JP2017501111A - 粘液を増加または減少させる製剤および方法 - Google Patents
粘液を増加または減少させる製剤および方法 Download PDFInfo
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Abstract
Description
本願は、「Formulation to Reduce Mucus」なる発明の名称で2013年10月15日に出願した米国特許仮出願番号61/891,270号に基づく優先権を主張し、該出願の開示は出典明示して本明細書の一部とみなす。
本開示は、目的の標的組織への、例えば眼への目的の医薬剤の制御持続型の送達に関する。本開示は、一般的に、粘液の形成および/または蓄積を減少または増加させながら眼に目的の医薬を送達する眼科用デバイス、例えば眼科用インサートを含む、眼科の分野に関する。
医薬剤を含む眼科用インサートを眼に設置して持続様式で医薬剤を送達する場合、患者は眼科用インサートに関係する副作用、例えば眼における粘液の産生および/または蓄積を経験する場合がある。眼科用インサートに起因する望ましくないまたは過剰な粘液の産生および/または蓄積を減少または予防するためには、新規なインサート組成物(複数可)が必要とされる。本開示は、これらのニーズに対応するものである。
本開示は、ポリマーマトリクスおよび医薬剤および/または非−医薬剤を含む組成物(複数可)を特徴とし、ここに医薬剤および/または非−医薬剤(例えば、脂質および/または薬物)はポリマーマトリクス中に分散している。
本開示は、ポリマーマトリクスと医薬剤および/または非−医薬剤とを含む組成物(複数可)を特徴とし、ここに該医薬剤および/または非−医薬剤(例えば、脂質および/または薬物)はポリマーマトリクス中に分散している。
本開示は、対象の標的組織の上または中の医薬剤送達デバイスの設置を含む、粘液の形成および/または蓄積を緩和および/または減少する方法を提供する。本開示は、さらに、粘液の形成を増加する方法を提供する。デバイスは、重合性または非−重合性の流体を用いて調製し、デバイスを対象の標的組織の上または中に設置した後に粘膜の産生および/または蓄積を賦形剤が減少するように、1以上の医薬剤および/または非−医薬剤(例えば、脂質)を含む。本開示のデバイスに存在する1以上の賦形剤(複数可)は、デバイスを対象の標的組織の上または中に設置した後に粘膜の産生および/または蓄積の開始を遅延する。
本開示は、対象の標的組織、例えば、眼の中または上に薬物送達デバイスを移植した後に対象における快適度を改善する組成物(複数可)および方法を提供する。例えば、本開示は、眼における快適性を改善することを提供し;快適度はスケール範囲0−3を用いて測定し、ここに0=眼中に何も存在しないと対象が報告;0.5=対象はインサートに気付くが通常に感じる;1=対象は軽度の不快を感じる;2=対象は中度の不快を感じる;および3=対象は眼中のデバイスに耐えられない。快適性データは、リッカート尺度(リッカート尺度は提示文に対する肯定的反応または否定的反応のいずれかを測定する二極尺度手法である)を用いて分析することができ、1日目、2日目、3日目、4日目、5日目、6日目、1週間、2週間、3週間、4週間、5週間、6週間、7週間、8週間、9週間、または10週間に収集することができる。例えば、データは、試験に登録した対象から適切な週に5〜6日間収集し、各対象についてスコアを平均することができる。
本開示は、ポリマーマトリクス、賦形剤、および医薬剤を含む眼科用インサート組成物(複数可)を提供するもので、ここに該賦形剤は眼における粘液の産生および/または蓄積を減少または予防する(すなわち、そのリスクを低下する)。例えば、本開示は、賦形剤が着色剤または染料、油、脂質、脂肪酸、脂肪アルコール、および/または水溶性ポリマーである眼科用インサート組成物(複数可)を提供する。例えば、本開示は、賦形剤が油を含むまたはそれからなる着色剤/染料である眼科用インサート組成物(複数可)を提供する。
本開示の実施形態は、また、涙点プラグシステムおよび円蓋系インサートのようなシリコーン系持続放出デバイスを提供する。本開示の主題の様々な解剖学的部位(眼を含む)における薬物送達のための涙点プラグは、例えば、2006年3月28に発行された米国特許第7017580号および2005年10月20日に公開された米国特許出願公開2005/0232972に開示されている。円蓋系インサートは記載されている(例えば、Francis, I.C., Aust. J. Ophthalmol.(1984)12:57-59を参照されたい)。
本開示の組成物(複数可)(組成物(複数可)および製剤は本開示全体にわたって交換可能に用いる)の眼への医薬剤の持続放出を提供する。医薬剤の持続放出は、(最大6ヶ月など)長期間である。本開示の組成物(複数可)は、連続持続的な治療レベルを維持するための頻繁な投与の治療要件を回避することができる。さらに、本開示の組成物(複数可)は、例えば、目のかすみ、眼瞼発赤、睫毛の恒久的な黒ずみ、眼の不快感、虹彩の永久恒久的暗化(茶色に)、使用、まつ毛の成長および/または肥厚の間の一時的な灼熱感、髪の予想外の成長、目蓋または眼の下の地域の暗化のような溶液投与に関連する副作用のリスクを低下する(すなわち、リスクを低下するが個々の対象は副作用を経験する場合がある)。
ピロカルピン、カルバコール、フィゾスチグミンおよびブリモニジン、クロニジン、グアンファシン、グアナベンズ、グアノキサベンズ(guanoxabenz)、キシラジン、チザニジン、メチルドパ、ファドルミジン(fadolmidine)、デクスメデトミジン、アミデフリン、アミトラズ、アニソダミン、アプラクロニジン、シラゾリン、デトミジン、デクスメデトミジン、エピネフリンのような副交感神経興奮剤、エルゴタミン、エチレフリン、インダニジン、イソフェキシジン(iofexidine)、メデトミジン、メフェンテルミン、メタラミノール、メトキサミン、ミバゼロール、ナファゾリン、ノルエピネフリン、ノルフェネフリン、オクトパミン、オキシメタゾリン、フェニルプロパノールアミン、リルメニジン、ロミフィジン、シネフリン、およびタリペキソールなどのようなαアドレナリン作動薬が含まれる。
本開示の組成物(複数可)は、デバイス、例えば、眼疾患を治療するために使用することができる眼科用デバイスのような医療用デバイスとして調製することができる。
本開示の追加実施形態は、医薬剤送達デバイスを含むキットを含み、ここに該デバイスは重合性流体を用いて調製し、賦形剤および医薬剤および/または非−医薬剤(例えば、脂質)を含み、該賦形剤はデバイスを対象の標的組織の上または中に設置した後に粘液の産生および蓄積を減少する。
本明細書中で用いる用語「ビマトプロスト」とは7−[3,5−ジヒドロキシ−2−(3−ヒドロキシ−5−フェニル−ペント−1−エニル)−シクロペンチル]−N−エチル−ヘプト−5−エンアミド:
をいう。
実施例
2の第I相臨床試験を、薬物送達用の眼科用インサートの安全性を試験するために行った(例えば、図1を参照されたい)。これらの臨床実験において、薬物を含むまたは薬物を含まないいずれかの眼科用インサートを各対象(すなわち、実験の参加者)の眼に設置した。ついで、2のフェーズI試験のコホートを、眼科用インサートの悪影響を評価するために保存した。2の第I相試験の保存した「安全な」コホート(合計36人の患者)で、三分の二以上は、薬物、例えば、ビマトプロストを含まないものだけでなく、薬剤を含むインサート(すなわち、薬物送達デバイス)を装着した場合に、眼の粘液が増加した。
薬物放出速度に対する油の影響を判定するための実験を行い、そこでは薬物送達デバイスのインサート(例えば、眼科用インサート)(図1参照)をin vitro試験において設置し、油を含まない以外は同じである薬物送達デバイス製品(例えば、眼科用インサート)と比較した。
表2に示すように、NuSil MED−4830を様々な充填量で種々な油を用いて調製した。重合性および非−重合性の両方の、使用したすべての油で20%の充填量でさえ、シリコーンMED−4830は成形することができ、未だ妥当なショアA硬度を有していた。
本開示の対象の目に薬物を送達するための眼科用インサートは、種々の色、例えば、白、肌色基調およびピンクで調製した。薬物を含まない白色の眼科用インサートは、MED−4830シリコーン中に2%のMED−4800−1を含めることによって調製した(MED−4800−1の構成要素のうちの1がMED−370である)。薬物ビマトプロストを含有する白色の眼科用インサートは、MED−4830中に1.18%のMED−370および20%のビマトプロストを含めることによって調製した。薬物放出の一貫性を試験するために、薬物を含む白色の眼科用インサートは、MED−4830中に2%のMED−4800−1、20%の場間とプロストを含めることによって調製した(%は重量により測定した)。
本開示をその詳細な説明と結合して記載したが、前述の説明は説明を意図するものであって、添付する特許請求の範囲によって規定される開示の範囲を限定するものではない。他の態様、利点および修飾は以下の特許請求の範囲の中に存在する。添付する特許請求の範囲によって包含される開示の範囲から逸脱することなく、形状および詳細における種々の変化をなし得ることは当業者には理解されよう。
Claims (34)
- ポリマーマトリクスおよび1以上の賦形剤を含む眼科用インサート組成物であって、ここに賦形剤は眼の中に眼科用インサートが存在することに起因する過剰な粘液形成を経験しているおよび/またはそのリスクがある対象の眼における粘液の産生および/または蓄積を減少する組成物。
- さらに1以上の医薬剤を含む、請求項1記載の組成物。
- 賦形剤が着色剤または染料、油、脂質、脂肪酸、脂肪アルコール、および水溶性ポリマーから選択される、請求項1または2記載の組成物。
- 脂質がリン脂質である、請求項3記載の組成物。
- リン脂質がDMPC(1,2−ジミリストイル−sn−グリセロ−3−ホスホコリン)である、請求項4記載の組成物。
- 着色剤または染料が油を含み、着色剤がMED−4800−1、MED−4800−2、MED−4800−3、MED−4800−4、MED−4800−5、MED−4800−6、MED−4800−7、MED50−4800−1、MED50−4800−2、MED50−4800−3、MED50−4800−4、MED50−4800−5、MED50−4800−6、MED50−4800−7、MED51−4800−7およびそれらのいずれかの組合せ(複数可)よりなる群から選択される、請求項3記載の組成物。
- 油が鉱油およびシリコーン油から選択される、請求項3記載の組成物。
- 油が眼における粘液の産生および/または蓄積を減少する、請求項3記載の組成物。
- ポリマーがシリコーンである、請求項1または2記載の組成物。
- シリコーンがMED−4810、MED−4820、MED−4830、MED−4840、MED−4842、MED−4850、MED1−4855、MED−4860、MED−4870またはMED−4880を含む、請求項9記載の組成物。
- 所望により1以上の賦形剤を含んでいてもよい、ポリマーマトリクスを含む眼科用インサート組成物であって、それを必要とする対象の眼の中または上にインサートを設置した際にインサートが対象の眼における粘液の産生および/または蓄積を増加する、組成物。
- さらに医薬剤を含む、請求項11記載の組成物。
- 組成物が医薬剤を含まない、請求項11記載の組成物。
- ポリマーマトリクスおよび1以上の賦形剤を含むが、医薬剤を含まない眼科用インサート組成物であって、それを必要とする対象の眼の中または上にインサートを設置した際に賦形剤が対象の眼における粘液の産生および/または蓄積を減少する、組成物。
- ポリマーマトリクス、1以上の賦形剤、および1以上の医薬剤を含む眼科用インサート組成物であって、それを必要とする対象の眼の中または上にインサートを設置した際に賦形剤が対象の眼における粘液の産生および/または蓄積を減少する、組成物。
- ポリマーマトリクスおよび1以上の医薬剤を含むが、賦形剤を含まない眼科用インサート組成物であって、それを必要とする対象の眼の中または上にインサートを設置した際に医薬剤が対象の眼の疾病または障害を治療する、組成物。
- 賦形剤が着色剤または染料、油、脂質、脂肪酸、脂肪アルコール、および水溶性ポリマーから選択され、着色剤がMED−4800−1、MED−4800−2、MED−4800−3、MED−4800−4、MED−4800−5、MED−4800−6、MED−4800−7、MED50−4800−1、MED50−4800−2、MED50−4800−3、MED50−4800−4、MED50−4800−5、MED50−4800−6、MED50−4800−7およびMED51−4800−7から選択される、請求項11〜15のいずれか1項に記載の眼科用インサート組成物。
- 脂質がリン脂質である、請求項17記載の組成物。
- リン脂質がDMPC(1,2−ジミリストイル−sn−グリセロ−3−ホスホコリン)である、請求項18記載の組成物。
- 油が鉱油およびシリコーン油から選択される、請求項17記載の組成物。
- ポリマーがシリコーンである、請求項11〜20のいずれか1項に記載の組成物。
- シリコーン油がMED−360およびMED−370から選択される、請求項7または20記載の組成物。
- 水溶性ポリマーがポリエチレングリコール、グリセロール、ヒアルロン酸、および水溶性メチルセルロース誘導体から選択される、請求項3または17記載の組成物。
- 請求項1〜23のいずれか1項に記載の組成物を含む眼科用インサート。
- 請求項1〜23のいずれか1項に記載の組成物を含む眼科用インサートを用いて、必要とする対象の眼の疾患または障害を治療する方法。
- インサートがリング形状を有する、請求項24記載の眼科用インサート。
- リングが約10〜40mmの直径および約0.1〜5mmの断面厚さを有する、請求項26記載の眼科用インサート。
- 直径が約20〜30mmであって断面厚さが約0.5〜1.5mmである、請求項27記載の眼科用インサート。
- 着色剤または染料、油、脂質、脂肪酸、脂肪アルコール、および/または水溶性ポリマーが約0.1〜20重量%である、請求項3または17記載の組成物。
- 医薬剤が組成物の約5重量%〜約30重量%である、請求項29記載の組成物。
- 医薬剤送達デバイスの設置を含む粘液の形成および/または蓄積を予防および/または減少させる方法であって、ここにデバイスは重合性または非−重合性の流体を用いて調製し、賦形剤および医薬剤を含み、ここに賦形剤はデバイスを対象の標的組織に設置した後に粘液の産生および/または蓄積を減少する、方法。
- 医薬剤送達デバイスを含むキットであって、ここにデバイスは重合性または非−重合性の流体を用いて調製し、賦形剤および医薬剤を含み、ここに賦形剤はデバイスを対象の標的組織に設置した後に粘液の産生および/または蓄積を減少する、キット。
- 組成物が約1.18重量%の油MED−370および/またはMED−360、ならびにMED4830シリコーン中の約20%のビマトプロストを含む、請求項3または12記載の組成物。
- 組成物がMED4830シリコーン中の約2%のMED−4800−1を含む、請求項3または17記載の組成物。
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AU2017290593A1 (en) | 2016-06-27 | 2019-01-03 | Achillion Pharmaceuticals, Inc. | Quinazoline and indole compounds to treat medical disorders |
CN110603252A (zh) | 2017-03-01 | 2019-12-20 | 艾其林医药公司 | 用于治疗医学障碍的芳基、杂芳基和杂环药物化合物 |
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CN110711075A (zh) * | 2018-07-11 | 2020-01-21 | 吴坚 | 一种泪小管栓塞 |
EP3841086A4 (en) | 2018-08-20 | 2022-07-27 | Achillion Pharmaceuticals, Inc. | PHARMACEUTICAL COMPOSITIONS FOR THE TREATMENT OF MEDICAL DISORDERS RELATED TO COMPLEMENT FACTOR D |
JP7504088B2 (ja) | 2018-10-16 | 2024-06-21 | ジョージア ステイト ユニバーシティー リサーチ ファウンデーション インコーポレイテッド | 医学的障害の治療のための一酸化炭素プロドラッグ |
TW202146412A (zh) | 2020-03-05 | 2021-12-16 | 美商C4醫藥公司 | 用於標靶降解brd9之化合物 |
US11344526B2 (en) | 2020-03-20 | 2022-05-31 | The Regents Of The University Of California | Implantable drug delivery devices for localized drug delivery |
US11338119B2 (en) * | 2020-03-20 | 2022-05-24 | The Regents Of The University Of California | Implantable drug delivery devices for localized drug delivery |
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