodegradable material so that it can be disassembled and cut.

The support protrusion 146 provided on the protrusion sheet 140 may be made of a material having a water-soluble material or a hydrophilic surface in consideration of a coupling force with the drug tip 160. Such a material makes it easier to manufacture the drug tip 160 as a biodegradable one.

Examples of materials having hydrophilic properties include materials such as carboxymethyl sodium cellulose (SCMC), sodium hyaluronate (HA), polyvinylpyrolidone (PVP), polyethylene glycol (PEG), polyvinyl alcohol polyvinyl alcohol (PVA), polylactic acid PLA, polyethylene oxide (PEO), polyacrylic acid, polystyrene sulfonatecellulose (HPC), hydroxyethyl cellulose (HEC) Hydroxypropyl methyl cellulose (HPMC), dextrin, dextran, monosaccharides and disaccharides, polyalcohol, gelatin, gum arabic, alginate, chitosan Chitosan cylcodextrin, carbohydrates, and other water-soluble natural and synthetic polymers or hydrophilic modified poly And combinations of these materials.

It is also possible to use a sugar derivative (for example trehalose, glucose, glucose, lactose, sucrose, maltulose, iso-maltulose, lactulose, fructose, But are not limited to, those selected from the group consisting of turanose, melitose, mannose, melezitose, dextran, maltodextrin, icodextrin, cyclodextrin, maltotol carbohydrate derivatives, such as maltotol, sorbitol, xylitol, inositol, palatinit, mannitol, stachyose and raffinose, May be used or mixed with the material.

Materials such as metals or lipophilic polymers that do not have hydrophilic properties themselves may be used. In this case, a surface treatment with a hydrophilic group or a plasma or the like or a compatibilizer may be used so that the projection sheet made of such a material can be combined with a drug tip made of an aqueous material.

The present invention is characterized in that both the drug tip 160 and the support protrusion 146 are formed of a biodegradable material and the drug tip 160 is formed of a material having a relatively lower rate of biodegradation than the support protrusion 146.

The projections 140 may be made of the same material as the support protrusions 140 and the support protrusions 146 may be made of different materials.

Since the protrusion sheet 140 itself does not penetrate into the skin, the material of the protrusion sheet 140 may be selected from materials that do not cause an allergic reaction due to skin contact.

Further, the projection sheet 140 may be formed in a multi-layered form. In other words, a layer made of the same material as that of the support protrusion 146 may be adhered to another layer of a material.

The present invention is characterized in that after the support protrusion 146 and the drug tip 160 have penetrated into the skin. The support protrusion 146 is first biodegraded and cut so that separating the protrusion sheet 140 from the skin after the cutting of the support protrusion 146 brings about an effect that the drug tip 160 can remain intruded into the skin .

Among the drugs included in the drug tip 160, when there is a drug to be slowly supplied to the body, the rate of drug administration can be controlled by controlling the biodegradation rate of the drug tip 160.

Further, the time required for attaching the microneedle sphere to the skin is reduced, thereby increasing the user's convenience.

For example, when the hyaluronic acid polymer is used as the base material of the drug tip 160 and the support protrusions 146, the molecular weight of the hyaluronic acid polymer is controlled so that the biodegradation of the drug tip 160 and the support protrusions 146 You can set different speeds.

The molecular weight of the hyaluronic acid polymer contained in the support protrusion 146 can be less than 100,000 and the molecular weight of the hyaluronic acid polymer contained in the drug tip 160 can be made 100,000 or more.

In addition, it is preferable that the time required for disassembling and cutting the support protrusion 146 is within 5 to 15 minutes.

This allows the support protrusions 146 to be cut by attaching the microneedle structures 100 during this time so that the drug tip 160 can be detached from the skin after that time, The drug contained in the drug tip 160 can be continuously supplied to the skin while remaining in the skin.

Sectional area of the lower end of the support projection 146 is preferably in the range of 0.005 to 0.050 mm < 2 >. If the cross-sectional area of the lower end of the supporting protrusion is less than 0.005 mm 2, it is difficult to secure the necessary strength for perforating the skin. If the sectional area of the lower end of the supporting protrusion 146 exceeds 0.050 mm 2, In addition, when the cross-sectional area of the lower end of the support protrusion 146 is increased, it may take an excessive time for the support protrusion 146 to be disassembled and cut.

The drug tip 160 is integrally formed on the upper end of the support protrusion 146 of the protrusion sheet 140 and is made of a biodegradable material that is inserted and dissolved in the skin, It consists of a substance with a slow biodegradation rate. The biodegradable material may include a medicine or a bioactive agent. The drug tip 160 may be entirely composed of a medicament or a bioactive material, and the medicament tip 160 may contain a medicament or a physiologically active substance.

The type of medicament is not particularly limited. Medicines can be used for currently used drugs. Examples of the water-soluble medicines include antipyretic analgesics, steroidal antiinflammatory agents, vasodilators, arteriovenous medicines, hypotensive agents, local anesthetics, hormones, antihistamines, general anesthetics, sleep analgesics, antiepileptics, psychotropic agents, skeletal muscle relaxants, , Antiparkinsonian agents, diuretics, vasoconstrictors, respiratory stimulants, and the like.

Examples of the physiologically active substance include a whitening component, a wrinkle-preventing component, a blood circulation promoting component, a diet component, an antibacterial component, and vitamins. In particular, coenzyme Q10 (ubiquinone), vitamin C, vitamin E, selenium, green tea extract, grape seed extract, ferulic acid, Leaf extract (Polypodium leucotomos extract), sylimarin, pycnogenol, vitamin A, and beta carotene AHA are physiologically active substances that can be used alone or in combination of two or more.

Also, biologically active peptides and derivatives thereof, chitosan, collagen, gelatin, hyaluronic acid, nucleic acid, oligonucleotide, various antigen proteins, bacteria, and virus fragments can be used as physiologically active substances.

The drug tip 160 should have a strength that can be inserted by puncturing the skin, and preferably has a sharp tip to facilitate perforation of the skin. For example, the three-dimensional shape of the drug tip 160 may be formed in the shape of a cone, a triangular pyramid, a quadrangular pyramid, a hexagonal pyramid, or other polygonal pyramids.

In addition, the tip may have a horn shape as described above, and the lower side thereof may be formed into a columnar shape.

The height h and the interval w of the drug tip 160 are determined by the amount of the drug to be injected and are not particularly limited, but the height h is 10 to 3000 占 퐉, It is preferable to set it to a range of 1500 mu m.

The height of the drug tip is related to the dose of the drug that can be injected into a single drug tip. If the height of the drug tip is too low, the dose of the drug becomes too small and too much is required for administration of the required amount. In addition, if the height of the drug tip is too high, the drug tip may not be inserted only in the portion to be administered, and the drug tip may be positioned over several layers.

In addition, by controlling the rate of biodegradation of the drug tip, the rate of administration of the drug can be controlled.

If the distance between the drug tips is too narrow, penetration of the drug tip into the skin is not easy, and if the distance between the drug tips is too wide, the area of the microneedle structure must be excessively widened to form a desired number of drug tips.

The skin is formed from the surface of the stratum corneum, skin layer, dermal layer, subcutaneous fat layer, and muscle layer.

The epidermis is about 50-100 μm thick and consists of five stratum corneum, stratum granulosum, stratum spinosum and basal stratum basale.

Most of the epidermal cells are keratinocyte, and they are composed of Langerhans cells, which are responsible for the immune function, and melanocytes, which make skin pigment. In normal skin, the epidermal cells are replaced with completely new cells every 30 days, and the stratum corneum acts as a epidermal barrier to prevent water evaporation and microbial invasion.

The dermal layer has a thickness of about 2 to 3 mm and occupies most of the skin volume. The main components of the dermis are point polysaccharides such as collagen and elastic fibers, and hyaluronic acid filling between them.

The subdermal layer is a loose structure connected to the lower part of the dermis. It is involved in the regulation of body temperature, absorbs external shocks, and fixes the skin to other internal organs.

The present invention is characterized in that the height of the support protrusion 146 formed on the protrusion sheet 140 is adjusted so that the drug tip 160 formed on the upper end of the support protrusion 146 can be inserted into the desired skin tissue .

For example, when the drug tip 160 is to be inserted into the skin layer, the height of the support protrusion 146 may be set to a height of less than 50 占 퐉. When the drug tip 160 is desired to be inserted into the skin layer, The height of the support protrusion 146 may be set in the range of 0.010 to 3.0 mm corresponding to the height. The height of the drug tip 160 and the height of the support protrusion 146 should be set so that the drug tip 160 can be positioned completely inside the dermis layer when the drug tip 160 is to be inserted into the dermis layer.

This structure can insert the entire drug tip 160 into the dermal layer, so that the entire drug tip 160 can be injected into the dermal layer and is very useful for injecting a prescribed amount of drug. Since the drug tip 160 is completely inserted into the dermis layer, the entire weight of the drug tip 160 can be put into the dermis layer. In the conventional case, the micro needle has a structure in which the micro needle is dissolved in the skin layer without any supporting protrusion, so it is not certain how much amount is absorbed into the dermal layer. On the other hand, in the present invention, the drug tip 160 containing the drug to be delivered is integrally formed on the upper end of the support protrusion, so that the entire drug tip 160 can be inserted into a desired skin tissue (for example, dermal layer) And the effect of delivering an accurate quantitative drug can be obtained.

The adhesive sheet 120 adheres to the back surface (the opposite surface 142 of the contact surface on which the support protrusions are formed) of the protrusion sheet 140 and functions to reinforce the strength of the protrusion sheet 140.

The adhesive sheet 100 does not directly contact the skin and does not penetrate into the skin. Therefore, the material of the adhesive sheet 100 may be a synthetic resin, a metal sheet, or the like if the material satisfies the required strength.

The adhesive sheet 120 has an adhesive surface and is adhered to the back surface 142 of the protruding sheet 140 as an adhesive surface. The adhesive sheet 120 is not a functionally essential structure, but is intended to improve the efficiency of the manufacturing method. In more detail, in a method of manufacturing a micro-needle structure using a mold, the structure for separating the projection sheet 140 from the mold may be omitted.

FIG. 3 is a perspective view of a microneedle structure according to a second embodiment of the present invention, and FIG. 4 is a sectional view of a microneedle structure according to a second embodiment of the present invention.

The microneedle structure according to the second embodiment of the present invention has a difference in the shape of the support protrusions.

In the first embodiment shown in Figs. 1 and 2, the support protrusions 146 and the drug tip 160 are integrally formed in a continuous horn shape (may be conical or polygonal in the case shown in the drawing) In the second embodiment shown in FIG. 4, the support protrusions 146 are formed in a columnar shape and the drug tip 160 is formed in a horn shape.

When the support protrusions 146 are formed into a columnar shape, the time for which the support protrusions 146 are disassembled and cut off can be reduced.

In the second embodiment, the cross-sectional area of the lower end of the drug tip 160 is equal to the cross-sectional area of the support projection 146, so that the cross-sectional area of the lower end of the drug tip 160 is preferably in the range of 0.005 to 0.050 mm 2. If the cross-sectional area of the lower end of the drug tip is less than 0.005 mm 2, it is difficult to secure the necessary strength for perforating the skin. If the cross-sectional area of the lower end of the drug tip 160 exceeds 0.050 mm 2,

In the case where the penetration depth into the skin is required more, the same shape as in the second embodiment is advantageous. When the drug tip 160 and the support protrusion 146 are inserted into the skin in the same manner as in the first embodiment, the cross-sectional area of the lower end of the support protrusion is limited, Resulting in too small a problem. However, when the support protrusion 146 is formed in a columnar shape as in the second embodiment, it is possible to secure a sufficient amount of the drug tip, which is useful.

5 is a cross-sectional view of another embodiment of a microneedle structure according to an embodiment of the present invention.

4, the support protrusions 146 are integrally formed on the protrusion sheet 140, and the protrusion sheet 140 and the support protrusions 146 are made of the same material. However, as shown in Fig. 5, , The projection sheet and the support protrusion may be made of different materials.

5A, the protrusion sheet 140 and the support protrusion 146 may be made of different materials. In this case, the protrusion sheet 140 is not inserted into the skin in the case of the protrusion sheet 140, , It is not necessary to be made of a biodegradable material, and it is sufficient that it is made of a material that does not cause allergy due to skin contact.

On the other hand, in the case of the support protrusions 146, it is preferable that the support protrusions 146 are made of a hyaluronic acid polymer having a molecular weight of less than 100,000.

the support protrusion includes a lower support protrusion 146a having the same material as the protrusion sheet 140 and an upper support protrusion 146b connecting between the lower support protrusion 146a and the drug tip 160 .

In this case, the lower support protrusions 146a and the projection sheet 140 are made of the same material. At this time, the lower support protrusions 146a and the projection sheet 140 are preferably made of a biodegradable material. However, in the case of the lower support protrusions 146a and the protrusion sheet 140, a material independent of the molecular weight and the decomposition rate may be used. It is possible.

Hereinafter, a method of preparing a microneedle structure capable of controlling the dose and the administration depth of the drug as described above will be described.

6 is a process diagram showing a method of manufacturing a microneedle structure according to a first embodiment of the present invention.

A method of manufacturing a microneedle structure according to the present invention includes: providing a mold having a mold having a negative angle corresponding to an outer shape of a microneedle structure to be manufactured, forming a liquid drug solution for forming a drug tip, And injecting a liquid sheet solution for curing, and then separating the solution from the mold using an adhesive sheet.

At this time, it is preferable that both the drug solution and the sheet solution are made of a biodegradable material.

In addition, it is preferable that the biodegradation rate of the sheet solution is relatively higher than the biodegradation rate of the drug solution.

The drug solution and the sheet solution may all comprise a biodegradable material, hyaluronic acid polymer.

At this time, by making the molecular weight of the hyaluronic acid polymer of the drug solution larger than the molecular weight of the hyaluronic acid polymer of the sheet solution, the drug solution can have a relatively slower biodegradation rate than the sheet solution.

For example, the molecular weight of the hyaluronic acid polymer contained in the drug solution may be 100,000 or more, and the molecular weight of the hyaluronic acid polymer contained in the sheet solution may be less than 100,000.

A method of manufacturing a microneedle structure according to an exemplary embodiment of the present invention includes the steps of: providing a mold having an engraved shape corresponding to an outer shape of the microneedle structure; a biodegradable material solution forming a drug tip in a mold of the mold; Sequentially injecting and curing the projection sheet solution, attaching an adhesive sheet to the back surface of the projection sheet, and separating the micro-needle structure from the mold.

As shown in the drawing, first, a mold 50 having a mold having a negative angle corresponding to the outer shape of the microneedle structure is provided,

After a predetermined amount of the drug solution 10 is applied to the template and cured to form a drug tip,

After the sheet solution 20 is applied to the mold having the drug tip formed therein and cured to form the projection sheet 140,

By adhering the adhesive sheet 100 to the back surface of the projection sheet 140 and separating the microneedle structure produced from the mold 50. [

A plurality of protruding sheets 140 may be formed in an array in the mold 50 and an adhesive sheet 100 having a size capable of covering the plurality of protruding sheets 140 may be attached to the mold 50, (140) can be separated from the mold.

The hardening of the drug tip 160 and the projection sheet 140 may be performed by natural drying at room temperature or by heating and drying using a heating means.

7 is a process diagram showing a method of manufacturing a microneedle structure according to a second embodiment of the present invention.

A method of manufacturing a microneedle structure according to a second embodiment of the present invention is a method for manufacturing a shape in which support protrusions are formed in a columnar shape.

A method of manufacturing a microneedle structure according to a second embodiment of the present invention includes the steps of: forming a first mold having an engraved mold corresponding to the shape of the drug tip, and a second mold having a through hole corresponding to the shape of the support protrusion A step of providing a second mold, applying and curing a drug solution forming a drug tip to a mold of the first mold, aligning and attaching the second mold to the first mold, Applying and curing the solution, attaching an adhesive sheet to the back surface of the projection sheet, and separating the micro-needle structure from the mold.

For the manufacturing method according to the second embodiment, the first mold 52 having the engraved mold corresponding to the shape of the drug tip and the second mold 52 having the through hole 62 corresponding to the shape of the support protrusion 60 are provided.

After the drug solution 10 is applied to the first mold 52 and cured to form the drug tip 160, the second mold 60 is aligned and laminated on the first mold 52, The adhesive sheet 140 is bonded to the back surface of the projection sheet 140 after the sheet solution 20 is applied to the mold of the two molds 60 and cured to form the projection sheet 140, Can be prepared by separating the needle structure.

8 is a process diagram illustrating a method of manufacturing a microneedle structure according to a third embodiment of the present invention.

The method of manufacturing a micro-needle structure according to a third embodiment of the present invention is a method for manufacturing a shape in which support protrusions are formed in a columnar shape and includes a mold 54 having an engraved mold corresponding to the shape of the drug tip and the support protrusions And a squeeze mold 70 having a squeeze protrusion 72 corresponding to the shape of the support protrusion are used to manufacture the microneedle structure.

A method of manufacturing a microneedle structure according to a third embodiment of the present invention includes a mold having a mold with a negative angle corresponding to the shape of the drug tip and the support protrusion and a squeeze protrusion corresponding to the shape of the support protrusion A step of applying a drug solution for forming a drug tip to the mold of the mold and pressing the drug solution by the squeeze mold to adjust the application amount of the drug solution, removing the squeeze mold, Injecting and curing the projection sheet solution into a mold, attaching an adhesive sheet to the back surface of the projection sheet, and separating the micro-needle structure from the mold.

The drug solution 10 is first applied to the mold 54 having the engraved mold corresponding to the shape of the drug tip 160 and the support protrusion 146 and then the squeeze mold 70 is placed on the mold 54 After the alignment, the squeeze protrusion is inserted into the mold so that a predetermined amount of the drug solution is completely injected into the mold.

Next, after the sheet solution 20 is applied and cured to form the projection sheet 140, the adhesive sheet 120 is bonded to the back surface of the projection sheet 140, and the micro-needle structure produced from the mold is separated Can be manufactured.

The drug solution can be completely injected into the mold by using the squeeze mold, and the amount of the drug solution can be precisely controlled.

9 is a photograph of a micro-needle structure according to the present invention.

As shown in the figure, the photoreceptor micro-needle structure has a supporting protrusion having a quadrangular pyramid shape, and the drug tip has a quadrangular pyramid shape.

The drug tip is made in red to clarify the distinction between drug tip and support. As can be seen from the photograph, it can be seen that the drug tip is integrally formed on the upper end of the supporting projection of the quadrangular pyramid shape.

FIG. 10 is a perspective view of a microneedle structure according to a fourth embodiment of the present invention, and FIG. 10 is a sectional view of a microneedle structure according to a fourth embodiment of the present invention.

As shown, the micro-needle structure 100 according to the fourth embodiment of the present invention includes a projection sheet 140 and a drug tip 160.

The protrusion sheet 140 serves to support the microneedle structure 100 and to penetrate the drug tip 160 to a desired depth in the skin.

The projection sheet 140 has a support projection 146 protruding from a contact surface 144 that contacts the skin. The support protrusion 146 forms a lower region of the microneedle, and the drug tip 160 is integrally formed on the upper end of the support protrusion 146.

The support protrusion 146 formed on the protrusion sheet 140 penetrates into the skin together with the drug tip 160 and the support protrusion 146 is made of a biodegradable material so that it can be disassembled and cut in the skin.

The projection sheet 140 may be made of a material having a water-soluble or hydrophilic surface in consideration of the bonding force with the drug tip 160. Such a material makes it easier to manufacture the drug tip 160 as a biodegradable one.

Examples of materials having hydrophilic properties include materials such as carboxymethyl sodium cellulose (SCMC), sodium hyaluronate (HA), polyvinylpyrolidone (PVP), polyethylene glycol (PEG), polyvinyl alcohol polyvinyl alcohol (PVA), polylactic acid PLA, polyethylene oxide (PEO), polyacrylic acid, polystyrene sulfonatecellulose (HPC), hydroxyethyl cellulose (HEC) Hydroxypropyl methyl cellulose (HPMC), dextrin, dextran, monosaccharides and disaccharides, polyalcohol, gelatin, gum arabic, alginate, chitosan Chitosan cylcodextrin, carbohydrates, and other water-soluble natural and synthetic polymers or hydrophilic modified poly And combinations of these materials.

It is also possible to use a sugar derivative (for example trehalose, glucose, glucose, lactose, sucrose, maltulose, iso-maltulose, lactulose, fructose, But are not limited to, those selected from the group consisting of turanose, melitose, mannose, melezitose, dextran, maltodextrin, icodextrin, cyclodextrin, maltotol carbohydrate derivatives, such as maltotol, sorbitol, xylitol, inositol, palatinit, mannitol, stachyose and raffinose, May be used or mixed with the material.

Materials such as metals or lipophilic polymers that do not have hydrophilic properties themselves may be used. In this case, a surface treatment with a hydrophilic group or a plasma or the like or a compatibilizer may be used so that the projection sheet made of such a material can be combined with a drug tip made of an aqueous material.

The support protrusion 146 has a neck portion 147 having a relatively small cross-sectional area.

The support protrusions 146 may be formed in a columnar shape and the neck portion 147 may be formed in a shape having a concave groove 148 on the outer circumferential surface of the support protrusion 146.

The neck portion 147 has a relatively narrow cross-sectional area than other portions of the support protrusion 146 so that the neck portion can be cut before the other portion when the support protrusion 146 is biodegraded in the skin.

The drug tip 160 may remain in the skin when the neck 147 is cut when the support protrusion 146 separates the micro-needle structure 100 from the skin after the drug tip 160 has penetrated the skin .

By adjusting the cross-sectional area of the neck portion 147, the neck portion can be broken even after the support protrusion 146 and the drug tip 160 are inserted into the skin, and the neck portion can be broken. May be broken.

This structure eliminates the need for attaching the microneedle structure 100 until the time when the drug tip 160 is biodegraded. Therefore, it is possible to shorten the time required to attach the microneedle structure 100, Even if the structure 100 is detached, the drug tip 160 can supply the drug in the skin.

The drug tip 160 may be formed of a biodegradable material and the drug tip 160 may be formed of a material having a slower biodegradation rate than that of the support protrusion 146. [

This structure can further shorten the time required for cutting the neck of the support protrusion 146 and can control the rate of administration of the drug supplied through the drug tip 160 using the biodegradation speed of the drug tip 160 Bring it.

Among the drugs included in the drug tip 160, when there is a drug to be slowly supplied to the body, the rate of drug administration can be controlled by controlling the biodegradation rate of the drug tip 160.

Further, the time required for attaching the microneedle sphere to the skin is reduced, thereby increasing the user's convenience.

For example, when the hyaluronic acid polymer is used as the base material of the drug tip 160 and the support protrusions 146, the molecular weight of the hyaluronic acid polymer is controlled so that the biodegradation of the drug tip 160 and the support protrusions 146 You can set different speeds.

The molecular weight of the hyaluronic acid polymer contained in the support protrusion 146 can be less than 100,000 and the molecular weight of the hyaluronic acid polymer contained in the drug tip 160 can be made 100,000 or more.

In addition, it is preferable that the time required for disassembling and cutting the support protrusion 146 is within 5 to 15 minutes.

This allows the support protrusions 146 to be cut by attaching the microneedle structures 100 during this time so that the drug tip 160 can be detached from the skin after that time, The drug contained in the drug tip 160 can be continuously supplied to the skin while remaining in the skin.

Sectional area of the lower end of the support projection 146 is preferably in the range of 0.005 to 0.050 mm < 2 >. If the cross-sectional area of the lower end of the supporting protrusion is less than 0.005 mm 2, it is difficult to secure the necessary strength for perforating the skin. If the sectional area of the lower end of the supporting protrusion 146 exceeds 0.050 mm 2, In addition, when the cross-sectional area of the lower end of the support protrusion 146 is increased, it may take an excessive time for the support protrusion 146 to be disassembled and cut.

The drug tip 160 is integrally formed on the upper end of the support protrusion 146 of the protrusion sheet 140 and is made of a biodegradable material that is inserted and dissolved in the skin, It consists of a substance with a slow biodegradation rate. The biodegradable material may include a medicine or a bioactive agent. The drug tip 160 may be entirely composed of a medicament or a bioactive material, and the medicament tip 160 may contain a medicament or a physiologically active substance.

The type of medicament is not particularly limited. Medicines can be used for currently used drugs. Examples of the water-soluble medicines include antipyretic analgesics, steroidal antiinflammatory agents, vasodilators, arteriovenous medicines, hypotensive agents, local anesthetics, hormones, antihistamines, general anesthetics, sleep analgesics, antiepileptics, psychotropic agents, skeletal muscle relaxants, , Antiparkinsonian agents, diuretics, vasoconstrictors, respiratory stimulants, and the like.

Examples of the physiologically active substance include a whitening component, a wrinkle-preventing component, a blood circulation promoting component, a diet component, an antibacterial component, and vitamins. In particular, coenzyme Q10 (ubiquinone), vitamin C, vitamin E, selenium, green tea extract, grape seed extract, ferulic acid, Leaf extract (Polypodium leucotomos extract), sylimarin, pycnogenol, vitamin A, and beta carotene AHA are physiologically active substances that can be used alone or in combination of two or more.

Also, biologically active peptides and derivatives thereof, chitosan, collagen, gelatin, hyaluronic acid, nucleic acid, oligonucleotide, various antigen proteins, bacteria, and virus fragments can be used as physiologically active substances.

The drug tip 160 should have a strength that can be inserted by puncturing the skin, and preferably has a sharp tip to facilitate perforation of the skin. For example, the three-dimensional shape of the drug tip 160 may be formed in the shape of a cone, a triangular pyramid, a quadrangular pyramid, a hexagonal pyramid, or other polygonal pyramids.

In addition, the tip may have a horn shape as described above, and the lower side thereof may be formed into a columnar shape.

The height h and the interval w of the drug tip 160 are determined by the amount of the drug to be injected and are not particularly limited, but the height h is 10 to 3000 占 퐉, It is preferable to set it to a range of 1500 mu m.

The height of the drug tip is related to the dose of the drug that can be injected into a single drug tip. If the height of the drug tip is too low, the dose of the drug becomes too small and too much is required for administration of the required amount. In addition, if the height of the drug tip is too high, there is a possibility that the drug tip may not be inserted only in the part to be squeezed, and the drug tip may be positioned over several layers.

In addition, by controlling the rate of biodegradation of the drug tip, the rate of administration of the drug can be controlled.

If the distance between the drug tips is too narrow, penetration of the drug tip into the skin is not easy, and if the distance between the drug tips is too wide, the area of the microneedle structure must be excessively widened to form a desired number of drug tips.

The skin is formed from the surface of the stratum corneum, skin layer, dermal layer, subcutaneous fat layer, and muscle layer.

The epidermis is about 50-100 μm thick and consists of five stratum corneum, stratum granulosum, stratum spinosum and basal stratum basale.

Most of the epidermal cells are keratinocyte, and they are composed of Langerhans cells, which are responsible for the immune function, and melanocytes, which make skin pigment. In normal skin, the epidermal cells are replaced with completely new cells every 30 days, and the stratum corneum acts as a epidermal barrier to prevent water evaporation and microbial invasion.

The dermal layer has a thickness of about 2 to 3 mm and occupies most of the skin volume. The main components of the dermis are point polysaccharides such as collagen and elastic fibers, and hyaluronic acid filling between them.

The subdermal layer is a loose structure connected to the lower part of the dermis. It is involved in the regulation of body temperature, absorbs external shocks, and fixes the skin to other internal organs.

The present invention is characterized in that the height of the support protrusion 146 formed on the protrusion sheet 140 is adjusted so that the drug tip 160 formed on the upper end of the support protrusion 146 can be inserted into the desired skin tissue .

For example, when the drug tip 160 is to be inserted into the skin layer, the height of the support protrusion 146 may be set to a height of less than 50 占 퐉. When the drug tip 160 is desired to be inserted into the skin layer, The height of the support protrusion 146 may be set in the range of 0.010 to 3.0 mm corresponding to the height. The height of the drug tip 160 and the height of the support protrusion 146 should be set so that the drug tip 160 can be positioned completely inside the dermis layer when the drug tip 160 is to be inserted into the dermis layer.

This structure can insert the entire drug tip 160 into the dermal layer, so that the entire drug tip 160 can be injected into the dermal layer and is very useful for injecting a prescribed amount of drug. Since the drug tip 160 is completely inserted into the dermis layer, the entire weight of the drug tip 160 can be put into the dermis layer. In the conventional case, the micro needle has a structure in which the micro needle is dissolved in the skin layer without any supporting protrusion, so it is not certain how much amount is absorbed into the dermal layer. On the other hand, in the present invention, the drug tip 160 containing the drug to be delivered is integrally formed on the upper end of the support protrusion, so that the entire drug tip 160 can be inserted into a desired skin tissue (for example, dermal layer) And the effect of delivering an accurate quantitative drug can be obtained.

The adhesive sheet 120 adheres to the back surface (the opposite surface 142 of the contact surface on which the support protrusions are formed) of the protrusion sheet 140 and functions to reinforce the strength of the protrusion sheet 140.

The adhesive sheet 100 does not directly contact the skin and does not penetrate into the skin. Therefore, the material of the adhesive sheet 100 may be a synthetic resin, a metal sheet, or the like if the material satisfies the required strength.

The adhesive sheet 120 has an adhesive surface and is adhered to the back surface 142 of the protruding sheet 140 as an adhesive surface. The adhesive sheet 120 is not a functionally essential structure, but is intended to improve the efficiency of the manufacturing method. In more detail, in a method of manufacturing a micro-needle structure using a mold, the structure for separating the projection sheet 140 from the mold may be omitted.

Hereinafter, a method for manufacturing a micro-needle structure capable of controlling the rate of drug injection, which can be administered in a quantitative manner as described above, will be described.

12 is a process diagram showing a method of manufacturing a microneedle structure according to a fourth embodiment of the present invention.

A method of manufacturing a microneedle structure according to the present invention includes: providing a mold having a mold having a negative angle corresponding to an outer shape of a microneedle structure to be manufactured, forming a liquid drug solution for forming a drug tip, And injecting a liquid sheet solution for curing, and then separating the solution from the mold using an adhesive sheet.

At this time, the mold 50 is preferably made of an elastic material such as silicone.

A protrusion 51 is provided at a portion of the mold 50 corresponding to the neck of the support protrusion and a constriction hole 51a is formed at the inner side of the protrusion 51. The protruding portion 51 is maintained in a protruded state until the sheet solution is injected and cured, and in the step of separating the cured micro-needle structure from the mold, a negative pressure is applied to the constricted hole 51a, The micro-needle structure 100 can be detached from the mold without causing damage to the neck of the support protrusion.

Of course, since the mold itself has elasticity, depending on the size of the projecting portion 51, the projecting portion 51 is deformed by the elastic force of the material itself and the neck portion of the support projection is not damaged, May be separated.

It is preferable that both the drug solution and the sheet solution are made of a biodegradable material.

In addition, it is preferable that the biodegradation rate of the sheet solution is relatively higher than the biodegradation rate of the drug solution.

The drug solution and the sheet solution may all comprise a biodegradable material, hyaluronic acid polymer.

At this time, by making the molecular weight of the hyaluronic acid polymer of the drug solution larger than the molecular weight of the hyaluronic acid polymer of the sheet solution, the drug solution can have a relatively slower biodegradation rate than the sheet solution.

For example, the molecular weight of the hyaluronic acid polymer contained in the drug solution may be 100,000 or more, and the molecular weight of the hyaluronic acid polymer contained in the sheet solution may be less than 100,000.

A method of manufacturing a microneedle structure according to an exemplary embodiment of the present invention includes the steps of: providing a mold having an engraved shape corresponding to an outer shape of the microneedle structure; a biodegradable material solution forming a drug tip in a mold of the mold; Sequentially injecting and curing the projection sheet solution, attaching an adhesive sheet to the back surface of the projection sheet, and separating the micro-needle structure from the mold.

As shown in the drawing, first, a mold 50 having a mold having a negative angle corresponding to the outer shape of the microneedle structure is provided,

After a predetermined amount of the drug solution 10 is applied to the template and cured to form a drug tip,

After the sheet solution 20 is applied to the mold having the drug tip formed therein and cured to form the projection sheet 140,

By adhering the adhesive sheet 100 to the back surface of the projection sheet 140 and separating the microneedle structure produced from the mold 50. [ At this time, negative pressure is applied to the constricted hole 51a of the protruding portion 51 to contract the protruding portion 51, so that the neck of the microneedle structure can be separated from the mold without being damaged.

A plurality of protruding sheets 140 may be formed in an array in the mold 50 and an adhesive sheet 100 having a size capable of covering the plurality of protruding sheets 140 may be attached to the mold 50, (140) can be separated from the mold.

The hardening of the drug tip 160 and the projection sheet 140 may be performed by natural drying at room temperature or by heating and drying using a heating means.

13 is a process diagram illustrating a method of manufacturing a microneedle structure according to a fifth embodiment of the present invention.

A method of manufacturing a microneedle structure according to a fifth embodiment of the present invention includes the steps of: forming a first mold having an engraved mold corresponding to the shape of the drug tip; and a second mold having a through hole corresponding to the shape of the support protrusion A step of providing a second mold, applying and curing a drug solution forming a drug tip to a mold of the first mold, aligning and attaching the second mold to the first mold, Applying and curing the solution, attaching an adhesive sheet to the back surface of the projection sheet, and separating the micro-needle structure from the mold.

For the manufacturing method according to the fifth embodiment, the first mold 52 having the engraved mold corresponding to the shape of the drug tip and the second mold 52 having the through hole 62 corresponding to the shape of the support protrusion 60 are provided.

After the drug solution 10 is applied to the first mold 52 and cured to form the drug tip 160, the second mold 60 is aligned and laminated on the first mold 52, The adhesive sheet 140 is bonded to the back surface of the projection sheet 140 after the sheet solution 20 is applied to the mold of the two molds 60 and cured to form the projection sheet 140, Can be prepared by separating the needle structure.

14 is a process diagram showing a method of manufacturing a microneedle structure according to a sixth embodiment of the present invention.

The method of manufacturing a micro-needle structure according to a third embodiment of the present invention is a method for manufacturing a shape in which support protrusions are formed in a columnar shape and includes a mold 54 having an engraved mold corresponding to the shape of the drug tip and the support protrusions And a squeeze mold 70 having a squeeze protrusion 72 corresponding to the shape of the support protrusion are used to manufacture the microneedle structure.

A method of manufacturing a microneedle structure according to a third embodiment of the present invention includes a mold having a mold with a negative angle corresponding to the shape of the drug tip and the support protrusion and a squeeze protrusion corresponding to the shape of the support protrusion A step of applying a drug solution for forming a drug tip to the mold of the mold and pressing the drug solution by the squeeze mold to adjust the application amount of the drug solution, removing the squeeze mold, Injecting and curing the projection sheet solution into a mold, attaching an adhesive sheet to the back surface of the projection sheet, and separating the micro-needle structure from the mold.

The drug solution 10 is first applied to the mold 54 having the engraved mold corresponding to the shape of the drug tip 160 and the support protrusion 146 and then the squeeze mold 70 is placed on the mold 54 After the alignment, the squeeze protrusion is inserted into the mold so that a predetermined amount of the drug solution is completely injected into the mold.

Next, after the sheet solution 20 is applied and cured to form the projection sheet 140, the adhesive sheet 120 is bonded to the back surface of the projection sheet 140, and the micro-needle structure produced from the mold is separated Can be manufactured.

The drug solution 10 can be completely injected into the mold 54 by using the squeeze mold 70 and the amount of the drug solution 10 can be precisely controlled.

It is to be understood that the above-described embodiments are to be considered in all respects as illustrative and not restrictive, and the scope of the present invention will be indicated by the appended claims rather than by the foregoing detailed description. It is intended that all changes and modifications that come within the meaning and range of equivalency of the claims, as well as any equivalents thereof, be within the scope of the present invention.

10: drug solution
20: Sheet solution
50: Mold
51, 55, 61:
51a, 55a, 61a: shrinkage ball
52: First mold
54: mold
60: second mold
70: Squeeze mold
120: Pressure sensitive adhesive sheet
140: projection sheet
142:
144: contact surface
146: support projection
146a: Lower support projection
146b: upper support projection
147: neck
148: concave groove
160: Drug Tips

Claims (23)

delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete A protruding sheet formed of a biodegradable material protruding from a contact surface in contact with the skin and being melted and penetrated into the skin and having a neck portion having a relatively narrow cross section; and a protrusion sheet attached to the support protrusion, A method for manufacturing a microneedle structure comprising a drug tip comprising a biodegradable material,

A mold providing step of a mold having an embossed shape identical to an outer shape of the microneedle structure and made of an elastic material;
Forming a drug tip in a mold of the mold and injecting a drug solution as a biodegradable material solution and curing the drug solution to form a drug tip;
Injecting a protrusion sheet solution, which is a biodegradable material solution having a relatively high biodegradation rate, into the template of the mold on which the drug tip is formed, and curing the protrusion sheet to form a protrusion sheet; And
And separating the microneedle structure from the mold,
Wherein the mold has a protrusion at a portion corresponding to a neck of the support protrusion, and a shrinkage hole is provided in the protrusion.
A protruding sheet formed of a biodegradable material protruding from a contact surface in contact with the skin and being melted and penetrated into the skin and having a neck portion having a relatively narrow cross section; and a protrusion sheet attached to the support protrusion, A method for manufacturing a microneedle structure comprising a drug tip comprising a biodegradable material,

Providing a first mold having an engraved mold corresponding to the shape of the drug tip and a second mold having an elastic material and having a through hole corresponding to the shape of the support protrusion;
Applying and curing a drug solution as a biodegradable material solution forming a drug tip on a mold of the first mold;
Aligning and attaching a second mold to the first mold, applying and curing a projection sheet solution, which is a biodegradable material solution having a relatively fast biodegradation rate, on the second mold, And
And separating the microneedle structure from the first mold and the second mold,
Wherein the second mold has a protrusion at a portion corresponding to a neck of the support protrusion, and a shrinkage hole is provided in the protrusion.
A protruding sheet including a supporting protrusion formed of a biodegradable material protruding from a contact surface contacting with the skin and being inserted and dissolved in the skin and having a relatively narrow cross-sectional area; and a protrusion sheet attached to the supporting protrusion, A method for manufacturing a microneedle structure comprising a drug tip comprising a biodegradable material,

Providing a squeeze mold having a mold having an engraved shape corresponding to the shape of the drug tip and the support protrusion and having a resilient material and a squeeze protrusion corresponding to the shape of the support protrusion;
Applying a drug solution, which is a biodegradable material solution forming a drug tip to a mold of the mold, and pressing the drug solution with the squeeze mold to adjust the application amount of the drug solution;
Removing the squeeze mold, injecting a protrusion sheet solution, which is a biodegradable material solution having a relatively high biodegradation rate, into the mold of the mold, and curing the mold; And
And separating the microneedle structure from the mold,
Wherein the mold has a protrusion at a portion corresponding to a neck of the support protrusion, and a shrinkage hole is provided in the protrusion.
delete 19. The method according to any one of claims 16 to 18,
The step of separating the microneedle structure
Wherein negative pressure is applied to the shrinkage cavity so that the projection is contracted.
19. The method according to any one of claims 16 to 18,
Wherein the drug solution and the projection sheet solution comprise a hyaluronic acid polymer.
22. The method of claim 21,
The hyaluronic acid polymer contained in the projection sheet solution has a molecular weight of less than 100,000,
Wherein the hyaluronic acid polymer contained in the drug solution has a molecular weight of 100,000 or more.
19. The method according to any one of claims 16 to 18,
Prior to the step of separating the microneedle structure,
And attaching an adhesive sheet to the back surface of the protruding sheet.
KR1020160067712A 2016-05-31 2016-05-31 Micro needle device and it's manufacturing method which can control drug quantity and dosing speed KR101832716B1 (en)

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WO2020232394A1 (en) 2019-05-16 2020-11-19 University Of Pittsburgh - Of The Commonwealth System Of Higher Education Microneedle arrays with undercut features for cutaneous and non-cutaneous drug delivery
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