JP2020522354A - グルカゴン様ペプチドアナログを適用するためのマイクロニードルシステム - Google Patents
グルカゴン様ペプチドアナログを適用するためのマイクロニードルシステム Download PDFInfo
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- JP2020522354A JP2020522354A JP2019567601A JP2019567601A JP2020522354A JP 2020522354 A JP2020522354 A JP 2020522354A JP 2019567601 A JP2019567601 A JP 2019567601A JP 2019567601 A JP2019567601 A JP 2019567601A JP 2020522354 A JP2020522354 A JP 2020522354A
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- controlled release
- glucagon
- microneedle array
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Images
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- 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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Abstract
Description
a)本発明によるマイクロニードルシステムを皮膚に固定する工程と、
b)PVPおよび少なくとも1種のグルカゴン様ペプチドアナログの製剤を含むマイクロニードルアレイを皮膚に貫入させる工程と
を含む、方法である。
a.)結合剤または乳化剤、例えばカルボキシメチルセルロース、アルギネート、ゼラチン
b.)保湿剤、例えばグリセリン、尿素、トレハロース
c.)湿潤剤、例えばセチルアルコール、モノステアリン酸グリセリン
d.)アスコルビン酸、ビタミンEのような抗酸化剤
しかしながら、好ましいのは、ポロクサマー、アルギネート、およびポリソルベート(Tween)である。
− ポリビニルピロリドン(PVP)タイプ1:MW 20−60kDa;タイプ2:>1000kDa
− ポロクサマー(Pluronic F−68)
− アルギン酸ナトリウム
− グリセリン
− ポリオキシエチレンソルビタンモノオレエート(ポリソルベート、Tween−80)
Claims (12)
- 皮内適用において制御放出に使用するためのマイクロニードルアレイであって、ポリビニルピロリドンおよび少なくとも1種のグルカゴン様ペプチドアナログの製剤を含む、前記マイクロニードルアレイ。
- 皮内適用において制御放出に使用するための製品、特に医薬製品であって、ポリビニルピロリドンおよび少なくとも1種のグルカゴン様ペプチドアナログの製剤を含むマイクロニードルアレイを有する、前記製品。
- 糖尿病、2型糖尿病、インスリン抵抗性、高血圧、肥満症、および代謝症候群の予防および処置のために、皮内適用において制御放出に使用するための、請求項2に記載の製品。
- グルカゴン様ペプチドアナログは、以下の群:エキセナチド、リラグルチド、リキシセナチドより選択されることを特徴とする、請求項1〜3のいずれか1項に記載の皮内適用において制御放出に使用するためのマイクロニードルアレイまたは製品。
- 制御放出の時間は、2時間より長く、12時間より長く、または24時間であることを特徴とする、請求項1〜4のいずれか1項に記載の皮内適用において制御放出に使用するためのマイクロニードルアレイまたは製品。
- 製剤は、最大99%のポリビニルピロリドン、ならびに他の補助剤および添加剤、特に乳化剤を含有することを特徴とする、請求項1〜5のいずれか1項に記載の皮内適用において制御放出に使用するためのマイクロニードルアレイまたは製品。
- 製剤中に2〜7%のポロクサマー、または2〜7%のアルギネート、または0.1〜1%のポリソルベートが存在することを特徴とする、請求項6に記載の皮内適用において制御放出に使用するためのマイクロニードルアレイまたは製品。
- 1つの製剤が、50〜99%、70〜90%、特に75〜80%のポリビニルピロリドンを含有することを特徴とする、請求項6または7に記載の皮内適用において制御放出に使用するためのマイクロニードルアレイまたは製品。
- 1用量最大50μg/MNAのグルカゴン様ペプチドアナログを適用することを特徴とする、請求項1〜8のいずれか1項に記載の皮内適用において制御放出に使用するためのマイクロニードルアレイまたは製品。
- アプリケータシステムを含む、請求項1〜9のいずれか1項に記載の皮内適用において制御放出に使用するためのマイクロニードルアレイまたは製品。
- 少なくとも1種のグルカゴン様ペプチドアナログを制御放出するための皮内適用を実行するための方法であって、PVPおよび少なくとも1種のグルカゴン様ペプチドアナログの製剤を含むマイクロニードルアレイを有する皮内適用における前記方法。
- a.)本発明によるマイクロニードルシステムを皮膚に固定する工程と、
b.)PVPおよび少なくとも1種のグルカゴン様ペプチドアナログの製剤を含むマイクロニードルアレイを皮膚に貫入させる工程と
を含む、請求項11に記載の少なくとも1種のグルカゴン様ペプチドアナログを制御放出するための皮内適用を実行するための方法。
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DE102017112573.6A DE102017112573A1 (de) | 2017-06-07 | 2017-06-07 | Mikronadelsystem zur Applikation von Glukagon-ähnlichen-Peptid Analoga |
PCT/EP2018/064919 WO2018224559A1 (de) | 2017-06-07 | 2018-06-06 | Mikronadelsystem zur applikation von glukagon-ähnlichen-peptid analoga |
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DE102021118997A1 (de) | 2021-07-22 | 2023-01-26 | Lts Lohmann Therapie-Systeme Ag. | Mikronadelarray mit Antiseptika |
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EP1534376B1 (en) | 2002-06-25 | 2016-08-31 | Theraject, Inc. | Rapidly dissolving micro-perforator for drug delivery and other applications |
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CA2650197A1 (en) * | 2006-05-09 | 2008-02-28 | Apogee Technology, Inc. | Nanofiber structures on asperities for sequestering, carrying and transferring substances |
US8821446B2 (en) | 2007-01-22 | 2014-09-02 | Corium International, Inc. | Applicators for microneedles |
US20090136554A1 (en) * | 2007-10-23 | 2009-05-28 | Alza Corporation | Transdermal sustained release drug delivery |
CA2739876A1 (en) | 2008-10-07 | 2010-04-15 | Tuo Jin | Phase-transition polymeric microneedles |
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