JP2021107420A - 埋込み型薬物送達組成物およびその使用法 - Google Patents
埋込み型薬物送達組成物およびその使用法 Download PDFInfo
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Abstract
Description
本願は、2015年6月18日に出願された米国仮特許出願第62/181,707号の利益を主張するものであり、上記出願の内容全体が参照により本明細書に組み込まれる。
本発明は、埋込み型薬物送達組成物およびその使用法に関する。
A.組成物
第一の実施形態では、本開示は、マトリックスとともに少なくとも1つのポリマーと治療活性物質とを含む、埋込み型組成物を提供する。
合物;(130)ビタミンA、ビタミンEおよびビタミンE化合物;(131)ラシン(racin)などの毒物;(132)プロタミンなどの抗出血剤;(133)メトロニダゾールなどの抗蠕虫抗感染症剤;ならびに(134)タルク、アルコールおよびドキシサイクリンなどの硬化剤から選択され、組成物の残りの特徴は、本明細書、例えば第一、第二、第三、第四、第五、第六、第七、第八、第九、第十または第十一の実施形態に記載される通りのものである。
本明細書に記載される組成物、例えば、第一〜第二十五の実施形態に例示される組成物などは、対象(例えば、ヒト)の様々な疾患もしくは病態を治療する、または対象(例えば、ヒト)がそれに罹患するリスクを低下させるのに有用である。このような疾患および病態についてはのちに例示する。
本明細書に開示される組成物の特定の技術的利点を以下に示す。これらの利点は決して限定的なものではなく、単に例示を目的に記載されるものである。これらは本発明の範囲を限定することを意図するものでも、そのように解釈されるべきものでもない。さらに、本明細書に記載される利点が本発明の組成物のあらゆる利点を包括することを決して意図するものではないことが理解されよう。以下に記載される利点はむしろ、本発明によって解決される問題をさらに説明するために特定の技術的特徴を示すものにすぎない。
フィルム塗布具/Gate方法を用いて、20%重量/体積の25%PEG8K 50/50PLGA+Pax溶液を含むPGAメッシュまたはPGA/TMCメッシュをコーティングすることにより、7%、10%、15%および20%のパクリタキセルを含む本明細書に記載される組成物を調製した。図3に、基質の様々な位置の試料間の再現性を示す。図4A〜4Cに示されるように、放出データから、パクリタキセル(Pax)充填量の増大とともにバーストおよび全体の放出量が増大することが明らかになった。
エチレンオキシド(EtO)で処理すると、本開示の組成物のin vitroでの放出に特定の影響がみられた。例えば、図8A〜8Cは、全製剤とも、EtO処理がいずれの全測定基準(ug、%、ug/cm2)でもパクリタキセル(Pax)放出を阻害することを示している。この影響は%Paxが最も高い製剤で最も顕著であった。しかし、この結果が薬物充填量の増大に有害な作用を及ぼすようにみえても、in vivoではあまり顕著な影響は及ぼさないように思われたのは驚くべきことである。実際、パクリタキセルの放出速度の低下(および%Pax充填量が高いときのバースト放出量の減少)は、本開示の組成物がin vivoで極めて優れた性能を発揮する理由に関する別の累積効果であり得る。
麻酔をかけたウサギの胸部を第8肋間腔で切開した。尾側肺葉の一部を下層の靭帯から剥離した。切除する尾側肺葉の先端部に埋植物をサンドイッチのように貼付した。いずれの場合も、上下2つの埋植物を30mm GIAステープラーに予め装填した。30mm GIAステープラーを用いてステープリングおよび切除を実施した。ウサギに縫合を実施し、胸部から空気を除去し、創傷を回復させた。いずれの個体もこの方法に耐容性を示し、正常に回復した。リセット法の概略を図13に示す。例えば、組織をつかむようにステープラーの顎部を(埋植物とともに)配置する(図13A)。次いで、ステープルを埋植物全体に配置して組織に留め、同時に、ステープルで留めた組織を内部の刃物で2分する(図13B)。2分された埋植物をステープラーから切り離す。切除した組織を除去する。埋植物がステープルによって切除縁に固定されて空気および血液の漏出を防ぎ、パクリタキセルが局所投与される(図13C)。
標準PGAバットレス(すなわち、PGAメッシュ)。
血液、胸水および組織のパクリタキセル濃度をアッセイした。第2日、第7日および最後に第14日に血中のパクリタキセル濃度を測定し、定量限界未満(500pg/ml未満)であることが明らかになった。パクリタキセル代謝産物はこのプロトコルの一環として測定しなかった。胸水中のパクリタキセルを第0日および剖検時の第14日に検査し、肺組織を剖検時の第14日に検査した。切開時に主要臓器および胸壁をすべて回収して2つに分け、一方を−80℃で凍結させてのちのパクリタキセル分析に供し、もう一方をホルマリンで固定してのちに組織学検査に供した。図9に、パクリタキセル分析用に5mmの肺連続切片を切り口から2.5cmまで回収する方法を示す。下の表1に、ウサギ肺の切除縁から放射状に5mm間隔で離れた位置での組織中パクリタキセル濃度(nM)を示す。
第14日まで血液漏出、空気漏出、擦過創および肉眼レベルでの正常な組織学的治癒の進行を観察した。第14日に臓器、組織および体液でのパクリタキセルの分布を測定した。
ヨークシャーブタにABC103−Aを用量225μg/cm2=約1mg(1cm×4.5cmの埋植物)および用量415μg/cm2=約1.9mg(1cm×4.5cmの埋植物)で投与した。
Claims (53)
- マトリックスとともに少なくとも1つのポリマーと治療活性物質とを含む、埋込み型組成物。
- 少なくとも1つの賦形剤をさらに含む、請求項1に記載の埋込み型組成物。
- 前記少なくとも1つのポリマー、前記少なくとも1つの賦形剤および前記治療活性物質が、分離した別個の実体である、請求項1または2に記載の埋込み型組成物。
- 前記少なくとも1つのポリマー、前記治療活性物質および前記少なくとも1つの賦形剤が、前記マトリックス内に包埋されているか、前記マトリックス上にコーティングされているか、前記マトリックス内に包埋され前記マトリックス上にコーティングされているか、または前記マトリックスと共有結合している、請求項2または3に記載の埋込み型組成物。
- 前記マトリックスが膜または多孔性の足場を含む、請求項1〜4のいずれか1項に記載の埋込み型組成物。
- 前記マトリックスが不織ポリマーメッシュである、請求項1〜5のいずれか1項に記載の埋込み型組成物。
- 前記マトリックスが、織ったポリマーメッシュである、請求項1〜5のいずれか1項に記載の埋込み型組成物。
- 前記マトリックスが生体マトリックスである、請求項1〜7のいずれか1項に記載の埋込み型組成物。
- 前記マトリックスが、コラーゲンシート、ウシ心膜、ヒトまたは動物の硬膜などから選択される生体マトリックスである、請求項1〜8のいずれか1項に記載の埋込み型組成物。
- 前記マトリックスが、ポリ(エチレン)、ポリ(プロピレン)、ポリ(テトラフルロエチレン(tetrafluroethylene))、ポリ(メチメタクリラート(methymethacrylate))、エチレン−co−酢酸ビニル、ポリ(ジメチルシロキサン)、ポリ(エーテル−ウレタン)、ポリカルボナート、ポリエーテルスルホン、ポリベンゾイミダゾール、アクリロニトリルブタジエンスチレン(ABS)、ポリ塩化ビニル(PVC)、ポリエーテルエーテルケトン(PEEK)、ポリ(エチレンテルフタラート(ethylene terphthalate))、ポリ(スルホン)、ポリラクチド(PLA)系、ポリグリコリド(PGA)系、ポリカプロラクトン(PCL)系のポリ(エステル)、ポリ(ヒドロキシアルカン酸)、ポリ(サッカリド)、そのコポリマーおよび混合物またはコポリマーと混合物の組合せのうちの1つまたは複数のものを含むポリマーマトリックスである、請求項1〜7のいずれか1項に記載の埋込み型組成物。
- 前記マトリックスが、ポリグリコール酸(PGA)を含むポリマーマトリックスである、請求項1〜7および10のいずれか1項に記載の組成物。
- 前記治療活性物質が、前記マトリックス内に包埋されているか、前記マトリックス上にコーティングされているか、または前記マトリックス内に包埋され前記マトリックス上にコーティングされている前記少なくとも1つのポリマーと前記少なくとも1つの賦形剤の総重量の約50重量%以下または約25重量%以下を占める、請求項3〜11のいずれか1項に記載の埋込み型組成物。
- 前記治療活性物質が、前記マトリックス内に包埋されているか、前記マトリックス上にコーティングされているか、または前記マトリックス内に包埋され前記マトリックス上にコーティングされている前記少なくとも1つのポリマーと前記少なくとも1つの賦形剤の総重量の約20重量%以下を占める、請求項3〜12のいずれか1項に記載の埋込み型組成物。
- 前記治療活性物質が、前記マトリックス内に包埋されているか、前記マトリックス上にコーティングされているか、または前記マトリックス内に包埋され前記マトリックス上にコーティングされている前記少なくとも1つのポリマーと前記少なくとも1つの賦形剤の総重量の約15重量%以下を占める、請求項3〜13のいずれか1項に記載の埋込み型組成物。
- 前記治療活性物質が、前記マトリックス内に包埋されているか、前記マトリックス上にコーティングされているか、または前記マトリックス内に包埋され前記マトリックス上にコーティングされている前記少なくとも1つのポリマーと前記少なくとも1つの賦形剤の総重量の約10重量%、約5重量%または約1重量%を占める、請求項3〜14のいずれか1項に記載の埋込み型組成物。
- 前記賦形剤が、前記マトリックス内に包埋されているか、前記マトリックス上にコーティングされているか、または前記マトリックス内に包埋され前記マトリックス上にコーティングされている前記少なくとも1つのポリマーと前記治療活性物質の総重量の約50重量%以下を占める、請求項3〜15のいずれか1項に記載の埋込み型組成物。
- 前記賦形剤が、前記マトリックス内に包埋されているか、前記マトリックス上にコーティングされているか、または前記マトリックス内に包埋され前記マトリックス上にコーティングされている前記少なくとも1つのポリマーと前記治療活性物質の総重量の約5重量%〜約50重量%を占める、請求項3〜16のいずれか1項に記載の埋込み型組成物。
- 前記賦形剤が、前記マトリックス内に包埋されているか、前記マトリックス上にコーティングされているか、または前記マトリックス内に包埋され前記マトリックス上にコーティングされている前記少なくとも1つのポリマーと前記治療活性物質の総重量の約5重量%〜約35重量%を占める、請求項3〜17のいずれか1項に記載の埋込み型組成物。
- 前記治療活性物質が、タンパク質、多糖、脂質、核酸、合成小分子およびその組合せから選択される、請求項1〜18のいずれか1項に記載の埋込み型組成物。
- 前記治療活性物質が、抗真菌剤、抗感染症抗悪性腫瘍剤、抗ウイルス剤、鎮痛剤、非ステロイド性抗炎症剤、麻薬、アルツハイマー病剤、抗癌剤、アンドロゲン剤、アンジオテンシンモジュレーター、抗凝固剤、抗痙攣剤、抗うつ剤、抗パーキンソン病剤、抗精神病剤、抗狭心症剤、βブロッカー、αブロッカー、骨吸収抑制剤および関連薬剤、BPH剤、ブロンコダイアレーター(bronchodialator)抗コリンおよびβアンタゴニスト剤、カルシウムチャネル遮断剤、サイトカインおよびCAMアンタゴニスト、グルココルチコイド、ホルモン、肝炎治療剤、ロイコトリエン調節剤、多発性硬化症剤、点眼緑内障剤ならびに肺血圧降下−エンドセリン受容体アンタゴニストから選択される、請求項1〜19のいずれか1項に記載の埋込み型組成物。
- 前記治療活性物質が抗癌剤である、請求項1〜20のいずれか1項に記載の埋込み型組成物。
- 前記治療活性物質が、アルキル化剤,DNA架橋剤,阻害核酸,抗腫瘍抗生物質,チロシン/セリン/スレニン(Threnine)キナーゼ阻害剤,トポイソメラーゼ阻害剤,有糸分裂阻害剤,副腎皮質ステロイド剤,治療用抗体,生体応答修飾物質または微小管安定剤から選択される抗癌剤である、請求項1〜21のいずれか1項に記載の埋込み型組成物。
- 前記治療活性物質が、パクリタキセル、ディスコデルモリド、エポチロンA、エポチロンB、エポチロンC、エポチロンD、エポチロンE、エポチロンF、エポチロンB N−オキシド、エポチロンA N−オキシド、16−アザ−エポチロンB、21−アミノエポチロンB、21−ヒドロキシエポチロンD、プレドニゾン、26−フルオロエポチロン、トポテカン、ブレオマイシン、ドキソルビシン、5‐フルオロウラシル、6−メルカプトプリン、カペシタビン、シタラビン、フロクスウリジン、フルダラビン、ゲムシタビン、ペメトレキセド、アクチノマイシンD、イリノテカン、エトポシド、デキサメタゾン、FR−182877、BSF−223651、AC−7739、AC−7700、フィジアノリドB、ラウリマライド、カリベオシド、カリベオリン、タッカロノリド、エロイテロビン、サルコジクチイン、ラウリマライド、ジクチオスタチン1およびジャトロファンエステルならびにそのアナログおよび誘導体から選択される、請求項1〜22のいずれか1項に記載の埋込み型組成物。
- 前記治療活性物質がパクリタキセルである、請求項1〜23のいずれか1項に記載の埋込み型組成物。
- 前記治療活性物質が、10ug/cm2〜450ug/cm2、約150ug/cm2〜約300ug/cm2または約225ug/cm2〜約275ug/cm2の範囲の量のパクリタキセルである、請求項1〜24のいずれか1項に記載の埋込み型組成物。
- 前記治療活性物質が、約250ug/cm2の量のパクリタキセルである、請求項1〜24のいずれか1項に記載の埋込み型組成物。
- 前記少なくとも1つの賦形剤が、ポリビニルピロリドン(PVP)、ポリエチレンオキシド(PEO)、ポリビニルアルコール(PVA)、ヒドロキシプロピルセルロース(HPC)、ヒドロキシプロピルメチルセルロースアセタートスクシナート(HPMCAS)、エチレン酢酸ビニル(EVA)、メタクリラート、エチルセルロース(EC)、セルロースアセタートブチラート(CAB)、酢酸フタル酸セルロース(CAP)、ポリエチレングリコール、ポリビニルアセタート(PVAc)、ポリラクチド(PLA)、ポリグリコリド(PGA)、PLA/PGAとポリカプロラクトン(PCL)のコポリマー、ポリビニルピロリドン−co−酢酸ビニルおよびポリウレタンから選択される、請求項2〜26のいずれか1項に記載の埋込み型組成物。
- 前記少なくとも1つの賦形剤がポリエチレングリコールである、請求項2〜27のいずれか1項に記載の埋込み型組成物。
- 前記少なくとも1つの賦形剤が、約1,000g/mol超の分子量を有するポリエチレングリコールである、請求項2〜28のいずれか1項に記載の埋込み型組成物。
- 前記少なくとも1つの賦形剤が、約2,000g/mol〜約15,000g/molの範囲の分子量を有するポリエチレングリコールである、請求項2〜29のいずれか1項に記載の埋込み型組成物。
- 前記少なくとも1つの賦形剤が、約4,000g/mol〜約10,000g/molの範囲の分子量を有するポリエチレングリコールである、請求項2〜30のいずれか1項に記載の埋込み型組成物。
- 前記少なくとも1つの賦形剤が、約7,000g/mol〜約9,000g/molの範囲の分子量を有するポリエチレングリコールである、請求項2〜31のいずれか1項に記載の埋込み型組成物。
- 前記少なくとも1つの賦形剤がポリエチレングリコール8000である、請求項2〜32のいずれか1項に記載の埋込み型組成物。
- 前記少なくとも1つのポリマーがポリ(乳酸−co−グリコール酸)コポリマー(PGLA)である、請求項1〜33のいずれか1項に記載の組成物。
- 前記少なくとも1つのポリマーが、約20:80、約25:75、約40:60、約45:55、約53:47、約55:45、約50:50、約60:40、約75:25または約80:20のラクチド/グリコリドモル比を有するポリ(乳酸−co−グリコール酸)コポリマー(PGLA)である、請求項1〜34のいずれか1項に記載の埋込み型組成物。
- 前記少なくとも1つのポリマーが、約50:50、47:53〜53:47、より好ましくは50:50のラクチド/グリコリドモル比を有するポリ(乳酸−co−グリコール酸)コポリマー(PGLA)である、請求項1〜35のいずれか1項に記載の埋込み型組成物。
- 前記少なくとも1つのポリマーが、約20,000g/mol〜約250,000g/mol、約50,000g/mol〜約150,000g/mol、約65,000g/mol〜約100,000g/molまたは約70,000g/mol〜約80,000g/molの範囲の分子量を有するポリ(乳酸−co−グリコール酸)コポリマー(PGLA)である、請求項1〜36のいずれか1項に記載の埋込み型組成物。
- 前記少なくとも1つのポリマーが、約72,5000g/molの分子量を有するポリ(乳酸−co−グリコール酸)コポリマー(PGLA)である、請求項1〜37のいずれか1項に記載の埋込み型組成物。
- 前記治療活性物質が、マイクロ構造物またはナノ構造物に封入されている、請求項1〜38のいずれか1項に記載の埋込み型組成物。
- 前記治療活性物質が、リポソーム、ポリマー、デンドリマー、ケイ素材料もしくは炭素材料または磁性粒子の中に封入されている、請求項1〜39のいずれか1項に記載の埋込み型組成物。
- 前記治療活性物質がポリマーの中に封入されている、請求項1〜40のいずれか1項に記載の埋込み型組成物。
- 必要とする対象が癌に罹患するリスクを低下させる方法であって、請求項1〜41のいずれか1項に記載の埋込み型組成物を前記対象の体内または身体上に外科的に貼付することを含む、方法。
- 前記埋込み型組成物を前記対象の胸部内もしくは胸部上、前記対象の腹部内もしくは腹部上、前記対象の四肢内もしくは四肢上、前記対象の膀胱、肝臓、膵臓、腎臓、胃、腸、心臓、頭部内もしくは頭部上、前記対象の頸部内もしくは頸部上、前記対象の肺内もしくは肺上、前記対象の眼球内もしくは眼球上、前記対象の鼻内もしくは鼻上または前記対象の咽喉部内もしくは咽喉部上あるいはその組合せに貼付する、請求項42に記載の方法。
- 前記埋込み型組成物を、前記対象の肺組織内または肺組織上に貼付する、請求項42または43に記載の方法。
- 前記埋込み型組成物を切除縁または病巣の部位に貼付する、請求項42〜44のいずれか1項に記載の方法。
- 前記埋込み型組成物を、癌の除去によって生じる切除縁または病巣の部位に貼付する、請求項42〜45のいずれか1項に記載の方法。
- 必要とする対象が肺癌に罹患するリスクを低下させる方法であって、肺癌の除去によって生じる切除縁または病巣の部位に埋込み型組成物を外科的に貼付することを含み、前記埋込み型組成物が、
ポリグリコール酸もしくはポリグリコール酸:トリメチレンカルボナート(PGA:TMC)のメッシュもしくはバットレスまたは
ポリ(乳酸−co−グリコール酸)コポリマー(PGLA)とパクリタキセルと少なくとも1つの賦形剤とを含む混合物
を含む、方法。 - 前記埋込み型組成物が、ポリエチレングリコール8000と、ラクチド/グリコリドモル比が約50:50のポリ(乳酸−co−グリコール酸)コポリマーと、総量が約10ug/cm2総組成物〜450ug/cm2総組成物の範囲になる量のパクリタキセルとを含む、請求項47に記載の方法。
- 前記パクリタキセルが450ug/cm2総組成物の量で存在する、請求項47または48に記載の方法。
- 前記対象に投与するパクリタキセルの総用量が約10.1mgである、請求項47〜49のいずれか1項に記載の方法。
- 前記パクリタキセルの持続性、変動性またはS字状の放出を維持する、請求項47〜50のいずれか1項に記載の組成物。
- 前記パクリタキセルの70%超、75%超、80%超または85%超が放出される、請求項47〜51のいずれか1項に記載の組成物。
- 送達および放出の全体を通じてパクリタキセルの完全溶出が維持される、請求項47〜52のいずれか1項に記載の組成物。
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US20180193282A1 (en) | 2018-07-12 |
WO2016205652A1 (en) | 2016-12-22 |
EP3310343A4 (en) | 2019-02-20 |
JP2018524310A (ja) | 2018-08-30 |
IL287749B2 (en) | 2024-02-01 |
RU2018101287A (ru) | 2019-07-19 |
BR112017026746A2 (pt) | 2018-08-28 |
MX2021004546A (es) | 2021-09-10 |
MX2017016217A (es) | 2018-04-24 |
CN107847447A (zh) | 2018-03-27 |
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