JP4935391B2 - Drug delivery device - Google Patents
Drug delivery device Download PDFInfo
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- JP4935391B2 JP4935391B2 JP2007026611A JP2007026611A JP4935391B2 JP 4935391 B2 JP4935391 B2 JP 4935391B2 JP 2007026611 A JP2007026611 A JP 2007026611A JP 2007026611 A JP2007026611 A JP 2007026611A JP 4935391 B2 JP4935391 B2 JP 4935391B2
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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
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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
- A61M2037/0038—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 channel at the side surface
Description
本発明は、薬物を投与するための薬物輸送デバイスに関するものである。 The present invention relates to a drug delivery device for administering a drug.
薬物を投与する方法として、注射針により薬剤を皮内、皮下、筋肉層等へ注入が行われている。しかし、従来の注射針では表皮、真皮、皮下または筋肉層に穿刺することができるが、真皮は神経細胞が含まれるので注射針の真皮への穿刺は苦痛が大きい。これを克服するため、塗布軟膏やホクナリンテープ等のツロブテロール貼付剤のような経皮吸収剤を使用し薬剤を皮膚から投与する方法が知られている。 As a method for administering a drug, a drug is injected into an intradermal, subcutaneous, muscle layer or the like with an injection needle. However, although the conventional injection needle can puncture the epidermis, dermis, subcutaneous or muscle layer, the dermis contains nerve cells, so that the puncture of the injection needle into the dermis is very painful. In order to overcome this, a method is known in which a drug is administered from the skin using a transdermal absorbent such as a tulobuterol patch such as a coated ointment or hocnarine tape.
しかしながら、上述の方法は、穿刺による苦痛を避けることができるが、薬物を皮膚から投与するため非常に制限がある。すなわち、皮膚を容易に浸透／透過することができるのは少数の薬剤のみであり、大半の薬剤は十分な量または速度で皮膚を浸透／透過することができない。大半の薬剤が十分な量または速度で皮膚を浸透／透過することができないのは、皮膚の最表面にある角質層が原因である。角質層は厚さ２０μｍ程度の層構造をとっており、異物や微生物、ウィルス等の体内への侵入および水分等の体内からの蒸発を防ぐバリア機能を持っている。そのため、薬剤が角質層を浸透／透過することが困難となる。 However, the above-mentioned method can avoid pain caused by puncture, but is very limited because the drug is administered from the skin. That is, only a small number of drugs can easily penetrate / penetrate the skin, and most drugs cannot penetrate / penetrate the skin in a sufficient amount or rate. The inability of most drugs to penetrate / penetrate the skin at a sufficient amount or rate is due to the stratum corneum on the outermost surface of the skin. The stratum corneum has a layer structure with a thickness of about 20 μm, and has a barrier function that prevents foreign substances, microorganisms, viruses and the like from entering the body and evaporation of moisture and the like from the body. This makes it difficult for the drug to penetrate / penetrate the stratum corneum.
そこで、上述の問題点を解決する手段として、痛みを伴わない無痛針であるマイクロニードルの開発が進められている。例えば、医療用マイクロニードルとして、アレイ状に配置した貫通口の無いマイクロニードルのニードルアレイ面に予め薬剤を塗布し、ニードルアレイ面を皮膚に押し付けることにより、ニードル表面と皮膚の間を浸透する物が提案されている（特許文献１参照、非特許文献１参照）。 Therefore, as a means for solving the above-described problems, development of a microneedle, which is a painless needle without pain, is in progress. For example, as medical microneedles, an agent that penetrates between the needle surface and the skin by applying a drug in advance to the needle array surface of microneedles arranged in an array and having no through holes and pressing the needle array surface against the skin Has been proposed (see Patent Document 1 and Non-Patent Document 1).
しかしながら、上述の方法では、マイクロニードルのニードルアレイ面に薬剤を塗布するため、薬物の皮膚からの投与量は、マイクロニードルの表面積に依存する。マイクロニードルは、薬物を効率よく皮膚内に浸透させるために、表皮の厚み（５０〜１５０μｍ）を超える数百μｍ程度の長さのニードルを、アレイ状に多数配置して用いられるのが一般的であり、従来のマイクロニードルの形状、大きさでは、ニードル１本あたりの薬剤の塗布量が足りない場合、単にニードルをアレイ状に配置するだけでは、十分な量の薬剤を投与することが困難である。また、表面積を大きくするために、ニードルをそれ以上大きくすると、疼痛を感じてしまうため、無痛針として機能しなくなってしまう問題があった。 However, in the above-described method, since the drug is applied to the needle array surface of the microneedle, the dose of the drug from the skin depends on the surface area of the microneedle. In order to efficiently infiltrate the drug into the skin, microneedles are generally used by arranging a large number of needles with a length of several hundreds of micrometers exceeding the thickness of the epidermis (50 to 150 μm) in an array. In the case of the shape and size of the conventional microneedle, when the amount of drug applied per needle is insufficient, it is difficult to administer a sufficient amount of drug simply by arranging the needles in an array. It is. In addition, if the needle is made larger to increase the surface area, pain will be felt, and the needle will not function as a painless needle.
そこで、マイクロニードルの表面積に薬剤の投与量が依存しない薬物輸送デバイスとして、マイクロニードルが形成された基板が板厚方向を貫通する薬液通過用孔を持ち、マイクロニードルが形成された基板の他方の面にろ過滅菌用フィルター層と押圧されると内部から薬液が流出するように構成された薬液層が順次積層され、薬液層から流出する薬液が、ろ過滅菌用フィルター層、基板の薬液通過孔を順に通過してマイクロニードルが形成された貼付面へと移動する薬物輸送デバイスが提案されている（特許文献２参照）。
しかしながら、濾過滅菌用フィルター層と薬液層とが直接接触する構成では、押圧の程度が低い場合、充分な応力が薬液層にかからないため、薬液層の破損が起こらず、薬剤を放出できない恐れがある。 However, in the configuration where the filter layer for filter sterilization and the chemical solution layer are in direct contact, if the degree of pressing is low, sufficient stress is not applied to the chemical solution layer, so that the chemical solution layer does not break and the drug cannot be released .
そこで、本発明は、上述の問題を解決するためになされたものであり、生体へ薬物を供給する効率を向上した薬物輸送デバイスを提供することを目的とする。 Therefore, the present invention has been made to solve the above-described problems, and an object of the present invention is to provide a drug transport device with improved efficiency for supplying a drug to a living body.
請求項１に記載の本発明は、薬物を投与するための薬物輸送デバイスであって、基板と、
前記基板表面に設けられた第一の微細針状構造体と、前記第一の微細針状構造体が設けられた基板表面と逆側の基板表面に設けられた第二の微細針状構造体と、前記第二の微細針状構造体が突出している側の基板に積層された薬液層と、前記薬液層の壁面に囲まれた薬剤保持部と、を備え、第二の微細針状構造体側から最も近い薬液層の壁面の厚さが、第二の微細針状構造体の高さよりも小さく、かつ、第二の微細針構造体が、基板外縁部に選択的に形成されており、かつ、第二の微細針構造体が設けられた基板表面が、基板外縁部から基板中心部にむけて傾斜していることを特徴とする薬物輸送デバイスである。
The invention of claim 1 is a drug delivery device for administering a drug comprising a substrate,
The first fine needle-like structure provided on the substrate surface and the second fine needle-like structure provided on the substrate surface opposite to the substrate surface provided with the first fine needle-like structure And a drug solution layer laminated on the substrate on the side from which the second fine needle-like structure protrudes, and a drug holding part surrounded by the wall surface of the drug solution layer, the second fine needle-like structure the thickness of the wall of the closest chemical layer from body side, rather smaller than the height of the second fine needle-like structure, and a second microneedle structures, is selectively formed on the substrate outer edge In addition, the drug transport device is characterized in that the substrate surface on which the second fine needle structure is provided is inclined from the outer edge of the substrate toward the center of the substrate .
請求項２に記載の本発明は、請求項１に記載の薬物輸送デバイスであって、薬液層が複数積層されており、薬剤保持部を複数設けたことを特徴とする薬物輸送デバイスである。 The present invention described in claim 2 is the drug transport device according to claim 1, wherein a plurality of drug solution layers are stacked and a plurality of drug holding portions are provided.
請求項３に記載の本発明は、請求項１または２のいずれかに記載の薬物輸送デバイスであって、第二の微細針状構造体側から最も遠い薬液層の壁面の厚さと、各薬液層の壁面の厚さと、の和が、第二の微細針状構造体の高さよりも大きいことを特徴とする薬物輸送デバイスである。 The present invention according to claim 3 is the drug transport device according to claim 1 or 2, wherein the thickness of the wall surface of the drug solution layer farthest from the second fine needle-like structure side, and each drug solution layer The drug transport device is characterized in that the sum of the wall thickness and the height of the second fine needle-like structure is larger.
請求項４に記載の本発明は、請求項１から３のいずれかに記載の薬物輸送デバイスであって、基板に、第一の微細針状構造体が設けられた基板表面と、第二の微細針状構造体が設けられた基板表面と、を繋ぐ貫通孔を設けたことを特徴とする薬物輸送デバイスである。 The present invention according to claim 4 is the drug transport device according to any one of claims 1 to 3, wherein the substrate surface is provided with a first fine needle-like structure on the substrate, and the second A drug transport device comprising a through-hole that connects a substrate surface provided with a fine needle-like structure.
請求項５に記載の本発明は、請求項４に記載の薬物輸送デバイスであって、基板は、多孔質材料を用いた基板であり、貫通孔は、前記多孔質材料に形成された細孔であることを特徴とする薬物輸送デバイスである。 The present invention according to claim 5 is the drug transport device according to claim 4, wherein the substrate is a substrate using a porous material, and the through hole is a pore formed in the porous material. It is a drug delivery device characterized by being.
なお、本明細書において、「基板外縁部」とは、基板の最外周部のみに限定されず、基板表面の任意の一点から、一定の範囲の距離だけ離れた基板上の部位として定義する。
Contact name herein, "substrate edge portion" is not limited only to the outermost peripheral portion of the substrate from any one point of the substrate surface is defined as a site on the substrate at a distance of a predetermined range .
請求項６に記載の本発明は、請求項１から５のいずれかに記載の薬物輸送デバイスであって、第一の微細針状構造体は、薬理効果を示す材料により形成され、薬剤保持部に前記薬理効果を示す材料を溶出する溶剤が充填されていることを特徴とする薬物輸送デバイスである。 The present invention according to claim 6 is the drug transport device according to any one of claims 1 to 5 , wherein the first fine needle-like structure is formed of a material exhibiting a pharmacological effect, A drug transport device characterized in that a solvent for eluting the material exhibiting the pharmacological effect is filled in.
本発明の薬物輸送デバイスは、押圧された場合、機械的応力が第二の微細針状構造体の先端部に集中するため、押圧の程度が低くとも、第二の微細針状構造体は薬液層の壁面に穿刺し、薬剤保持部に保持された薬剤を効率的に放出することが出来る。 In the drug delivery device of the present invention, when pressed, the mechanical stress concentrates on the tip of the second fine needle-like structure, so the second fine needle-like structure is a chemical solution even if the degree of pressing is low. The wall of the layer is punctured and the drug held in the drug holding part can be efficiently released.
本発明の薬物輸送デバイスについて説明を行う。
本発明の薬物輸送デバイスは、
基板と、
前記基板表面に設けられた第一の微細針状構造体と、
前記第一の微細針状構造体が設けられた基板表面と逆側の基板表面に設けられた第二の微細針状構造体と、
前記第二の微細針状構造体が突出している側の基板に積層された薬液層と、
前記薬液層の壁面に囲まれた薬剤保持部と、を備え、
第二の微細針状構造体側から最も近い薬液層の壁面の厚さが、第二の微細針状構造体の高さよりも小さいこと
を特徴とする。
The drug delivery device of the present invention will be described.
The drug delivery device of the present invention comprises:
A substrate,
A first fine needle-like structure provided on the substrate surface;
A second fine needle-like structure provided on the substrate surface opposite to the substrate surface provided with the first fine needle-like structure;
A chemical solution layer laminated on the substrate on which the second fine needle-like structure protrudes, and
A drug holding part surrounded by the wall surface of the drug solution layer,
The thickness of the wall surface of the chemical solution layer closest to the second fine needle-like structure side is smaller than the height of the second fine needle-like structure.
本発明の薬物輸送デバイスの一例について、図１〜５を用いて具体的に説明を行う。当然のことながら、本発明の薬物輸送デバイスは図１〜５に例示した一例に限定されるものではない。図１は、本発明に係る薬物輸送デバイスの一例を示す断面図であり、図１（ａ）は薬液層２を穿刺する前の状態を示す図、図１（ｂ）は薬液層２を穿刺した状態を示す図である。 An example of the drug delivery device of the present invention will be specifically described with reference to FIGS. As a matter of course, the drug delivery device of the present invention is not limited to the example illustrated in FIGS. FIG. 1 is a cross-sectional view showing an example of a drug delivery device according to the present invention, where FIG. 1 (a) shows a state before puncturing the drug solution layer 2, and FIG. 1 (b) shows a puncture of the drug solution layer 2. It is a figure which shows the state which carried out.
基板は、第一の微細針状構造体と、第二の微細針状構造体を支持するために設けられる。基板の厚さは、特に限定されず、材料、薬物輸送デバイスの用途などに応じて決定することが出来る。具体的には、１００μｍ〜３ｍｍ程度であっても良い。 The substrate is provided to support the first fine needle-like structure and the second fine needle-like structure. The thickness of the substrate is not particularly limited and can be determined according to the material, the use of the drug delivery device, and the like. Specifically, it may be about 100 μm to 3 mm.
また、基板には、第一の微細針状構造体が設けられた基板表面と、第二の微細針状構造体が設けられた基板表面と、を繋ぐ貫通孔を設けることが好ましい。基板に貫通孔を設けることで、押圧時に放出された薬剤を第一の微細針状構造体が形成された表面側へと移動させる薬剤通過路として貫通孔を用いることが出来る。基板に貫通孔を設ける方法としては、貫通孔の寸法に応じて好適な方法を選択して良い。例えば、エッチング、レーザー加工などを用いて形成しても良い。貫通孔の寸法は、薬剤、薬物輸送デバイスの用途などに応じて決定することが出来る。人間の皮膚を対象とし、一般的な経皮浸透薬を用いた場合、具体的には、内径は５μｍ〜１００μｍ程度、密度は１ｃｍ２あたり５００個〜１０００個程度、より好ましくは７００個〜９００個程度であることが望ましい。 The substrate is preferably provided with a through hole that connects the substrate surface provided with the first fine needle-like structure and the substrate surface provided with the second fine needle-like structure. By providing a through-hole in the substrate, the through-hole can be used as a drug passage for moving the drug released at the time of pressing to the surface side on which the first fine needle-like structure is formed. As a method of providing the through hole in the substrate, a suitable method may be selected according to the size of the through hole. For example, it may be formed using etching, laser processing, or the like. The size of the through hole can be determined according to the use of the drug, the drug delivery device, and the like. When human skin is used and a general transdermal penetrating agent is used, specifically, the inner diameter is about 5 μm to 100 μm, and the density is about 500 to 1000 per cm 2 , more preferably 700 to 900. It is desirable to have about one.
また、基板の材料は、特に限定されず、例えば、プラスチック、セラミック、シリコン、ガラス、金属などを用いても良い。生体に薬剤を供給するための薬物輸送デバイスであることを考慮するとチタン、ポリ乳酸等の生体に低刺激な物質が好ましい。 The material of the substrate is not particularly limited, and for example, plastic, ceramic, silicon, glass, metal, or the like may be used. Considering that it is a drug transport device for supplying a drug to a living body, a substance that is hypoallergenic to the living body such as titanium and polylactic acid is preferable.
また、図２に示すように、基板は、多孔質材料を用いた基板であり、貫通孔は、前記多孔質材料に形成された細孔であることが好ましい。材料として多孔質材料を用いることにより、薬剤通過路にろ過滅菌フィルターを兼ね備えた構成とすることが出来る。前記多孔質材料としては、例えば、多孔質シリコンや多孔質ガラス等を用いて良い。 In addition, as shown in FIG. 2, the substrate is preferably a substrate using a porous material, and the through hole is preferably a pore formed in the porous material. By using a porous material as the material, it is possible to adopt a configuration in which a drug sterilization filter is also provided with a filter sterilization filter. For example, porous silicon or porous glass may be used as the porous material.
第一の微細針状構造体は、薬物投与先を穿刺するために設けられる。第一の微細針状構造体は、対象を穿刺することが出来れば、少なくとも１つあれば良いが、薬剤供給の効率を重視すれば多数をアレイ状に形成することが望ましい。第一の微細針状構造体の寸法は、対象の構造、薬物輸送デバイスの用途などに応じて決定することが出来る。人間の皮膚を対象とした場合、無痛針としての機能を保持するためには、皮膚における角質層の厚さ以上、表皮の厚さ以下とすることが好ましく、具体的には、高さは２０μｍ以上５００μｍ以下、より好ましくは３０μｍ以上２５０μｍ以下の範囲であることが望ましい。また、アレイ密度は、１ｃｍ２あたり５００個〜１０００個、より好ましくは７００個〜９００個程度であることが望ましい。 The first fine needle-like structure is provided to puncture a drug administration destination. At least one first fine needle-like structure may be used as long as the target can be punctured. However, it is desirable that a large number of the first fine needle-like structures be formed in an array if importance is placed on the efficiency of drug supply. The dimension of the first fine needle-like structure can be determined according to the structure of the object, the use of the drug delivery device, and the like. In the case of human skin, in order to maintain the function as a painless needle, it is preferable that the thickness is not less than the stratum corneum thickness in the skin and not more than the thickness of the epidermis. Specifically, the height is 20 μm. It is desirable that it is in the range of not less than 500 μm, more preferably not less than 30 μm and not more than 250 μm. The array density is desirably about 500 to 1000, more preferably about 700 to 900 per 1 cm 2 .
また、第一の微細針状構造体は、薬理効果を示す材料により形成され、後述する薬剤保持部に前記薬理効果を示す材料を溶出する溶剤が充填されていることが好ましい。これにより、押圧時に穿刺した第一の微細針状構造体が溶出し、第一の微細針状構造体が穿刺した部位のみに選択的に薬理効果を示す物質を投与することが出来る。このため、少ない投与量であっても対象部位に薬理効果が発現することが期待できる。 In addition, the first fine needle-like structure is preferably formed of a material exhibiting a pharmacological effect, and a drug holding portion described later is filled with a solvent that elutes the material exhibiting the pharmacological effect. As a result, the first fine needle-like structure punctured at the time of pressing is eluted, and a substance exhibiting a pharmacological effect can be selectively administered only to the site where the first fine needle-like structure is punctured. For this reason, it can be expected that a pharmacological effect appears in the target site even with a small dose.
第二の微細針状体構造体は、薬液層の壁面を穿刺するために設けられる。このため、少なくとも、第二の微細針状構造体の高さは、第二の微細針状構造体側から最も近い薬液層の壁面の厚さよりも高いことが求められる。第二の微細針状体構造体は、対象を穿刺することが出来れば、少なくとも１つあれば良いが、薬剤放出の効率を重視すれば多数をアレイ状に形成することが望ましい。 The second fine needle-like body structure is provided to puncture the wall surface of the drug solution layer. For this reason, at least the height of the second fine needle-like structure is required to be higher than the thickness of the wall surface of the chemical liquid layer closest to the second fine needle-like structure. At least one second fine needle-like body structure may be used as long as the target can be punctured. However, if importance is placed on the efficiency of drug release, it is desirable to form a large number in the form of an array.
また、図３に示すように、本発明の薬物輸送デバイスは、第二の微細針状構造体が、基板外縁部に選択的に形成されていることが好ましい。基板外縁部に選択的に形成されていることにより、押圧時にかかる負荷を、より第二の微細針状構造体の先端に集中することが出来る。 Moreover, as shown in FIG. 3, it is preferable that the 2nd fine acicular structure is selectively formed in the board | substrate outer edge part as for the drug delivery device of this invention. By being selectively formed on the outer edge of the substrate, the load applied during pressing can be more concentrated on the tip of the second fine needle-like structure.
このとき、図４に示すように、本発明の薬物輸送デバイスは、第二の微細針構造体が設けられた基板表面が、基板外縁部から基板中心部にむけて傾斜していることが好ましい。基板が傾斜することにより、放出された薬剤は基板の傾斜に沿って流れるため、押圧によって放出された薬剤が基板側面から溢れ出すことを抑制することが出来る。このため、押圧した部位のみに、選択的に薬剤を投与することが出来る。 At this time, as shown in FIG. 4, in the drug delivery device of the present invention, it is preferable that the substrate surface on which the second fine needle structure is provided is inclined from the outer edge of the substrate toward the center of the substrate. . Since the released medicine flows along the inclination of the substrate due to the inclination of the substrate, it is possible to suppress the medicine released by pressing from overflowing from the side surface of the substrate. For this reason, a chemical | medical agent can be selectively administered only to the site | part pressed.
第一の微細針状構造体および第二の微細針状構造体（以下、単に微細針状構造体と呼称する）は、共に、寸法に応じて好適な製造方法を選択して良く、例えば、基板を加工することで基板と一体となって形成する方法、基板に外部から微細針状構造体別途接着する方法、片方の微細針状構造体を基板に加工して形成し、もう一方の微細針状構造体を別途接着する方法、基板に微細針状構造体の材料を積層し、積層した材料を所望の形状に形成する方法などを用いて良い。また、加工する工程に際して、例えば、エッチング、フォトリソグラフィー、メッキ形成、レーザー加工、射出成型等の公知の技術を活用して良い。また、各微細針状構造体と基板とは、それぞれ同じ材料からなるものでも、別の材料からなるものでもよい。 For the first fine needle-like structure and the second fine needle-like structure (hereinafter simply referred to as the fine needle-like structure), a suitable manufacturing method may be selected according to the dimensions. A method of forming the substrate integrally with the substrate by processing, a method of separately adhering the fine needle-like structure to the substrate from the outside, processing one of the fine needle-like structures on the substrate, and forming the other fine A method of separately adhering the acicular structure, a method of laminating the material of the fine acicular structure on the substrate, and forming the laminated material into a desired shape may be used. In the processing step, a known technique such as etching, photolithography, plating formation, laser processing, injection molding, or the like may be used. Further, each fine needle-like structure and the substrate may be made of the same material or different materials.
また、微細針状構造体の形状は、用いた製造方法に応じて適宜設計することが出来、穿刺に好ましい形状であることが望ましい。例えば、円錐状、四角錐状等の各種錐形状などであっても良い。また、微細針状構造体に、薬剤が流れるための流路を設けた構造として、中空構造、多孔質構造、側面部に溝を設けた構造であっても良い。 Further, the shape of the fine needle-like structure can be appropriately designed according to the manufacturing method used, and is preferably a shape preferable for puncture. For example, various cone shapes such as a cone shape and a quadrangular pyramid shape may be used. In addition, the structure in which the flow path for the drug flows is provided in the fine needle-like structure may be a hollow structure, a porous structure, or a structure in which a groove is provided in the side surface.
薬液層は、第二の微細針状構造体が突出している側の基板に積層され、薬剤保持部を外気から気密するために設けられる。薬液層を設けることにより、その内部の空孔である薬剤保持部に薬剤を保持することが出来る。このため、マイクロニードルの表面積に依存することなく、処方に応じて、薬剤を投与する量を決定することが出来る。また、薬剤の保持量を考慮することなく、第一の微細針状構造体を設計することが出来るため、第一の微細状針構造体の１つ１つを小さくしたり、本数を減らしたりすることが出来、無痛針としての効果をより発揮することが期待できる。 The drug solution layer is laminated on the substrate on the side from which the second fine needle-like structure protrudes, and is provided to hermetically seal the drug holding part from the outside air. By providing the drug solution layer, the drug can be held in the drug holding part which is a hole inside the drug solution layer. For this reason, the quantity which administers a chemical | medical agent can be determined according to prescription, without depending on the surface area of a microneedle. In addition, since the first fine needle-like structure can be designed without considering the amount of the drug retained, each of the first fine needle-like structures can be made smaller or the number can be reduced. It can be expected that it will be more effective as a painless needle.
薬剤保持部は、薬液層の壁面に囲まれた部位であり、薬剤を保持するために設けられる。薬液の漏洩防止や、薬液と外気との接触を防止するためには、薬液層の壁面により密封されていることが好ましい。また、薬剤保持部は、海綿や不織布、水性ゲルなどの柔軟な多孔性物質を内部に備えていても良い。多孔性物質を備えることで、薬液や溶媒を多孔性物質内の細孔に保持することが出来る。 The drug holding part is a part surrounded by the wall surface of the drug solution layer and is provided to hold the drug. In order to prevent leakage of the chemical solution and contact between the chemical solution and the outside air, it is preferably sealed by the wall surface of the chemical solution layer. Moreover, the chemical | medical agent holding | maintenance part may be equipped with flexible porous substances, such as sponge, a nonwoven fabric, and aqueous gel, inside. By providing the porous material, the chemical solution and the solvent can be held in the pores in the porous material.
また、図５に示すように、本発明の薬物輸送デバイスは、薬液層が複数積層されており、薬剤保持部を複数設けたことが好ましい。薬剤保持部を複数設けることにより、複数の薬剤を一つの薬物輸送デバイス内に収納することが出来、一度に複数種の薬剤を投与することが出来る。このため、処方により複数の薬剤を一度に投与する場合であっても対応することが出来る。 In addition, as shown in FIG. 5, the drug transport device of the present invention preferably includes a plurality of drug solution layers and a plurality of drug holding portions. By providing a plurality of drug holding portions, a plurality of drugs can be stored in one drug transport device, and a plurality of types of drugs can be administered at one time. For this reason, even if it is a case where a plurality of medicines are administered at a time by prescription, it can cope.
本発明の薬物輸送デバイスは、第二の微細針状構造体側から最も近い薬液層の壁面の厚さが、第二の微細針状構造体の高さよりも小さいことを特徴とする。第二の微細針状構造体側から最も近い薬液層の壁面の厚さが、第二の微細針状構造体の高さよりも小さいことにより、押圧された場合、第二の微細針状構造体は薬液層の壁面に穿刺し、最も近い薬液層の壁面を貫通することが出来る。このため、薬剤保持部に保持された薬剤を、第二の微細針状構造体が貫通した部位から、効率的に放出することが出来る。第二の微細針状構造体側から最も近い薬液層の壁面の厚さは、薬剤を気密できる程度に応じて、適宜設計を行って良い。一般的な経皮浸透薬を用いた場合、具体的には、２００μｍ以上４ｍｍ以下、より好ましくは１５０μｍ以上２ｍｍ以下とすることが望ましい。 The drug delivery device of the present invention is characterized in that the thickness of the wall surface of the drug solution layer closest from the second fine needle-like structure side is smaller than the height of the second fine needle-like structure. When the thickness of the wall surface of the chemical liquid layer closest to the second fine needle-like structure side is pressed by being smaller than the height of the second fine needle-like structure, the second fine needle-like structure is It is possible to puncture the wall surface of the chemical solution layer and penetrate the wall surface of the closest chemical solution layer. For this reason, the chemical | medical agent hold | maintained at the chemical | medical agent holding | maintenance part can be efficiently discharge | released from the site | part through which the 2nd fine acicular structure penetrated. The thickness of the wall surface of the drug solution layer closest to the second fine needle-like structure side may be appropriately designed according to the extent to which the drug can be airtight. Specifically, when a general transdermal penetrating agent is used, it is desirable that the thickness be 200 μm or more and 4 mm or less, more preferably 150 μm or more and 2 mm or less.
また、第二の微細針状構造体側から最も遠い薬液層の壁面の厚さと、各薬液層の壁面の厚さと、の和が、第二の微細針状構造体の高さよりも大きいことが好ましい。これにより、押圧後、第二の微細針状構造体が薬液層のすべてを貫通し、基板と反対側に穿孔を作ることを抑制することが出来る。このため、余分な薬剤の流出を抑制することが出来る。また、押圧に際して、押圧する側への刺突（例えば、使用者の指などへの刺突）を抑制することが出来る（図１（ｂ）、図５（ｂ））。また、第二の微細針状構造体側から最も遠い薬液層の壁面は、押圧する側への刺突（例えば、使用者の指などへの刺突）への考慮として、柔軟な層であっても良く、例えば、不織布、発泡スチロール、スポンジにより構成されていても良い。 Further, the sum of the wall thickness of the chemical liquid layer farthest from the second fine needle-like structure side and the wall thickness of each chemical liquid layer is preferably larger than the height of the second fine needle-like structure. . Thereby, it can suppress that a 2nd fine acicular structure penetrates all the chemical | medical solution layers, and makes a perforation on the opposite side to a board | substrate after pressing. For this reason, the outflow of excess medicine can be suppressed. Moreover, the puncture to the side to press (for example, piercing to a user's finger | toe etc.) can be suppressed in the case of a press (FIG.1 (b), FIG.5 (b)). Further, the wall surface of the chemical solution layer farthest from the second fine needle-like structure side is a flexible layer in consideration of a piercing to the pressing side (for example, a piercing to a user's finger). For example, you may be comprised by the nonwoven fabric, the polystyrene foam, and sponge.
薬液層を、第二の微細針状構造体が突出している側の基板に積層する方法としては、押圧前に薬液層が貫通されない程度に保持することが出来ればよく、特に限定されない。例えば、熱融着、接着剤や粘着剤による接着などにより積層を行っても良い。 The method for laminating the chemical liquid layer on the substrate on the side from which the second fine needle-like structure protrudes is not particularly limited as long as the chemical liquid layer can be held so as not to penetrate before pressing. For example, lamination may be performed by heat fusion, adhesion with an adhesive or a pressure sensitive adhesive, and the like.
本発明の薬物輸送デバイスを使用するときは、第一の微細針状構造体側を生体に対面し、押圧する。これにより、第二の微細針状構造体は薬液層の壁面に穿刺し、薬剤保持部に保持された薬剤を効率的に放出することが出来、第一の微細針状構造体は薬剤投与先の対象に穿孔し、放出された薬剤を対象に効率的に投与することが出来る。このとき、押圧の程度が低くとも、機械的応力が第二の微細針状構造体の先端部に集中するため、薬剤保持部に保持された薬剤を、効率的に放出することが出来る（図１（ｂ）、図５（ｂ））。 When using the drug delivery device of the present invention, the first fine needle-like structure side faces the living body and is pressed. Thereby, the second fine needle-like structure can puncture the wall surface of the drug solution layer, and the drug held in the drug holding part can be efficiently released. In this case, the released drug can be efficiently administered to the subject. At this time, even if the degree of pressing is low, the mechanical stress concentrates on the distal end portion of the second fine needle-like structure, so that the medicine held in the medicine holding portion can be efficiently released (FIG. 1 (b), FIG. 5 (b)).
本発明の薬物輸送デバイスは、薬物を投与することが求められる分野について広範に用いることが出来、例えば、医療、創薬、化粧品などの分野に用いることが期待できる。 The drug delivery device of the present invention can be widely used in fields where it is required to administer drugs, and can be expected to be used in fields such as medicine, drug discovery, and cosmetics.
１・・・基板
２・・・薬液層
３・・・第一の微細針状構造体
４・・・第二の微細針状構造体
５・・・貫通孔
６・・・薬剤保持部
７・・・第二の微細針状構造体側から最も遠い薬液層の壁面
８・・・第二の微細針状構造体側から最も近い薬液層の壁面
９・・・多孔性の基板
１０・・・各薬液層の壁面
DESCRIPTION OF SYMBOLS 1 ... Board | substrate 2 ... Chemical solution layer 3 ... 1st fine acicular structure 4 ... 2nd fine acicular structure 5 ... Through-hole 6 ... Drug holding | maintenance part 7 .... Wall surface 8 of the chemical solution layer farthest from the second fine needle-like structure side ... Wall surface 9 of the chemical solution layer closest to the second fine needle-like structure side ... Porous substrate 10 ... Each chemical solution Layer wall
Claims (6)
基板と、
前記基板表面に設けられた第一の微細針状構造体と、
前記第一の微細針状構造体が設けられた基板表面と逆側の基板表面に設けられた第二の微細針状構造体と、
前記第二の微細針状構造体が突出している側の基板に積層された薬液層と、
前記薬液層の壁面に囲まれた薬剤保持部と、を備え、
第二の微細針状構造体側から最も近い薬液層の壁面の厚さが、第二の微細針状構造体の高さよりも小さく、かつ、
第二の微細針構造体が、基板外縁部に選択的に形成されており、かつ、
第二の微細針構造体が設けられた基板表面が、基板外縁部から基板中心部にむけて傾斜していること
を特徴とする薬物輸送デバイス。 A drug delivery device for administering a drug, comprising:
A substrate,
A first fine needle-like structure provided on the substrate surface;
A second fine needle-like structure provided on the substrate surface opposite to the substrate surface provided with the first fine needle-like structure;
A chemical solution layer laminated on the substrate on which the second fine needle-like structure protrudes, and
A drug holding part surrounded by the wall surface of the drug solution layer,
The thickness of the wall of the closest chemical layer from the second fine acicular structure side is rather smaller than the height of the second fine needle-like structure, and,
A second fine needle structure is selectively formed on the outer edge of the substrate; and
A drug transport device , wherein a substrate surface provided with the second fine needle structure is inclined from the outer edge of the substrate toward the center of the substrate .
薬液層が複数積層されており、
薬剤保持部を複数設けたこと
を特徴とする薬物輸送デバイス。 The drug delivery device according to claim 1, wherein
Multiple chemical layers are stacked,
A drug transport device comprising a plurality of drug holding portions.
第二の微細針状構造体側から最も遠い薬液層の壁面の厚さと、各薬液層の壁面の厚さと、
の和が、第二の微細針状構造体の高さよりも大きいこと
を特徴とする薬物輸送デバイス。 A drug delivery device according to claim 1 or 2,
The thickness of the wall surface of the chemical solution layer farthest from the second fine needle-like structure side, the thickness of the wall surface of each chemical solution layer,
The drug transport device, wherein the sum of the above is greater than the height of the second fine needle-like structure.
基板に、第一の微細針状構造体が設けられた基板表面と、第二の微細針状構造体が設けられた基板表面と、を繋ぐ貫通孔を設けたこと
を特徴とする薬物輸送デバイス。 The drug delivery device according to any one of claims 1 to 3,
A drug transport device comprising a substrate provided with a through-hole connecting a substrate surface provided with a first fine needle-like structure and a substrate surface provided with a second fine needle-like structure. .
基板は、多孔質材料を用いた基板であり、
貫通孔は、前記多孔質材料に形成された細孔であること
を特徴とする薬物輸送デバイス。 A drug delivery device according to claim 4,
The substrate is a substrate using a porous material,
The drug transport device, wherein the through-hole is a pore formed in the porous material.
第一の微細針状構造体は、薬理効果を示す材料により形成され、
薬剤保持部に前記薬理効果を示す材料を溶出する溶剤が充填されていること
を特徴とする薬物輸送デバイス。
The drug delivery device according to any one of claims 1 to 5 ,
The first fine needle-like structure is formed of a material exhibiting a pharmacological effect,
A drug delivery device, wherein a drug holding part is filled with a solvent that elutes a material exhibiting the pharmacological effect.
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