JP5495034B2 - Multi-needle microneedle patch - Google Patents
Multi-needle microneedle patch Download PDFInfo
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- JP5495034B2 JP5495034B2 JP2010053712A JP2010053712A JP5495034B2 JP 5495034 B2 JP5495034 B2 JP 5495034B2 JP 2010053712 A JP2010053712 A JP 2010053712A JP 2010053712 A JP2010053712 A JP 2010053712A JP 5495034 B2 JP5495034 B2 JP 5495034B2
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Description
本発明は皮膚表層及び／又は皮膚角質層に修飾効果及び／又は機能効果を与えるためのマイクロニードルパッチに関する。 The present invention relates to a microneedle patch for imparting a modifying effect and / or a functional effect to the skin surface layer and / or the skin stratum corneum.
薬物を人の体内に投与する手法として、注射投与法、経口的投与と経皮的投与がよく用いられている。注射は医師・看護師のような専門家の手を煩わせねばならず、苦痛を伴い、更にエイズやＢ型肝炎などの感染もあり得る、多くの人にとって歓迎すべからざる手法である。これに対し、最近マイクロニードルアレイを利用した、苦痛を伴わない経皮的投与法が注目されてきた（特許文献１）。 As a method for administering a drug into a human body, injection administration, oral administration and transdermal administration are often used. Injection is an indispensable technique for many people who must bother the hands of specialists such as doctors and nurses, can be painful, and can also be infected with AIDS or hepatitis B. On the other hand, a transdermal administration method using a microneedle array without causing pain has recently attracted attention (Patent Document 1).
薬物の経皮的投与の際、皮膚角質層は薬物透過のバリアとして働き、単に皮膚表面に薬物を塗布するだけでは透過性は必ずしも十分ではない。これに対し微小な針、すなわちマイクロニードルを用いて角質層を穿孔することにより、塗布法より薬物投与効率を格段に向上させることができる。このマイクロニードルを基板上に多数集積したものがマイクロニードルアレイである。また、マイクロニードルアレイに、マイクロニードルアレイを皮膚に付着させるための粘着テープや使用まで無菌状態を維持するためのカバーシートなど各種テープを付加して使用しやすい製品としたものをマイクロニードルパッチという。
ここにテープとは、フィルムに粘着剤を塗布したものをいう。During the transdermal administration of a drug, the skin stratum corneum acts as a barrier for drug permeation, and simply applying the drug to the skin surface does not necessarily provide sufficient permeability. On the other hand, by perforating the stratum corneum using a fine needle, that is, a microneedle, the drug administration efficiency can be significantly improved over the coating method. A microneedle array is a large number of microneedles integrated on a substrate. Microneedle patches are products that are easy to use by adding various tapes to the microneedle array, such as adhesive tape for attaching the microneedle array to the skin and a cover sheet for maintaining sterility until use. .
Here, the tape refers to a film in which an adhesive is applied.
マイクロニードルの素材として糖質などの体内で代謝により消失する物質を用いてマイクロニードルを作成すれば、仮にニードルが折れ皮膚内に残存したとしても事故とはならない。そればかりか、糖質中に薬物を含ませておくならば刺入されたマイクロニードルが体内で溶解されることにより、容易に薬物を皮内や皮下に投与することができる（特許文献２）。
特に、ヒアルロン酸やコラーゲンなどの生体溶解性高分子物質からなるマイクロニードルは、皮膚に適用すると皮膚内水分が針部に拡散し、皮膚に差し込まれた針部が膨潤しその後溶解する。針部の溶解によるヒアルロン酸やコラーゲンの皮膚内拡散により抗しわ作用を発現し、あるいは針部に前もって溶解させている薬物や有価物質を皮膚内に放散する（特許文献３、４）。If a microneedle is made using a substance that disappears by metabolism in the body, such as sugar, as a material of the microneedle, no accident will occur even if the needle breaks and remains in the skin. In addition, if the drug is contained in the carbohydrate, the inserted microneedle is dissolved in the body, so that the drug can be easily administered intracutaneously or subcutaneously (Patent Document 2). .
In particular, when a microneedle made of a biosoluble polymer material such as hyaluronic acid or collagen is applied to the skin, moisture in the skin diffuses into the needle portion, and the needle portion inserted into the skin swells and then dissolves. Anti-wrinkle action is expressed by diffusion of hyaluronic acid and collagen into the skin due to dissolution of the needle, or drugs and valuable substances previously dissolved in the needle are released into the skin (Patent Documents 3 and 4).
マイクロニードルアレイを皮膚に長時間安定的に保持するためには、アレイよりも大面積の粘着性保護テープにより裏打ちしその粘着性によってアレイを皮膚へ密着させることが必要である。しかしながらこの粘着性保護テープは針部の溶解性に大きな影響を与える。 In order to stably hold the microneedle array on the skin for a long time, it is necessary to line the array with the adhesive protective tape having a larger area than the array and to adhere the array to the skin by the adhesiveness. However, this adhesive protective tape greatly affects the solubility of the needle part.
マイクロニードルアレイを皮膚に密着保持するため、どのような粘着テープを用いるかは、マイクロニードルパッチ設計上の重要な問題である。
すなわち水蒸気透過性の高い粘着保護テープを用いると、皮膚からの水分蒸散を保護テープが押さえることができず、針部が十分に水分膨潤しない。また、皮膚に面する側の基板側とその反対側の基板との間に膨張性の差を生じ、マイクロニードルアレイが皮膚から反り返るという不都合な現象が起こる。
水蒸気透過性が低い粘着保護テープを用いると皮膚からの水分蒸散をテープが抑え、マイクロニードルアレイの反り返りを防ぎ、しかも針部の膨潤と溶解を促進し、マイクロニードルの効果の発現が早まるとの利点を有する。しかし、皮膚からの水分蒸散を抑えるため皮膚刺激が強くなる欠点を有する。In order to keep the microneedle array in close contact with the skin, what kind of adhesive tape is used is an important problem in designing the microneedle patch.
That is, when an adhesive protective tape having a high water vapor permeability is used, the protective tape cannot suppress moisture evaporation from the skin, and the needle portion does not swell sufficiently. In addition, an inflatable difference occurs between the substrate facing the skin and the substrate on the opposite side, which causes a disadvantageous phenomenon that the microneedle array is warped from the skin.
Adhesive protective tape with low water vapor permeability suppresses moisture transpiration from the skin, prevents warping of the microneedle array, promotes needle swelling and dissolution, and accelerates the onset of microneedle effects. Have advantages. However, there is a drawback that the skin irritation becomes stronger in order to suppress moisture transpiration from the skin.
マイクロニードルアレイの基板にも問題点があった。
マイクロニードルアレイの基板を薄くすると皮膚から吸湿により曲がりやすく、端部のニードルが皮膚から抜けて効果を生じることができなくなる。これを避けるためには基板を厚くして機械的に丈夫にしなければならないが、基板を厚くすると剛直な平板形状とならざるを得ず、皮膚の微妙な曲面にフィットできなくなり、サイズが小さくせざるを得なくなる点である。There were also problems with the microneedle array substrate.
If the substrate of the microneedle array is made thin, it is likely to bend due to moisture absorption from the skin, and the needle at the end cannot be removed from the skin to produce an effect. To avoid this, the substrate must be thick and mechanically strong. It is a point that must be done.
マイクロニードルを利用する化粧品は、コスメディ製薬により世界で初めて商業的に製造され、２００８年１０月より発売された（非特許文献１）。 Cosmetics using microneedles were first commercially produced by Cosmedy Pharmaceutical and were launched in October 2008 (Non-patent Document 1).
本発明が解決しようとする課題は、従来技術の問題点を解決し、弾力性ある皮膚に広範囲にわたって確実にマイクロニードルアレイを投与できるマイクロニードルパッチを提供することである。
このためにはマイクロニードルアレイからの水分の蒸散を調節し、アレイの反り返りを防ぐと共に薬物の透過を促進し、かつ皮膚刺激を低減するマイクロニードルパッチを開発することが必要である。The problem to be solved by the present invention is to solve the problems of the prior art and to provide a microneedle patch that can reliably administer a microneedle array over a wide area on elastic skin.
For this purpose, it is necessary to develop a microneedle patch that regulates the transpiration of water from the microneedle array, prevents the array from warping, promotes drug permeation, and reduces skin irritation.
上記課題を解決するためになされた本発明に係るマイクロニードルパッチは、生体内溶解物質を素材としたマイクロニードルアレイの背部を水分低透過性の層で覆い、その背面をさらに水分高透過性の粘着保護テープで被覆することを特徴とする。Microneedle patch according to the present invention has been made to solve the above problems, the back of the microneedle arrays in vivo dissolved material as a material covered with a moisture reduced-permeability layer, further moisture hyperpermeability the rear It is characterized by being covered with an adhesive protective tape.
水分低透過性の層はマイクロニードルの背部と同じ大きさの水分低透過性テープから構成され、水分高透過性テープはマイクロニードルアレイの背部外縁より各方向に３−２０ｍｍ広がっているよう構成することが好都合である。
しかし、水分低透過性の層はテープではなく、マイクロニードルアレイ背部の被覆膜であっても良い。The low moisture permeable layer is composed of a low moisture permeable tape having the same size as the back of the microneedle, and the high moisture permeable tape is configured to extend 3-20 mm in each direction from the outer edge of the back of the microneedle array. Is convenient.
However, the low moisture permeable layer may be a coating film on the back of the microneedle array instead of the tape.
水分低透過性のフィルムとしては、ポリエチレン、ポリプロピレン、ポリエチレンテレフタレート等の水蒸気透過率が１００ｇ／ｍ２（２４ｈｒ／０．１ｍｍ）以下であるフィルムが適当である。下記の水分高透過性フィルムであってもその厚さを増大させれば水分低透過性フィルムとしての使用が可能である。水分高透過性フィルムとしては、セロハン、酢酸セルロース、ポリウレタン等の水蒸気透過率が２００ｇ／ｍ２（２４ｈｒ／０．１ｍｍ）以上のフィルムが適当である。上記の水分低透過性フィルムであってもその厚さを極めて薄くすれば水分高透過性フィルムとしての使用が可能である。これらのフィルムに粘着剤を塗布しテープとした。本発明は、水分低透過性テープと水分高透過性テープの特性を使い分け、重ね合わすことにより大きな効果を得たことが特徴である。A film having a water vapor permeability of 100 g / m 2 (24 hr / 0.1 mm) or less, such as polyethylene, polypropylene, and polyethylene terephthalate, is suitable as the low moisture permeable film. Even the following highly moisture permeable film can be used as a moisture permeable film if its thickness is increased. As the highly moisture permeable film, a film having a water vapor transmission rate of 200 g / m 2 (24 hr / 0.1 mm) or more such as cellophane, cellulose acetate and polyurethane is suitable. Even the above-described low moisture permeable film can be used as a highly permeable film if its thickness is extremely reduced. An adhesive was applied to these films to form a tape. The present invention is characterized in that a great effect is obtained by using and superimposing characteristics of a low moisture permeable tape and a high moisture permeable tape.
マイクロニードルパッチは、マイクロニードルアレイにまず水分低透過性テープを貼付し、つづいて水分高透過性テープを貼付して、３層に積層するのが製造上好都合である。
粘着剤の水蒸気透過性もフィルム材料と同様に針部溶解性に影響する。アクリル粘着剤は水蒸気透過性はゴム系粘着剤に比べて良好である。また、アクリル粘着剤の中でも親水性アクリル粘着剤はより好ましい。The microneedle patch is conveniently manufactured in such a manner that a low moisture permeable tape is first applied to the microneedle array, followed by a high moisture permeable tape and laminated in three layers.
The water vapor permeability of the pressure-sensitive adhesive affects the needle part solubility as well as the film material. The acrylic adhesive has better water vapor permeability than the rubber-based adhesive. Of the acrylic pressure-sensitive adhesives, hydrophilic acrylic pressure-sensitive adhesives are more preferable.
本発明のマイクロニードルは、ヒアルロン酸やコラーゲンのような生体内溶解物質を素材とし、針部長さは３０−１０００μｍとした。
マイクロニードルアレイの基板の面積は、特に限定する必要はないが、典型的には０．５−２００ｃｍ２とした。また、その厚みは５−３０００μｍとすることができる。The microneedle of the present invention is made of a substance dissolved in a living body such as hyaluronic acid or collagen, and has a needle length of 30 to 1000 μm.
The area of the microneedle array substrate is not particularly limited, but is typically 0.5 to 200 cm 2 . Moreover, the thickness can be 5-3000 micrometers.
水分低透過性テープは、基本的にはマイクロニードルと同型同大であるが、若干大きくても良い。厚さは３−５００μｍとした。
水分高透過性テープは、厚さは５−２００μｍとし、その面積は皮膚への粘着性を確保し、マイクロニードルアレイを皮膚上に密着保持するためマイクロニードルアレイより大きい。マイクロニードルアレイの外縁から３−２０ｍｍ程度大きくすることが適当である。粘着剤としては皮膚刺激の小さいアクリル粘着剤が適当である。The moisture low permeability tape is basically the same type and size as the microneedle, but may be slightly larger. The thickness was 3-500 μm.
The moisture-permeable tape has a thickness of 5-200 μm, and its area is larger than the microneedle array in order to ensure adhesion to the skin and to keep the microneedle array in close contact with the skin. It is appropriate to enlarge the outer edge of the microneedle array by about 3 to 20 mm. As the adhesive, an acrylic adhesive having a small skin irritation is suitable.
従来は、マイクロニードルアレイの背部のテープは１層であった。そのテープを水分低透過性とすると、針の溶解性は良好であるが、皮膚の赤みなどの皮膚刺激が発生しやすい。また水分高透過性とすると、皮膚刺激は少ないが、針部の膨潤と溶解が遅く、効果発現が悪く、アレイの反り返りも起こる。両種のテープを用いて３層構造とすることによりこのような欠点を防止することができる。
この結果マイクロニードルアレイが反ることを防止でき、これらの３層構造はマイクロニードルアレイを大面積とする時極めて優れた効果を発揮する。かつ皮膚刺激を最小限とすることができ、１枚のマイクロニードルパッチの使用で皮膚の広い範囲のしみやしわを改善することができる。Conventionally, the tape on the back of the microneedle array is a single layer. When the tape has low moisture permeability, the needle has good solubility, but skin irritation such as redness of the skin tends to occur. Further, when the moisture permeation is high, the skin irritation is small, but the swelling and dissolution of the needle part is slow, the effect is not good, and the array is warped. Such a drawback can be prevented by employing a three-layer structure using both types of tapes.
As a result, the microneedle array can be prevented from warping, and these three-layer structures exhibit extremely excellent effects when the microneedle array has a large area. In addition, skin irritation can be minimized, and the use of a single microneedle patch can improve a wide range of skin spots and wrinkles.
次に、本発明の実施例を図面を参照して詳細に説明するが、本発明は実施例に限定されるものではない。 Next, examples of the present invention will be described in detail with reference to the drawings. However, the present invention is not limited to the examples.
本発明のマイクロニードルアレイは、鋳型を用いて製造した。感光性樹脂に光照射するリソグラフィ法により円錐台型のマイクロニードルパターンを形成した後、電鋳加工することにより円錐台型のマイクロニードルパターンを転写した円錐台型のマイクロニードル形成用凹部が形成された鋳型を用いた。 The microneedle array of the present invention was manufactured using a template. After the frustoconical microneedle pattern is formed by the lithography method of irradiating the photosensitive resin with light, the frustoconical microneedle forming recess is formed by transferring the frustoconical microneedle pattern by electroforming. Used molds.
マイクロニードル形成用凹部は根元の直径が０．２ｍｍ、先端直径が０．０４ｍｍ、深さ０．８ｍの円錐台状であり、０．８ｍｍ間隔に格子状に配列されており、１ｃｍ２あたり１４４個形成されている。又、マイクロニードル形成用凹部は直径３０ｍｍの円形に形成されている。The concave portions for forming microneedles have a truncated cone shape with a root diameter of 0.2 mm, a tip diameter of 0.04 mm, and a depth of 0.8 m, and are arranged in a grid at intervals of 0.8 mm, and 144 per cm 2. Individually formed. The concave portion for forming the microneedle is formed in a circular shape having a diameter of 30 mm.
ヒアルロン酸水溶液層は、重量平均分子量１０万の高分子量ヒアルロン酸（紀文フードケミカル社製、商品名「ＦＵＨ−ＳＵ」）、培養由来）１３．５重量部と重量平均分子量１万の低分子量ヒアルロン酸（キューピー社製、商品名「ヒアルオリゴ」、培養由来）１．５重量部を水８５重量部に溶解して得られたヒアルロン酸水溶液を鋳型上に流延して形成した。
次に、加熱してヒアルロン酸水溶液層の水分を蒸発させた後、鋳型から剥離した。Hyaluronic acid aqueous solution layer is a high molecular weight hyaluronic acid having a weight average molecular weight of 100,000 (from Kibun Food Chemical Co., Ltd., trade name “FUH-SU”, derived from culture) 13.5 parts by weight and a low molecular weight hyaluron having a weight average molecular weight of 10,000. An aqueous solution of hyaluronic acid obtained by dissolving 1.5 parts by weight of acid (made by Kewpie, trade name “Hialoligo”, derived from culture) in 85 parts by weight of water was cast on a mold.
Next, after heating to evaporate the moisture in the hyaluronic acid aqueous solution layer, it was peeled off from the mold.
マイクロニードルアレイの背部に、マイクロニードルアレイと同型同大のポリエチレンテレフタレート（ＰＥＴ）テープを貼付した。さらにその上からマイクロニードルアレイ各周辺より１０ｍｍ広いポリウレタンテープを貼付した。
このようにして得られたマイクロニードルパッチを図１に示す。但し、図ではニードルの数が多くないが、実際は上記したように１ｃｍ２あたり１４４個形成されている。A polyethylene terephthalate (PET) tape of the same type and size as the microneedle array was attached to the back of the microneedle array. Further, a polyurethane tape 10 mm wider than the periphery of each microneedle array was attached thereto.
The microneedle patch thus obtained is shown in FIG. However, although the number of needles is not large in the figure, in reality, 144 needles are formed per 1 cm 2 as described above.
得られたマイクロニードルパッチを被験者の額に軽く押し当てると、マイクロニードルアレイは皮膚に容易に刺入された。６０分間刺入したがその間基板の反り返りは観察されなかった。６０分後にマイクロニードルパッチを剥離したが基板の軟化が観察された。基板を顕微鏡で観察したところ、皮膚内刺入部（マイクロニードルアレイ）は皮膚内で溶解して形をとどめなかった。 When the obtained microneedle patch was lightly pressed against the subject's forehead, the microneedle array was easily inserted into the skin. During insertion for 60 minutes, no warping of the substrate was observed during that time. After 60 minutes, the microneedle patch was peeled off, but softening of the substrate was observed. When the substrate was observed with a microscope, the puncture site (microneedle array) in the skin was dissolved in the skin and did not retain its shape.
マイクロニードルアレイと同型同大のポリエチレンテレフタレート（ＰＥＴ）テープを使用しなかった以外は全く実施例と同様なマイクロニードルパッチを作製し被験者の額に軽く押し当てると、マイクロニードルアレイは皮膚に容易に刺入された。６０分間刺入したがその間基板の著しい反り返りが観察された。６０分後にマイクロニードルパッチを剥離したが基板はまだ硬かった。基板を顕微鏡で観察したところ、皮膚内刺入部（マイクロニードルアレイ）は皮膚内で先端部が溶解していたが全体的に形をとどめていた。 The microneedle array is easily applied to the skin when a microneedle patch that is the same as the microneedle array and the same type as the polyethylene terephthalate (PET) tape is not used and is lightly pressed against the subject's forehead. It was inserted. During the 60 minutes of insertion, significant warping of the substrate was observed. The microneedle patch was peeled off after 60 minutes, but the substrate was still hard. When the substrate was observed with a microscope, the puncture site (microneedle array) in the skin had the shape of the tip portion dissolved in the skin, but remained in its entirety.
本発明によるマイクロニードルパッチは、医療や美容の分野において広く利用されるものと期待される。 The microneedle patch according to the present invention is expected to be widely used in the fields of medicine and beauty.
２……マイクロニードルアレイ
３……水分低透過性テープ
４……水分高透過性テープ2 ... Microneedle array 3 ... Low
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| US20160279401A1 (en) | 2015-03-27 | 2016-09-29 | Allergan, Inc. | Dissolvable microneedles for skin treatment |
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