JP4502812B2 - 医薬品を投与するための医療装置 - Google Patents
医薬品を投与するための医療装置 Download PDFInfo
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Description
拡張されたバルーンカテーテルを、酢酸エチル溶液の中におけるパクリタキセルでコーティングすること
ドイツ、オーベルプファーフェンホーフェン/ミュンヘンのBMT社(BMT,Oberpfaffenhofen/Munich,Germany)によって作られ、製品名がジョーカーライト(Joker Lite)であり、バルーン寸法が2.5mm×20mmであるバルーンカテーテルは、最大限膨脹して、その全長が、酢酸エチル1ml当たり18.8mgのパクリタキセル、+1%薬剤用オリーブオイルの中に1分間浸漬され、その後、乾燥され、パクリタキセル含有量が39μgになる(エタノール、HPLCで抽出された後)。
折り曲げられたバルーンカテーテルを、酢酸エチル溶液の中におけるパクリタキセルでコーティングすること
ドイツ、オーベルプファーフェンホーフェン/ミュンヘンのBMT社(BMT,Oberpfaffenhofen/Munich,Germany)によって作られ、製品名がジョーカーライト(Joker Lite)であり、バルーン寸法が2.5mm×20mmであるバルーンカテーテルは、その全長が、酢酸エチル1ml当たり18.8mgのパクリタキセル、+1%薬剤用オリーブオイルの中に1分間、折り曲げられた状態に浸漬され、その後、乾燥され、パクリタキセル含有量が69μgになる。
折り曲げられたバルーンカテーテルを、酢酸エチル溶液の中におけるパクリタキセルでコーティングすること
a)ドイツ、オーベルプファーフェンホーフェン/ミュンヘンのBMT社(BMT,Oberpfaffenhofen/Munich,Germany)によって作られ、製品名がジョーカーライト(Joker Lite)であり、バルーン寸法が2.5mm×20mmであるバルーンカテーテルは、その全長が、酢酸エチル1ml当たり16.6mgのパクリタキセルの中に1分間、折り曲げられた状態に浸漬され、その後、4時間乾燥され、パクリタキセル含有量が54μgになる。
b)同じ処置であるが、溶液A(=3.33mlの酢酸エチル+100.0mgのパクリタキセル)の中に5秒間、2回浸漬され、その後、それぞれの浸漬の後に1時間の乾燥時間があり、パクリタキセル含有量が126μgになる。
c)同じ処置であるが、同じ溶液の中に5秒間、4回浸漬され、その後、それぞれの浸漬の後に1時間の乾燥時間があり、パクリタキセル含有量が158μgになる。
バルーンカテーテルを、アセトンの中におけるパクリタキセルでコーティングすること
9.0mlのアセトンの中に350mgのパクリタキセルが溶解され、ドイツ、オーベルプファーフェンホーフェン/ミュンヘンのBMT社(BMT,Oberpfaffenhofen/Munich,Germany)によって作られ、製品名がジョーカーライト(Joker Lite)であり、バルーン寸法が2.5mm×20mmであるバルーンカテーテルは、最大限膨脹して、その全長が、1分間浸漬されて取り出される。溶媒は室温で12時間乾燥される。その後、バルーンは膨脹して、普通はPTFEでコーティングされたツールを用いて折り曲げられる。場合によっては、バルーンの表面に適切な寸法のステントを圧着することができ、バルーンにおけるパクリタキセル含有量が29μgになる。
バルーンカテーテルを、アセトンの中におけるパクリタキセルでコーティングすること
a)BMT社によって作られ、製品名がアレグロ(Allegro)であり、バルーン寸法が2.5mm×20mmである折り曲げられたバルーンカテーテルは、0.15mlのエタノール+4.5μlのウルトラビスト300(ドイツ、ベルリンのSchering AG社によって作られたX線造影剤)+1.35mlのアセトン+0.8mgのスーダンレッド+30.0mgのパクリタキセルからなる混合物の中に浸漬される。
b)飽和された水性マンニット溶液が、ウルトラビスト300の代わりに用いられる。
c)飽和された水性サリチル酸ナトリウム溶液(pH7.5)が、ウルトラビスト300の代わりに用いられる。
d)5mgのアセチルサリチル酸が、(5a)によって完全な溶液に添加される。
e)5mgのグリセリンが、(5a)によって完全な溶液に添加される。
血流の中への活性物質の溶着
BMT社によって作られ、製品名がアレグロ(Allegro)であり、バルーン寸法が2.5mm×20mmである12個のバルーンカテーテルが用いられた。6個のグループのカテーテルにおける折り曲げられたバルーン部分は、(0.15mlのエタノール+4.5μlのウルトラビスト300+1.35mlのアセトン+0.8mgのスーダンレッド+30.0mgのパクリタキセル)の中に5回、あるいは(1.5mlの酢酸エチル+0.8mgのスーダンレッド+31.0mgのパクリタキセル)の中に5回、浸漬されたが、その第1回目は、それぞれ1分間の浸漬で3時間の乾燥であり、その後の4回は、それぞれ1時間の間隔を置いた5秒間の浸漬である。次いで、それぞれのグループにおける折り曲げられた3個のバルーンは、パクリタキセルの含有量を測定するために、50mlの人の血液中において37℃で5分間、おだやかに動かされて除去された。血液中でカテーテルを動かすと、血液中で動かされなかった3個の対照カテーテルに比べて、平均値(コーティング法についてn=3)が減少する。
アセトン:12%
酢酸エチル:10%
豚の冠状動脈の中での血管形成およびステント移植の後における再狭窄抑制の試験
BMT社によって作られ、寸法が3.5mm×20mmあるいは3.0mm×20mmであるジョーカーライト型の折り曲げられたバルーンカテーテルは、
溶液A)3.33mlの酢酸エチル(EA)+100.0mgのパクリタキセル
の中にあるいは、
溶液B)0.45mlのエタノール+100μlのウルトラビスト370+4.5mlのアセトン(ac)+150.0mgのパクリタキセル
の中に1分間浸漬され、次いで室温で一晩にわたって乾燥された。翌日に、あと一回(低投与量=Lのとき)あるいはあと4回(高投与量=Hのとき)の浸漬処理が、1時間の間隔を置いてちょうど5秒間、それぞれ行われた。
血管拡張およびステント移植の後におけるカテーテルの活性物質含有量
ステントの移植および動物からの除去の後に、長さがほぼ3cmの例8から一片のバルーンが、バルーンカテーテルとは切り離されて、1.5mlのエタノールの中に置かれた。パクリタキセル含有量がHPLCを用いて測定された。入手可能なすべてのコーティングされたバルーンおよび選択された非コーティングのバルーンが試験された。
冠状動脈
3.0×20mm、コーティング
高Ac 38±4μg(n=4)
低Ac 22±5μg(n=2)
高EEE 41μg (n=1)
3.5×20mm、コーティング
高Ac 37±10μg(n=8)
低Ac 26±6μg(n=8)
高EEE 53±9μg(n=9)
非コーティング(大きさおよび血管区域とは無関係) 0.9±1.0μg(n=7)
アセトンにプロブコールが1ml当たり100mgの濃度で添加され、この溶液が、前記の例において説明されたバルーンカテーテルをコーティングするために用いられる。
ラパマイシンが、ジエチルエーテルの中に10mg/mlの濃度で溶解される。カテーテルのバルーン区域が、先の例において説明されたようにコーティングされる。コーティング溶液から取り出した後に、バルーンは水平位置に置かれ、引き続いてそれらの長手軸の周りに回転される。
エポチロンBが、酢酸エチルに2mg/mlの濃度で添加され、この溶液が、前記の例において説明されたバルーンカテーテルをコーティングするために用いられる。
Claims (25)
- バルーン(14)から突出するかあるいはバルーン(14)の表面に位置する、少なくとも病変した組織部位あるいは器官部分の範囲における狭窄を切り開くための装置(24)を備えるバルーンカテーテル(12)であって、
バルーンが膨張されたとき、圧力下で少なくとも短時間、病変組織と接触するバルーンカテーテルの装置の平滑な表面が、基質がないかあるいは分子量が5,000D未満である低分子量の易水溶性の親水性物質からなる固体基質がある乾燥固体コーティングとして、任意の組織成分に結合するパクリタキセルでコーティングされ、前記パクリタキセルが、病変した特定の組織部位あるいは器官部分の選択療法のために組織に接触すると即時に分離することを特徴とする、バルーンカテーテル。 - 狭窄を切り開くための装置(24)が、バルーン(14)の長手軸に対して平行に配置された少なくとも1つのワイヤ状装置(16)であることを特徴とする、請求項1に記載のバルーンカテーテル。
- 狭窄を切り開くための装置(24)が、少なくとも2つのワイヤ状装置(16)から構成されていると共に、格子状構造体を形成しており、該構造体の長手軸が、バルーン(14)の長手軸に対して平行にすなわち軸平行に配置されることを特徴とする、請求項2に記載のバルーンカテーテル。
- ワイヤ状装置(16)が、金属、合金、あるいはプラスチックからなることを特徴とする、請求項2または3に記載のバルーンカテーテル。
- 合金が、形状記憶合金である、請求項4に記載のバルーンカテーテル。
- 狭窄を切り開くための装置(24)が、少なくとも1つのブレード状装置からなることを特徴とする、請求項1に記載のバルーンカテーテル。
- 狭窄を切り開くための装置(24)が、バルーン(14)から突出するかあるいはバルーン(14)の表面に位置する少なくとも1つの突起部からなることを特徴とする、請求項1に記載のバルーンカテーテル。
- ブレード状装置あるいは突起部が、金属、合金、あるいはプラスチックからなることを特徴とする、請求項6または7に記載のバルーンカテーテル。
- バルーンカテーテル(12)が、カテーテルおよび/またはカテーテルの部品、針、および案内ワイヤを案内するために連結されることを特徴とする、請求項1から8のいずれか一項に記載のバルーンカテーテル。
- パクリタキセルでコーティングされ予備成形された長手折曲部を特徴とする、請求項1から9のいずれか一項に記載のバルーンカテーテル。
- バルーン(14)が、パクリタキセルの低粘度溶液の中に完全に折り曲げた状態で浸漬することによってコーティングされることを特徴とする、請求項1から10のいずれか一項に記載のバルーンカテーテル。
- 折曲部によって覆われた範囲だけが、塗布された後に乾燥したパクリタキセルで被覆されることを特徴とする、請求項1から11のいずれか一項に記載のバルーンカテーテル。
- 有効量のパクリタキセルが、パクリタキセルの水への溶解度が低いにもかかわらず迅速に溶解する、粒径が0.1μm未満から5μmの範囲にある無定形構造を含むことを特徴とする、請求項1に記載のバルーンカテーテル。
- 基質物質が、診断用処置のために生体内で用いられる造影剤および色素、糖および関連物質、特に糖アルコール、生体適合性の有機塩および無機塩、特にベンゾアート、サリチル酸の塩および他の誘導体からなる群から選択されることを特徴とする、請求項1に記載のバルーンカテーテル。
- 基質物質が、1種類あるいは数種類のヨード化されたX線造影剤および/または常磁性キレートであることを特徴とする、請求項14に記載のバルーンカテーテル。
- パクリタキセルが、粒子に吸収されるか、あるいは低分子量基質を有する装置の表面に塗布されることを特徴とする、請求項1に記載のバルーンカテーテル。
- 表面は、装置のすべり特性のような特定の性質に影響を及ぼすか、あるいは血液凝固を防止する物質で追加コーティングされることを特徴とする、請求項1に記載のバルーンカテーテル。
- 溶液、懸濁液、あるいはエマルジョン媒体の中におけるパクリタキセルおよび補助薬が、浸漬、散布、噴霧処理あるいは容積計量器を用いて塗布され、一方、表面にゆるく付着する物質は、除去されることを特徴とする、請求項1から17のいずれか一項に記載のバルーンカテーテルの製造方法。
- コーティング処理が、同じかあるいは異なる溶液、懸濁液、またはエマルジョン媒体および/または補助薬を用いて、パクリタキセルの再現可能な増加のために繰り返し行われることを特徴とする、請求項18に記載の方法。
- 溶液、懸濁液、およびエマルジョン媒体として、エタノール、イソプロパノール、酢酸エチル、ジエチルエーテル、アセトン、水あるいはこれらの混合物が用いられる、請求項19に記載の方法。
- 滅菌の前あるいは後に、コーティングされる使用のための準備が整っている折り曲げられたバルーン(14)が、パクリタキセルのキャリアとして使われることを特徴とする、請求項18から20のいずれか一項に記載の方法。
- バルーン(14)が、折り曲げられていない状態でパクリタキセルによりコーティングされることと、バルーンが、特に潤滑性のある、場合によっては生体適合性のあるすべり物質で濡らされたツールで折り曲げられることを特徴とする、請求項21に記載の方法。
- 完全にコーティングされたバルーンカテーテルが、エチレンオキシドを用いて滅菌されることを特徴とする、請求項18に記載の方法。
- パクリタキセルの高い局部的濃度を生じさせる手段として構成された、請求項1から17のいずれか一項に記載のバルーンカテーテル。
- 体内に開放通路を形成する手段として構成された、請求項1から17のいずれか一項に記載のバルーンカテーテル。
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