JP2020503950A - 経皮薬剤送達の装置及び方法 - Google Patents
経皮薬剤送達の装置及び方法 Download PDFInfo
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- A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
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- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
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- A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body
- A61M31/002—Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time
Abstract
Description
本出願は、参照によってその全内容が本明細書に組み込まれている、2017年1月6日に出願された米国特許仮出願第62/443,421号、件名「経皮薬剤送達の装置及び方法(TRANSDERMAL DRUG DELIVERY DEVICES AND METHODS)」の優先権を主張するものである。
本明細書中において言及される全ての公表文献及び特許出願は、それぞれ個々の公表文献又は特許出願が参照により具体的且つ個別に示されて組み込まれる場合と同程度に、参照により全内容が本明細書に組み込まれている。
Claims (33)
- 製剤を中に保持するように構成されたリザーバと、
前記リザーバからの前記製剤が通り抜けることを可能にするように構成された経皮膜と、
前記リザーバに入っていくように構成されたピストンと、
前記ピストンに取り付けられた制御棒であって、表面に複数の歯がある前記制御棒と、
前記リザーバの方向に前記制御棒に力をかけるように構成されたばねと、
第1のカム面及び第2のカム面を有する回転カムであって、前記第1のカム面及び前記第2のカム面は前記複数の歯と係合するように構成されている、前記回転カムと、
を含み、
前記回転カムは、回転すると、前記第1のカム面の、前記複数の歯のうちの第1の歯との係合を解除し、それによって、前記ばねが前記ピストンを前記リザーバ内へ前進させて、前記製剤を前記経皮膜上に押し出すことを可能にするように構成されている、
経皮薬剤送達装置。 - 前記回転カムを回転させるように構成されたモータを更に含む、請求項1に記載の経皮薬剤送達装置。
- 前記リザーバ、前記膜、前記ピストン、前記制御棒、前記ばね、及び前記回転カムを含む第1の部分と、前記モータ及び電源を含む第2の部分と、を含み、前記第1及び第2の部分は互いに係合したり係合解除したりするように構成されている、請求項2に記載の経皮薬剤送達装置。
- 前記第1の部分は使い捨てであり、前記第2の部分は再利用可能である、請求項3に記載の経皮薬剤送達装置。
- 前記第1の部分は更に、保管中は前記ばねを前記制御棒から離して保持するように構成された保管ラッチを含み、前記保管ラッチは、前記第1の部分と前記第2の部分が係合したときに前記ばねを解放するように構成されている、請求項3に記載の経皮薬剤送達装置。
- ユーザインタフェース及びディスプレイを更に含む、請求項1に記載の経皮薬剤送達装置。
- 前記制御棒及び前記プランジャはほぼ直線形状である、請求項1に記載の経皮薬剤送達装置。
- 前記リザーバはほぼ直線形状である、請求項7に記載の経皮薬剤送達装置。
- 前記制御棒及び前記プランジャは湾曲形状である、請求項1に記載の経皮薬剤送達装置。
- 前記リザーバは半環状である、請求項9に記載の経皮薬剤送達装置。
- 前記制御棒上の前記複数の歯の間隔が歯間隔パターンを定義し、前記歯間隔パターンは、前記経皮薬剤送達装置の薬剤送達プロファイルに対応する、請求項1に記載の経皮薬剤送達装置。
- 前記歯間隔パターンは間隔がほぼ均一である、請求項11に記載の経皮薬剤送達装置。
- 前記第1のカム面と前記第2のカム面との間の距離が、隣接する歯の間の距離とほぼ同等である、請求項12に記載の経皮薬剤送達装置。
- 前記歯間隔パターンは間隔が不均一である、請求項11に記載の経皮薬剤送達装置。
- 前記薬剤送達プロファイルは、前記経皮薬剤送達装置を使用する患者のサーカディアンリズム又は生物同期パターンに対応する、請求項11に記載の経皮薬剤送達装置。
- 前記第1及び第2のカム面は、互いに対して円周方向にオフセットしている、請求項1に記載の経皮薬剤送達装置。
- 前記第1及び第2のカム面は円周方向に重なり合わない、請求項16に記載の経皮薬剤送達装置。
- 前記第1のカム面が、前記第1の歯との係合を解除し、前記ばねを押すことによって前記制御棒及び前記ピストンを前記リザーバ内に押し込むと、前記第2のカム面が前記複数の歯のうちの第2の歯と係合して、前記ピストンがそれ以上前記リザーバ内へ動かないようにするように構成されている、請求項16に記載の経皮薬剤送達装置。
- 前記カムは、前記第1のカム面が前記第1の歯との係合を解除し、前記第2のカム面が前記第2の歯と係合するように、第1の方向に回転可能であり、前記カムは、前記第2のカム面が前記第2の歯との係合を解除するように、且つ、前記ピストンが前記リザーバ内へ更に動いて、前記製剤のより多くを押し出すように、第2の方向に回転可能である、請求項18に記載の経皮薬剤送達装置。
- 前記カムは、前記製剤の順次ボーラス送達を可能にする為に、前記第1及び第2の方向に交互に回転可能である、請求項18に記載の経皮薬剤送達装置。
- 前記カムは、前記第1のカム面が前記第1の歯との係合を解除し、前記第2のカム面が前記第2の歯と係合するように、第1の方向に第1の距離だけ回転可能であり、前記カムは、前記第2のカム面が前記第2の歯との係合を解除するように、且つ、前記ピストンが前記リザーバ内へ更に動いて、前記製剤のより多くを押し出すように、第2の方向に第2の距離だけ回転可能である、請求項18に記載の経皮薬剤送達装置。
- 前記ばねは、前記制御棒を動かす為に約12N以下の力をかけるように構成されている、請求項1に記載の経皮薬剤送達装置。
- 前記リザーバと前記経皮膜との間の経路を更に含む、請求項1に記載の経皮薬剤送達装置。
- 前記リザーバと前記経皮膜との間の前記経路に沿う弁を更に含む、請求項23に記載の経皮薬剤送達装置。
- 前記製剤は、ニコチン、アカンプロセート、アセトアミノフェン、アルフェンタニル、アロプリノール、アルモトリプタン、アルプラゾラム、アミトリプチリン、アモキサピン、アポモルヒネ、アリピプラゾール、アルモダフィニル、アセナピン、アトモキセチン、アゼラスチン、バクロフェン、ベンズブロマロン、ベンジダミン、ブレクスピプラゾール、ブデソニド、ブピバカイン、ブプレノルフィン、ブプレノルフィン、ブプロピオン、ブスピロン、カベルゴリン、カプサイシン、カルバマゼピン、カルビドパ、カリソプロドール、セレコキシブ、シタロプラム、クロバザム、クロナゼパム、クロニジン、クロピドグレル、コルヒチン、シクロベンザプリン、ダルテパリン、デスベンラファキシン、デキストロアンフェタミン、デキストロメチルフェニデート、ジアゼパム、ジクロフェナク、ジスルフィラム、ジバルプロエクス、ドラセトロン、ドキセピン、ドロナビノール、ドロキシドパ、デュロキセチン、エレトリプタン、エンタカポン、エスシタロプラム、エスリカルバゼピン、エソメプラゾール、エストラジオール、エストロゲン、エスゾピクロン、エトスクシミド、エトドラク、エゾガビン、フェブキソスタット、フェルバメート、フェンブフェン、フェンタニル、フルニソリド、フルオロウラシル、フルオキセチン、フルチカゾン、フルボキサミン、ホルモテロール、フォスフェニトイン、フロバトリプタン、ガバペンチン、グラニセトロン、グアンファシン、ヒドロコドン、ヒドロコドン、ヒドロコルチゾン、ヒドロモルフォン、ヒドロキシジン、オトギリソウエキス、イブプロフェン、インドメタシン、ケトロラク、ラコサミド、ラモトリギン、レベチラセタム、レボドパ、レボミルナシプラン、レボサルブタモール、リドカイン、リスデキサンフェタミン、リチウム、ロラゼパム、ロルカセリン、ロサルタン、ロキサピン、メクリジン、メロキシカム、メタキサロン、メチルフェニデート、ミルナシプラン、ミルタザピン、モダフィニル、モルヒネ、ナビロン、ナドロール、ナロキソン、ナルトレキソン、ナプロキセン、ナラトリプタン、ネドクロミル、ネファゾドン、ニトログリセリン、オランザピン、オンダンセトロン、オルリスタット、オキサプロジン、オクスカルバゼピン、オキシブチニン、オキシコドン、オキシモルフォン、パロノセトロン、パミドロネート、パロキセチン、ペランパネル、フェンテルミン、フェントラミン、プラミペキソール、プラスグレル、プラゼパム、プレドニゾン、プレガバリン、プロカイン、プロメタジン、プロポフォール、クエチアピン、ラメルテオン、ラサギリン、レミフェンタニル、リスペリドン、リバスチグミン、リザトリプタン、ロピニロール、ロピバカイン、ロチゴチン、ルフィナミド、サルブタモール、スコポラミン、セレギリン、セルトラリン、オキシバートナトリウム、ストロンチウム、スフェンタニル、スマトリプタン、スボレキサント、タペンタドール、タシメルテオン、テマゼパム、テストステロン、テトラカイン、テオフィリン、チアガビン、チオトロピウム、チロフィバン、トルカポン、トピラマート、トラマドール、トラゾドン、トリアゾラム、トリミプラミン、バルプロ酸、ベンラファキシン、ビガバトリン、ビラゾドン、ボルチオキセチン、ザレプロン、ジロートン、ジプラシドン、ゾルミトリプタン、ゾルピデム、ノルエチステロン、エナラプリル、エチニルエストラジオール、インスリン、メマンチン、メタンフェタミン、ノルエルゲストロミン、ペルゴリド、ラミプリル、タクリン、チモロール、トルテロジン、及びゾニサミドから成る群から選択される、請求項1に記載の経皮薬剤送達装置。
- 前記経皮膜はポリプロピレンを含む、請求項1に記載の経皮薬剤送達装置。
- 前記経皮薬剤送達装置を患者の皮膚に粘着させる為の粘着剤を更に含む、請求項1に記載の経皮薬剤送達装置。
- 長さが60〜80mmであり、幅が30〜45mmであり、厚さが6〜12mmである、請求項1に記載の経皮薬剤送達装置。
- 体積が15〜30cm3である、請求項1に記載の経皮薬剤送達装置。
- 経皮薬剤送達の方法であって、
経皮送達システムを患者の皮膚に貼り付けるステップであって、前記経皮送達システムは、リザーバと、経皮膜と、ピストンと、複数の歯がある制御棒と、第1及び第2のカム面を有する回転カムと、を含む、前記貼り付けるステップと、
前記第1のカム面が、前記複数の歯のうちの第1の歯と係合する第1の位置から、前記第1の歯との係合を解除する第2の位置まで動くことにより、前記ピストンが前進して、製剤の第1の用量を前記リザーバから前記経皮膜上に、そして前記患者の皮膚に押し出すように、前記カムを回転させるステップと、
を含む方法。 - 前記製剤の一連の用量を送達する為に、前記カムを第1の方向及び第2の方向に交互に回転させるステップを更に含む、請求項30に記載の方法。
- 製剤の一連の用量を送達する為に、前記カムを同じ方向に回転させるステップを更に含む、請求項30に記載の方法。
- 前記複数の歯のうちの第2の歯を前記第2のカム面と係合させて、前記製剤が前記リザーバから流出しないようにするステップを更に含む、請求項30に記載の方法。
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CA3049529A1 (en) | 2018-07-12 |
AU2018205529A1 (en) | 2019-07-18 |
AU2018205529B2 (en) | 2023-08-10 |
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