JP2017060789A - 鼻涙系用の薬物送達方法、構造および組成物 - Google Patents
鼻涙系用の薬物送達方法、構造および組成物 Download PDFInfo
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Abstract
Description
本発明は患者の眼組織の涙点から治療薬を送達するためのインプラント装置、システムおよび方法を提供する。
多くの実施形態では、患者へ挿入するためのインプラントが提供される。患者は眼に付随する涙液の流路を持ち、インプラントは本体を含む。本体は治療薬と支持構造を含むことができる。本体は、涙液の流路に沿った標的位置に埋め込まれると、数日間の徐放期間にわたって毎日、ある量の治療薬を涙液に放出するように構成できる。その量は、治療薬の推奨される一日の点眼量よりも著しく少なくなってもよい。例えば、その量は推奨される点眼量の10%未満であってもよい。特定の実施形態では、その量は推奨される点眼量の5%未満であってもよい。
鞘体は薬物芯からの治療薬の移行を制御するために適切な形状と材料からなる。鞘体は芯を格納し、芯に対してぴったりと適合し得る。治療薬の移行速度が、鞘体によって覆われない薬物芯の暴露表面積によって十分に制御され得るように、鞘体は治療薬に対してほぼ不浸透性の材料で作られる。多くの実施形態では、鞘体を通る治療薬の移行は、薬物芯の暴露面を通る治療薬の移行の約1/10以下となり得、しばしば1/100以下となることがある。言い換えれば、鞘体を通る治療薬の移行は、薬物芯の暴露面を通る治療薬の移行よりも、少なくとも約一桁小さい。適切な鞘体材料は、ポリイミド、ポリエチレンテレフタレート(以下“PET”)を含む。鞘体は、芯付近の鞘表面から、芯から離れた反対の鞘表面までと規定される、約0.00025"から約0.0015"の厚みを持つ。芯に及ぶ鞘の総直径は、約0.2mmから約1.2mmの範囲である。芯は鞘材料内に芯を浸漬被覆することによって形成され得る。別の方法として、もしくは組み合わせて、鞘体は、例えば鞘体管にスライド、挿入、および/または押出することができる液体もしくは固体として、鞘に導入される管および芯を含むことができる。鞘体は芯の周囲に浸漬被覆させることもできる(例えば前もって作られた芯の周囲に浸漬被覆する)。
保持構造は、インプラントを所望の組織位置(例えば涙小管)に容易に位置付けることができるようなサイズと形状の適切な材料からなる。保持構造は機械的に配置可能で、通常は所望の断面形状に拡張し、例えば保持構造はNitinolTMなどの超弾性形状記憶合金からなる。所望の拡張をもたらすために、NitinolTMに加え他の材料、例えば弾性金属もしくはポリマー、塑性的に変形可能な金属もしくはポリマー、形状記憶ポリマーなどが使用できる。いくつかの実施形態では、Biogeneral, Inc. of San Diego, Californiaから購入できるポリマーおよび被覆繊維を用いてもよい。ステンレス鋼などの多くの金属および非形状記憶合金を使用でき、所望の拡張を与える。この拡張能力は、例えば0.3mmから1.2mmの範囲の涙小管など、様々なサイズの中空組織構造にインプラントが適合することを可能にする(すなわちフリーサイズ)。直径0.3から1.2 mmの涙小管に適合するようにただ一つの保持構造を作ることができるが、必要に応じてこの範囲に適合するように、複数のその代わりに選択可能な保持構造(例えば0.3から約0.9mmの涙小管用の第一の保持構造と、約0.9から1.2mmの涙小管用の第二の保持構造)を使用することができる。保持構造は、保持構造が結合する解剖学的構造に適切な長さを持ち、例えば涙小管の涙点付近に配置される保持構造は約3mmの長さである。別の解剖学的構造では、長さは適当な保持力を提供するのに適切なもの(例えば必要に応じて1mmから15mm)となり得る。
閉塞部材は、インプラントが中空組織構造を通る流体の流れ(例えば涙小管を通る涙液)を少なくとも部分的に阻止、さらに遮断することができるようなサイズと形状の適切な材料からなる。示される閉塞材料は、保持構造と共に拡張、収縮が可能な、例えばシリコンなどの生体適合性材料の薄壁膜である。閉塞部材は、保持構造の末端にわたってスライドされ、上述のように保持構造の一端に固定される材料の独立した薄管として形成される。別の方法として、閉塞部材は、例えばシリコンポリマーなどの生体適合性ポリマーに保持構造を浸漬被覆することによって形成することができる。閉塞部材の厚みは約0.01mmから約0.15mmの範囲となり得、しばしば約0.5mmから0.1mmとなる。
“治療薬”とは、以下のいずれかもしくはその均等物、誘導体もしくはアナログとなり得る薬物を含むことができ、抗緑内障薬(例えばアドレナリン作動薬、アドレナリン拮抗薬(βブロッカー)、炭酸脱水素酵素阻害薬(CAI、全身および局所)、副交感神経作用薬、プロスタグランジン、降圧性脂質(hypotensive lipids)、およびそれらの組み合わせ)、抗微生物薬(例えば、抗生物質、抗ウィルス薬、駆虫(antiparacytic)薬、抗真菌薬など)、コルチコステロイドもしくは他の抗炎症薬(例えばNSAID)、充血除去剤(例えば血管収縮剤)、アレルギー性反応の修正を防ぐ薬(例えば抗ヒスタミン、サイトカイン阻害剤、ロイコトリエン阻害剤、IgE阻害剤、免疫調節剤)、マスト細胞安定剤、毛様筋調節薬などを含む。治療薬(群)で処置され得る症状の例としては、緑内障、術前および術後の処置、ドライアイおよびアレルギーを含むが限定はされない。いくつかの実施形態では、治療薬は潤滑剤もしくは界面活性剤(例えばドライアイを処置する潤滑剤)であってもよい。
薬物芯は治療薬の徐放をもたらす材料と治療薬を含む。治療薬は薬物芯から標的組織(例えば眼の毛様筋)に移行する。少量の治療薬がマトリクスに溶解し、薬物芯110の表面からの放出に利用可能であるように、治療薬は随意にマトリクスにわずかしか溶けないものとなり得る。治療薬は芯の暴露面から涙液もしくは涙液膜に拡散するので、芯から涙液もしくは涙液膜への移行速度は、マトリクスに溶解する治療薬の濃度に関係し得る。加えて、もしくは相まって、芯から涙液もしくは涙液膜への治療薬の移行速度は、治療薬が溶解するマトリクスの性質に関連し得る。特定の実施形態では、薬物芯から涙液もしくは涙液膜への移行速度は、シリコン製剤に基づき得る。いくつかの実施形態では、薬物に溶解する治療薬の濃度は、治療薬の所望の放出速度をもたらすように制御され得る。芯に含まれる治療薬は、液体、固体、固体ゲル、固体単結晶、固体非晶質、固体粒子、および/または治療薬の溶解した形を含むことができる。好ましい実施形態では、薬物芯は治療薬を含むシリコンマトリクスを含む。治療薬は、液体もしくは固体の含有物を含んでもよく、例えばそれぞれシリコンマトリクスに分散される、液体ラタノプロスト液滴もしくは固体ビマトプロスト粒子を含んでもよい。
治療薬の放出速度は、薬物芯に溶解する治療薬の濃度に関係し得る。多くの実施形態では、薬物芯は、薬物芯中で治療薬の所望の溶解度をもたらすように選択される、非治療薬を含む。薬物芯の非治療薬は上述のポリマーと添加剤を含むことができる。芯のポリマーは、マトリクス中で治療薬の所望の溶解度をもたらすように選択できる。例えば、芯は親水性の治療薬の溶解度を促進し得るヒドロゲルを含むことができる。いくつかの実施形態では、マトリクス中で治療薬の所望の溶解度をもたらすために、官能基をポリマーに加えることができる。例えば、官能基をシリコンポリマーに結合させることができる。
上述の薬物芯を、0.006インチ、0.012インチ、0.025インチの異なる断面サイズと、シリコンマトリクス中で5%、10%、20%の薬物濃度で製造した。これらの薬物芯は、注射器とカートリッジの組立、ラタノプロストとシリコンの混合、および所望の長さに切断して密封したポリイミド管への混合物の注入で作ることができる。薬物芯の長さはおよそ0.80から0.95mmとし、これは0.012インチ(0.32mm)の直径で、それぞれ5%、10%、20%の濃度で、薬物芯においておよそ3.5μg、7μg、14μgの総ラタノプロスト含有量に相当する。
実施例1に記載の薬物芯を、21.2%の濃度を持つシクロスポリンで作製した。図8Aは、本発明の実施形態に従って、薬物芯からの、界面活性剤を含まないバッファー溶液へのシクロスポリンの溶出特性と、界面活性剤を含むバッファー溶液へのシクロスポリンの溶出特性を示す。バッファー溶液は上述の通り作製した。界面活性剤を含む溶液は、95%のバッファーと5%の界面活性剤(Dow Corning, Midland MIのUP-1005 Ultra Pure Fluid)を含む。本発明の実施形態に関連する研究は、眼が天然の界面活性剤(例えば涙液膜中のサーファクタントタンパク質D)を含み得るので、眼からのin situ溶出をモデル化するために、少なくともいくつかの例では、界面活性剤がin vitroで使用され得ることを示唆する。界面活性剤へのシクロスポリンの溶出特性は、30から60日まででおよそ50から100ng/dayである。例えば10人の患者の、患者集団の涙から実験データを計測でき、適切な量の界面活性剤を用いてin vitroモデルを改良するために使用できる。薬物芯マトリクスは、改良in vitroモデルで決定されるヒトの涙液の界面活性剤に応じて調整され得る。薬物芯はヒトの涙液膜の界面活性剤に応じて多くの方法で調整でき、例えば増加した暴露表面積および/または添加物を用いて、上述の通り芯中に溶解するシクロスポリン薬物の量を増加させ、必要であれば芯からの溶出を治療レベルにまで増加させることで調整できる。
0.076cm(0.76mm)の既知の直径を持つ、1%ビマトプロストのバルクサンプルを用意した。各サンプルの高さはサンプルの重量と既知の直径から計算した。
薬物芯は、上述の通り、ラタノプロストと、シリコン4011、6385、および/またはNaClで製造された。四通りの処方を次のように製造した。A)シリコン4011、約20%のラタノプロスト、約20%のNaCl;B)シリコン4011、約20%のラタノプロスト、約10%のNaCl;C)シリコン4011、約10%のラタノプロスト、約10%のNaCl;D)シリコン6385、約20%のラタノプロスト。図10Aは、本発明の実施形態に従う、ラタノプロストの四通りの処方に対する、芯からのラタノプロストの溶出特性を示す。結果は、約300ng/device/dayの初期速度が3週間(21日)で約100ng/device/dayに減少したことを示す。示された結果は非滅菌薬物芯のものである。同様の結果はラタノプロストの滅菌薬物芯で得られている。これらのデータは、上述の通り、ラタノプロストの液滴が薬物芯マトリクスに懸濁しており、中に溶解したラタノプロストで薬物芯マトリクスが実質的に飽和していることに矛盾しない。
Claims (1)
- 患者の眼又は周辺組織又はその双方に治療剤の徐放を提供すべく患者の涙小管へ挿入するために構成され、インプラント内に設置させるために構成された薬物挿入部であって、
マトリクス内に含まれる治療剤を含む薬物芯と、
前記薬物芯を部分的に覆い、前記薬物芯の一部分から前記治療剤が放出されるのを防ぐとともに前記薬物芯の末端である1以上の暴露面を画定するように前記一部分が暴露される鞘体であって、前記鞘体で覆われていない前記暴露面から前記治療剤が放出されるようになっている前記鞘体と、
を含み、
前記薬物芯が前記鞘体内に配置され、前記薬物挿入部が前記インプラント内に配置され前記インプラントが前記患者の涙小管に挿入された時、前記患者の眼に前記治療剤を放出する前記薬物芯の暴露された近位末端を提供するように前記鞘体が構成され、前記薬物芯の遠位末端が医療グレード接着剤で密封されることを特徴とする薬物挿入部。
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