JP2013522314A - 薬物送達のための不均一な埋め込み型デバイス - Google Patents
薬物送達のための不均一な埋め込み型デバイス Download PDFInfo
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- JP2013522314A JP2013522314A JP2013500190A JP2013500190A JP2013522314A JP 2013522314 A JP2013522314 A JP 2013522314A JP 2013500190 A JP2013500190 A JP 2013500190A JP 2013500190 A JP2013500190 A JP 2013500190A JP 2013522314 A JP2013522314 A JP 2013522314A
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Abstract
Description
この特許出願は、2010年3月16日に出願された米国仮特許出願第61/314,465号の利益を主張する。この出願の全内容は、参考として本明細書に援用される。
本発明は、埋め込み型デバイスであって、コアポリマー材料と必要に応じたコア医薬物質とを含むコアを含み、前記コアが、第一層ポリマー材料と(前記第一層のものと同一であってもよく、または同一でなくてもよい)追加のポリマー材料と医薬物質(単数または複数)とを含む1つ以上の層によって包囲されているものであるデバイスを提供する。
多くの患者は、疼痛管理用の物質をはじめとする薬物または医薬物質の長期、規則的投与を要する。有効な処置は、多くの場合、1日に多数の錠剤の摂取を必要とする。この投与計画の遵守は、多くの場合、難しい。さらに、経腸薬物送達は、時として、特定の適応症を有する患者では認容性が低い、または禁止される。加えて、経口錠剤は、乱用または他の不法使用に付されることがある。経口および舌下送達は、薬物の血漿濃度の急速なピーク到達および急降下をもたらす場合がある。医薬品物質の継続的非経口送達は、高価であり、厄介であり、ならびに冷蔵、カテーテル、ポンプおよび訓練された職員の利用可能性に依存する。これらの方法は、患者の投与レジメン遵守不良に終わる場合がある。それ故、患者に医薬品物質を規則正しく投与するデバイスが必要とされている。
一部の実施形態では、前記埋め込み型デバイスを押出プロセスによって製造することができる。粉砕(例えば、ボールミル粉砕、衝撃粉砕)、スプレー乾燥、溶媒沈殿法、ふるい分け、または微粒子を製造するための当該技術分野において公知の他の方法もしくは方法の組み合わせによって、医薬品物質を調製することができる。薬物をポリマーと併せることができ、このポリマーも微粒子として調製される。ブレンドされた混合物を、例えばMicrotruderスクリュー押出機、モデル番号RCP−025、ニュージャージー州シーダー・グローブのRandcastle Extrusion Systems)によって、または当業界で公知の他の押出装置によって、押し出すことができる。押し出しの直径、ならびに温度、圧力および他のパラメータをそれぞれの薬物について適宜制御することができる。
一部の実施形態において、デバイスは、直径約0.5から約7mmの寸法を含む。一部の実施形態において、前記デバイスは、長さ約0.5から10cmである。1つの実施形態において、前記デバイスは、長さ約1から約3cmである。1つの実施形態において、前記デバイスは、長さ約2cmから約3cmである。もう1つの実施形態において、前記デバイスは、長さ約2.6cmである。1つの実施形態において、前記デバイスは、直径約1から約3mmである。もう1つの実施形態において、前記デバイスは、直径約2から約3mmである。1つの実施形態において、前記でデバイスは、直径約2.4mmである。デバイスが全直径約2.4mmおよび全長約2.6cmの寸法を含む一部の実施形態において、それらのデバイスは、それぞれ、1日に1mgの医薬物質を放出する。
前記デバイスからの薬物の放出は、溶解速度におよびポリマーマトリックスを通っての受動的拡散に依存する。従って、インプラントの表面積によって放出速度が決まる。ポリマーマトリックスからの薬物の放出メカニズムもポリマーおよび薬物の性質に依存する。薬物は、ポリマーを通って周囲組織および体液に拡散する。放出は、受食性または生体内受食性ポリマーの場合、ポリマーの分解または侵食によっても起こり得る。ポリマーの分解または侵食は、加水分解によって起こることもあり、酵素的分解によって起こることもあり、または他のプロセスによって起こることもある。
前記埋め込み型デバイスは、コアポリマー材料を含む(場合により、医薬物質も含有する)コアを含み、前記コアは、層ポリマー材料と医薬物質とを含む1つ以上の層によって包囲されている。前記コアおよび層ポリマー材料は、同じであってもよいし、または異なってもよい。前記コアまたは任意の層は、2つ以上のポリマーの混合物を含んでもよく;前記コアおよび様々な層は、ポリマーの異なる混合物を含有してもよい。前記ポリマーは、生体内受食性または非生体内受食性であることができる。従って、前記コアは、生体内受食性ポリマーを含んでよく、前記1つ以上の包囲層も生体内受食性ポリマーを含む。もう1つの実施形態において、前記コアは、非生体内受食性ポリマーを含んでもよく、その一方で1つ以上の包囲層は、生体内受食性ポリマー(単数または複数)を含んでもよい。もう1つの実施形態では、前記コアおよび少なくとも1つの包囲層の両方が、非生体内受食性ポリマーを含んでもよい。コアを包囲する隣接層は、生体内受食性および非生体内受食性ポリマーを含んでもよいが、但し、任意の生体内受食性ポリマー層が、任意の非生体内受食性ポリマー層の外側に位置すること、すなわち、任意の生体内受食性ポリマー層が、任意の非受食性ポリマー層よりコアから遠くに位置することを条件とする。
本明細書において用いる場合、「薬物」または「医薬物質」は、限定ではないが抗血栓薬、抗癌剤、抗血液凝固薬、抗血小板剤、血栓溶解薬、増殖抑制薬、抗炎症薬、再狭窄を抑制する薬剤、平滑筋細胞阻害剤、抗生物質、ヘパリン、およびこれらに類するもの、および/もしくはそれらの混合物を含む、生きている生物に対して治療効果がある任意の生物活性薬剤または他の物質、ならびに/または生きている生物に治療効果をもたらす作用を果たすに当たり別の物質を援助することができる任意の物質である。適する治療および予防薬の例としては、治療、予防または診断活性を有する、合成無機および有機化合物、タンパク質およびペプチド、多糖類および他の糖、脂質ならびにDNAおよびRNA核酸配列が挙げられる。核酸配列としては、遺伝子、相補DNAに結合して転写を阻害するアンチセンス分子、およびリボザイムが挙げられる。
薬物送達は、インプラントの寿命の間中、制御放出することができる。ポリマーを含むコアと、ポリマーおよび薬物を含む多数の層とを含む多層積層デバイスでは、異なる層中の様々な薬物濃度を用いて、薬物送達速度を経時的に調整することができる。1つの実施形態において、前記デバイスは、経時的に概して線形の薬物放出を提示する。もう1つの実施形態において、前記デバイスからの薬物放出は、そのデバイスの寿命にわたって、またはそのデバイスの寿命中の特定の期間、ほぼ一定している、または本質的に一定している。前記薬物は、最外層から最内層まで、一層ずつ、前記デバイスから放出される。しかし、各層は、その外側の層より小さい直径および表面積を有するであろう。従って、ほぼ一定したまたは本質的に一定した薬物放出速度を維持するために、内部に近い層のほうが外側の層より高い薬物濃度を有する必要がある。もう1つの実施形態では、異なる薬物放出速度を生じさせるように一層一層の薬物濃度を設計することができる。例えば、各層が、より外側の隣接層と同じまたはそれより低い薬物濃度を含有する場合、これは、漸減的な減少し続ける薬物送達速度を生じさせる結果となるだろう。薬物の濃度を一層ずつ調整することで、インプラントの寿命にわたってまたはインプラントの寿命中の特定の期間にわたって薬物送達のゆっくりとした増加を生じさせることもできる。相対的に高い薬物濃度と相対的に低い薬物濃度の交互層は、時間の経過に伴って増加および減少するパルス型の薬物送達速度を生じさせることができる。
本発明の1つの方法では、前記デバイスを皮下埋め込みによって施与する。様々な実施形態において、前記デバイスを、上腕、肩甲部、背部、下肢および腹部から成る群より選択される部位の皮下に埋め込む。埋め込み前、例えばイソフルランもしくは当該技術分野において公知の他の麻酔薬で、患者に軽く麻酔をしてもよく、および/または埋め込み部位に局所、経皮もしくは皮下麻酔をかけてもよい。皮膚に小切開を施し、トロカールを皮下挿入して、1つのインプラントを負荷することができる。スタイレットを挿入して、インプラントを適所に保持し、皮下空間にインプラントを残してトロカールを注意深く除去することができる。各部位を縫合して閉鎖し、後に検査することができる。合併症、例えば、皮膚刺激、炎症、感染または他の部位特異的有害反応をモニターし、必要に応じて例えば抗生物質で処置することができる。
前記デバイスの一部の実施形態において、そのコアは、エチレンビニルアセタート(EVA)のコアポリマー材料を含む。前記コアを包囲する第一層は、EVAから作製され、物質ブプレノルフィンを含有する。
Claims (30)
- 患者への医薬物質の送達のための埋め込み型デバイスであって、前記デバイスは:
コアポリマー材料を含み、かつ必要に応じてコア医薬物質を含む、コア;および
前記コアを包囲する、第一層医薬物質と第一層ポリマー材料とを含む、第一層
を含み;かつ
追加の医薬物質と追加のポリマー材料とを含む1つ以上の追加の層
を必要に応じて含み;ここで、
前記コアポリマー材料、前記第一層ポリマー材料および前記追加のポリマー材料が、同じであるかまたは異なり;ならびに前記コア医薬物質(存在する場合)、前記第一層医薬物質および前記追加の医薬物質が、同じであるかまたは異なるものである、デバイス。 - 実質的に棒形または円筒形である、請求項1に記載のデバイス。
- 前記コアポリマー材料および前記第一層ポリマー材料が同じである、請求項1に記載のデバイス。
- 前記コアポリマー材料、前記第一層ポリマー材料および前記追加のポリマー材料のうちの少なくとも1つが、他の材料と異なる、請求項1に記載のデバイス。
- 非生体内受食性層内に生体内受食性層を配置しないという条件で、前記コアポリマー材料、前記第一層ポリマー材料および必要に応じた前記層の前記追加のポリマー材料のうちの少なくとも1つが生体内受食性である、請求項1に記載のデバイス。
- 非生体内受食性層内に生体内受食性層を配置しないという条件で、前記コアポリマー材料、前記第一層ポリマー材料および必要に応じた前記層の前記追加のポリマー材料のうちの少なくとも1つが非生体内受食性である、請求項1に記載のデバイス。
- 前記コアポリマー材料、前記第一層ポリマー材料および必要に応じた前記層の前記追加のポリマー材料が、エチルビニルアセタート(EVA)である、請求項6に記載のデバイス。
- 前記生体内受食性材料が、ポリアミド、脂肪族ポリカーボネート、ポリアルキルシアノアクリラート、ポリアルキレンオキサラート、ポリ無水物、ポリカルボン酸、ポリエステル、ポリ(ヒドロキシブチラート)、ポリイミド、ポリ(イミノカーボネート)、ポリカプロラクトン(PCL)、ポリ−D,L−乳酸(DL−PLA)、ポリ−L−乳酸−co−グリコール酸(PLGA)、ポリジオキサノン、ポリ(グリコール酸)、ポリ−L−乳酸(L−PLA)、ポリオルトエステル、ポリホスファゼン、ポリホスホエステル、およびポリ(トリメチレンカーボネート)から成る群のメンバーの生体内受食性形態である、請求項5に記載のデバイス。
- 前記非生体内受食性材料が、ポリ(エチレン−co−ビニルアセタート)(EVA)、ポリビニルアルコール、ポリウレタン、およびポリカーボネート系ポリウレタンから成る群のメンバーの非生体内受食性形態である、請求項6に記載のデバイス。
- 前記コアポリマー材料、前記第一層ポリマー材料、および必要に応じた前記層の前記追加のポリマー材料が、アクリル樹脂、アガロース、アルギナート、セルロースエーテル、コラーゲン、ポリ(エチレングリコール)セグメントとポリブチレンテレフタラートセグメント(PEG/PBT)を含有するコポリマー、ポリ(乳酸)およびグリコール酸のコポリマー、それらとポリ(エチレングリコール)のコポリマー、デキストラン、デキストロース、エラスチン、エポキシド、エチレンビニルアセタート(EVAコポリマー)、フルオロポリマー、ゼラチン、ヒドロキシプロピルメチルセルロース、無水マレイン酸コポリマー、メチルセルロースおよびエチルセルロース、非水溶性酢酸セルロース、非水溶性キトサン、非水溶性ヒドロキシエチルセルロース、非水溶性ヒドロキシプロピルセルロース、ペプチド、PLLA−ポリグリコール酸(PGA)コポリマー(PLGA)、ポリ(L−乳酸)、ポリ(2−エトキシエチルメタクリラート)、ポリ(2−ヒドロキシエチルメタクリラート)、ポリ(2−メトキシエチルアクリラート)、ポリ(2−メトキシエチルメタクリラート)、ポリ(アクリルアミド)、ポリ(アルギン酸)、ポリ(無水物)、ポリ(アスパラギン酸)、ポリ(ベンジルグルタマート)、ポリ(ベータ−ヒドロキシブチラート)、ポリ(カプロラクトン)、ポリ(D,L−乳酸)、ポリ(D,L−ラクチド)(PLA)、ポリ(D,L−ラクチド−co−カプロラクトン)(PLA/PCL)およびポリ(グリコリド−co−カプロラクトン)(PGA/PCL)、ポリ(D,L−ラクチド−co−グリコリド)(PLA/PGA)、ポリ(エーテルウレタン尿素)、ポリ(エチルグルタマート−co−グルタミン酸)、ポリ(エチレンカーボネート)、ポリ(エチレングリコール)、ポリ(エチレン−co−ビニルアルコール)、ポリ(グルタミン酸)、ポリ(グルタミン酸−co−エチルグルタマート)、ポリ(グリコール酸)、ポリ(グリコリド−co−トリメチレンカーボネート)(PGA/PTMC)、ポリ(ヒドロキシプロピルメタクリルアミド)、ポリ(イミノカーボネート)、ポリ(ロイシン)、ポリ(ロイシン−co−ヒドロキシエチルグルタミン)、ポリ(L−ラクチド−co−D,L−ラクチド)(PLLA/PLA)、ポリ(L−ラクチド−co−グリコリド)(PLLA/PGA)、ポリ(リジン)、ポリ(オルト エステル)、ポリ(オルトエステル)、ポリ(オキサアミド)、ポリ(オキサエステル)、ポリ(リン酸エステル)、ポリ(ホスファゼン)、ポリ(ホスホ エステル)、ポリ(ホスホエステル)、ポリ(プロピレンカーボネート)、ポリ(プロピレングリコール)、ポリ(ピロール)、ポリ(tert−ブチルオキシ−カルボニルメチルグルタマート)、ポリ(テトラメチレングリコール)、ポリ(トリメチレンカーボネート)、ポリ(尿素)、ポリ(ウレタン)、ポリ(ウレタン−尿素)、ポリ(ビニルアルコール)、ポリ(ビニルアルコール−co−ビニルアセタート)、ポリ(ビニルピロリドン)(PVP)、ポリ[(97.5%ジメチル−トリメチレンカーボネート)−co−(2.5%トリメチレンカーボネート)]、ポリアクリル酸、ポリアルキレンオキシド、ポリアミド、ポリカプロラクトン(PCL)ポリ−(ヒドロキシブチラート−co−ヒドロキシバレラート)コポリマー(PHBV)、ポリカプロラクトン(PCL)、ポリカプロラクトン co−ブチルアクリラート、ポリデプシペプチド、ポリジオキサノン(PDS)、ポリエステル、ポリエチレングリコール、ポリエチレンオキシド(PEO)、ポリエチレンテレフタラート(PET)、ポリグリコール酸およびコポリマーならびにそれらの混合物、ポリ(L−ラクチド)(PLLA)、ポリグリコール酸[ポリグリコリド(PGA)]、ポリヒドロキシブチラート(PHBT)およびポリヒドロキシブチラートのコポリマー、ポリイミノカーボネート、ポリ乳酸、ポリメタクリル酸、ポリオレフィン、ポリホスファゼンポリマー、ポリプロピレンフマラート、多糖類、ヒアルロン酸、ポリテトラフルオロエチレン)、ポリウレタン、シリコーン、チロシン由来ポリアリーレート、チロシン由来ポリカーボネート、チロシン由来ポリイミノカーボネート、チロシン由来ポリホスホナート、ならびにウレタンから成る群より独立して選択される、請求項1に記載のデバイス。
- 前記コアポリマー材料、前記第一層ポリマー材料、および必要に応じた前記層の前記追加のポリマー材料が、セルロースエステル、ポリブチレンテレフタラート、ポリカーボネート、ポリエステル、ポリエーテルエーテルケトン、ポリエチレン−co−テトラフルオロエチレン、ポリメチルメタクリラート、ポリオレフィン、ポリプロピレン、ポリスルホン、ポリテトラフルオロエチレン、ポリウレタン、ポリ塩化ビニル、ポリフッ化ビニリデン、シリコーン、ABS樹脂、アクリル酸ポリマーおよびコポリマー、アクリロニトリル−スチレンコポリマー、アルキド樹脂、およびカルボキシメチルセルロース、およびエチレン−ビニルアセタートコポリマー、セロファン、酪酸セルロース、酢酸酪酸セルロース、酢酸セルロース、セルロースエーテル、硝酸セルロース、プロピオン酸セルロース、ビニルモノマーの互いとのおよびオレフィンとのコポリマー、エチレン−メチルメタクリラートコポリマー、エポキシ樹脂、エチレンビニルアルコールコポリマー(一般名EVOHによりまたは商用名EVALにより一般に公知)、ポリ(グリセリルセバカート)、ポリ(グリコール酸−co−トリメチレンカーボネート)、ポリ(ヒドロキシブチラート−co−バレラート)、ポリ(ヒドロキシバレラート)、ポリ(ラクチド−co−グリコリド)、ポリ(プロピレンフマラート)、ポリ(トリメチレンカーボネート)、ポリアクリロニトリル、ポリアミド、ナイロン66、ポリカプロラクタム、ポリカーボネート、ポリシアノアクリラート、ポリジオキサノン、ポリエステル、ポリエーテル、ポリイミド、ポリイソブチレンおよびエチレン−アルファオレフィンコポリマー、ポリオキシメチレン、ポリホスホエステルウレタン、ポリビニルケトン、ポリビニル芳香族、ポリスチレン、ポリビニルエステル、ポリ酢酸ビニル、ポリビニルエーテル、ポリビニルメチルエーテル、ポリハロゲン化ビニリデン、フッ化ビニリデン系ホモ−またはコポリマー、例えばポリフッ化ビニリデン(PVDF)またはポリ(ビニリデン−co−ヘキサフルオロプロピレン)(PVDF−co−HFP)およびポリ塩化ビニリデン、レーヨン、レーヨン−トリアセタート、シリコーン、ハロゲン化ビニルポリマーおよびコポリマー、ポリ塩化ビニル、ならびにこれらのポリマーのポリ(エチレングリコール)(PEG)とのコポリマーから成る群より独立して選択される、請求項1に記載のデバイス。
- 前記コアポリマー材料、前記第一層ポリマー材料、および必要に応じた前記層の前記追加のポリマー材料が、ポリ(乳酸)およびグリコール酸のコポリマー、ポリ(無水物)、ポリ(D,L−乳酸)、ポリ(D,L−ラクチド)、ポリ(D,L−ラクチド−co−グリコリド)、ポリ(エチレンカーボネート)、ポリ(グリコール酸)、ポリ(グリコリド)、ポリ(L−乳酸)、ポリ(L−ラクチド)、ポリ(L−ラクチド−co−グリコリド)、ポリ(オルト エステル)、ポリ(オキサアミド)、ポリ(オキサエステル)、ポリ(ホスファゼン)、ポリ(ホスホ エステル)、ポリ(ホスホエステル)、ポリ(プロピレンカーボネート)、ポリ(トリメチレンカーボネート)、ポリ(チロシン由来カーボネート)、ポリ(チロシン由来イミノカーボネート)、ポリ(チロシン由来アリーレート)、およびこれらのポリマーのポリ(エチレングリコール)(PEG)とのコポリマーから成る群より独立して選択される、請求項1に記載のデバイス。
- 前記コアポリマー材料、前記第一層ポリマー材料、および必要に応じた前記層の前記追加のポリマー材料が、コ−ポリマー、トリ−ポリマーおよびテトラ−ポリマー、ならびに1つ以上のポリマーの混合物から成る群より独立して選択される、請求項1に記載のデバイス。
- 前記コアポリマー材料、前記第一層ポリマー材料および必要に応じた前記層の前記追加のポリマー材料のいずれかが、2つ以上のポリマーの混合物を含む、請求項1に記載のデバイス。
- 必要に応じた前記コア医薬物質、前記第一層医薬物質、および必要に応じた前記追加の医薬物質が、アナストロゾール、アポモルフィン、ベラプロスト、ブプレノルフィン、ブセレリン、デュタステライド、フィナステライド、ハロペリドール、イロプロスト、L−チロキシン、L−トリヨードサイロニン、ロイプロリド、リスリド、ナルメフェン、ニコチン、プラミペキソール、ラサギリン、リスペリドン、ロピニロール(ropinerole)、ロチゴチン、セレギリン、シロリムス、タクロリムス、タムスロシン、およびテストステロンから成る群より独立して選択される、請求項1に記載のデバイス。
- 前記第一層医薬物質が、ブプレノルフィンである、請求項1に記載のデバイス。
- 必要に応じた前記コア医薬物質、前記第一層医薬物質、および必要に応じた前記追加の医薬物質が、5−アルファ−レダクターゼ阻害剤、蘇生薬、鎮痛薬、アンギオテンシン転換酵素、抗癌剤、抗癌製剤、抗コリン作用薬阻害剤、抗血液凝固薬、抗痙攣薬、抗うつ薬、抗糖尿病剤、抗遺尿症剤(antienuresis agent)、抗炎症剤、抗肥満製剤、駆虫薬、抗パーキンソン症候群薬、抗血小板剤、抗精神病剤、鎮痙薬および抗コリン作用薬、抗血栓薬、抗ウイルス剤、気管支拡張薬、カルシウムチャネル遮断薬、中枢神経興奮薬、コレステロール低下薬および抗高脂血症薬、利尿薬、ドーパミン作動薬、ヒスタミンH受容体拮抗薬、ホルモン、ステロイドホルモン、ペプチドホルモン、甲状腺ホルモン、ホルモン模倣薬、ステロイドホルモンの模倣薬、ペプチドホルモンの模倣薬、甲状腺ホルモンの模倣薬、血糖上昇剤、免疫抑制薬、麻薬拮抗薬、麻薬解毒剤、眼科用浸透圧性脱水剤(ophthalmological osmotic dehydrating agent)、呼吸興奮薬、再狭窄抑制剤、交感神経遮断薬、甲状腺製剤、ならびに尿酸排泄剤から成る群より独立して選択される、請求項1に記載のデバイス。
- 必要に応じた前記コア医薬物質、前記第一層医薬物質、および必要に応じた前記追加の医薬物質が、ホルモン、成長因子、アンギオペプチン、アンギオテンシン転換酵素阻害剤、カプトプリル、シラザプリル、およびリシノプリルから成る群より独立して選択される、請求項1に記載のデバイス。
- 必要に応じた前記コア医薬物質、前記第一層医薬物質、および必要に応じた前記追加の医薬物質が、カルシウムチャネル遮断薬、ニフェジピン、およびトリアゾロピリミジンから成る群より独立して選択される、請求項1に記載のデバイス。
- 前記抗癌剤が、アンドロゲンから成る群より選択される、請求項17に記載のデバイス。
- 前記抗血栓剤が、ベラプロスト、クロピドグレル、およびイロプロストから成る群より選択される、請求項17に記載のデバイス。
- 必要に応じた前記コア医薬物質、前記第一層医薬物質、および必要に応じた前記追加の医薬物質が、ブプレノルフィンおよびフェンタニルから成る群より独立して選択される、請求項1に記載のデバイス。
- 前記第一層および必要に応じた前記追加の層のそれぞれが、医薬物質の異なる平均濃度を有する、請求項1に記載のデバイス。
- 前記第一層および1つ以上の必要に応じた前記追加の層のそれぞれにおける医薬物質の平均濃度が、前記コアからの距離が増加するとともに減少する、請求項23に記載のデバイス。
- 前記第一層および1つ以上の必要に応じた前記追加の層のそれぞれにおける医薬物質の平均濃度が、前記コアからの距離が増加するとともに増加する、請求項23に記載のデバイス。
- コアポリマー材料を含む前記コアが、エチレンビニルアセタート(EVA)から成り;前記第一層医薬物質が、ブプレノルフィンであり、および前記第一層ポリマー材料が、EVAである、請求項1に記載のデバイス。
- EVAおよびブプレノルフィンから成る前記第一層が、約10%〜約85%のブプレノルフィンを含む、請求項26に記載のデバイス。
- 必要に応じたコア医薬物質、第一層医薬物質、および必要に応じた追加の医薬物質を、それを必要とする患者に送達するための方法であって、請求項1に記載のデバイスを前記患者に皮下挿入する工程を含む、方法。
- 前記デバイスが、少なくとも約3カ月、約6カ月、約9カ月、約12カ月、約15カ月、約18カ月、約21カ月または約24カ月にわたり前記患者に埋め込まれたままである、請求項28に記載の方法。
- 血液中の医薬物質の濃度が、少なくとも約3カ月、約6カ月、約9カ月、約12カ月、約15カ月、約18カ月、約21カ月または約24カ月にわたり、ほぼ一定しているか、または本質的に一定している、請求項29に記載の方法。
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JP2019529507A (ja) * | 2016-10-05 | 2019-10-17 | タイタン ファーマシューティカルズ インコーポレイテッド | バースト放出を低減する薬剤送達用の埋込可能な装置 |
JP2020533331A (ja) * | 2017-09-12 | 2020-11-19 | ポリテクニコ ディ ミラノPolitecnico Di Milano | 医薬品の眼内放出用デバイス |
JP2021524841A (ja) * | 2018-05-24 | 2021-09-16 | セラニーズ・イーブイエイ・パフォーマンス・ポリマーズ・エルエルシー | 高分子薬剤化合物の持続放出用の埋め込み型デバイス |
JP2021524840A (ja) * | 2018-05-24 | 2021-09-16 | セラニーズ・イーブイエイ・パフォーマンス・ポリマーズ・エルエルシー | 高分子薬剤化合物の持続放出用の埋め込み型デバイス |
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JP2019504855A (ja) * | 2016-02-12 | 2019-02-21 | ウニベルシダデ デ コインブラ | 非侵襲性眼内薬物送達技法 |
JP2019529507A (ja) * | 2016-10-05 | 2019-10-17 | タイタン ファーマシューティカルズ インコーポレイテッド | バースト放出を低減する薬剤送達用の埋込可能な装置 |
JP7407595B2 (ja) | 2016-10-05 | 2024-01-04 | タイタン ファーマシューティカルズ インコーポレイテッド | バースト放出を低減する薬剤送達用の埋込可能な装置 |
JP2020533331A (ja) * | 2017-09-12 | 2020-11-19 | ポリテクニコ ディ ミラノPolitecnico Di Milano | 医薬品の眼内放出用デバイス |
JP7304849B2 (ja) | 2017-09-12 | 2023-07-07 | ポリテクニコ ディ ミラノ | 医薬品の眼内放出用デバイス |
JP2021524841A (ja) * | 2018-05-24 | 2021-09-16 | セラニーズ・イーブイエイ・パフォーマンス・ポリマーズ・エルエルシー | 高分子薬剤化合物の持続放出用の埋め込み型デバイス |
JP2021524840A (ja) * | 2018-05-24 | 2021-09-16 | セラニーズ・イーブイエイ・パフォーマンス・ポリマーズ・エルエルシー | 高分子薬剤化合物の持続放出用の埋め込み型デバイス |
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PL2547332T3 (pl) | 2019-07-31 |
HRP20182014T1 (hr) | 2019-01-25 |
CY1120964T1 (el) | 2019-12-11 |
KR20130038840A (ko) | 2013-04-18 |
US20130202673A1 (en) | 2013-08-08 |
WO2011116132A1 (en) | 2011-09-22 |
DK2547332T3 (en) | 2018-12-17 |
AU2011227289B2 (en) | 2016-01-21 |
US20130195950A1 (en) | 2013-08-01 |
RS58011B1 (sr) | 2019-02-28 |
MX2012010611A (es) | 2013-02-21 |
SI2547332T1 (sl) | 2019-01-31 |
US10111830B2 (en) | 2018-10-30 |
US20130189342A1 (en) | 2013-07-25 |
LT2547332T (lt) | 2018-12-10 |
EP2547332A1 (en) | 2013-01-23 |
US10123971B2 (en) | 2018-11-13 |
CA2792179C (en) | 2019-04-02 |
EP2547332B1 (en) | 2018-08-29 |
EP2547332A4 (en) | 2014-04-16 |
SG184059A1 (en) | 2012-10-30 |
US20130195951A1 (en) | 2013-08-01 |
ES2699200T3 (es) | 2019-02-07 |
PT2547332T (pt) | 2018-11-27 |
MX354444B (es) | 2018-03-06 |
KR101914119B1 (ko) | 2018-11-02 |
JP6022649B2 (ja) | 2016-11-09 |
SG10201501964QA (en) | 2015-05-28 |
JP2015227371A (ja) | 2015-12-17 |
AU2011227289A1 (en) | 2012-09-27 |
CA2792179A1 (en) | 2011-09-22 |
JP5869551B2 (ja) | 2016-02-24 |
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