JP2022549977A - 発熱素子を有するマイクロニードルアレイ - Google Patents
発熱素子を有するマイクロニードルアレイ Download PDFInfo
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- JP2022549977A JP2022549977A JP2021552564A JP2021552564A JP2022549977A JP 2022549977 A JP2022549977 A JP 2022549977A JP 2021552564 A JP2021552564 A JP 2021552564A JP 2021552564 A JP2021552564 A JP 2021552564A JP 2022549977 A JP2022549977 A JP 2022549977A
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- Prior art keywords
- microneedle array
- intradermal administration
- microneedle
- administration according
- heat
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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- Epidemiology (AREA)
- Medicinal Preparation (AREA)
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Abstract
Description
1.マイクロニードルシステムの製造
スマトリプタンコハク酸塩、ポリビニルピロリドン(PVP)、ポリソルベート80およびグリセリンを、表1にしたがって異なる割合で水に溶解した。これらの溶液をシリコーン製のニードルネガティブマトリクス鋳型(needle-negative matrices)に注ぎ、その表面にプラチナの薄層を蒸着した。ネガティブマトリクスを様々な溶液とともに室温で一晩乾燥させた。乾燥したマイクロニードルシステムは、慎重にマトリックスから押し出され、次の使用まで防湿性のある特別なPE容器に保管された。
皮膚として、ゲッティンガー・ミニピッグハウト(Ellegaard Gottingen Minipigs Agricultural Service, Dalmose, Denmark)の背中の部分を使用した。冷凍状態で皮下脂肪組織のない、いわゆるフルスキンとして届けられた皮膚は、まず室温で解凍し、シェービングフォームを使わずにたっぷりの水で丁寧に剃って剛毛を除去する必要がある。
透過試験は,拡散面積1.595cm2,受容体容量10mlの静的および垂直なFranzセル(Glastechnik Grafenroda,ドイツ)で行った。使用したアクセプター媒体は、DAB10に準拠したpH値7.4のリン酸塩緩衝液で、浸透時間全体を通して32℃に調温され、浸透した活性成分を均一に混合するために絶えず撹拌された。
C18-Inertsil分離カラム(250×4.6mm、粒子径5μm、VDS Optilab社、ベルリン)を用いたHPLCにより、282nm、30℃でUV検出を行い、分析測定を行った。溶離液には、アセトニトリル、メタノール、0.02167mリン酸二水素ナトリウム水溶液10:20:85(v%/v%/v%)、pH3.2からなる混合液を用いた。流速は1.0ml/minで、20μlを注入した。本実施例は、他の有効成分についても類推して同様に行うことができる。図5は、例えば、有効成分であるカフェインを用いた場合の類似の性能を示す。マイクロニードルシステムの組成を表2に示す。
C12-Synergi-Max-RP分離カラム(150×4.6mm,粒径4μm,Phenomenex社,Aschaffenburg)を用いたHPLCにより、273nm、25℃でUV検出を行い、分析を行った。溶離液として、メタノールとHPLC用水40:60(v%/v%)からなる混合液を用いた。流速は1.0ml/minで、20μlを注入した。
Claims (14)
- 担体上に複数のマイクロニードルを含む皮内投与に用いるマイクロニードルアレイであって、前記マイクロニードルが少なくとも1つの有効成分を含む実質的に水溶性の製剤を含み、前記マイクロニードルアレイが少なくとも1つの発熱素子を有することを特徴とするマイクロニードルアレイ。
- 少なくとも1つの有効成分を含む水溶性製剤が、マイクロニードルの先端部に存在すること、および/または、コーティングの一部であることを特徴とする、請求項1に記載の皮内投与に用いるマイクロニードルアレイ。
- 前記発熱素子が蓄熱体であることを特徴とする、請求項1または2のいずれかに記載の皮内投与に用いるマイクロニードルアレイ。
- i.) 化学的酸化反応、特に大気中の酸素と活性炭上の発火性鉄との水の存在下での酸化反応により、または ii.) 物理化学的反応、特に結晶化熱の放出により、熱が過飽和溶液から再結晶後に生成されることを特徴とする、請求項3に記載の皮内投与に用いるマイクロニードルアレイ。
- 外部または内部電源の供給により熱を発生させることができる、導電性繊維が互いに接触した導電性の繊維布を含むことを特徴とする、請求項1に記載の皮内投与用マイクロニードルアレイ。
- 超音波送信機と導電性の圧電フィルムを内蔵しており、外部または内部から電源を供給することで熱を発生させることができることを特徴とする、請求項1に記載の皮内投与用マイクロニードルアレイ。
- 発熱素子の熱が42~50℃であることを特徴とする、請求項1~6のいずれか1項に記載の皮内投与用マイクロニードルアレイ。
- 浸透したマイクロニードルが少なくとも部分的に溶解し、熱の影響でその場で再吸収されることを特徴とする、請求項1~7のいずれか1項に記載の皮内投与用マイクロニードルアレイ。
- 前記水溶性製剤が、水溶性ポリマーを含むことを特徴とする、請求項1~8のいずれか1項に記載の皮内投与に用いるマイクロニードルアレイ。
- 前記水溶性ポリマーが、ポリビニルピロリドン、ポリビニルアルコール、セルロース、デキストラン、乳酸および/またはグリコール酸などのα-ヒドロキシ酸、ポリラクチド、ポリグリコーゲン、乳酸および/またはグリコール酸のようなα-ヒドロキシ酸、ポリラクチド、ポリグリコリド、ポリラクチド-グリコリド共重合体、およびそれらとポリエチレングリコールのコポリマー、ポリ無水物、ポリ(オルト)エステル、ポリウレタン、ポリ酪酸、ポリ吉草酸、ポリラクチド-コ-カプロラクトンからなるグループから選択されることを特徴とする、請求項9に記載の皮内投与用マイクロニードルアレイ。
- 担体上のマイクロニードルの密度が5~5,000個/cm2である、請求項1~10のいずれか1項に記載の皮内投与に用いるマイクロニードルアレイ。
- 少なくとも1つの有効成分が、催眠薬、鎮静薬、抗てんかん薬、航法アミン、精神神経鎮静薬、神経筋遮断薬、鎮痙薬、抗ヒスタミン薬、抗アレルギー薬の群から選択されることを特徴とする。強心剤、抗不整脈剤、利尿剤、血圧降下剤、血管圧迫剤、鎮咳剤、去痰剤、鎮痛剤、甲状腺ホルモン剤、性ホルモン剤、グルココルチコイドホルモン剤、抗糖尿病剤、抗腫瘍剤、抗生物質、化学療法剤、麻薬、抗パーキンソン剤、抗アルツハイマー剤、トリプタン、ワクチン血清からなるグループから選択されることを特徴とする、請求項1~11のいずれか1項に記載の皮内投与に用いるマイクロニードルアレイ。
- 蓄熱体が、マイクロニードルアレイの表層(支持層)として設けられていることを特徴とする、請求項1~12のいずれか1項に記載の皮内投与に用いるマイクロニードルアレイ。
- マイクロニードルアレイが、接着剤、絆創膏、テープ、弾性バンド、ゴム、ベルトからなるグループから選択される固定手段を有していることを特徴とする、請求項1~13のいずれか1項に記載の皮内投与に用いるマイクロニードルアレイ。
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PCT/EP2020/055967 WO2020178416A1 (de) | 2019-03-06 | 2020-03-06 | Mikronadelarray aufweisend ein wärmeerzeugendes element |
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Publication number | Priority date | Publication date | Assignee | Title |
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US5658583A (en) | 1995-07-28 | 1997-08-19 | Zhang; Jie | Apparatus and methods for improved noninvasive dermal administration of pharmaceuticals |
DE10353629A1 (de) | 2003-11-17 | 2005-06-16 | Lts Lohmann Therapie-Systeme Ag | Vorrichtung zur transdermalen Verabreichung von Wirkstoffen |
CN1946452A (zh) * | 2004-01-09 | 2007-04-11 | 阿尔扎公司 | 频率促进的药物透皮释放方法和*** |
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AU2006287603B2 (en) * | 2005-09-06 | 2012-05-10 | Theraject, Inc. | Solid solution perforator containing drug particle and/or drug-adsorbed particles |
US7785301B2 (en) * | 2006-11-28 | 2010-08-31 | Vadim V Yuzhakov | Tissue conforming microneedle array and patch for transdermal drug delivery or biological fluid collection |
US20080208162A1 (en) * | 2007-02-26 | 2008-08-28 | Joshi Ashok V | Device and Method For Thermophoretic Fluid Delivery |
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