JP6946324B2 - 眼科用送達装置および眼科用活性成分含有組成物 - Google Patents
眼科用送達装置および眼科用活性成分含有組成物 Download PDFInfo
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Description
本発明の一実施態様に係る装置は、固体または半固体物質を眼の上脈絡膜腔内または上毛様体腔内に投与するように作製した。筒要素は、0.5 mLインスリンシリンジの近位末端を30 mmの筒長まで切断することにより作製した。一体化された針を筒から取り外し、標準的なルアーハブ針の取り付けを可能にした。筒の先端は、ルアーハブ針を確実に保持することができるルアーテーパーの残存部分を残して切断した。筒端キャップは、4.5 mmのねじ長を有するナイロン10-32穴付きねじから作製した。直径1.86 mmの貫通穴を、筒端キャップを通して穿穴し、プランジャーが筒端キャップを自由に摺動できるようにした。プランジャーシャフトは、外径1.8 mmおよび内径0.8 mmならびに長さ43 mmの筒状のテフロンコーティングしたステンレス鋼ロッドから作製した。シャフトの遠位末端は、直径1.74 mmへと細くし、外径4.1 mmおよび内径1.70 mmならびに厚さ0.5 mmのステンレス鋼製ワッシャーをロッドに圧入して、プランジャースプリングのための末端止め具を与えた。ロッドの近位末端は、直径1.55 mmまで穿穴した。
実施例1に係る装置を作製した。送達する個体要素は、担体物質中に薬物を充填した微小球を含むスラリーを押し出すことにより製造した。薬物を充填した微小球は、直径10〜20ミクロンの範囲のポリ乳酸−グリコール酸共重合体の球状粒子を含んだ。微小球には、コルチコステロイドであるフルオシノロンアセトニドを25重量%で充填した。押し出し用のスラリーは、85重量%の微小球と15重量%の結合剤とを用いて製剤化した。結合剤には、92重量%の高分子量K90ポリビニルピロリドンおよび8重量%の低分子量K12ポリビニルピロリドンが処方され、脱イオン水で25重量%濃度の溶液とした。スラリーは、内径0.25 mmの先端針を有する0.3 mLシリンジを用いて50マイクロリットル/分のポンプ速度で分注し、シリンジポンプを使用して、分注針偏向要素の内径に対して同様の直径のフィラメントを押し出した。フィラメントは、さらに処理する前に、環境条件で乾燥させた。微小球含有フィラメントは10 mmの長さに切断し、実施例1に記載した通りに、送達装置内に充填した。
組織接点は、実施例1および実施例3に記載されたものと同様にして作製した。外径が1.75mmおよび2.50 mmと異なる、2種の組織接点を作製した。それぞれの直径の組織接点のサンプルは、ショア10A、30A、50Aおよび70Aの4種の異なるデュロメータの液体シリコーンエラストマーを用いて作製した。
半固体活性成分含有組成物を製造した。平均分子量700万ダルトンのポリエチレンオキシド(PolyOx(登録商標)、WSR-301)を、1.5重量%で脱イオン水に分散させた。平均直径15ミクロンの微小球を、ポリエチレンオキシド分散液中に2.5重量%の濃度で混合した。微小球は、50重量%のデキサメタゾンおよび50重量%のポリ乳酸−グリコール酸共重合体を含有した。半固体組成物は、観察するため、フルオレセインナトリウムにより染色した。
本発明の実施態様による装置を作製し、ガスおよび薬物を、眼の上脈絡膜腔中または上毛様体腔中に連続的にうまく送達することができるかどうかについて試験を行った。装置は、装置のガス送達部分が、プッシュロッドおよび活性成分含有組成物の送達機構から独立するように構成した。
Claims (37)
- 遠位末端に管腔のある針を有する細長状体;
針を通って送達されるガス体積のための第一の容器;
針を通って送達される活性成分含有組成物の送達のための第二の容器;
第一の容器から針管腔へのガス流路;
装置の遠位末端と組織表面との接触の前または接触と同時に、
ガスの第一の容器を加圧するように構成された力要素を備えた第一のプランジャー;
前記力要素から前記活性成分含有組成物に送達力を与えるように構成された第二のプランジャーまたはプッシュロッド;
送達力下でのガスの送達から針管腔を密封するように構成された装置の遠位末端に取り付けられた末端要素; および
一定量のガスおよび活性剤含有組成物の連続送達プロセスを提供するように構成された機構
を備える送達装置であって、
末端要素は、組織接点および末端シールを備え、末端シールは、装置の遠位末端で組織表面に圧力を加えることにより、針の先端により貫通され;
貫通された末端要素は、針を組織内に前進させることができるように針上で摺動可能であるように構成され;
貫通された末端シールは、第一の容器からガス流路を通って針の遠位末端へのガスの流入または送達のための経路を開くように構成され;および
第二の容器からの活性成分含有組成物は、ガスの体積の全部または一部が針を通して送達された後、第二のプランジャまたはプッシュロッドおよび力要素によって針を通して送達される、
送達装置。 - ガス体積を圧縮するために送達力を加える第一の力要素、および活性成分含有組成物に送達力を加える第二の力要素を備える、請求項1に記載の装置。
- ガス流路が、針管腔、針管腔の一部または別個の管腔を備える、請求項1または2に記載の装置。
- ガス流路が、針と同軸の筒および筒内の針のシャフトに穴を備える、請求項3に記載の装置。
- 活性成分含有組成物の送達が、少なくとも一部分のガス体積の送達後に、使用者により手動で開始される、請求項1〜4のいずれか1項に記載の装置。
- 活性成分含有組成物の送達が、少なくとも一部分のガス体積の送達後に、機構により自動で開始される、請求項1〜4のいずれか1項に記載の装置。
- 機構が、ガス体積および活性成分含有組成物に連続的に送達力を付与するように構成された、請求項6に記載の装置。
- 機構が、ガス体積の少なくとも一部分が送達されるまで、活性成分含有組成物の送達を阻止するように構成された、請求項6に記載の装置。
- 機構が、ガス体積に作動する第一の力要素と活性成分含有組成物に作動する第二の力要素との間にリンク機構を備える、請求項6に記載の装置。
- 機構が、ガス体積に作動するプランジャーと活性成分含有組成物に作動するプランジャーまたはプッシュロッドとの間にリンク機構を備える、請求項6に記載の装置。
- 針が、投与用物質を針の長軸から斜めに方向づけるために湾曲した先端を有する、請求項1〜10のいずれか1項に記載の装置。
- 針が、投与用物質を針の長軸から斜めに方向づけるために、針斜角において針管腔内に内部偏向要素を備える、請求項1〜11のいずれか1項に記載の装置。
- 針が、投与用物質が針先端から送達される前に、投与用物質を断片化するために、針斜角において針管腔内に偏向要素を備える、請求項1〜12のいずれか1項に記載の装置。
- 偏向要素が、針内径の0.20%〜50%の幅を有する、請求項13に記載の装置。
- 偏向要素が、針内径の0.25%〜50%の高さを有する、請求項13に記載の装置。
- 装置本体と、針先端が末端シールを貫通する間に、末端要素に前方に向けられた力を付与するように構成された末端要素との間に、第三の力要素をさらに備える、請求項1〜15のいずれか1項に記載の装置。
- 組織接点が、10〜30ショアA硬度を有するエラストマーを含む、請求項16に記載の装置。
- 前方に向けられた力が、40〜82グラム力の範囲にある、請求項16に記載の装置。
- 活性成分含有組成物をさらに備える、請求項1〜18のいずれか1項に記載の装置であって、活性成分含有組成物が固体または半固体である、装置。
- 容器が、針管腔内である、請求項1〜19のいずれか1項に記載の送達装置。
- 容器が、針管腔内および装置本体への針の伸長部内である、請求項1〜20のいずれか1項に記載の送達装置。
- 装置本体と、末端要素が、送達力によって末端へ移動することを防ぐように構成された末端要素との間に、折り畳み可能要素をさらに備える、請求項1〜21のいずれか1項に記載の装置。
- 折り畳み可能要素が、細長い支柱を備える、請求項22に記載の装置。
- 折り畳み可能要素が、ニチノールまたはポリイミドを含む、請求項22または23に記載の装置。
- 装置本体と、針先端が末端シールを貫通する間に、末端要素に前方に向けられた力を付与するように構成された末端要素との間に、折り畳み可能要素をさらに備える、請求項1〜24のいずれか1項に記載の装置。
- 折り畳み可能要素が、最初の力の後に一定の力を付与するように構成された、請求項25に記載の装置であって、最初の力が、末端要素が針に沿って近位に最初に0.5 mm移動する間に加えられる、装置。
- 組織接点および末端シールが、管状の末端筺体上に取り付けられた、請求項1〜26のいずれか1項に記載の装置。
- 筺体と針との間で圧縮され、筺体を密閉する弾性要素をさらに備える、請求項27に記載の装置。
- 第一の力要素および/または第二の力要素がスプリングである、請求項1〜28のいずれか1項に記載の送達装置。
- 第一の力要素が、プランジャーに機械的に連結されたスプリングである、請求項29に記載の送達装置。
- 第一の力要素および/または第二の力要素が加圧ガスである、請求項1〜28のいずれか1項に記載の送達装置。
- 装置への活性成分含有組成物の挿入が力要素を作動させ、活性成分含有組成物に送達力を付加する、請求項1〜31のいずれか1項に記載の送達装置。
- 装置の外部から第一の力要素および/または第二の力要素を圧縮する機構により、送達力を作動させる、請求項1〜32のいずれか1項に記載の送達装置。
- 使用前は、第一の力要素および/または第二の力要素が束縛されており、束縛された力要素を機械的に解放することにより、送達力が作動する、請求項1〜33のいずれか1項に記載の送達装置。
- 針の有効全長が1〜4 mmであり、上脈絡膜腔または上毛様体腔に活性成分含有組成物を投与するための、請求項1〜34のいずれか1項に記載の送達装置。
- 針の有効全長が10〜15 mmであり、硝子体腔に活性成分含有組成物を投与するための、請求項1〜34のいずれか1項に記載の送達装置。
- 針の有効全長が0.35〜2 mmであり、上脈絡膜腔に活性成分含有組成物を投与するための、請求項1〜34のいずれか1項に記載の送達装置。
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