JP5437563B2 - 眼の後部の処置のための組成物および方法 - Google Patents
眼の後部の処置のための組成物および方法 Download PDFInfo
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- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
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- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0048—Eye, e.g. artificial tears
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- A61P31/06—Antibacterial agents for tuberculosis
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
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- A—HUMAN NECESSITIES
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
- A61P31/14—Antivirals for RNA viruses
- A61P31/18—Antivirals for RNA viruses for HIV
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P33/00—Antiparasitic agents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P33/00—Antiparasitic agents
- A61P33/02—Antiprotozoals, e.g. for leishmaniasis, trichomoniasis, toxoplasmosis
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
- A61P35/04—Antineoplastic agents specific for metastasis
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P41/00—Drugs used in surgical methods, e.g. surgery adjuvants for preventing adhesion or for vitreum substitution
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/38—Drugs for disorders of the endocrine system of the suprarenal hormones
- A61P5/40—Mineralocorticosteroids, e.g. aldosterone; Drugs increasing or potentiating the activity of mineralocorticosteroids
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
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Description
ヒトまたは動物の眼の後部を処置するための新規な組成物および方法を開発した。本組成物は、「洗浄ステップ」を要することなく、眼内に用いる場合に眼の損傷(例えば、網膜の損傷)を減少する一方、眼の後部への硝子体内投与に非常に適している。有利なことに、本組成物は、保存料成分は実質的に添加されていない。例えば、ベンジルアルコール保存料を含有しない。さらに、有利には、本組成物は再懸濁補助剤を必要としない。概して、本組成物は、ヒトまたは動物の眼の後部に容易に且つ効果的に注射可能であり、長期間、例えば約1週間以上、再懸濁処理なしに、例えば、実質的に均一な懸濁を得るため組成物を振盪またはその他の攪拌を要することなく、実質的に均一な懸濁液として維持することができる。要するに、本組成物および方法は、ヒトまたは動物の眼の後部において、例えば従来のケナログ(登録商標)およびそのような従来の組成物を用いる方法と比較して、実質的な増大および利点を提供する。
本発明は、好ましくは注射による、ヒトまたは動物の眼の後部への配置に有用な組成物に関する。眼の後部(例えばガラス体)における、このような組成物は、眼の後部の1またはそれ以上の状態および/または疾患、および/または眼の後部のそのような状態および/または疾患の1またはそれ以上の症状に対して治療上有効である。
4種類の組成物は以下のとおり:
濃縮トリアムシノロンアセトニド分散液は、トリアムシノロンアセトニド、水、ビタミンE−TPGSおよび8−シクロデキストリン(存在する場合)を混合することにより調製する。これらの成分を混合してトリアムシノロンアセトニド中に分散させた後、オートクレーブに付する。ヒアルロン酸ナトリウムは、滅菌粉末として購入するかまたは希釈液を濾過した後凍結乾燥して滅菌粉末を得ることができる。この滅菌ヒアルロン酸ナトリウムを水に溶解して水性の濃縮液を得る。濃縮トリアムシノロンアセトニド分散液を混合しスラリーとしてヒアルロン酸ナトリウム濃縮液に加える。水を適量加え、混合物を均一になるまで混合する。
劇的にずり流動化(shear thinning)するため、これらの組成物は、27ゲージまたは30ゲージの注射針にて容易に注射される。
2種類の組成物は以下のとおり:
劇的にずり流動化(shear thinning)するため、これらの組成物は、27ゲージまたは30ゲージの注射針にて容易に注射される。
Claims (21)
- ヒトまたは動物の眼の後部へ注入するための組成物であって、
複数の粒子として存在する治療上有効な量で存在するトリアムシノロンアセトニド;
組成物の1%〜4%(w/v)の範囲の量のヒアルロン酸塩成分;および
水性担体成分
を含有し、保存料成分および再懸濁成分を含有しない、剪断速度0.1/秒で少なくとも70000cpsの粘度を有する、組成物。 - 剪断速度0.1/秒で140,000cps〜300,000cpsの粘度を有する請求項1記載の組成物。
- 27ゲージの注射針でヒトまたは動物の眼の後部へ注入可能な請求項1記載の組成物。
- 30ゲージの注射針でヒトまたは動物の眼の後部へ注入可能な請求項1記載の組成物。
- 前記組成物において前記粒子が均一に懸濁している請求項1記載の組成物。
- 前記組成物において、前記粒子が再懸濁処理を要することなく均一な懸濁が少なくとも1週間持続する請求項5記載の組成物。
- 組成物において、再懸濁処理を要することなく前記粒子の均一な懸濁が少なくとも1ヶ月持続する請求項5記載の組成物。
- 組成物において、再懸濁処理を要することなく前記粒子の均一な懸濁が少なくとも6ヶ月持続する請求項5記載の組成物。
- 組成物において、再懸濁処理を要することなく前記粒子の均一な懸濁が少なくとも1年間持続する請求項5記載の組成物。
- 組成物において、再懸濁処理を要することなく前記粒子の均一な懸濁が少なくとも2年間持続する請求項5記載の組成物。
- トリアムシノロンアセトニドが、組成物の25%(w/v)までの量で存在する請求項1記載の組成物。
- トリアムシノロンアセトニドが、組成物1mL当たり少なくとも10mgの量で存在する請求項1記載の組成物。
- トリアムシノロンアセトニドが、組成物の1%〜20%(w/v)の範囲の量で存在する請求項1記載の組成物。
- トリアムシノロンアセトニドが、組成物の1%〜10%(w/v)の範囲の量で存在する請求項1記載の組成物。
- 担体成分が、少なくとも1つの等張化成分および緩衝成分の有効量を含有する請求項1記載の組成物。
- ヒアルロン酸塩成分がヒアルロン酸ナトリウムを含んでなる請求項1記載の組成物。
- 前記注入が硝子体内注射によって行われる請求項1記載の組成物。
- 前記注入が結膜下注射によって行われる請求項1記載の組成物。
- 前記注入がテノン嚢下注射によって行われる請求項1記載の組成物。
- 前記注入が球後注射によって行われる請求項1記載の組成物。
- 前記注入が脈絡膜上注射によって行われる請求項1記載の組成物。
Applications Claiming Priority (7)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US51923703P | 2003-11-12 | 2003-11-12 | |
US60/519,237 | 2003-11-12 | ||
US53006203P | 2003-12-16 | 2003-12-16 | |
US60/530,062 | 2003-12-16 | ||
US10/966,764 | 2004-10-14 | ||
US10/966,764 US20050101582A1 (en) | 2003-11-12 | 2004-10-14 | Compositions and methods for treating a posterior segment of an eye |
PCT/US2004/037436 WO2005046641A2 (en) | 2003-11-12 | 2004-11-08 | Compositions and methods for treating a posterior segment of an eye |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2011183912A Division JP5592321B2 (ja) | 2003-11-12 | 2011-08-25 | 眼の後部の処置のための組成物および方法 |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2007510744A JP2007510744A (ja) | 2007-04-26 |
JP5437563B2 true JP5437563B2 (ja) | 2014-03-12 |
Family
ID=34557415
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Application Number | Title | Priority Date | Filing Date |
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JP2006539780A Expired - Fee Related JP5437563B2 (ja) | 2003-11-12 | 2004-11-08 | 眼の後部の処置のための組成物および方法 |
JP2011183912A Expired - Fee Related JP5592321B2 (ja) | 2003-11-12 | 2011-08-25 | 眼の後部の処置のための組成物および方法 |
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Application Number | Title | Priority Date | Filing Date |
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JP2011183912A Expired - Fee Related JP5592321B2 (ja) | 2003-11-12 | 2011-08-25 | 眼の後部の処置のための組成物および方法 |
Country Status (19)
Country | Link |
---|---|
US (3) | US20050101582A1 (ja) |
EP (2) | EP1997497B1 (ja) |
JP (2) | JP5437563B2 (ja) |
KR (1) | KR20060113709A (ja) |
CN (1) | CN105748407A (ja) |
AT (2) | ATE424220T1 (ja) |
AU (2) | AU2004289300B2 (ja) |
BR (1) | BRPI0416506A (ja) |
CA (1) | CA2545878C (ja) |
CY (2) | CY1110469T1 (ja) |
DE (2) | DE602004027773D1 (ja) |
DK (2) | DK1997497T3 (ja) |
ES (2) | ES2345018T3 (ja) |
NZ (1) | NZ546699A (ja) |
PL (2) | PL1682185T3 (ja) |
PT (2) | PT1682185E (ja) |
SI (2) | SI1997497T1 (ja) |
TW (1) | TWI362264B (ja) |
WO (1) | WO2005046641A2 (ja) |
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