JP2016537370A - 眼科用デバイス - Google Patents
眼科用デバイス Download PDFInfo
- Publication number
- JP2016537370A JP2016537370A JP2016531690A JP2016531690A JP2016537370A JP 2016537370 A JP2016537370 A JP 2016537370A JP 2016531690 A JP2016531690 A JP 2016531690A JP 2016531690 A JP2016531690 A JP 2016531690A JP 2016537370 A JP2016537370 A JP 2016537370A
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- Prior art keywords
- polymer
- drug delivery
- delivery device
- sustained release
- polymer matrix
- Prior art date
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- SKIVFJLNDNKQPD-UHFFFAOYSA-N sulfacetamide Chemical compound CC(=O)NS(=O)(=O)C1=CC=C(N)C=C1 SKIVFJLNDNKQPD-UHFFFAOYSA-N 0.000 description 1
- 229960002673 sulfacetamide Drugs 0.000 description 1
- VACCAVUAMIDAGB-UHFFFAOYSA-N sulfamethizole Chemical compound S1C(C)=NN=C1NS(=O)(=O)C1=CC=C(N)C=C1 VACCAVUAMIDAGB-UHFFFAOYSA-N 0.000 description 1
- 229960005158 sulfamethizole Drugs 0.000 description 1
- 229940124530 sulfonamide Drugs 0.000 description 1
- 150000003456 sulfonamides Chemical class 0.000 description 1
- FIAFUQMPZJWCLV-UHFFFAOYSA-N suramin Chemical compound OS(=O)(=O)C1=CC(S(O)(=O)=O)=C2C(NC(=O)C3=CC=C(C(=C3)NC(=O)C=3C=C(NC(=O)NC=4C=C(C=CC=4)C(=O)NC=4C(=CC=C(C=4)C(=O)NC=4C5=C(C=C(C=C5C(=CC=4)S(O)(=O)=O)S(O)(=O)=O)S(O)(=O)=O)C)C=CC=3)C)=CC=C(S(O)(=O)=O)C2=C1 FIAFUQMPZJWCLV-UHFFFAOYSA-N 0.000 description 1
- 229960005314 suramin Drugs 0.000 description 1
- 239000004094 surface-active agent Substances 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 229940127230 sympathomimetic drug Drugs 0.000 description 1
- 230000009885 systemic effect Effects 0.000 description 1
- 238000009121 systemic therapy Methods 0.000 description 1
- 229960001967 tacrolimus Drugs 0.000 description 1
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- IWVCMVBTMGNXQD-UHFFFAOYSA-N terramycin dehydrate Natural products C1=CC=C2C(O)(C)C3C(O)C4C(N(C)C)C(O)=C(C(N)=O)C(=O)C4(O)C(O)=C3C(=O)C2=C1O IWVCMVBTMGNXQD-UHFFFAOYSA-N 0.000 description 1
- 229960002180 tetracycline Drugs 0.000 description 1
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- 235000019364 tetracycline Nutrition 0.000 description 1
- 150000003522 tetracyclines Chemical class 0.000 description 1
- 229960000337 tetryzoline Drugs 0.000 description 1
- 229920001169 thermoplastic Polymers 0.000 description 1
- 239000002562 thickening agent Substances 0.000 description 1
- 210000001578 tight junction Anatomy 0.000 description 1
- 230000036962 time dependent Effects 0.000 description 1
- 239000010936 titanium Substances 0.000 description 1
- JIVZKJJQOZQXQB-UHFFFAOYSA-N tolazoline Chemical compound C=1C=CC=CC=1CC1=NCCN1 JIVZKJJQOZQXQB-UHFFFAOYSA-N 0.000 description 1
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- 230000032258 transport Effects 0.000 description 1
- 230000008733 trauma Effects 0.000 description 1
- 229960002368 travoprost Drugs 0.000 description 1
- MKPLKVHSHYCHOC-AHTXBMBWSA-N travoprost Chemical compound CC(C)OC(=O)CCC\C=C/C[C@H]1[C@@H](O)C[C@@H](O)[C@@H]1\C=C\[C@@H](O)COC1=CC=CC(C(F)(F)F)=C1 MKPLKVHSHYCHOC-AHTXBMBWSA-N 0.000 description 1
- 229960002117 triamcinolone acetonide Drugs 0.000 description 1
- YNDXUCZADRHECN-JNQJZLCISA-N triamcinolone acetonide Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@]2(F)[C@@H]1[C@@H]1C[C@H]3OC(C)(C)O[C@@]3(C(=O)CO)[C@@]1(C)C[C@@H]2O YNDXUCZADRHECN-JNQJZLCISA-N 0.000 description 1
- 150000003852 triazoles Chemical class 0.000 description 1
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- YFNGWGVTFYSJHE-UHFFFAOYSA-K trisodium;phosphonoformate Chemical compound [Na+].[Na+].[Na+].OP(O)(=O)C([O-])=O.OP(O)(=O)C([O-])=O.OP(O)(=O)C([O-])=O YFNGWGVTFYSJHE-UHFFFAOYSA-K 0.000 description 1
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- 231100000397 ulcer Toxicity 0.000 description 1
- 229960004317 unoprostone Drugs 0.000 description 1
- TVHAZVBUYQMHBC-SNHXEXRGSA-N unoprostone Chemical compound CCCCCCCC(=O)CC[C@H]1[C@H](O)C[C@H](O)[C@@H]1C\C=C/CCCC(O)=O TVHAZVBUYQMHBC-SNHXEXRGSA-N 0.000 description 1
- 229960005486 vaccine Drugs 0.000 description 1
- OGWKCGZFUXNPDA-XQKSVPLYSA-N vincristine Chemical compound C([N@]1C[C@@H](C[C@]2(C(=O)OC)C=3C(=CC4=C([C@]56[C@H]([C@@]([C@H](OC(C)=O)[C@]7(CC)C=CCN([C@H]67)CC5)(O)C(=O)OC)N4C=O)C=3)OC)C[C@@](C1)(O)CC)CC1=C2NC2=CC=CC=C12 OGWKCGZFUXNPDA-XQKSVPLYSA-N 0.000 description 1
- 229960004528 vincristine Drugs 0.000 description 1
- OGWKCGZFUXNPDA-UHFFFAOYSA-N vincristine Natural products C1C(CC)(O)CC(CC2(C(=O)OC)C=3C(=CC4=C(C56C(C(C(OC(C)=O)C7(CC)C=CCN(C67)CC5)(O)C(=O)OC)N4C=O)C=3)OC)CN1CCC1=C2NC2=CC=CC=C12 OGWKCGZFUXNPDA-UHFFFAOYSA-N 0.000 description 1
- 239000003190 viscoelastic substance Substances 0.000 description 1
- BCEHBSKCWLPMDN-MGPLVRAMSA-N voriconazole Chemical compound C1([C@H](C)[C@](O)(CN2N=CN=C2)C=2C(=CC(F)=CC=2)F)=NC=NC=C1F BCEHBSKCWLPMDN-MGPLVRAMSA-N 0.000 description 1
- 229960004740 voriconazole Drugs 0.000 description 1
- 239000000080 wetting agent Substances 0.000 description 1
- 229960002555 zidovudine Drugs 0.000 description 1
Classifications
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- A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
- A61F9/0008—Introducing ophthalmic products into the ocular cavity or retaining products therein
- A61F9/0017—Introducing ophthalmic products into the ocular cavity or retaining products therein implantable in, or in contact with, the eye, e.g. ocular inserts
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Abstract
Description
(a)少なくとも1種の治療薬がその中に混合されたポリマーマトリックスコア、および
(b)前記ポリマーマトリックス材料を完全に覆うポリマーコーティング、
を含み、
前記ポリマーマトリックスコアおよびポリマーコーティングは眼液において不溶性および不活性であり、前記徐放性眼内薬物送達デバイスが環形状を呈するデバイスが提供される。好ましくは、前記デバイスは環状の柔軟なセグメントを含み、前記セグメントは90から360°の範囲であり得る。より好ましくは、前記デバイスは、眼の溝に挿入するために構成され、さらにより好ましくは、前記デバイスは0.10から0.80mmの範囲の断面直径を有する。
−少なくとも1種の治療薬と、不溶性および不活性なポリマーを混合すること、
−前記混合物をモールディングおよび/または押出し成形して、ポリマーマトリックスコアを供給すること、ならびに
−得られたポリマーマトリックスコアにポリマーコーティングを提供すること、
を含む方法を提供する。
(a)少なくとも1種の治療薬を含有するマトリックスコア、および
(b)前記マトリックスコアを完全に覆うポリマーコーティング、
を含み、
前記マトリックスコアおよびポリマーコーティングが眼液において不溶性および不活性であり、眼の溝のために構成されるデバイスを提供する。
(a)少なくとも1種の治療薬が混合されたポリマーマトリックスコア、および
(b)前記ポリマーマトリックス材料を完全に覆うポリマーコーティング、
を含み、
前記マトリックスコアおよびポリマーコーティングが眼液において不溶性および不活性であり、眼の溝のために構成されたデバイスが提供される。
(a)ポリエチレン(PE)、好ましくは高密度ポリエチレン(HDPE)、ポリ(メチルメタクリレート)(PMMA)およびこれらの組み合わせからなる群より選択されるポリマーを含み、少なくとも1種の治療薬、好ましくはチモロールが前記ポリマーに混合されたマトリックスコア、および
(b)ポリエチレン(PE)、好ましくは高密度ポリエチレン(HDPE)、ポリ(メチルメタクリレート)(PMMA)、およびこれらの組み合わせなる群より選択されるポリマーを含む、前記マトリックスを完全に覆うコーティング、
を含み、眼の溝のために構成された除放性眼内薬物送達デバイスが提供される。
(a)ポリエチレン(PE)、好ましくは高密度ポリエチレン(HDPE)を含み、少なくとも1種の治療薬、好ましくはチモロールが前記PEに混合されたマトリックスコア、および
(b)ポリエチレン(PE)、好ましくは高密度ポリエチレン(HDPE)を含むコーティング、
を含む。
(a)ポリエチレン(PE)、好ましくは高密度ポリエチレン(HDPE)を含み、少なくとも1種の治療薬、好ましくはチモロールが前記PEに混合されたマトリックスコア、および
(b)ポリ(メチルメタクリレート)(PMMA)を含むコーティング、
を含む。
(a)ポリ(メチルメタクリレート)(PMMA)を含み、少なくとも1種の治療薬、好ましくはチモロールが前記PMMAに混合されたマトリックスコア、および
(b)ポリ(メチルメタクリレート)(PMMA)を含むコーティング、
を含む。
(a)ポリ(メチルメタクリレート)(PMMA)を含み、少なくとも1種の治療薬、好ましくはチモロールが前記PMMAに混合されたマトリックスコア、および
(b)ポリエチレン(PE)、好ましくは高密度ポリエチレン(HDPE)を含むコーティング、
を含む。
(a)ポリ(メチルメタクリレート)(PMMA)を含み、少なくとも1種の治療薬、好ましくはチモロールが前記PMMAに混合されたマトリックスコア、および
(b)エチレン−co−酢酸ビニル(EVA)を含むコーティング、
を含む。
(a)ポリエチレン(PE)、好ましくは高密度ポリエチレン(HDPE)を含み、少なくとも1種の治療薬、好ましくはチモロールが前記PEに混合されたマトリックスコア、および
(b)エチレン−co−酢酸ビニル(EVA)を含むコーティング、
を含む。
(a)ポリ(メチルメタクリレート)(PMMA)を含み、少なくとも1種の治療薬、好ましくはチモロールが前記PMMAに混合されたマトリックスコア、および
(b)ポリプロピレン(PP)を含むコーティング、
を含む。
(a)ポリエチレン(PE)、好ましくは高密度ポリエチレン(HDPE)を含み、少なくとも1種の治療薬、好ましくはチモロールが前記PEに混合されたマトリックスコア、および
(b)ポリプロピレン(PP)を含むコーティング、
を含む。
−少なくとも1種の治療薬と、不溶性および不活性なポリマーとを混合すること、
−前記混合物をモールディングおよび/または押出し成形して、ポリマーマトリックスコアを供給すること、ならびに
−得られたポリマーマトリックスコアにポリマーコーティングを提供すること、
を含む方法を提供する。
−少なくとも1種の治療薬と、不溶性および不活性なポリマーとを混合すること、
−前記混合物をモールディングして、ポリマーマトリックスコアを供給すること、ならびに
−得られたポリマーマトリックスコアにポリマーコーティングを提供すること、
を含む。
−少なくとも1種の治療薬と、不溶性および不活性なポリマーとを混合すること、
−前記混合物を押出し成形およびモールディングして、ポリマーマトリックスコアを供給すること、ならびに
−得られたポリマーマトリックスコアにポリマーコーティングを提供すること、
を含む。
インプラントを、使用するポリマーのタイプに依存して実施例1または2に記載のようにモールディングによって、または表1に示すレーザーカッティングによって作製した。表1に示すさまざまなタイプのポリマー、特にEVA(Elvax3165(酢酸ビニル18%)またはElvax3129(酢酸ビニル10%))、HDPE(Lupolen)およびPMMA(Diakon)を、インプラントの製造のために使用した。
インプラントを、実施例2に記載のようにモールディングにより作製した。コアは50重量%のチモロールおよび50重量%の、EVA(Elvax3129(酢酸ビニル10%))、HDPE(Lupolen)またはPMMA(Diakon)のいずれかを含んでいた。インプラントのシェルは、EVA(Elvax3129(酢酸ビニル10%))、HDPE(Lupolen)またはPPで構成された。さらにシェルを有さないインプラントも作製した。
Claims (23)
- 眼の溝のために構成された徐放性眼内薬物送達デバイスであって、
(a)少なくとも1種の治療薬がその中に混合されたポリマーマトリックスコア、および
(b)前記ポリマーマトリックス材料を完全に覆うポリマーコーティング、
を含み、
前記ポリマーマトリックスコアおよびポリマーコーティングが眼液において不溶性および不活性であり、前記徐放性眼内薬物送達デバイスが、好ましくは0.10から0.80mmの範囲の断面直径を有する柔軟な環状セグメントの形態である、
徐放性眼内薬物送達デバイス。 - 前記ポリマーマトリックスコアが、0.05mmから0.48mmの断面直径を有する棒形状である、請求項1に記載のデバイス。
- 前記ポリマーコーティングが、0.05から0.32mmの範囲の厚さを有するポリマー膜である、請求項1または2に記載のデバイス。
- 前記環状セグメントがリングの90から360°の範囲、好ましくは180から360°、より好ましくはリングの300から360°の範囲である、請求項1から3のいずれか一項に記載のデバイス。
- 前記ポリマーマトリックスコアが、エチレン−co−酢酸ビニル、ポリ(ジメチルシロキサン)、ポリプロピレン、ポリエチレン、好ましくは高密度ポリエチレン、可塑化ポリエチレンテレフタレート、ポリ(メチルメタクリレート)、ポリ酢酸ビニル、架橋ポリビニルアルコール、架橋ポリビニルブチレート、エチレンエチルアクリレートコポリマー、ポリエチルヘキシルアクリレート、ポリ塩化ビニル、ポリビニルアセタール、ポリビニルアルコール、ポリ酢酸ビニル、エチレン塩化ビニルコポリマー、ポリビニルエステル、ポリビニルブチレート、ポリビニルホルマール、ポリアミド、ポリメチルメタクリレート、ポリブチルメタクリレート、可塑化ポリ塩化ビニル、可塑化ナイロン、可塑化ソフトナイロン、天然ゴム、ポリイソプレン、ポリイソブチレン、ポリブタジエン、ポリエチレン、ポリテトラフルオロエチレン、ポリ塩化ビニリデン、ポリアクリロニトリル、架橋ポリビニルピロリドン、ポリトリフルオロクロロエチレン、塩素化ポリエチレン、ポリ(1,4−イソプロピリデンジフェニレンカーボネート)、塩化ビニリデン、アクリロニトリルコポリマー、塩化ビニル−ジエチルフメレール(fumerale)コポリマー、シリコーンゴム、エチレン−プロピレンゴム、シリコーン−カーボネートコポリマー、塩化ビニリデン−塩化ビニルコポリマー、塩化ビニル−アクリロニトリルコポリマーおよび塩化ビニリデン−アクリロニトリド(acrylonitride)コポリマー、ポリカーボネート、ポリウレタン、熱可塑性エラストマー(TPE)(例えばSEBS(スチレン−エチレン−ブチレン−スチレン)、SBS(スチレン−ブタジエン−スチレン)、MBM(メチルメタクリレート−ブタジエン−メチルメタクリレート)など)またはこれらの組み合わせからなる群より選択されるポリマーを含む、請求項1から4のいずれか一項に記載のデバイス。
- 前記ポリマーマトリックスコアが、ポリエチレン、好ましくは高密度ポリエチレン、ポリ(メチルメタクリレート)およびこれらの組み合わせからなる群より選択されるポリマーを含む、請求項1から5のいずれか一項に記載のデバイス。
- 前記ポリマーマトリックスコアが、ポリマーマトリックス材料の全重量に基づき0.1から50重量%の前記少なくとも1種の治療薬を含む、請求項1から6のいずれか一項に記載のデバイス。
- 前記ポリマーコーティングが、エチレン−co−酢酸ビニル、ポリ(ジメチルシロキサン)、ポリプロピレン、ポリエチレン、可塑化ポリエチレンテレフタレート、ポリ(メチルメタクリレート)、架橋ポリビニルアルコール、ポリオレフィン、ポリ塩化ビニルまたは架橋ゼラチン;再生された不溶性、耐食性セルロース、アシル化セルロース、エステル化セルロース、酢酸プロピオン酸セルロース、酢酸酪酸セルロース、酢酸フタル酸セルロース、酢酸セルロースジエチル−アミノアセテート;ポリウレタン、ポリカーボネートならびに不溶性コラーゲンで修飾されたポリカチオンおよびポリアニオンの共沈殿により形成される微多孔質ポリマーまたはこれらの組み合わせからなる群より選択されるポリマーを含む、請求項1から7のいずれか一項に記載のデバイス。
- 前記ポリマーコーティングが、ポリエチレン、好ましくは高密度ポリエチレン、ポリ(メチルメタクリレート)およびこれらの組み合わせからなる群より選択されるポリマーを含む、請求項1から8のいずれか一項に記載のデバイス。
- 前記少なくとも1種の治療薬が、抗生物質製剤、抗菌剤、抗ウイルス剤、プロスタグランジン類似体、抗緑内障薬、抗アレルギー薬、抗炎症薬、抗血管新生薬、免疫系調節薬、抗がん剤、アンチセンス剤、抗真菌剤、縮瞳薬および抗コリンエステラーゼ薬、散瞳薬、分化調節剤、交感神経作動薬、麻酔薬、血管収縮剤、血管拡張剤、充血除去薬、細胞輸送/移動切迫剤(cell transport/mobility impending agents)、ポリペプチド製剤およびタンパク製剤、ステロイド薬、炭酸脱水酵素阻害剤、ポリカチオン、ポリアニオンならびに滑沢剤からなる群より選択される、請求項1から9のいずれか一項に記載のデバイス。
- 前記少なくとも1種の治療薬が、プロスタグランジン類似体、抗緑内障薬、抗炎症薬、抗血管新生化合物、免疫系調節薬からなる群より選択される、請求項1から10のいずれか一項に記載のデバイス。
- 前記少なくとも1種の治療薬が、ベバシズマブ、ラニビズマブ、アフリベルセプト、チモロール、ラタノプロスト ドルゾラミド、トリアムシノロン、デキサメタゾンまたはシクロスポリンからなる群より選択される、請求項1から11のいずれか一項に記載のデバイス。
- 前記ポリマーマトリックスコアが、ポリエチレン、好ましくは高密度ポリエチレンを含み、前記ポリマーコーティングが、ポリエチレン、好ましくは高密度ポリエチレンまたはポリ(メチルメタクリレート)を含む、請求項1から12のいずれか一項に記載のデバイス。
- 前記ポリマーマトリックスコアがポリ(メチルメタクリレート)を含み、前記ポリマーコーティングがポリエチレン、好ましくは高密度ポリエチレンまたはポリ(メチルメタクリレート)を含む、請求項1から12のいずれか一項に記載のデバイス。
- 前記少なくとも1種の治療薬がチモロールを含む、請求項13または14に記載のデバイス。
- 眼疾患の治療に使用するための治療薬であって、請求項1から15のいずれか一項に記載の徐放性眼内薬物送達デバイスで投与され、前記徐放性眼内薬物送達デバイスが眼の溝に挿入される治療薬。
- ベバシズマブ、ラニビズマブ、アフリベルセプト、チモロール、ラタノプロスト、ドルゾラミド、トリアムシノロン、デキサメタゾンおよびシクロスポリンからなる群より選択される、請求項16に記載の使用のための治療薬。
- 眼疾患を治療する方法であって、眼疾患の治療に使用するための治療有効量の化合物を投与することを含み、前記化合物が請求項1から15に記載の徐放性眼内薬物送達デバイスで投与され、前記徐放性眼内薬物送達デバイスが、眼疾患が治療されるように眼の溝に挿入される方法。
- 前記化合物が、ベバシズマブ、ラニビズマブ、アフリベルセプト、チモロール、ラタノプロスト、ドルゾラミド、トリアムシノロン、デキサメタゾンおよびシクロスポリンからなる群より選択される、請求項18に記載の方法。
- 請求項1から15に記載の徐放性眼内薬物送達デバイスの作製方法であって、
−少なくとも1種の治療薬と、不溶性および不活性なポリマーとを混合すること、
−前記混合物をモールディングおよび/または押出し成形して、ポリマーマトリックスコアを供給すること、ならびに
−得られたポリマーマトリックスコアにポリマーコーティングを提供すること、
を含む方法。 - 得られたポリマーマトリックスコアにポリマーコーティングを提供するステップが、前記得られたポリマーマトリックスコアをポリマー膜により鋳型中で覆うこと、および前記鋳型を加熱することにより実施される、請求項20に記載の方法。
- 眼内デバイスを眼の溝に挿入することによって眼疾患を治療する、当該デバイスの製造に使用するための、請求項20または21に記載の方法。
- 請求項1から15のいずれか一項に記載のデバイスを挿入または移植するための外科的方法であって、力を印加することによってデバイスを部分的に直線化するステップ、該デバイスを眼の溝に挿入するステップ、および前記デバイスを解放するステップを含む方法。
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CN105792812A (zh) | 2016-07-20 |
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EA201690967A1 (ru) | 2016-10-31 |
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ES2864274T3 (es) | 2021-10-13 |
IL245405A0 (en) | 2016-06-30 |
HK1223271A1 (zh) | 2017-07-28 |
US20160287513A1 (en) | 2016-10-06 |
EP3566693B1 (en) | 2021-02-17 |
JP6602761B2 (ja) | 2019-11-06 |
US9999595B2 (en) | 2018-06-19 |
CL2016001160A1 (es) | 2017-03-17 |
AU2014350095B9 (en) | 2019-09-12 |
MA39111A1 (fr) | 2017-04-28 |
AU2014350095A1 (en) | 2016-06-09 |
ES2740352T3 (es) | 2020-02-05 |
EP3068372B1 (en) | 2019-05-08 |
CN105792812B (zh) | 2020-10-23 |
EA032183B1 (ru) | 2019-04-30 |
EP3068372A1 (en) | 2016-09-21 |
BR112016010638B1 (pt) | 2023-01-31 |
TN2016000162A1 (en) | 2017-10-06 |
EP3566693A1 (en) | 2019-11-13 |
AU2014350095B2 (en) | 2019-08-29 |
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