WO2011043085A1 - マイクロニードルシートのスタンパー及びその製造方法とそれを用いたマイクロニードルの製造方法 - Google Patents
マイクロニードルシートのスタンパー及びその製造方法とそれを用いたマイクロニードルの製造方法 Download PDFInfo
- Publication number
- WO2011043085A1 WO2011043085A1 PCT/JP2010/050407 JP2010050407W WO2011043085A1 WO 2011043085 A1 WO2011043085 A1 WO 2011043085A1 JP 2010050407 W JP2010050407 W JP 2010050407W WO 2011043085 A1 WO2011043085 A1 WO 2011043085A1
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- Prior art keywords
- stamper
- sheet
- microneedle
- base material
- manufacturing
- Prior art date
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Classifications
-
- 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
- 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
- A61M2037/003—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles having a lumen
-
- 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
- A61M2037/0046—Solid 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
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C59/00—Surface shaping of articles, e.g. embossing; Apparatus therefor
- B29C59/02—Surface shaping of articles, e.g. embossing; Apparatus therefor by mechanical means, e.g. pressing
Definitions
- the present invention relates to a microneedle sheet for injecting a drug into the epidermis of a skin, and particularly to a stamper that is a mold for producing a microneedle and a method for producing a microneedle sheet using the same.
- the length of the microneedle is about several hundreds of micrometers, so there is almost no colic. Further, when the sheet is removed from the skin, the microneedle portion is formed of a self-dissolving substance so that even if the microneedle remains in the skin, the human body is not affected.
- the original 90 of the microneedle sheet is produced by a method such as micromachining, vacuum processing, or photolithography.
- the length 93 of the needle has a cone shape of several hundred ⁇ m or less. Cross sections include circles, corners, and ellipses. Since the needle has a very small size, it is preferable to cut the needle 92 from the original plate 91 and form it.
- the original plate 90 is pressed against the stamper base material 81 to produce a stamper 80 (microneedle sheet mold). Then, a resin solution or a drug 85 is poured into the stamper 80, and after drying, the microneedle sheet 77 can be obtained by attaching to the fixing substrate 88 and transferring it by peeling (see Patent Document 1).
- the microneedle sheet is produced by pouring the needle material into the produced stamper.
- the recess of the stamper has a very small size, the raw material of the microneedle is not easily filled into the recess of the stamper due to air or surface tension.
- the air 72 exists in the recess of the stamper, and when the air 72 peels from the stamper, the air 72 is removed.
- the needle can be formed only in an incomplete shape (FIG. 8D).
- Patent Documents 2 and 3 discloses that when a raw material is filled in a stamper, it is performed in a reduced pressure state. Further, Patent Document 3 discloses that pressurization is performed from the raw material side to fill the concave portion of the stamper. However, in the case where a large number of microneedles are arranged, there is a problem that some planned microneedles may not be planted because raw materials are not filled in some recesses.
- the present invention has been conceived in view of the above-described problems.
- the present invention is a stamper for a microneedle sheet formed on a fixed base, and is directed from one surface of a sheet-like base material to the other surface.
- the present invention provides a stamper for producing a microneedle sheet having a conical recess formed in this manner and a through-hole formed from the bottom of the recess toward the other surface.
- seat using this stamper are provided.
- the raw material can be filled, and a microneedle sheet in which all the expected number of microneedles is formed can be obtained.
- stamper of this invention It is the schematic of the stamper of this invention. It is a figure which shows the manufacturing process of the stamper of this invention. It is a figure which shows the other manufacturing process of the stamper of this invention. It is a figure which shows another manufacturing process of the stamper of this invention. It is a figure which shows the manufacturing process of the microneedle sheet
- FIG. 1 shows a stamper 1 of a microneedle sheet according to the present invention.
- the stamper 1 is a sheet-like base material 2 having a conical recess 3 formed therein.
- the material of the base material 2 is not particularly limited, but since it is a pharmaceutical, a material that is not easily contaminated (contaminated) or a material that does not affect the human body is preferable.
- SUS316L and Hastelloy are suitably used for metals
- PTFE, polypropylene, polyethylene and the like are suitably used for plastics.
- a through hole 4 penetrating the other surface of the base material is formed at the bottom of the recess 3.
- the through-hole 4 is not limited to having a hole with a finite length at all, as long as the air accumulated in the recess is removed so that the raw material of the microneedle is filled in the recess 3. That is, even though it has a cut line that penetrates and usually appears to be closed, it is sufficient that air is removed when filling the raw material.
- the original plate 10 is formed by forming a conical protrusion 12 on a planar main body 11.
- the material is not particularly limited, but a metal excellent in workability can be suitably used. Since the cone-shaped protrusions are minute and the cross-section differs at the root and tip, a material with high machinability is preferable. For example, copper, aluminum, nickel, silicon, etc. can be used. Further, the protrusion 12 may be formed by a method using photolithography in addition to processing by cutting out from the main body 11.
- the protrusion 12 has a height 13 of about 1 ⁇ m to 500 ⁇ m on the main body 11.
- the epidermis into which drugs, etc. are injected using a microneedle sheet is formed by the stratum corneum, granule layer, spiny layer, and basal layer. This is because the height of the protrusion may be changed depending on the body part and the drug.
- the cross-sectional shape There is no particular limitation on the cross-sectional shape, and a circle, an ellipse, a square including a square, or the like is preferably applied.
- channel may be formed in the protrusion surface. This is because the microneedle reflecting the groove shape may be able to be smoothly inserted into the skin.
- the original plate 10 is pressed against the base material 2 of the stamper 1 to form a conical recess 3 on the surface of the base material.
- an organic compound (plastic) can be mainly used for the base material 2.
- the thickness is preferably 10 ⁇ m or more and 50 ⁇ m or less than the depth of the recess 3 formed in the stamper 1. This is because if the thickness is too large, the through hole cannot be formed after the recess is formed.
- the organic compound mainly used as the base material 2 is partly plastically deformed when the conical protrusions 12 are pressure-bonded from the surface, but the elastically deformed part remains, and when the protrusions 12 are removed, 3 may be smaller than the shape expanded by the projection 12 of the original plate. Therefore, it is preferable to prepare an extra size for the projection 12 of the original plate than the concave portion of the stamper to be manufactured.
- a through hole 4 is formed in the bottom of the recess 3 of the stamper 1.
- the through hole can be opened with a micro drill 70.
- a micro drill may form a through-hole by penetrating a needle-like protrusion in which a spiral blade is not formed.
- the thickness 5 of the base material is selected to be slightly thinner than the projection 12 of the original plate in advance, and the original plate protrusion penetrates the base material when the original plate is pressed. In this way, the through hole may be formed. In this case, the step of pressing the original plate and the step of forming the through-hole are performed simultaneously. As a result, as shown in FIG. 3B, the stamper 1 has a through hole 4 whose cross-sectional area changes from the front surface to the back surface of the base material 2.
- FIG. 4 shows a case where the protrusion 12 and the stamper of the original 10 are heated in advance. Since the stamper base material 2 is a so-called plastic, if the protrusion 12 is higher than the melting temperature of the base material 2, plastic deformation can be easily caused. In this case, when the projection 12 is inserted into the base material 2 and released, the surface of the base material is deformed by receiving heat. Therefore, it is preferable to release the original and the stamper after cooling to room temperature.
- a through-hole may be formed after forming a recess part way through the thickness of the base material 2, or the projection 12 of the original plate 10 may be formed with the stamper base material 2.
- the recess and the through hole may be formed at the same time.
- FIG. 4 shows a case where the stamper is formed by the latter method.
- a microneedle sheet is produced with the stamper produced as described above.
- the microneedle sheet is produced by applying needle material 20 to stamper 1 (FIG. 5 (a)).
- the needle raw material 20 it is preferable to use a material that is discharged without remaining in the body.
- the needle part may break or come off and not all be recovered. This is because any material that can be absorbed by the body is safe.
- a material mainly composed of a leaky substance or the like is preferable.
- a drug may be mixed in the needle raw material in advance.
- the drug is a pure chemical substance having a physiological activity, and includes peptide protein drugs such as insulin, growth hormone, erythropoietin, and interferon, polymer drugs, vitamin C, and the like. It may be a thing.
- the stamper 1 of the present invention has a through hole 4 formed at the bottom of the recess 3. Therefore, the needle material is injected into the stamper only by coating, and the needle material is recessed. To be filled. That is, even if there is air 72 at the bottom of the recess 3 of the stamper 1, it is easily discharged through the through hole 4, and the needle material is filled in the recess 3.
- pressurization 15 may be performed after coating (FIG. 6A). If pressure is applied, the air accumulated at the bottom of the recess 3 of the stamper can be extracted more easily.
- the stamper 1 may be disposed on the flat table 18 formed of a porous solid, and the needle raw material 20 may be applied while applying the negative pressure 16 from the back surface of the flat table 18 (see FIG. 6B). Also in this case, the needle raw material can be easily injected into the recess 3 of the stamper. Further, it is better if pressure 15 is applied from the upper surface of the flat table 18 and negative pressure 16 is applied from the rear surface.
- the needle raw material 20 After the needle raw material 20 is applied to the stamper 1, it is dried and peeled off from the stamper to complete the microneedle sheet 30 (see FIG. 6C).
- the fixed base 88 is attached from the back surface of the dried needle material 20 and peeled off from the stamper. If the drug is not charged in the microneedle sheet 30 peeled from the stamper, the drug is sprayed on the needle portion 31 after peeling from the stamper.
- the stamper according to the present invention has a through-hole penetrating to the opposing surface of the stamper at the bottom of the recess forming the needle. It is possible to obtain a microneedle sheet that is high, that is, has no incomplete needles.
- FIG. 7 shows another embodiment of the microneedle sheet.
- the manufacturing method up to the stamper is the same as in the first embodiment.
- the drug is also dispersed in the sheet base material portion.
- the base material portion basically touches the skin surface, but the drug is not injected into the epidermis. Therefore, in the present embodiment, the drug is concentrated on the tip of the needle.
- the drug 21 is applied to the stamper (FIG. 7 (a)). At this time, the drug 21 is applied to such an extent that it accumulates at the bottom of the recess 3 of the stamper 1.
- a solution in which a drug is diluted is applied on a stamper. Thereafter, it is more preferable to scrape off the excess solution with a squeegee or the like.
- pressure may be applied or negative pressure may be applied from the back surface.
- the drug solution 21 After the drug solution 21 is dried, it stays on the inner surface and the bottom of the recess 3 of the stamper (FIG. 7 (b)).
- the needle raw material 20 is applied (FIG. 7C). Since the needle raw material is not in direct contact with the material of the stamper at the concave portion of the stamper, it can be applied with good wettability, and air does not accumulate.
- the needle raw material may be applied immediately and pressurized or negative pressure may be applied from the back side.
- the application since the application is wet-on-wet, the microneedle sheet containing the drug at the tip can be obtained just by applying, as in the first embodiment, air is released from the through hole.
- the fixing base 88 is attached to the back surface of the dried needle material, and is peeled off from the stamper 1.
- the obtained microneedle sheet 32 is a microneedle sheet in which the drug 21 is disposed at the tip of the needle.
- the microneedle sheet is composed of two layers, ie, a drug-containing layer and a needle-constituting layer.
- the microneedle sheet may have a layer structure of three or more layers.
- the present invention can be widely used not only for a microneedle sheet for injecting a drug into the epidermis, but also for a method for generating microprojections on a substrate.
Abstract
Description
図1に本発明のマイクロニードルシートのスタンパー1を示す。スタンパー1はシート状の母材2に錐状の凹部3が形成されたものである。母材2の材質は特に限定されるものではないが、医薬品であるため、コンタミネーション(汚染)がされにくい材質または人体に影響のない材質が良い。例えば、金属であればSUS316L、ハステロイ、プラスチックであればPTFE、ポリプロピレン、ポリエチレンなどが好適に用いられる。凹部3の底部分には母材の他の面に貫通する貫通孔4が形成されている。貫通孔4はマイクロニードルの原料が凹部3に充填されるように、凹部に溜まった空気が抜ければよく、常に有限長の径の孔があいていなくてもよい。すなわち、貫通した切れ目が形成されており、通常は閉じているように見えても、原料を充填する際に空気が抜ければよい。
図7にはマイクロニードルシートの他の実施形態を示す。スタンパーの作製方法までは実施の形態1と同じである。ニードル原料に薬物を混入させる場合は、シート基材部分にも薬物が分散される。しかし、基材部分は基本的に皮膚表面に触れることはあるが、表皮内に薬物が注入されるわけではない。そこで、本実施の形態では、薬物をニードル先端部分に集中させる。
2 母材
3 凹部
4 貫通孔
5 母材厚み
10 原版
11 原版本体
12 突起
13 突起高さ
15 圧力
16 陰圧
18 多孔質固体の平面台
20 ニードル原料
21 薬物
30、32 マイクロニードルシート
31 ニードル
70 マイクロドリル
72 空気
77 マイクロニードルシート
80 従来のスタンパー
81 従来のスタンパー母材
85 ニードル原料
88 固定基材
90 原版
91 本体
92 突起
93 突起の長さ
Claims (8)
- 固定基体上に形成されるマイクロニードルシートのスタンパーであって、
シート状の母材の一方の表面から他方の表面に向かって形成された錐状の凹部と、
前記凹部の底から前記他方の表面に向かって形成された貫通孔とを有するマイクロニードルシート作製用のスタンパー。 - 固定基体上に形成されるマイクロニードルシートのスタンパーの製造方法であって、
シート状の母材の一方の表面から他方の表面に向かって錐状の凹部を形成する工程と、
前記凹部の底から前記他方の表面に向かって貫通孔を形成する工程を有する雌型の製造方法。 - 前記凹部を形成する工程は、
前記シート状の母材の前記一方の表面から錐状の凸部を有する原版を圧接する工程であり、
前記貫通孔を形成する工程は、
前記圧接した原版の凸部の先端を前記母材の前記他方の表面を穿通する工程である請求項
2に記載されたスタンパーの製造方法。 - 前記原版を圧接する工程では、
前記母材に樹脂を用い、加熱した前記原版を圧接する工程である請求項3に記載されたスタンパーの製造方法。 - 固定基体上に形成されるマイクロニードルシートの製造方法であって、
シート状の母材の一方の表面から他方の表面に向かって錐状の凹部を形成する工程と、
前記凹部の底から前記他方の表面に向かって貫通孔を形成し、シート状のスタンパーを得る工程と、
前記スタンパーの前記一方の表面からニードル原料を注入する工程と、
前記一方の表面側に固定基材を貼り付ける工程を有するマイクロニードルシートの製造方法。 - 前記ニードル原料を注入する工程は、
最初に第1のニードル原料を注入する工程と、
続いて少なくとも第2のニードル原料を注入する工程である請求項5に記載されたマイクロニードルシートの製造方法。 - 前記ニードル原料を注入する工程は、前記一方の表面側から加圧しながら注入する工程で
ある請求項5または6のいずれかの請求項に記載されたマイクロニードルシートの製造方法。 - 前記ニードル原料を注入する工程は、前記他方の表面側から吸引しながら注入する工程で
ある請求項5乃至6のいずれかの請求項に記載されたマイクロニードルシートの製造方法。
Priority Applications (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CA2696956A CA2696956A1 (en) | 2009-10-08 | 2010-01-15 | Stamper for microneedle sheet, production method thereof, and microneedle production method using stamper |
US12/674,716 US20110192562A1 (en) | 2009-10-08 | 2010-01-15 | Stamper for microneedle sheet, production method thereof, and microneedle production method using stamper |
CN2010800006065A CN102202723A (zh) | 2009-10-08 | 2010-01-15 | 微针片材的压模及其制造方法和采用该压模的微针的制造方法 |
EP10703212A EP2343101A4 (en) | 2009-10-08 | 2010-01-15 | MICRO NEEDLE SHEET MATRIX, METHOD OF MANUFACTURING THE MATRIX, AND METHOD OF MANUFACTURING MICRO NEEDLE USING THE MATRIX |
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JP2009-234109 | 2009-10-08 | ||
JP2009234109A JP5558772B2 (ja) | 2009-10-08 | 2009-10-08 | マイクロニードルシートのスタンパー及びその製造方法とそれを用いたマイクロニードルの製造方法 |
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WO2011043085A1 true WO2011043085A1 (ja) | 2011-04-14 |
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US (1) | US20110192562A1 (ja) |
EP (1) | EP2343101A4 (ja) |
JP (1) | JP5558772B2 (ja) |
KR (1) | KR20110067008A (ja) |
CN (1) | CN102202723A (ja) |
AU (1) | AU2010201438A1 (ja) |
TW (1) | TW201113056A (ja) |
WO (1) | WO2011043085A1 (ja) |
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AU2010201438A1 (en) | 2011-05-12 |
JP5558772B2 (ja) | 2014-07-23 |
US20110192562A1 (en) | 2011-08-11 |
JP2011078617A (ja) | 2011-04-21 |
TW201113056A (en) | 2011-04-16 |
CN102202723A (zh) | 2011-09-28 |
EP2343101A4 (en) | 2012-09-26 |
EP2343101A1 (en) | 2011-07-13 |
KR20110067008A (ko) | 2011-06-20 |
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