JP6039719B2 - 点眼薬送達 - Google Patents
点眼薬送達 Download PDFInfo
- Publication number
- JP6039719B2 JP6039719B2 JP2015048244A JP2015048244A JP6039719B2 JP 6039719 B2 JP6039719 B2 JP 6039719B2 JP 2015048244 A JP2015048244 A JP 2015048244A JP 2015048244 A JP2015048244 A JP 2015048244A JP 6039719 B2 JP6039719 B2 JP 6039719B2
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- Prior art keywords
- ejection
- hydrochloride
- less
- eye
- droplet
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Description
本発明は、米国仮特許出願第61/400,864号(2010年7月15日出願)、米国仮特許出願第61/401,850号(2010年8月20日出願)、米国仮特許出願第61/401,920号(2010年8月20日出願)、米国仮特許出願第61/401,918号(2010年8月20日出願)、米国仮特許出願第61/401,848号(2010年8月20日出願)、米国仮特許出願第61/401,849号(2010年8月20日出願)、米国仮特許出願第61/462,576号(2011年2月4日出願)、米国仮特許出願第61/462,791号(2011年2月5日出願)、米国仮特許出願第61/463,280号(2011年2月15日出願)、米国仮特許出願第61/516,462号(2011年4月4日出願)、米国仮特許出願第61/516,496号(2011年4月4日出願)、米国仮特許出願第61/516,495号(2011年2月4月4日出願)、及び米国仮特許出願第61/516,694号(2011年4月6日出願)(これらの各出願の全内容は、参照することにより本明細書に組み込まれる)の出願日の利益を請求する。本発明はまた、米国仮特許出願第61/396,531号(2010年5月28日出願)(この全内容は、参照することにより本明細書に組み込まれる)にも関する。
本発明は、駆出される液滴の生成のための器具、その投与法と使用法、及びそのために製剤化された医薬組成物とに関する。
点眼瓶により投与される典型的な医薬液滴は、液体の粘度と表面張力により変化する。一滴で投与される活性成分の量を調節するために、活性成分の濃度は容量により調整される。いったん濃度が確定すると、正しい投与量が一滴以上を必要とする場合がある。しかしヒトの眼は一回に7μlの液体しか保持できないため、一回の医薬液滴でもあふれ出て、薬剤の一部が眼から失われることがある。複数回の液滴投与はしばしば、眼における薬剤の保持の問題をより複雑にする。人はたいてい、投与量に必要な液滴のすべてを一回で投与するが、これは問題を悪化させ、薬剤の50〜90%が眼からあふれて洩れていくことになる。
そのようなニーズなどに対処するために、本発明は、安定な医薬組成物とその使用法を提供する。
A.駆出液滴の生成方法
本発明は、投与方策を始めるための有効なアプローチを提供する。投与方策はまた、治療の開始、治療の停止、治療の変更、及び異なる被験体の状態への対応のための、種々のアプローチを含む。
必要な被験体の眼に薬剤を送達する方法であって、(a)特定の平均サイズと平均初期駆出速度とを有する薬剤を含有する液滴を準備する工程と、(b)眼に薬剤を送達する工程であって、液滴は眼に液滴の駆出量のある割合を送達する工程を、含んでなる方法が提供される。
本明細書に記載した種類の液滴を生成することができるエジェクタ器具の例は、米国代理人整理番号第24591.003−US03号明細書に記載されており、これは「液滴生成器具」という標題で、本発明と同時に出願され、その全体が参照することにより本明細書に組み込まれる。そのような器具のある態様において、エジェクタプレートはアクチュエータに連結している。アクチュエータのプレートへの結合方法と位置は、駆出アセンブリーの操作と、アクチュエータが圧電性アクチュエータであるという選択肢を用いる液滴流の生成に、影響を与える。
所望の眼科治療活性を示す任意の薬剤を投与することができる。ある態様において薬剤は、処方箋で入手することができる。他の態様において薬剤は、点灯で入手することができる。生ある態様において薬剤は、物学的製剤であるか又はこれを含む。ある態様において生物学的製剤は、完全長抗体、完全長抗体の活性断片、ペプチド、PEG化ペプチド、及び酵素成分よりなる群から選択される。他の態様において生物学的製剤は、ベバシズマブ、ラニビズマブ、FV断片、二重特異的抗体、融合分子、ペガプタニブ、プラスミン、及びミクロプラスミンよりなる群から選択される。さらなる態様において、生物学的製剤は、ラニビズマブ抗体FAB(ルセンティス(登録商標)(LucentisTM)を含む)、VEGF Trap融合分子(VEGF Trap−EyeTMを含む)、ミクロプラスミン酵素(オクリプラスミン(登録商標)(OcriplasminTM)を含む)、マキュジェンPEG化ポリペプチド(ペガプタニブ(登録商標)(PegaptanibTM)を含む)、及びベバシズマブ(アバスチン(登録商標)(AvastinTM)を含む)よりなる群から選択される。
再度、本発明のある態様において、生理学的pHと張性での水溶液中の活性物質の調製が行われる。しかし、組成物に充分な溶解度を与えるためには、溶解度増強物質の使用が必要な場合がある。
溶解度以外に活性物質は、投与中に生物活性を維持するために、加水分解や酸化的分解に耐えるように組成物内で充分な安定でなければならない。活性物質は一般に、通常の投与中に観察される治療効果を有していなければならない;中枢投与前の組成物中の薬剤の安定性も重要である。このために、ある態様では本発明の組成物は、眼での使用が許容される安定化賦形剤及び緩衝液をさらに含んでよい。
Claims (14)
- 被験体の眼の疾患又は症状の治療用の、被験体の眼への医薬の送達における使用のための圧電駆動性駆出器具であって、ここで、前記器具が、圧電性アクチュエータに連結されたエジェクタプレートを備え、
上記器具が、上記医薬を含んでなる複数の駆出液滴を生成し、該駆出液滴が少なくとも20ミクロンの平均駆出液滴直径、及び平均初期液滴駆出速度0.5m/s〜20m/sを有し、圧電駆動性駆出器具の使用中に該駆出液滴の質量の少なくとも85%が被験体の眼に沈着し、それにより上記眼の疾患又は症状が治療される、圧電駆動性駆出器具。 - 前記医薬が水溶液である、請求項1に記載の器具。
- 前記水溶液が、1%〜2.5%の塩分濃度の範囲の生理食塩水である、請求項2に記載の器具。
- 前記医薬が、油/水エマルジョンである、請求項1に記載の器具。
- 前記油/水エマルジョン中の油が、グリセリン、ヒマシ油、又はポリソルベート80混合物を含んで成る、請求項4に記載の器具。
- 前記医薬が緑内障医薬であり、前記疾患が緑内障である、請求項1に記載の器具。
- 前記医薬が抗生物質である、請求項1に記載の器具。
- 前記駆出液滴が、30ミクロン〜60ミクロンの平均駆出液滴直径を有する、請求項1に記載の器具。
- 前記平均初期液滴駆出速度が、1m/s〜5m/sである、請求項1に記載の器具。
- 前記医薬が、ラニビズマブ抗体FAB、VEGF Trap融合分子、ミクロプラスミン酵素、マキュジェンPEG化ポリペプチド、ベバシズマブ、カルボキシメチルセルロースナトリウム、塩酸テトラヒドロゾリン、マレイン酸フェニラミン、フマル酸ケトチフェン、塩酸オキシメタゾリン、塩酸ナファゾリン、塩酸モキシフロキサシン、ブロムフェナク、塩酸プロパラカイン、ジフルプレドネート、ガチフロキサシン、トラボプロスト、ベシル酸ベポタスチン、ガチフロキサシン、エタボン酸ロテプレドノール、眼科用チモロール、塩酸オロパタジン、塩酸フェニレフリン、レボフロキサシン、ケトロラクトロメタミン、レタノプロスト、ビマトプロスト、BAK不含ラタノプロスト、アクリル酸フルオロシリコーン、カルボキシメチルセルロースナトリウム、ヒドロキシプロピルメチルセルロース、カルボキシメチルセルロースナトリウム、プロピレングリコール、ヒプロメロース、硫酸亜鉛、ドルゾラミド、マレイン酸チモロール塩酸、アジスロマイシン、ネパフェナク、ブリンゾラミド、ベシフロキサシン、酢酸プレニソン、トブラマイシン、ゲンタマイシン、トブラマイシン/デキサメタゾン、シクロスポリン、マレイン酸チモロール、及び酒石酸ブリモニジン、からなる群から選択される、請求項1に記載の器具。
- 前記圧電駆動性駆出器具を介した駆出において、駆出され被験体の眼に沈着される液滴の量の総体積が、30μl未満、20μl未満、15μl未満、10μl未満、5μl未満、又は2μl未満、から成る群から選択される、請求項1に記載の器具。
- 前記医薬を含んで成る複数の駆出液滴が、0.0001%〜5%の活性成分濃度を有する、請求項1に記載の器具。
- 前記医薬が、保存剤、添加剤、ポリマー、溶解度増強剤、安定化賦形剤、又はそれらの組合せ、を含んで成る、請求項1に記載の器具。
- 前記医薬が、25℃で、約0.3〜約300cPの粘度を有する、請求項1に記載の器具。
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-
2011
- 2011-07-15 EA EA201390121A patent/EA201390121A8/ru unknown
- 2011-07-15 US US13/184,468 patent/US8733935B2/en active Active
- 2011-07-15 WO PCT/US2011/044286 patent/WO2012009702A1/en active Application Filing
- 2011-07-15 JP JP2013519867A patent/JP2013531548A/ja not_active Withdrawn
- 2011-07-15 EP EP11738113.7A patent/EP2593055A1/en not_active Withdrawn
- 2011-07-15 CN CN201180040911.1A patent/CN103118643B/zh active Active
- 2011-07-15 CA CA2805635A patent/CA2805635A1/en not_active Abandoned
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Also Published As
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CN103118643B (zh) | 2015-06-10 |
US8733935B2 (en) | 2014-05-27 |
EA201390121A1 (ru) | 2013-06-28 |
CL2013000152A1 (es) | 2013-07-19 |
CN103118643A (zh) | 2013-05-22 |
WO2012009702A1 (en) | 2012-01-19 |
JP2013531548A (ja) | 2013-08-08 |
EP2593055A1 (en) | 2013-05-22 |
CL2013000153A1 (es) | 2013-07-12 |
CA2805635A1 (en) | 2012-01-19 |
US20170151088A1 (en) | 2017-06-01 |
US20140249491A1 (en) | 2014-09-04 |
JP2015120035A (ja) | 2015-07-02 |
EA201390121A8 (ru) | 2014-02-28 |
US20120062840A1 (en) | 2012-03-15 |
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