JP6334592B2 - 中空のマイクロニードルアレイ及び方法 - Google Patents
中空のマイクロニードルアレイ及び方法 Download PDFInfo
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- JP6334592B2 JP6334592B2 JP2016077924A JP2016077924A JP6334592B2 JP 6334592 B2 JP6334592 B2 JP 6334592B2 JP 2016077924 A JP2016077924 A JP 2016077924A JP 2016077924 A JP2016077924 A JP 2016077924A JP 6334592 B2 JP6334592 B2 JP 6334592B2
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- 230000003612 virological effect Effects 0.000 description 1
- 108020001612 μ-opioid receptors Proteins 0.000 description 1
Classifications
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Description
マイクロニードルデバイス10は、複数の18個のマイクロニードル14がそこから延在する基材12を備えるマイクロニードルアレイ11を有する。それぞれのマイクロニードル14は、基部16から先端18までおよそ500μmの高さを有する。中空のチャネル(図示せず)は、基材12及びマイクロニードル14を通して延在し、マイクロニードルの先端近くにおいてチャネル開口部20で抜ける。これによって、アレイの後部から(例えばリザーバ(図示せず)から)それぞれのマイクロニードル14を通って、流体連通が可能である。チャネルは、マイクロニードル14の中心軸線に沿って伸びるが、皮下注射針と同様に、マイクロニードルの勾配のある側壁で抜けて、挿入時の組織による閉塞を防ぐのに役立つ。チャネルは、約20〜50平方μmの平均断面積を有する。
図1Aに関連して上述のマイクロニードルアレイデバイスが、次の実験及び実施例に使用された。
無毛モルモット(HGP)
オスのHGPを、IACUC承認の3M動物使用の適用に準拠して、Charles River Laboratories(Wilmington,MA)から注文し、そのプロトコルに基づいて使用した。本試験で使用した動物はすべて、体重が0.8〜1kgであった。
試験は、IACUC承認の3M動物使用の適用に準拠して取得した、体重がおよそ10〜30kgである、生後およそ6〜18週のメスの家畜ブタに行った。注入中、及び本試験全体を通して、ブタは、イソフルラン(2〜5%)と酸素との混合の麻酔下に維持された。ブタの上臀部を、最初に手術用クリッパー(クリップ刃#50)を使用して剃毛し、次に少量のGillette Foamシェービングクリームを使用して、Schick3かみそりで剃毛した。剃毛後、部位を水で濯ぎ、軽くたたいて水気を拭き取ってから、イソプロピルアルコール(Phoenix Pharmaceutical,Inc.,St.Joseph,MO)で拭いた。
それぞれの時点で、Vacutainer Collections Set(Becton Dickenson & Co.,Franklin Lakes,NJ)を使用して、ブタの耳静脈から1.5〜2mLの全血を採取した。血液は、少なくとも30分間室温で放置した後、1500rpmで10分間遠心分離した。遠心分離後、血清は全血から分離されて、抽出まで冷所に保管された。
技術文献に基づき、かつミクロ構造の寸法を考慮して、角質層を貫通するために1ミクロ構造当たり0.004〜0.16Nの力が必要であると推定された。S.P.David,B.J.Landis,Z.H.Adams,M.G.Allen,M.R.Prausnitz.Insertion of microneedles into skin:measurement and prediction of insertion force and needle fracture force.Journal of Biomechanics.37:115〜116(2004)。本明細書で用いられるミクロ構造の十分な耐久性を確実にするために、アレイは非弾性表面に接して押され、およそ245Nの力がアレイに加えられたとき、先端に曲げが生じた。
大量注入が家畜ブタに実証された。ブタに使用した注入システムは、貼付後に中空のマイクロニードルアレイ貼付剤に接続されて、標準医療用具を用いて、配合物の送達を提供する。中空のマイクロニードル貼付用貼付剤は、インライン滅菌済みDTX Plus TNF−R圧変換器(BD Infusion Therapy Systems,Inc,Sandy,UT)を含む、市販の滅菌済みPolyethylene IV Extension Set(Vygon Corporation,Ecouen,France)を経由して、Medfusion 3500シリンジポンプ(Smiths Medical,St.Paul,MN)につながれる。Medfusion 3500ポンプは、病院現場で一般に使用され、あらかじめ設定された安全停止機能有する。圧力数値を、2秒ごとにおよそ1測定の速度で記録した。5%デキストロースUSP注射剤液(Baxter Healthcare,Deerfield,IL)をそのまま注入に使用した。0.001%メチレンブルー溶液を滅菌水で調製して、投与前にろ過した。
注入の定量化を改善させるために、中空のマイクロニードルPOCデバイスを使用して、ナロキソンの1mg/mLの市販配合物をブタに注入した。ナロキソンは、μ−オピオイドレセプター競合拮抗薬で、ヘロイン等の薬物の過剰投与を抑制するために主に使用される。ナロキソンは、速く反応させるために通常は静脈内に投与され、経口投与の場合、約2%のみ生体に作用する。ナロキソンは吸収性が良いが、初回通過中にほぼ90%が除去される。文献レビューによると、ナロキソンの半減期は成人の場合30〜81分で、小児の場合はそれより相当長い(およそ3時間)。ナロキソンは代謝産物として尿に排泄される。
上述した用具と同じものを使用して、大量、高速注入をヒトで実証した。ヒト臨床試験において、28人の被験者に、4〜6回連続の中空のマイクロニードルによるプラセボ注入が、上腕、及び/又は大腿部に投与された。背圧は、注入全体を通して、連続的にモニタされた。10点の痛みの尺度(図4を参照)を使用して、被験者はそれぞれ、中空のマイクロニードル貼付剤の貼付、及び除去に関連する痛みを評価することを求められた。被験者は、注入中10分ごとに、又は注入が10分未満で終了した場合は注入の終了時に、注入に関連した痛みを評価することも求められた。
Claims (4)
- 中空のマイクロニードルのアレイであって、
基材と、
該基材から突出するように配置され、100μm超〜1mm未満の長さを有する10〜30個の中空のマイクロニードルであって、1個の前記マイクロニードルは、隣接する他の前記マイクロニードルと平均2mm以上の間隔を持つ、中空のマイクロニードルと、を備え、
前記マイクロニードルのうちの少なくとも一部は、勾配のある側壁を有し、該勾配のある側壁は、チャネルの出口孔を含み、
前記マイクロニードルは、断面積20〜50平方μmの平均チャネル孔を有している、中空のマイクロニードルのアレイ。 - 13〜20個の前記マイクロニードルを有する、請求項1に記載の中空のマイクロニードルのアレイ。
- 前記マイクロニードルは、金属、シリコン、またはポリカーボネートを有する、請求項1又は2に記載の中空のマイクロニードルのアレイ。
- 前記マイクロニードルは、500μm超の長さを有する、請求項1〜3のいずれか一項に記載の中空のマイクロニードルのアレイ。
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EP3354312A1 (en) | 2009-07-31 | 2018-08-01 | 3M Innovative Properties Co. | Hollow microneedle arrays |
US9693950B2 (en) | 2010-05-28 | 2017-07-04 | 3M Innovative Properties Company | Aqueous formulations for coating microneedle arrays |
US20120143119A1 (en) * | 2010-12-02 | 2012-06-07 | Lanco Biosciences, Inc. | Delivery of Serotonin Receptor Antagonists By Microinjection Systems |
WO2012098503A1 (en) * | 2011-01-18 | 2012-07-26 | Nanopass Technologies Ltd. | Medication delivery assembly |
CA2847711C (en) | 2011-09-07 | 2019-08-20 | 3M Innovative Properties Company | Delivery system for hollow microneedle arrays |
AU2012328448B2 (en) * | 2011-10-28 | 2017-02-02 | Sung-Yun Kwon | Dissolving solid solution perforator patch for migraine treatment |
CA2857502C (en) | 2011-11-30 | 2019-08-13 | 3M Innovative Properties Company | Microneedle device including a peptide therapeutic agent and an amino acid and methods of making and using the same |
CN104736192B (zh) | 2012-10-10 | 2018-02-13 | 3M创新有限公司 | 用于将微针装置施用至皮肤的施用装置和方法 |
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ES2873202T3 (es) | 2013-01-08 | 2021-11-03 | Kindeva Drug Delivery Lp | Aplicador para aplicar un dispositivo de microagujas a la piel |
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SG10201500415VA (en) | 2015-03-30 |
EP2355887B1 (en) | 2017-08-02 |
AU2009316789A1 (en) | 2010-05-27 |
WO2010059605A2 (en) | 2010-05-27 |
KR20110086854A (ko) | 2011-08-01 |
JP2012509106A (ja) | 2012-04-19 |
MX349292B (es) | 2017-07-21 |
AU2009316789B2 (en) | 2013-09-19 |
KR20190064676A (ko) | 2019-06-10 |
KR20160150109A (ko) | 2016-12-28 |
RU2011120269A (ru) | 2012-12-27 |
RU2494769C2 (ru) | 2013-10-10 |
EP2355887A4 (en) | 2012-04-25 |
US20110213335A1 (en) | 2011-09-01 |
BRPI0916150A2 (pt) | 2015-11-03 |
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