JP2016538292A - 持続的薬物送達インプラントによる眼の状態の治療の方法 - Google Patents
持続的薬物送達インプラントによる眼の状態の治療の方法 Download PDFInfo
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- 229940033663 thimerosal Drugs 0.000 description 1
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- 231100000827 tissue damage Toxicity 0.000 description 1
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- 229960005294 triamcinolone Drugs 0.000 description 1
- GFNANZIMVAIWHM-OBYCQNJPSA-N triamcinolone Chemical compound O=C1C=C[C@]2(C)[C@@]3(F)[C@@H](O)C[C@](C)([C@@]([C@H](O)C4)(O)C(=O)CO)[C@@H]4[C@@H]3CCC2=C1 GFNANZIMVAIWHM-OBYCQNJPSA-N 0.000 description 1
- BSVBQGMMJUBVOD-UHFFFAOYSA-N trisodium borate Chemical compound [Na+].[Na+].[Na+].[O-]B([O-])[O-] BSVBQGMMJUBVOD-UHFFFAOYSA-N 0.000 description 1
- RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical compound [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O RYFMWSXOAZQYPI-UHFFFAOYSA-K 0.000 description 1
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- 230000009385 viral infection Effects 0.000 description 1
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- 208000000318 vitreous detachment Diseases 0.000 description 1
- PAPBSGBWRJIAAV-UHFFFAOYSA-N ε-Caprolactone Chemical compound O=C1CCCCCO1 PAPBSGBWRJIAAV-UHFFFAOYSA-N 0.000 description 1
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- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
- A61K9/204—Polyesters, e.g. poly(lactide-co-glycolide)
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- A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
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- A61K47/56—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0048—Eye, e.g. artificial tears
- A61K9/0051—Ocular inserts, ocular implants
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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Abstract
Description
本出願は、2013年11月15日に出願された米国仮特許出願第61/904,887号の優先権を主張するものであり、その内容全体を参照によって本明細書に組み込んだものとする。
本出願の開示は、概して薬物送達インプラントに関し、特に、薬物送達インプラントを使用して眼の状態を治療するための方法に関する。
以下の用語は、本明細書中で使用される場合、以下の意味を有する。
本発明のインプラントは、生分解性ポリマー内に分散した活性薬剤を含む。一部の実施形態において、抗炎症剤は、ステロイド系抗炎症剤、例えば、デキサメタゾンなどの副腎皮質ステロイド薬である。一部の実施形態において、デキサメタゾンは、インプラントに存在する唯一の活性薬剤である。
一変形において、活性薬剤は、インプラントの生分解性ポリマーマトリックス中に均一に分散していてもよい。利用する生分解性ポリマーマトリックスの選択は、所望の放出動態、患者の寛容性、治療される疾患の性質及び同種のものにより変化することになる。考慮されるポリマー特性としては、埋入の部位における生体適合性及び生分解性、対象の活性薬剤との適合性ならびに加工温度が挙げられるが、これらに限定されるものではない。生分解性ポリマーマトリックスは、通常、インプラントの少なくとも約10、少なくとも約20、少なくとも約30、少なくとも約40、少なくとも約50、少なくとも約60、少なくとも約70、少なくとも約80または少なくとも約90重量パーセントを構成する。一変形において、生分解性ポリマーマトリックスは、インプラントの約40重量%を構成する。
さまざまな用途用の製剤にその他の薬剤が利用されてもよい。例えば、緩衝剤及び保存料が利用されてもよい。使用されてもよい保存料としては、亜硫酸水素ナトリウム、硫酸水素ナトリウム、チオ硫酸ナトリウム、塩化ベンザルコニウム、クロロブタノール、チメロサール、酢酸フェニル水銀、硝酸フェニル水銀、メチルパラベン、ポリビニルアルコール及びフェニルエチルアルコールを挙げることができるが、これらに限定されるものではない。利用されてもよい緩衝剤の例としては、投与の所望の経路に対してFDAに承認されたような炭酸ナトリウム、ホウ酸ナトリウム、リン酸ナトリウム、酢酸ナトリウム、炭酸水素ナトリウム及び同種のものを挙げることができるが、これらに限定されるものではない。塩化ナトリウム及び塩化カリウムなどの電解質も製剤に含まれてよい。
本発明のインプラント及び方法によって治療され得る眼の医学的状態の例としては、ぶどう膜炎、黄斑浮腫、糖尿病黄斑浮腫、黄斑変性、網膜剥離、眼の腫瘍、真菌症、ウイルス感染症、多巣性脈絡膜炎、糖尿病網膜症、増殖性硝子体網膜症(PVR)、交感性眼炎、フォークト・小柳・原田(VKH)症候群、ヒストプラスマ症、ぶどう膜拡散及び血管閉塞が挙げられるが、これらに限定されるものではない。一変形において、本インプラントは、ぶどう膜炎、黄斑浮腫、血管閉塞状態、増殖性硝子体網膜症(PVR)及びさまざまなその他の網膜症などの医学的状態を治療する際に特に有用である。
本生分解性インプラントは、さまざまな方法によって眼に挿入されてもよく、この方法は、強膜を切開した後に鉗子、トロカールまたはその他のタイプのアプリケータによって設置することを含む。場合によっては、切開せずに、トロカールまたはアプリケータを使用してもよい。ある変形において、1つまたは複数の生分解性インプラントを眼に挿入するためにハンドヘルド型アプリケータが使用される。ハンドヘルド型アプリケータは、一般に18〜30GAステンレス鋼針、レバー、アクチュエータ及びプランジャーを備える。
ある実施形態において、眼の状態、例えば、糖尿病黄斑浮腫を治療する方法は、デキサメタゾンなどの活性成分及び生分解性ポリマーマトリックスを含む生体内分解性インプラントを、それを必要とする患者の眼に6ヶ月に1回から1年に1回の間の頻度で施すことを含む。生体内分解性インプラントは、本明細書中で開示されているタイプのものであってもよい。
Claims (7)
- 生分解性ポリマーマトリックス内に均一に分散したデキサメタゾンを含む連続的な二重押出成形された棒を含む生体内分解性インプラントを、約6ヶ月に1回から約9ヶ月に1回の頻度でヒトの硝子体に入れることを含む、糖尿病黄斑浮腫(DME)を治療するための方法であって、
前記生分解性ポリマーマトリックスは、親水性末端基を有するポリ(D,L−ラクチド−co−グリコリド)(PLGA)と、疎水性末端基を有するポリ(D,L−ラクチド−co−グリコリド)(PLGA)との混合物を含み、
前記生体内分解性インプラントはヒトの硝子体に埋入するための大きさに作られ、前記方法は、DMEを治療するのに治療効果がある、前記方法。 - 前記ヒトは、DMEに対する抗VEGF治療に抵抗性を示す、請求項1に記載の方法。
- 前記デキサメタゾンは、前記生体内分解性インプラント中に前記生体内分解性インプラントの総重量に基づいて60重量%の量で存在する、請求項1または2に記載の方法。
- 前記疎水性末端基を有するPLGAは、前記生体内分解性インプラント中に前記生体内分解性インプラントの総重量に基づいて10重量%の量で存在する、請求項1から3のいずれか一項に記載の方法。
- 前記親水性末端基を有するPLGAは、前記生体内分解性インプラント中に前記生体内分解性インプラントの総重量に基づいて30重量%の量で存在する、請求項1から4のいずれか一項に記載の方法。
- 前記ヒトは偽水晶体レンズを有する、請求項1から5いずれか一項に記載の方法。
- 前記ヒトは有水晶体レンズを有する、請求項1から5いずれか一項に記載の方法。
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US61/904,887 | 2013-11-15 | ||
PCT/US2014/065804 WO2015073895A1 (en) | 2013-11-15 | 2014-11-14 | Methods of treatment of ocular conditions with a sustained drug delivery implant |
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WO2017015604A1 (en) * | 2015-07-23 | 2017-01-26 | Envisia Therapeutics, Inc. | Intravitreal drug delivery systems for the treatment of ocular conditions |
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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