KR102627434B1 - Suction microneedle - Google Patents
Suction microneedle Download PDFInfo
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- KR102627434B1 KR102627434B1 KR1020160100605A KR20160100605A KR102627434B1 KR 102627434 B1 KR102627434 B1 KR 102627434B1 KR 1020160100605 A KR1020160100605 A KR 1020160100605A KR 20160100605 A KR20160100605 A KR 20160100605A KR 102627434 B1 KR102627434 B1 KR 102627434B1
- Authority
- KR
- South Korea
- Prior art keywords
- microneedle
- microneedle patch
- skin
- paragraph
- support plate
- Prior art date
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Classifications
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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
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- 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
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- 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
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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
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/08—Cupping glasses, i.e. for enhancing blood circulation
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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
- 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
- A61M2037/0007—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin having means for enhancing the permeation of substances through the epidermis, e.g. using suction or depression, electric or magnetic fields, sound waves or chemical agents
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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
- A61M2202/00—Special media to be introduced, removed or treated
- A61M2202/0057—Special media to be introduced, removed or treated retained by adsorption
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- General Health & Medical Sciences (AREA)
- Dermatology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Heart & Thoracic Surgery (AREA)
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- Anesthesiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Medical Informatics (AREA)
- Vascular Medicine (AREA)
- Media Introduction/Drainage Providing Device (AREA)
Abstract
본 발명은 흡착기에 관한 것으로서, 더욱 상세하게는 마이크로니들 패치에 포함된 마이크로니들의 피부 침투율 편차를 감소시키기 위한 흡착기에 관한 것이다. 본 발명에 따른 흡착기를 이용하는 경우 간단한 조작 만으로도 마이크로니들 패치에 포함된 마이크로니들의 피부 침투율 편차가 감소되는 효과가 있어 마이크로니들 패치의 효율을 향상시킬 수 있다.The present invention relates to an absorber, and more specifically, to an absorber for reducing the variation in skin penetration rate of microneedles included in a microneedle patch. When using the absorber according to the present invention, the skin penetration rate deviation of the microneedle included in the microneedle patch is reduced with a simple operation, thereby improving the efficiency of the microneedle patch.
Description
본 발명은 흡착기에 관한 것으로서, 더욱 상세하게는 마이크로니들 패치에 포함된 마이크로니들의 피부 침투율 편차를 감소시키기 위한 흡착기에 관한 것이다.The present invention relates to an absorber, and more specifically, to an absorber for reducing the variation in skin penetration rate of microneedles included in a microneedle patch.
일반적으로 마이크로니들(microneedle)은 생체 내 화장학적 활성물질, 약물, 백신 등의 전달, 체내 분석물질의 검출 및 생검(biopsy) 등에 사용된다. 마이크로니들을 이용한 약학적 또는 화장학적 활성물질의 전달은 혈관 또는 림프관과 같은 생체 순환계가 아닌 피부를 통한 활성물질의 전달을 목적으로 한다.In general, microneedles are used for delivery of cosmetic active substances, drugs, vaccines, etc. in vivo, detection of analytes in the body, and biopsy. Delivery of pharmaceutical or cosmetic active substances using microneedles is aimed at delivering the active substances through the skin rather than through the biological circulatory system such as blood vessels or lymphatic vessels.
이러한 마이크로니들을 이용하는 방법으로는 마이크로니들이 부착된 롤러(roller) 등의 마이크로니들 장치(device)를 적용하거나 마이크로니들이 부착된 마이크로니들 패치를 적용하는 형태 등이 일반적으로 이용되고 있다.Methods for using these microneedles include applying a microneedle device such as a roller with attached microneedles or applying a microneedle patch with attached microneedles.
마이크로니들 패치를 적용함에 있어서, 일반적으로 마이크로니들이 부착된 면을 피부에 올려놓고 손으로 눌러서 그 압력으로 마이크로니들이 피부를 투과할 수 있도록 한다. 그러나 사람마다 누르는 힘이 다르고, 피부의 탄성력 등과 관련된 변수 및 관절 부위 또는 모(hair)가 있는 피부에 사용되는 경우, 마이크로니들이 제대로 찔리지 않는 경우가 있고 마이크로니들이 끝까지 투과되지 않아 효율이 낮아지는 문제점이 발생하지만 각각의 사람에 맞추어 마이크로니들 패치를 제조할 수는 없기 때문에 해결이 어려운 실정이며, 마이크로니들 패치에 포함된 마이크로니들의 피부 침투율 편차를 감소시키기 위한 기술에 대해서는 연구가 활발히 이루어지고 있지 않다.When applying a microneedle patch, the side to which the microneedle is attached is generally placed on the skin and pressed with the hand to allow the microneedle to penetrate the skin with the pressure. However, the pressing force is different for each person, and when used on variables related to skin elasticity, joint areas, or skin with hair, the microneedle may not pierce properly and the microneedle does not penetrate all the way, which reduces efficiency. Although it occurs, it is difficult to solve because it is not possible to manufacture microneedle patches tailored to each person, and research is not actively being conducted on technology to reduce the variation in skin penetration rate of the microneedles included in the microneedle patch.
본 발명이 해결하고자 하는 과제는 마이크로니들 패치를 적용함에 있어서, 마이크로니들 패치에 포함된 마이크로니들의 피부 침투율 편차를 감소시키기 위한 흡착기를 제공하는 것이다.The problem to be solved by the present invention is to provide an absorber for reducing the variation in skin penetration rate of microneedle included in the microneedle patch when applying the microneedle patch.
본 발명은 상기 과제를 해결하기 위하여, 부압을 형성함으로써 마이크로니들 패치를 피부에 부착하는 것을 특징으로 하는, 마이크로니들 패치에 포함된 마이크로니들의 피부 침투율 편차를 감소시키기 위한 흡착기를 제공한다.In order to solve the above problems, the present invention provides an absorber for reducing the variation in skin penetration rate of microneedle included in the microneedle patch, which is characterized in that the microneedle patch is attached to the skin by forming negative pressure.
본 발명자들은 마이크로니들 패치에 부착된 마이크로니들의 피부 침투율 편차를 감소시켜, 피부 투과율을 향상시킬 뿐만 아니라 피부 내에 흡수시키고자 하는 활성물질의 피부 투과율을 향상시킬 수 있는 흡착기를 연구하였으며, 간단한 조작만으로도 현저한 효과를 나타내는 본 발명을 완성하였다.The present inventors studied an absorber that not only improves the skin permeability by reducing the deviation of the skin penetration rate of the microneedle attached to the microneedle patch, but also improves the skin penetration rate of the active substance to be absorbed into the skin, and simply operates it. The present invention, which exhibits remarkable effects, has been completed.
본 발명의 일 실시예에서, 상기 흡착기는, 내부 공간을 가지는 본체; 상기 본체의 하부에 형성되며, 테두리가 피부와 접촉될 수 있는 흡착구; 상기 본체의 상부에 형성되며, 상기 내부 공간에 부압을 형성할 수 있는 공기 배출수단을 포함하는 공기 배출부; 및 상기 본체의 내부에 위치하며, 마이크로니들 패치가 부압에 의한 이동 없이 지지될 수 있는 마이크로니들 패치 지지판을 포함하고, 상기 내부 공간은 상기 흡착구의 테두리가 피부와 접촉하게 될 때 피부와 접촉되지 않는 공간으로서 상기 흡착구의 내부에 존재하며, 상기 마이크로니들 패치 지지판은 공기 배출 구멍을 포함할 수 있다.In one embodiment of the present invention, the adsorber includes a main body having an internal space; a suction port formed at the bottom of the main body, the edge of which can be in contact with the skin; an air discharge unit formed on the upper part of the main body and including an air discharge means capable of creating negative pressure in the internal space; and a microneedle patch support plate located inside the main body and capable of supporting the microneedle patch without movement due to negative pressure, wherein the internal space is not in contact with the skin when the edge of the suction port comes into contact with the skin. It exists inside the suction port as a space, and the microneedle patch support plate may include an air discharge hole.
상기 본체의 형태는 특정한 형태에 한정되는 것은 아니며, 하부에 형성된 흡착구를 포함하여 테두리가 피부와 접촉할 수 있다면 어떠한 형태든 가능하다. 상기 본체는 이에 한정되는 것은 아니지만, 예를 들어 텅 빈 반구 형태일 수 있다.The shape of the main body is not limited to a specific shape, and any shape is possible as long as the edge, including the suction port formed at the bottom, can contact the skin. The main body is not limited thereto, but may have the shape of an empty hemisphere, for example.
상기 마이크로니들 패치 지지판은 상기 내부 공간의 하단부에 고정될 수 있다. 이는 공기 배출수단을 작동하여 흡착기를 사용하는 경우, 부압에 의하여 끌어올려지는 피부의 높이는 사람에 따라 차이가 있지만 그 한계가 있기 때문에 흡착기 내부 공간의 하단부에 고정된 형태일 수 있다.The microneedle patch support plate may be fixed to the lower end of the internal space. When using an adsorber by operating the air discharge means, the height of the skin pulled up by negative pressure varies depending on the person, but there is a limit, so it may be fixed to the lower part of the inner space of the adsorber.
상기 용어, "하단부"는 흡착구를 기준으로 하여 흡착기 전체 높이의 15 mm 미만을 의미한다. The term “lower part” means less than 15 mm of the total height of the adsorber based on the suction port.
바람직하게, 상기 마이크로니들 패치 지지판은 흡착구로부터 1 mm 내지 15 mm 높이에 위치할 수 있다. 더욱 바람직하게, 상기 마이크로니들 패치 지지판은 흡착구로부터 1 mm 내지 5 mm 높이에 위치할 수 있다.Preferably, the microneedle patch support plate may be positioned at a height of 1 mm to 15 mm from the suction port. More preferably, the microneedle patch support plate may be positioned at a height of 1 mm to 5 mm from the suction port.
한편, 상기 본체의 재질은 특정한 재질에 한정되는 것은 아니며 연질 또는 경질일 수 있고, 바람직하게는 연질일 수 있다. 예를 들어, 상기 본체의 재질은 고무, 플라스틱, 유리 등일 수 있다.Meanwhile, the material of the main body is not limited to a specific material and may be soft or hard, preferably soft. For example, the material of the main body may be rubber, plastic, glass, etc.
상기 공기 배출수단은 흡착기를 피부에 올려놓은 후 내부 공간에 존재하는 공기를 외부로 배출시켜주는 수단으로서, 어느 것에 한정되는 것은 아니지만 예를 들어, 펌프, 밸브 또는 튜브 등이 포함될 수 있으며, 즉 당 업계에서 통상의 기술자에게 알려진 공기 배출수단이 포함될 수 있다.The air discharge means is a means for discharging the air existing in the internal space to the outside after placing the absorber on the skin, and is not limited to any, but may include, for example, a pump, valve, or tube, that is, Any air exhaust means known to those skilled in the art may be included.
본 발명에 따른 흡착기의 일 실시예에서, 상기 흡착구는 원형이며, 직경은 1 내지 10cm 일 수 있다.In one embodiment of the adsorber according to the present invention, the adsorber is circular and may have a diameter of 1 to 10 cm.
본 발명자들은 마이크로니들 패치를 피부에 부착 후 그 위에 상기 흡착기를 사용하는 경우 종래 마이크로니들 패치를 사용함에 있어서 문제가 되었던 피부 침투율 편차가 높아 마이크로니들 및 원하는 활성물질의 낮은 피부 투과율 문제를 간단한 수단으로써 해결할 수 있다는 것을 발견하였다.The present inventors have developed a simple method to solve the problem of low skin penetration rate of microneedles and desired active substances due to the high deviation in skin penetration rate, which was a problem when using conventional microneedle patches, when attaching a microneedle patch to the skin and using the absorber on it. I found that it could be solved.
본 발명의 또 다른 일 실시예에서, 본 발명에 따른 흡착기에 포함된 상기 마이크로니들 패치 지지판에 마이크로니들 패치가 부착될 수 있다.In another embodiment of the present invention, a microneedle patch may be attached to the microneedle patch support plate included in the adsorber according to the present invention.
상기 마이크로니들 패치 지지판에 부착된 마이크로니들 패치는 마이크로니들 패치 지지판에 마이크로니들이 부착되어있지 않은 면이 부착되어 있는 형태이며, 흡착기에 포함된 공기 배출수단을 이용하여 피부에 흡착되면서 피부가 흡착기 내로 빨려 올라오게 되어 마이크로니들 패치 지지판에 피부가 밀착되어 마이크로니들이 피부를 투과하게 된다.The microneedle patch attached to the microneedle patch support plate is in a form where the side to which the microneedle is not attached is attached to the microneedle patch support plate, and is absorbed into the skin using the air discharge means included in the absorber, causing the skin to be sucked into the absorber. As it rises, the skin adheres to the microneedle patch support plate and the microneedle penetrates the skin.
또한, 본 발명에서 사용할 수 있는 마이크로니들은 이에 한정되는 것은 아니지만, 바람직하게는 용해성 마이크로니들일 수 있다. 본 발명자들은 용해성 마이크로니들이 부착된 마이크로니들 패치를 이용하여 상기 흡입기를 사용하는 경우 피부 내에 적용하고자 하는 활성물질의 피부 투과율이 현저히 향상되는 것을 확인하였다. 종래의 용해성 마이크로니들은 불용해성 마이크로니들에 비하여 강도가 약하여 용해성 마이크로니들 패치를 부적절하게 부착하면 용해성 마이크로니들이 부러지거나 끝까지 투과되지 않아 피부 투과율이 낮다는 문제점이 있었으나, 본 발명에 따른 마이크로니들 패치 키트를 이용하면 용해성 마이크로니들이 피부에 끝까지 밀착되어 이를 해결할 수 있다.Additionally, the microneedles that can be used in the present invention are not limited to this, but are preferably soluble microneedles. The present inventors confirmed that when using the inhaler using a microneedle patch with soluble microneedles attached, the skin penetration rate of the active substance to be applied to the skin is significantly improved. Conventional soluble microneedles have weaker strength than insoluble microneedles, so if the soluble microneedle patch is improperly attached, the soluble microneedles break or do not penetrate all the way, resulting in low skin penetration rate. However, the microneedle patch kit according to the present invention has a problem. This problem can be solved by using soluble microneedles that adhere to the skin all the way.
즉, 본 발명에 따른 마이크로니들 패치 키트는 마이크로니들의 피부 투과율을 향상시키며, 활성성분의 피부 투과율을 향상시킬 수 있다.In other words, the microneedle patch kit according to the present invention can improve the skin permeability of the microneedle and the skin permeability of the active ingredient.
따라서, 본 발명의 바람직한 일 실시예에서, 상기 마이크로니들을 형성하는 물질은 피부 내에서 용해되어 마이크로니들의 피부 적용시 마이크로니들이 용해 또는 붕괴됨으로써 마이크로니들의 내부에 포함된 활성물질이 피부 내부에 효과적으로 침투할 수 있다.Therefore, in a preferred embodiment of the present invention, the material forming the microneedle is dissolved in the skin, and when the microneedle is applied to the skin, the microneedle dissolves or collapses, so that the active material contained inside the microneedle is effectively absorbed into the skin. It can penetrate.
본 명세서에서 사용된 용어, "마이크로니들"은 마이크로니들의 니들부 및 마이크로니들 디스크(microneedle disk)를 모두 포함하는 용어이다. 즉, 마이크로니들의 니들부만으로 제조될 수 있으며, 마이크로니들의 니들부 및 마이크로니들 디스크를 포함하여 제조될 수 있다. 따라서, 상기 마이크로니들의 니들부 및 마이크로니들 디스크는 동일한 재질로 제조된다.As used herein, the term “microneedle” includes both the needle portion of the microneedle and the microneedle disk. That is, it can be manufactured only with the needle part of the microneedle, or it can be manufactured including the needle part of the microneedle and the microneedle disk. Therefore, the needle portion of the microneedle and the microneedle disk are made of the same material.
본 발명에서 상기 마이크로니들은 바람직하게는 피부 내에서 용해성일 수 있으며, 용해성 마이크로니들을 제조하기 위해서 예를 들어, 히알루론산(Hyaluronic acid), 소듐-카르복시메틸 셀룰로오스(Na-CMC, Sodium carboxymethyl cellulose), 비닐피롤리돈-비닐아세테이트 공중합체, 폴리비닐알코올(Poly vinyl alcohol), 및 폴리비닐피릴리돈(Poly vinyl pyrrolidone) 등의 수용성 고분자; 자일로즈(Xylose), 수크로스(Sucrose), 말토오스(Maltose), 락토오스(Lactose), 트레할로스(Trehalose) 등의 당류; 또는 이들의 혼합물이 사용될 수 있다. 특히 마이크로니들의 피부 투과 강도, 피부 내에서의 용해 속도 등을 종합적으로 고려하면 히알루론산(Hyaluronic acid), 소듐-카르복시메틸 셀룰로오스(Na-CMC, Sodium carboxymethyl cellulose), 및 당류(saccharide)(바람직하게는 트레할로스(Trehalose))의 혼합물이 바람직하며, 글리세린(Glycerin)까지 혼합된 것이 더욱 바람직하다.In the present invention, the microneedles may preferably be soluble in the skin, and to prepare soluble microneedles, for example, hyaluronic acid and sodium carboxymethyl cellulose (Na-CMC) are used. , water-soluble polymers such as vinylpyrrolidone-vinylacetate copolymer, polyvinyl alcohol, and polyvinylpyrrolidone; Sugars such as xylose, sucrose, maltose, lactose, and trehalose; Or a mixture thereof can be used. In particular, considering the skin penetration strength of the microneedle and the dissolution rate in the skin, hyaluronic acid, sodium carboxymethyl cellulose (Na-CMC), and saccharide (preferably A mixture of trehalose is preferable, and a mixture of glycerin is more preferable.
바람직하게는, 본 발명의 마이크로니들은 마이크로니들을 형성하는 상기 성분들 이외에 가소제, 계면활성제, 보존제, 항염제 등을 추가적으로 포함할 수 있다.Preferably, the microneedle of the present invention may additionally contain a plasticizer, a surfactant, a preservative, an anti-inflammatory agent, etc. in addition to the above ingredients forming the microneedle.
상기 가소제(plasticizer)로는, 예를 들어, 에틸렌글리콜(Ethylene glycol), 프로필렌글리콜(Propylene glycol), 디프로필렌글리콜(Dipropylene glycole), 부틸렌글리콜(Butylene glycol), 글리세린(Glycerin) 등의 폴리올이 단독으로 또는 혼합하여 사용될 수 있다.The plasticizer includes, for example, polyols such as ethylene glycol, propylene glycol, dipropylene glycole, butylene glycol, and glycerin. It can be used alone or in combination.
또한, 상기 마이크로니들 패치는 활성물질을 함유할 수 있다. 상기 마이크로니들 패치는 상기 마이크로니들이 부착된 시트를 의미한다. 상기 활성물질이 마이크로니들 패치에 함유될 수 있는 형태로는 예를 들어, i) 마이크로니들 패치에 부착된 마이크로니들 표면에 활성물질을 도포, ii) 마이크로니들 패치에 부착된 용해성 마이크로니들에 함침, 또는 iii) 피부에 부착되는 마이크로니들 패치 부분에 활성물질을 도포하는 형태를 포함할 수 있다. 상기 ii)의 함침은 이에 한정되는 것은 아니지만, 바람직하게는 마이크로니들을 형성하는 피부 내 용해성 물질과 함께 활성물질을 함유하거나, 마이크로니들에 구멍을 내어(다공성 마이크로니들 포함) 상기 구멍 내에 활성물질을 함유하는 것 등을 포함할 수 있다.Additionally, the microneedle patch may contain an active substance. The microneedle patch refers to a sheet to which the microneedle is attached. Forms in which the active material can be contained in the microneedle patch include, for example, i) applying the active material to the surface of the microneedle attached to the microneedle patch, ii) impregnating the soluble microneedle attached to the microneedle patch, Or iii) it may include applying the active material to the microneedle patch attached to the skin. The impregnation of ii) above is not limited to this, but preferably contains the active material together with a soluble material in the skin forming microneedles, or makes a hole in the microneedle (including porous microneedles) and deposits the active material into the hole. It may include things that it contains.
또한, 상기 활성물질은 작은 분자량의 화합물(chemical compound), 단백질, 항체 등의 약효 물질, 백신, 미용 성분 등 약학적, 의학적 또는 화장학적으로 사용이 허용된 어떠한 물질일 수 있다.Additionally, the active substance may be any substance permitted for pharmaceutical, medical, or cosmetic use, such as a small molecular weight chemical compound, a protein, a medicinal substance such as an antibody, a vaccine, or a cosmetic ingredient.
예를 들어, 인터페론, 빈혈 치료제인 에리스로포이에틴(EPO), 난포자극호르몬 (FSH), 부갑상선호르몬 (PTH), 과립구 대식세포 집락 자극인자 (G-CSF), 과립백혈구-대식세포 집락 자극 인자 (GM-CSF), 인간 융모성 고나도트로핀, 황체 호르몬, 칼시토닌, 글루카곤, GNRH 길항제, 인슐린, 인간 성장 호르몬(GHD), 테스토스테론, 리도카인, 디클로페낙, 옥시부티닌, 케토프로펜, 알렌드로네이트(Alendronate), 에나프릴 말레이트, 페닐프로판올아민, 크로몰린, 이소트레티노인, 옥시토신, 파록세틴, 플루르비프로펜, 세르탈린, 벤라팍신, 류프롤리드, 리스페리돈, 갈란타민, 항응고제인 에녹사프린, 류마티스 관절염 치료제인 에타너셉트, 통증 치료제인 펜타닐, 필그라스틴, 항응고제인 헤파린, 부갑상선 호르몬(PTH), 소마트로핀, 성장 호르몬 수마트립탄 등의 약물이 본 발명에 따른 시스템을 이용하여 투여될 수 있으며, 또한 A형, B형 및 C형 간염; HIV 백신; 인플루엔자; 디프테리아; 파상풍; 백일해; 라임 병; 공수병; 폐렴구균; 황열병; 콜레라; 백시니아; 결핵; 풍진; 홍역; 볼거리; 로타바이러스; 보툴리누스균; 헤르페스 바이러스 등의 백신이 본 발명에 따른 시스템을 이용하여 접종될 수 있다. 또한, 나이아신아마이드, 보톡스 독소, 디오스메틴, 마그네슘아스코빌포스페이트, 메이스리그난, 백출유, 아세틸피토스핑고신, 아스코빌글루코사이드, 아시아티코사이드, 알부틴, 에칠아스코빌에텔, 진세노사이드알이, 폴리다틴, 폴리에톡실레이티드레틴아마이드, 프란게니딘, 하이드록시프롤린, 휴먼 올리고펩타이드-1, 레티놀 등의 화장학적 성분이 상기 마이크로니들 패치에 함유될 수 있다.For example, interferon, anemia treatment erythropoietin (EPO), follicle-stimulating hormone (FSH), parathyroid hormone (PTH), granulocyte-macrophage colony-stimulating factor (G-CSF), and granulocyte-macrophage colony-stimulating factor (GM-). CSF), human chorionic gonadotropin, progesterone, calcitonin, glucagon, GNRH antagonist, insulin, human growth hormone (GHD), testosterone, lidocaine, diclofenac, oxybutynin, ketoprofen, alendronate, ena Pril malate, phenylpropanolamine, cromolyn, isotretinoin, oxytocin, paroxetine, flurbiprofen, sertaline, venlafaxine, leuprolide, risperidone, galantamine, enoxaprine, an anticoagulant, etanercept, a rheumatoid arthritis treatment, pain. Drugs such as the therapeutic agents fentanyl and filgrastin, the anticoagulant heparin, parathyroid hormone (PTH), somatropin, and the growth hormone sumatriptan can be administered using the system according to the present invention, and also types A, B, and C hepatitis; HIV vaccine; influenza; diphtheria; tetanus; whooping cough; Lyme disease; hydrophobia; pneumococcus; yellow fever; cholera; vaccinia; Tuberculosis; German measles; measles; things to see; rotavirus; botulism; Vaccines such as herpes virus can be administered using the system according to the present invention. In addition, niacinamide, botox toxin, diosmetin, magnesium ascorbyl phosphate, mace lignan, white chestnut oil, acetylphytosphingosine, ascorbyl glucoside, asiaticoside, arbutin, ethyl ascorbyl ether, ginsenoside R, poly Cosmetic ingredients such as datin, polyethoxylated retinamide, frangenidin, hydroxyproline, human oligopeptide-1, and retinol may be contained in the microneedle patch.
또한, 본 발명은 상기 흡착기, 및 마이크로니들 패치를 포함하는 마이크로니들의 피부 침투율 편차가 감소된 마이크로니들 패치 키트를 제공한다.In addition, the present invention provides a microneedle patch kit in which the variation in skin penetration rate of microneedles including the absorber and a microneedle patch is reduced.
또한, 본 발명은 (S1) 마이크로니들 패치를 원하는 부위의 피부에 부착하는 단계; (S2) 상기 흡착기의 흡착구 내에 마이크로니들 패치가 위치할 수 있도록 피부 위에 올려놓는 단계; 및 (S3) 상기 마이크로니들 패치에 포함된 마이크로니들이 피부를 투과할 수 있도록, 공기 배출수단을 이용하여 흡착기 본체 내부에 부압을 형성시키는 단계를 포함하는, 마이크로니들 패치에 부착된 마이크로니들의 피부 침투율 편차를 감소시키기 위한 방법을 제공한다.In addition, the present invention includes the steps of (S1) attaching a microneedle patch to the skin at a desired area; (S2) placing the microneedle patch on the skin so that it can be positioned within the suction port of the suction device; And (S3) the skin penetration rate of the microneedle attached to the microneedle patch, comprising the step of creating negative pressure inside the absorber body using an air discharge means so that the microneedle included in the microneedle patch can penetrate the skin. Provides a method for reducing deviation.
또한, 본 발명은 (S1) 상기 흡착기의 마이크로니들 패치 지지판에 마이크로니들 패치를 부착시키는 단계; (S2) 마이크로니들 패치가 부착된 (S1) 단계의 흡착기를 원하는 부위의 피부에 올려놓는 단계; 및 (S3) 상기 마이크로니들 패치에 부착된 마이크로니들이 피부를 투과할 수 있도록 공기 배출수단을 이용하여 흡착기 본체 내부에 부압을 형성시키는 단계를 포함하는, 마이크로니들 패치에 부착된 마이크로니들의 피부 침투율 편차를 감소시키기 위한 방법을 제공한다.In addition, the present invention includes the steps of (S1) attaching a microneedle patch to the microneedle patch support plate of the adsorber; (S2) placing the suction device of step (S1) attached with the microneedle patch on the skin of the desired area; and (S3) forming a negative pressure inside the absorber body using an air discharge means so that the microneedle attached to the microneedle patch can penetrate the skin. Deviation in skin penetration rate of the microneedle attached to the microneedle patch. Provides a method to reduce .
본 발명에 따른 흡착기를 이용하는 경우 간단한 조작 만으로도 마이크로니들 패치에 포함된 마이크로니들의 피부 침투율 편차가 감소되는 효과가 있어 마이크로니들 패치의 효율을 향상시킬 수 있다.When using the absorber according to the present invention, the skin penetration rate deviation of the microneedle included in the microneedle patch is reduced with a simple operation, thereby improving the efficiency of the microneedle patch.
도 1은 본 발명에서 사용할 수 있는 마이크로니들을 제조하는 일 실시예를 나타낸 도면이다.
도 2는 본 발명에 따른 흡착기의 일 실시예를 나타낸 도면이다.
도 3은 본 발명에 따른 흡착기의 일 실시예를 나타낸 도면이다.
도 4는 하기 실시예 및 비교예의 방법에 따른 마이크로니들의 돼지 피부 투과율을 확인한 사진이다.
도 5는 본 발명에 따른 흡착기를 이용하여 마이크로니들의 약물 방출 거동을 평가하기 위한 Franz diffusion cell을 나타낸다.
도 6은 실시예 및 비교예 방법을 이용하였을 때 알부틴의 피부 투과량을 나타낸 그래프이다.Figure 1 is a diagram showing an example of manufacturing a microneedle that can be used in the present invention.
Figure 2 is a diagram showing an embodiment of an adsorber according to the present invention.
Figure 3 is a diagram showing an embodiment of an adsorber according to the present invention.
Figure 4 is a photograph confirming the pig skin penetration rate of microneedles according to the methods of the examples and comparative examples below.
Figure 5 shows a Franz diffusion cell for evaluating the drug release behavior of microneedles using the adsorber according to the present invention.
Figure 6 is a graph showing the skin penetration amount of arbutin when using the Example and Comparative Example methods.
이하, 본 발명의 이해를 돕기 위하여 실시예 등을 들어 상세하게 설명하기로 한다. 그러나 본 발명에 따른 실시예들은 여러 가지 다른 형태로 변형될 수 있으며, 본 발명의 범위가 하기 실시예들에 한정되는 것으로 해석되어서는 안 된다. 본 발명의 실시예들은 당업계에서 평균적인 지식을 가진 자에게 본 발명을 보다 완전하게 설명하기 위해 제공되는 것이다.Hereinafter, to aid understanding of the present invention, it will be described in detail through examples. However, the embodiments according to the present invention may be modified into various other forms, and the scope of the present invention should not be construed as limited to the following embodiments. Embodiments of the present invention are provided to more completely explain the present invention to those skilled in the art.
본 발명자들은 본 발명에 따른 흡착기 및 마이크로니들 패치를 제조하기 위하여 바람직한 예로서 하기와 같은 흡착기 및 마이크로니들 패치를 제조하여 실험을 실시하였다.In order to manufacture the adsorber and microneedle patch according to the present invention, the present inventors manufactured the following adsorber and microneedle patch as preferred examples and conducted experiments.
<용해성 마이크로니들의 제조><Manufacture of soluble microneedles>
본 발명에서 사용된 마이크로니들은 용해성 마이크로니들이 사용되었으며, 용해성 마이크로니들은 solution casting 방법으로 제조되며, solution을 몰드에 캐스팅(casting)하여 진공 혹은 원심분리로 미세 몰드에 액을 채운 후 건조하여 제조하였다.The microneedles used in the present invention were soluble microneedles, and the soluble microneedles were manufactured by the solution casting method, by casting the solution into a mold, filling the micromold with the liquid by vacuum or centrifugation, and then drying it. .
마이크로니들 구조체를 형성하는 물질은 일반적인 합성 및 천연 수용성 고분자가 사용되었다.Common synthetic and natural water-soluble polymers were used as materials forming the microneedle structure.
<알부틴을 함유하는 용해성 <Solubility containing arbutin 마이크로니들의of microneedles 제조> Manufacturing>
본 발명자들은 알부틴을 함유하는 용해성 마이크로니들을 제조하기 위하여, Oligo-HA(Hyaluronic acid), Na-CMC(Sodium carboxymethyl cellulose), 트레할로스(Trehalose), 디프로필렌글리콜(DPG), 알부틴, 피이지-40 하이드로제네이티드캐스터오일을 정제수에 용해하여 마이크로니들 용액을 제조하였다. 제조한 용액을 실리콘 미세바늘 몰드에 캐스팅(casting) 한 후, 3000 rpm 에서 10 분간 원심분리하여 미세 몰드에 액을 충진하였다. 용액 충진 후 건조 오븐(70℃)에서 3시간 동안 건조하고, 점착 필름을 이용하여 미세바늘을 실리콘 몰드로부터 분리해 내어 마이크로니들 패치를 제조하였다.In order to manufacture soluble microneedles containing arbutin, the present inventors used Oligo-HA (Hyaluronic acid), Na-CMC (Sodium carboxymethyl cellulose), Trehalose, Dipropylene Glycol (DPG), Arbutin, and PEG-40. A microneedle solution was prepared by dissolving hydrogenated castor oil in purified water. After casting the prepared solution into a silicon microneedle mold, it was centrifuged at 3000 rpm for 10 minutes to fill the micromold with the solution. After filling the solution, it was dried in a drying oven (70°C) for 3 hours, and the microneedle was separated from the silicone mold using an adhesive film to prepare a microneedle patch.
<공기 배출수단을 포함하는 흡착기><Adsorber including air discharge means>
본 발명자들은 도 2에 나타낸 바와 같은 공기 배출수단이 포함된 흡착기를 이용하여 하기 실험을 진행하였다. (본체의 재질: 플라스틱, 공기 배출수단: 고무 밸브)The present inventors conducted the following experiment using an adsorber including an air discharge means as shown in FIG. 2. (Body material: plastic, air discharge means: rubber valve)
사용 방법How to use
본 발명자들은 하기와 같은 방법으로 마이크로니들 패치를 피부에 적용하였다.The present inventors applied the microneedle patch to the skin in the following manner.
- 비교예: 마이크로니들 패치만을 피부에 부착함.- Comparative example: Only the microneedle patch is attached to the skin.
- 실시예: 마이크로니들 패치를 피부에 부착한 후 흡착기를 마이크로니들 패치가 부착된 부위에 대고 공기 배출수단을 이용하여 피부에 흡착함.- Example: After attaching a microneedle patch to the skin, place an absorber on the area where the microneedle patch is attached and adsorb to the skin using an air discharge means.
실험예Experiment example 1: One: 마이크로니들의of microneedles 피부 투과율(피부 침투율 편차 감소 확인) Skin penetration rate (confirmation of reduction in skin penetration rate deviation)
본 발명자들은 실시예 및 비교예의 방법으로 돼지 피부에 마이크로니들 패치를 적용한 후, 일정 시간 후에 마이크로니들 패치를 제거하고 염료(트립판 블루)로 염색하여 광학 현미경으로 돼지 피부 표면을 조사하였다.The present inventors applied a microneedle patch to pig skin using the method of Examples and Comparative Examples, removed the microneedle patch after a certain period of time, stained it with a dye (trypan blue), and examined the pig skin surface under an optical microscope.
그 결과, 도 4에 나타낸 바와 같이 실시예는 약 95% 이상 마이크로니들이 피부를 투과한 것을 확인할 수 있으며, 비교예는 약 40% 마이크로니들이 피부를 투과한 것을 확인할 수 있었다.As a result, as shown in FIG. 4, it was confirmed that in the example, more than about 95% of the microneedles penetrated the skin, and in the comparative example, it was confirmed that about 40% of the microneedles penetrated the skin.
즉, 흡착기를 이용하여 마이크로니들 패치를 적용한 경우 마이크로니들 패치에 포함된 마이크로니들의 피부 침투율 편차가 현저히 감소되어 마이크로니들 패치에 포함된 거의 모든 마이크로니들이 유효하게 피부를 침투한 것을 확인하였다.That is, when the microneedle patch was applied using an absorber, the deviation of the skin penetration rate of the microneedles included in the microneedle patch was significantly reduced, confirming that almost all microneedles included in the microneedle patch effectively penetrated the skin.
실험예Experiment example 2: 알부틴의 피부 투과량 확인 2: Checking the skin penetration amount of arbutin
본 발명자들은 Franz diffusion cell 을 이용하여, 일정 시간 후 돼지피부 조직 및 acceptor solution의 알부틴 함량을 액체 크로마토그래피(Liquid Chromatography)를 이용하여 측정하였다. 돼지 피부에 실시예 및 비교예 방법으로 마이크로니들 패치를 부착(부착 시간: 2시간, 온도: 32℃)하여 돼지 피부 내에 침투하여 녹게 한 후, 마이크로니들 패치를 제거하였다.The present inventors used a Franz diffusion cell to measure the arbutin content of pig skin tissue and acceptor solution after a certain period of time using liquid chromatography. A microneedle patch was attached to pig skin using the Examples and Comparative Examples (attachment time: 2 hours, temperature: 32°C), allowed to penetrate and melt into the pig skin, and then the microneedle patch was removed.
실시예와 비교예에 의해 알부틴이 흡수된 돼지 피부를 franz diffusion cell에 넣어(도 5), 알부틴이 시간에 따라 돼지 피부에서 Acceptor solution으로 방출되는 거동을 확인하였다.Pig skin in which arbutin had been absorbed according to Examples and Comparative Examples was placed in a Franz diffusion cell (FIG. 5), and the behavior of arbutin being released from pig skin into the acceptor solution over time was confirmed.
돼지 피부에 잔존하는 알부틴 함량과 acceptor solution 내 알부틴 함량을 합한 수치를 보고 피부 투과 정도를 판단하였다. 그 결과, 도 6에 나타낸 바와 같이, 실시예가 비교예에 비해 현저히 높은 피부 투과 정도를 보였다.The degree of skin penetration was determined by looking at the sum of the arbutin content remaining in the pig skin and the arbutin content in the acceptor solution. As a result, as shown in Figure 6, the Example showed a significantly higher degree of skin penetration than the Comparative Example.
Claims (11)
- 여기서 상기 흡착기는 부압을 형성함으로써 마이크로니들 패치를 피부에 부착하는 것으로서,
내부 공간을 가지는 본체;
상기 본체의 하부에 형성되며, 테두리가 피부와 접촉될 수 있는 흡착구;
상기 본체의 상부에 형성되며, 상기 내부 공간에 부압을 형성할 수 있는 공기 배출수단을 포함하는 공기 배출부; 및
상기 본체의 내부에 위치하며, 마이크로니들 패치가 부압에 의한 이동 없이 지지될 수 있는 마이크로니들 패치 지지판을 포함하고,
상기 내부 공간은 상기 흡착구의 테두리가 피부와 접촉하게 될 때 피부와 접촉되지 않는 공간으로서 상기 흡착구의 내부에 존재하며,
상기 마이크로니들 패치 지지판은 공기 배출 구멍을 포함하는 것이고,
- 상기 마이크로니들을 형성하는 물질은 수용해성 고분자, 당류 및 가소제를 포함하는 것이고,
상기 약물은 상기 용해성 마이크로니들 내에 함침되어 있고,
상기 마이크로니들 패치를 피부에 부착하면 상기 마이크로니들을 형성하는 물질이 피부 내 수분에 의하여 용해됨에 따라 상기 약물이 방출되는 것임.A microneedle patch kit comprising (i) an absorber and (ii) an intradermal dissolvable microneedle patch containing a substance forming the microneedle and a drug,
- Here, the absorber attaches the microneedle patch to the skin by creating negative pressure,
a body having an internal space;
a suction port formed at the bottom of the main body, the edge of which can be in contact with the skin;
an air discharge unit formed on the upper part of the main body and including an air discharge means capable of creating negative pressure in the internal space; and
It is located inside the main body and includes a microneedle patch support plate on which the microneedle patch can be supported without movement due to negative pressure,
The internal space is a space that does not contact the skin when the edge of the suction port comes into contact with the skin, and exists inside the suction port,
The microneedle patch support plate includes an air discharge hole,
- The material forming the microneedle includes water-soluble polymers, saccharides, and plasticizers,
The drug is impregnated within the soluble microneedle,
When the microneedle patch is attached to the skin, the drug is released as the material forming the microneedle is dissolved by moisture in the skin.
상기 마이크로니들 패치 지지판은 상기 내부 공간의 하단부에 고정된 것을 특징으로 하는 마이크로니들 패치 키트.According to paragraph 1,
A microneedle patch kit, wherein the microneedle patch support plate is fixed to the lower end of the internal space.
상기 마이크로니들 패치 지지판은 흡착구로부터 1 내지 15mm 높이에 위치하는 것을 특징으로 하는 마이크로니들 패치 키트.According to paragraph 3,
A microneedle patch kit, characterized in that the microneedle patch support plate is located at a height of 1 to 15 mm from the suction port.
상기 본체의 재질은 연질인 것을 특징으로 하는 마이크로니들 패치 키트.According to paragraph 1,
A microneedle patch kit, characterized in that the material of the main body is soft.
상기 공기 배출수단은 펌프, 밸브 또는 튜브인 것을 특징으로 하는 마이크로니들 패치 키트.According to paragraph 1,
A microneedle patch kit, wherein the air discharge means is a pump, valve, or tube.
상기 흡착구는 원형이며, 직경은 1 내지 10cm 인 것을 특징으로 하는 마이크로니들 패치 키트.According to paragraph 1,
A microneedle patch kit, characterized in that the suction port is circular and has a diameter of 1 to 10 cm.
상기 흡착기는 상기 마이크로니들의 피부 침투율 편차를 감소시키기 위한 것인, 마이크로니들 패치 키트.According to paragraph 1,
The absorber is a microneedle patch kit for reducing variation in skin penetration rate of the microneedle.
상기 마이크로니들 패치 지지판에 마이크로니들 패치가 부착되어 있는 것을 특징으로 하는 마이크로니들 패치 키트.According to paragraph 1,
A microneedle patch kit, characterized in that a microneedle patch is attached to the microneedle patch support plate.
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| US20050137531A1 (en) * | 1999-11-23 | 2005-06-23 | Prausnitz Mark R. | Devices and methods for enhanced microneedle penetration of biological barriers |
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| JP2004503342A (en) * | 2000-07-14 | 2004-02-05 | ベクトン ディキンソン アンド カンパニー | Micro device and method for manufacturing the same |
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