JP7072520B2 - 二重ディスク経皮システム - Google Patents
二重ディスク経皮システム Download PDFInfo
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- JP7072520B2 JP7072520B2 JP2018554355A JP2018554355A JP7072520B2 JP 7072520 B2 JP7072520 B2 JP 7072520B2 JP 2018554355 A JP2018554355 A JP 2018554355A JP 2018554355 A JP2018554355 A JP 2018554355A JP 7072520 B2 JP7072520 B2 JP 7072520B2
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- A61F13/00—Bandages or dressings; Absorbent pads
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F13/02—Adhesive bandages or dressings
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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Description
製造の間に、連続的なキスカットおよび廃棄物巻戻しを可能にし、それによって、ラインスピードを上げて、欠陥を減少させる構造的完全性と、
本発明の連続的プロセスを行うために、同じ組成物の2つの剥離ライナを使用することを可能にする、活性フィルムが剥離ライナとは差動的に剥離することと、
活性成分または賦形剤が、活性内側リザーバ層から多孔性メッシュフィルムまたは非多孔性律速メンブランを通って外側裏打ち層まで浸出する速度を遅くすることであって、コーティングされたロールを少なくとも一時的に貯蔵することを可能にする、浸出する速度を遅くすることと、
キスカットおよび裏打ちロールでの積層化を可能にすることと、
活性リザーバ層を裏打ちフィルムに付着させることとを含む。
以下の実施例では、賦形剤の内側リザーバから外側接着剤オーバレイへの移行に関して、さまざまな二重ディスク経皮システムを比較する研究が実施された。経皮システム試料2および試料4が、本発明の皮膚用デバイスの代表的な実施形態である。
内側ディスクから外側ディスクへ賦形剤の移行研究(オーバサイズの裏打ちおよび二重ディスク設計比較)
試料1- プラセボ内側ディスクのみ(PET裏打ち、80g/m2、取り外し可能な剥離ライナ)
試料2- オーバサイズの裏打ち設計(外側ディスクアクリレート接着剤1層付き、より大きい面積のPET裏打ち上のプラセボ内側ディスク)
試料3- 二重ディスク設計(外側ディスクアクリレート接着剤1層上に、同じサイズのPET裏打ち上のプラセボ内側ディスク)
試料4- オーバサイズの裏打ち設計(外側ディスクアクリレート接着剤2層上に、より大きい面積PET裏打ち上のプラセボ内側ディスクのみ)
試料5- 二重ディスク設計(外側ディスクアクリレート接着剤2層上に、同じサイズのPET裏打ち上のプラセボ内側ディスク)
Claims (7)
- 1つまたは複数の活性薬剤を皮膚または粘膜に投与するための皮膚用デバイス(100,200,300,400,500,600,700)であって、
感圧接着剤(112,212,312,412,512,612,712)のコーティングを有する、第2の裏打ちオーバレイ(111,211,311,411,511,611,711);
前記第2の裏打ちオーバレイに隣接する第1の裏打ちオーバレイ(122,222,322,422,522,622,722)であって、前記第2の裏打ちオーバレイは前記第1の裏打ちオーバレイの周囲を越えて延在する、第1の裏打ちオーバレイ;
前記第1の裏打ちオーバレイに隣接する活性内側ディスク(120)であって、前記第1の裏打ちオーバレイは前記活性内側ディスクの周囲を越えて全方向に延在し、
前記活性内側ディスク(120)は活性内側リザーバ層(121,221,321,421,521,621,721)を備え、前記活性内側リザーバ層は:
前記感圧接着剤および前記活性薬剤を含有する活性接着剤層;ならびに
前記活性内側リザーバ層に構造的完全性をもたらす材料を含む前記活性接着剤層に隣接したフィルム層、
を備えることを特徴とする、
活性内側ディスク(120);
取り外し可能な剥離ライナ(130,230,330,430,530,630,730)、
を備え、
前記活性内側ディスク(120)は、前記活性内側リザーバ層と同じサイズの裏打ち層であって、前記裏打ち層が前記活性薬剤に対して不透過性の材料または材料の組合せによって構成される、裏打ち層と、前記活性内側リザーバ層と前記第1の裏打ちオーバレイの間に位置する接着剤タイ層(626)をさらに備える、
皮膚用デバイス(100,200,300,400,500,600,700)。 - 前記活性内側リザーバ層(121,221,321,421,521,621,721)に構造的完全性をもたらす前記材料が、多孔性メッシュフィルム(323,423,523)である、請求項1に記載の皮膚用デバイス(100,200,300,400,500,600,700)。
- 前記多孔性メッシュフィルム(323,423,523)が、ポリエステル、ポリプロピレン、ポリエチレン、ナイロン、セルロース、アクリレート、ガラス繊維、PET、PES、PVDF、PC、PTFE、MCE、およびそれらの混合物で構成される群から選択された材料を含む、請求項2に記載の皮膚用デバイス(100,200,300,400,500,600,700)。
- 前記活性内側リザーバ層(121,221,321,421,521,621,721)に構造的完全性をもたらす前記材料が、非多孔性フィルム(426,526)である、請求項1に記載の皮膚用デバイス(100,200,300,400,500,600,700)。
- 前記非多孔性フィルム(426,526)が、分解性および非分解性重合体材料で構成される群から選択された材料を備える、請求項4に記載の皮膚用デバイス(100,200,300,400,500,600,700)。
- 前記重合体材料が、スパンボンドポリエステル織物、ポリエチレン、ポリカプロラクトン、多糖類ベース重合体類、セルロース類、生体ポリエステル類、ポリラクチド類、ポリエステルアミド類、脂肪族または芳香族コポリエステル類、ゴム類、キトサン、澱粉類、およびそれらの混合物で構成される群から選択される、請求項5に記載の皮膚用デバイス(100,200,300,400,500,600,700)。
- 前記接着剤タイ層(626)が、耐乱用性または乱用抑止物質をさらに備える、請求項1に記載の皮膚用デバイス(100,200,300,400,500,600,700)。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US15/096,953 US20170291020A1 (en) | 2016-04-12 | 2016-04-12 | Double disk transdermal system |
US15/096,953 | 2016-04-12 | ||
PCT/US2017/024508 WO2017180324A1 (en) | 2016-04-12 | 2017-03-28 | Double disk transdermal system |
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JP2019516671A JP2019516671A (ja) | 2019-06-20 |
JP7072520B2 true JP7072520B2 (ja) | 2022-05-20 |
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JP2018554355A Active JP7072520B2 (ja) | 2016-04-12 | 2017-03-28 | 二重ディスク経皮システム |
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US (2) | US20170291020A1 (ja) |
EP (1) | EP3442511A4 (ja) |
JP (1) | JP7072520B2 (ja) |
CN (1) | CN109152746A (ja) |
AU (1) | AU2017249048B2 (ja) |
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WO (1) | WO2017180324A1 (ja) |
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US20180303764A1 (en) * | 2017-04-19 | 2018-10-25 | Inep Europe Sarl | Method for manufacturing a transdermal device |
US11052054B2 (en) * | 2017-04-19 | 2021-07-06 | Inep Europe Sarl | Method for manufacturing a transdermal device |
DE102018220589A1 (de) * | 2018-11-29 | 2020-06-04 | Lts Lohmann Therapie-Systeme Ag | Transdermales System mit Überpflaster und Ringsystem |
GB201914706D0 (en) | 2019-10-11 | 2019-11-27 | Smith & Nephew | Apparatuses and methods for negative pressure wound therapy with switcheable fluid management |
GB202004812D0 (en) * | 2020-04-01 | 2020-05-13 | Smith & Nephew | Apparatuses and methods for negative pressure wound therapy |
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US3797494A (en) * | 1969-04-01 | 1974-03-19 | Alza Corp | Bandage for the administration of drug by controlled metering through microporous materials |
US4573996A (en) * | 1984-01-03 | 1986-03-04 | Jonergin, Inc. | Device for the administration of an active agent to the skin or mucosa |
US5217718A (en) * | 1989-08-18 | 1993-06-08 | Cygnus Therapeutic Systems | Method and device for administering dexmedetomidine transdermally |
CA2075517C (en) * | 1992-04-01 | 1997-03-11 | John Wick | Transdermal patch incorporating a polymer film incorporated with an active agent |
US6010715A (en) * | 1992-04-01 | 2000-01-04 | Bertek, Inc. | Transdermal patch incorporating a polymer film incorporated with an active agent |
US6007836A (en) * | 1993-05-28 | 1999-12-28 | Vericade, Inc. | Transdermal vasodilator |
JPH0912448A (ja) * | 1995-04-28 | 1997-01-14 | Read Chem Kk | 薬物放出制御型経皮吸収製剤 |
US8790689B2 (en) * | 2003-04-30 | 2014-07-29 | Purdue Pharma L.P. | Tamper resistant transdermal dosage form |
US7740879B2 (en) * | 2006-01-17 | 2010-06-22 | Harrogate Holdings | Abuse resistant transdermal drug delivery patch |
KR101853082B1 (ko) * | 2011-03-24 | 2018-04-27 | 테이코쿠 팔마 유에스에이, 인코포레이티드 | 활성제층 및 활성제 변환층을 포함하는 경피 조성물 |
US20140243765A1 (en) * | 2011-09-22 | 2014-08-28 | Samyang Biopharmaceuticals Corporation | Percutaneously absorbable preparation containing fentanyl and homologue thereof |
-
2016
- 2016-04-12 US US15/096,953 patent/US20170291020A1/en not_active Abandoned
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2017
- 2017-03-28 CN CN201780031921.6A patent/CN109152746A/zh active Pending
- 2017-03-28 WO PCT/US2017/024508 patent/WO2017180324A1/en active Application Filing
- 2017-03-28 AU AU2017249048A patent/AU2017249048B2/en active Active
- 2017-03-28 EP EP17782832.4A patent/EP3442511A4/en not_active Withdrawn
- 2017-03-28 JP JP2018554355A patent/JP7072520B2/ja active Active
- 2017-03-28 CA CA3020512A patent/CA3020512A1/en not_active Abandoned
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EP3442511A1 (en) | 2019-02-20 |
AU2017249048A1 (en) | 2018-10-11 |
AU2017249048B2 (en) | 2023-02-02 |
EP3442511A4 (en) | 2019-11-27 |
WO2017180324A1 (en) | 2017-10-19 |
US20200188177A1 (en) | 2020-06-18 |
JP2019516671A (ja) | 2019-06-20 |
CA3020512A1 (en) | 2017-10-19 |
CN109152746A (zh) | 2019-01-04 |
US20170291020A1 (en) | 2017-10-12 |
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