JP2022065173A - 薬剤溶出眼内インプラント - Google Patents
薬剤溶出眼内インプラント Download PDFInfo
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- JP2022065173A JP2022065173A JP2022027469A JP2022027469A JP2022065173A JP 2022065173 A JP2022065173 A JP 2022065173A JP 2022027469 A JP2022027469 A JP 2022027469A JP 2022027469 A JP2022027469 A JP 2022027469A JP 2022065173 A JP2022065173 A JP 2022065173A
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- 229960003165 vancomycin Drugs 0.000 description 1
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- MYPYJXKWCTUITO-LYRMYLQWSA-O vancomycin(1+) Chemical compound O([C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@H]1OC1=C2C=C3C=C1OC1=CC=C(C=C1Cl)[C@@H](O)[C@H](C(N[C@@H](CC(N)=O)C(=O)N[C@H]3C(=O)N[C@H]1C(=O)N[C@H](C(N[C@@H](C3=CC(O)=CC(O)=C3C=3C(O)=CC=C1C=3)C([O-])=O)=O)[C@H](O)C1=CC=C(C(=C1)Cl)O2)=O)NC(=O)[C@@H](CC(C)C)[NH2+]C)[C@H]1C[C@](C)([NH3+])[C@H](O)[C@H](C)O1 MYPYJXKWCTUITO-LYRMYLQWSA-O 0.000 description 1
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- A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
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Abstract
Description
薬物送達装置単独として機能するいくつかの実施形態では、インプラントは、制御された形で1種または複数種の薬剤を眼の前方領域に送達するように構成されるのに対し、他の実施形態では、インプラントは、制御された形で1種または複数種の薬剤を眼の後方領域に送達するように構成される。なお他の実施形態では、インプラントは、制御された形で薬剤を眼の前方領域および後方領域の両方に同時に送達するように構成される。なお他の実施形態では、インプラントの構成は、標的化する形で特定の眼内組織、たとえば、黄斑または毛様体に薬剤を放出するような構成である。ある種の実施形態では、インプラントは、薬剤を毛様体突起および/または後房に送達する。他のある種の実施形態では、インプラントは、薬剤を毛様体筋および/または腱(または線維帯)の1つまたは複数に送達する。いくつかの実施形態では、インプラントは、シュレム管、小柱網、強膜上静脈、水晶体皮質、水晶体上皮、水晶体嚢、強膜、強膜岬、脈絡膜、脈絡膜上腔、網膜動脈および静脈、視神経乳頭、網膜中心静脈、視神経、黄斑、窩、および/または網膜の1つまたは複数に薬剤を送達する。なお他の実施形態では、インプラントからの薬剤の送達は、眼房全体を対象とする。本明細書に記載の各実施形態は、これらの領域の1つまたは複数を標的としてもよく、さらに任意にシャント特徴要素(以下に記載)と組み合わせてもよいことが理解されよう。
本開示は、眼科用薬物送達インプラントであって、植え込み部位に植え込み後、眼内の所望の標的領域への1種または複数種の薬剤の放出を制御し、放出の制御が長期間にわたる、薬物送達インプラントに関する。図2~20に、インプラントの種々の実施形態を示し、本明細書に言及する。
本明細書に記載の系および方法の別の態様は、薬剤を眼に送達し、任意に流体を前房から生理的流出スペースに排水するためのインプラントを移植するための送達器具に関する。いくつかの実施形態では、インプラントは、植え込み部位から眼を通って位置する部位から眼に挿入する。送達器具は、挿入部位から前房を横切って植え込み部位まで眼を通ってインプラントを前進させるのに十分に長いものである。器具の少なくとも一部は、可撓性であってもよい。器具は、相互に長軸方向に移動できる複数の部材を含んでもよい。いくつかの実施形態では、送達器具の少なくとも一部は、湾曲している。いくつかの実施形態では、送達器具の一部は、剛性であり、器具の別の部分は、可撓性である。
眼内インプラントのいくつかの実施形態を送達するための植え込みについては、粘弾性を用いてあるいは用いずに閉鎖した房で行う。
本明細書に記載するような薬物送達インプラントは、薬剤を収納し、インプラントの様々な要素の設計に基づき制御された形で、長期間インプラントから薬剤を溶出する働きをする。インプラントの組成の様々な要素、インプラントの物理的特徴、眼におけるインプラントの位置、および薬剤の組成が組み合わされて働き、所望の薬剤放出プロファイルが得られる。
(Ci-Co)=装置の内側と外側との薬剤濃度の差。
薬物送達インプラントと共に使用する治療薬として、以下に記載する1種または複数種の薬剤単独、あるいは、組み合わせたものを挙げることができる。また、利用する薬剤は、以下に記載する薬剤の1つまたは複数の等価物、誘導体、またはアナログであってもよい。薬剤としてさらに、医薬剤、たとえば抗緑内障薬、眼剤、制菌剤(たとえば、抗生物質、抗ウイルス薬、抗寄生虫薬、抗真菌薬)、抗炎症薬(ステロイドまたは非ステロイド性抗炎症剤など)、生物学的製剤、たとえばホルモン、酵素または酵素関連成分、抗体または抗体関連成分、オリゴヌクレオチド(DNA、RNA、低分子干渉RNA、アンチセンスオリゴヌクレオチドおよび同種のものなど)、DNA/RNAベクター、ウイルス(野生型あるいは遺伝子改変)またはウイルスベクター、ペプチド、タンパク質、酵素、細胞外マトリックス成分、ならびに1種または複数種の生物学的成分を産生するように構成される生細胞があるが、これに限定されるものではない。任意の特定の薬剤の使用は、その主要効果または規制機関の承認した処置適応、または使用法に限定されるものではない。薬剤はまた、別の薬剤もしくは治療薬の1つまたは複数の副作用を軽減あるいは処置する化合物または他の材料も含む。多くの薬剤が複数の作用機序を持つため、下記の任意の一治療薬クラスのうち任意の特定の薬剤を記載することは、その薬剤の考えられる1つの使用を示すものにすぎず、眼科用インプラント系との併用の範囲を限定することを意図するものではない。
Claims (15)
- 薬物送達眼内インプラントであって、
第1の端部と第2の端部を有し、内部空間を画定するように造形される任意に生分解性である細長いアウターシェルと、
前記内部空間内に配置された少なくとも第1の薬剤と、
前記アウターシェルの前記第1の端部に配置される1つまたは複数のオリフィスと、
前記アウターシェルの前記第1の端部の前記内部空間内に完全に配置される透過性材料であって、前記第1の薬剤と前記1つまたは複数のオリフィスとの間に位置する透過性材料と、
を有し、
前記透過性材料は、前記第1の薬剤に対して透過性であり、それにより前記薬剤を、前記透過性材料を通し、前記オリフィスを介して前記インプラントの外に通過させることができる、
薬物送達眼内インプラント。 - 前記第1の端部は、前記インプラントの遠位部分であり、且つ、当該インプラントの前記遠位部分の2/3を含み、前記透過性材料はヒドロゲルプラグである、請求項1に記載のインプラント。
- 前記第1の薬剤は、抗血管内皮細胞増殖因子(抗VEGF)薬である、請求項1または2に記載のインプラント。
- 前記抗VEGF薬は、ラニビズマブ(LUCENTIS(登録商標))、ベバシズマブ(AVASTIN(登録商標))、ペガプタニブ(MACUGEN(登録商標))、スニチニブ及びソラフェニブから選択される、請求項3に記載のインプラント。
- 前記薬剤は、ポリヒドロキシまたは炭水化物賦形剤と組み合わされる、請求項3または4に記載のインプラント。
- 前記ポリヒドロキシまたは炭水化物賦形剤は、エチルセルロース、メチルセルロース、ヒドロキシメチルセルロース、デキストラン、デキストロース、フルクトース、グリセリン、モノグリセリド、ジグリセリド、ラクトース、マルトデキストリン及びスターチから選択される、請求項5に記載のインプラント。
- 前記インプラントは、前記薬剤と任意のシャント部分との間の前記内部空間内に位置する任意に生分解性である間仕切りをさらに有する、請求項1~6のいずれか1項に記載のインプラント。
- 前記第1の薬剤はステロイドである、請求項1~7のいずれか1項に記載のインプラント。
- 前記インプラントは、当該インプラントの近位端または近位端近傍に、1つまたは複数の流出開口部と流入口を備えるシャント部分をさらに有する、請求項1~8のいずれか1項に記載のインプラント。
- 前記ヒドロゲルプラグは、前記内部空間の内壁に緊密に装着される、請求項2~9のいずれか1項に記載のインプラント。
- 前記インプラントは、直径21~27ゲージの中空針内に適合する、請求項1~10のいずれか1項に記載のインプラント。
- 前記透過性材料は、膜である、請求項1に記載のインプラント。
- 前記第1の薬剤は、プロスタグランジン、プロスタグランジン前駆体またはプロスタグランジンアナログである、請求項1または12に記載のインプラント。
- 前記第1の薬剤は、ビマトプロスト、ラタノプロスト、トラボプロストおよびウノプロストンから選択される、請求項13に記載のインプラント。
- 前記インプラントは、前房から生理的流出スペースに流体を排水するシャント部分をさらに有する、請求項1、12、13または14のいずれか1項に記載のインプラント。
Applications Claiming Priority (11)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US17933209P | 2009-05-18 | 2009-05-18 | |
US61/179,332 | 2009-05-18 | ||
US22052709P | 2009-06-25 | 2009-06-25 | |
US61/220,527 | 2009-06-25 | ||
US26460409P | 2009-11-25 | 2009-11-25 | |
US26461509P | 2009-11-25 | 2009-11-25 | |
US26459409P | 2009-11-25 | 2009-11-25 | |
US61/264,594 | 2009-11-25 | ||
US61/264,604 | 2009-11-25 | ||
US61/264,615 | 2009-11-25 | ||
JP2020098743A JP7033166B2 (ja) | 2009-05-18 | 2020-06-05 | 薬剤溶出眼内インプラント |
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