JP5592321B2 - 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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- JP5592321B2 JP5592321B2 JP2011183912A JP2011183912A JP5592321B2 JP 5592321 B2 JP5592321 B2 JP 5592321B2 JP 2011183912 A JP2011183912 A JP 2011183912A JP 2011183912 A JP2011183912 A JP 2011183912A JP 5592321 B2 JP5592321 B2 JP 5592321B2
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/10—Dispersions; Emulsions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/57—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
- 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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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—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
- 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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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
- A61P27/02—Ophthalmic agents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
- A61P31/06—Antibacterial agents for tuberculosis
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
-
- 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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- A—HUMAN NECESSITIES
- 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
-
- 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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- Inorganic Chemistry (AREA)
- Ophthalmology & Optometry (AREA)
- Tropical Medicine & Parasitology (AREA)
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- Cardiology (AREA)
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- Diabetes (AREA)
- Heart & Thoracic Surgery (AREA)
- AIDS & HIV (AREA)
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- Pulmonology (AREA)
- Urology & Nephrology (AREA)
- Surgery (AREA)
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Steroid Compounds (AREA)
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 (6)
- (a)8%のトリアムシノロンアセトニド;
(b)2.3%のヒアルロン酸ナトリウム;
(c)0.6%の塩化ナトリウム;
(d)0.3%の第二リン酸ナトリウム;
(e)0.04%の第一リン酸ナトリウム;
(f)水;および
(g)保存料の添加なし
を含んでなる、ヒトまたは動物の眼の後部へ投与するための組成物であって、剪断速度0.1/秒で、200,000cpsの粘度を有する組成物。 - 前記投与のステップが硝子体内注射を含んでなる、請求項1記載の組成物。
- 前記投与のステップが結膜下注射を含んでなる、請求項1記載の組成物。
- 前記投与のステップがテノン嚢下注射を含んでなる、請求項1記載の組成物。
- 前記投与のステップが球後注射を含んでなる、請求項1記載の組成物。
- 前記投与のステップが脈絡膜上注射を含んでなる、請求項1記載の組成物。
Applications Claiming Priority (6)
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 US20050101582A1 (en) | 2003-11-12 | 2004-10-14 | Compositions and methods for treating a posterior segment of an eye |
US10/966,764 | 2004-10-14 |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2006539780A Division 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 |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2012021011A JP2012021011A (ja) | 2012-02-02 |
JP5592321B2 true JP5592321B2 (ja) | 2014-09-17 |
Family
ID=34557415
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
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 |
Family Applications Before (1)
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 |
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) | DE602004019801D1 (ja) |
DK (2) | DK1682185T3 (ja) |
ES (2) | ES2345018T3 (ja) |
NZ (1) | NZ546699A (ja) |
PL (2) | PL1682185T3 (ja) |
PT (2) | PT1682185E (ja) |
SI (2) | SI1682185T1 (ja) |
TW (1) | TWI362264B (ja) |
WO (1) | WO2005046641A2 (ja) |
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