JPH09504294A - 耳、眼もしくは鼻の治療に使用されるロテプレドノールエタボナートの懸濁剤 - Google Patents
耳、眼もしくは鼻の治療に使用されるロテプレドノールエタボナートの懸濁剤Info
- Publication number
- JPH09504294A JPH09504294A JP7512725A JP51272595A JPH09504294A JP H09504294 A JPH09504294 A JP H09504294A JP 7512725 A JP7512725 A JP 7512725A JP 51272595 A JP51272595 A JP 51272595A JP H09504294 A JPH09504294 A JP H09504294A
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- Prior art keywords
- composition
- weight
- nonionic
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- 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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Classifications
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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
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0043—Nose
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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
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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
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
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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
- A61K31/74—Synthetic polymeric materials
-
- 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
- A61K31/74—Synthetic polymeric materials
- A61K31/785—Polymers containing nitrogen
- A61K31/787—Polymers containing nitrogen containing heterocyclic rings having nitrogen as a ring hetero atom
- A61K31/79—Polymers of vinyl pyrrolidone
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
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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
- A61P27/00—Drugs for disorders of the senses
- A61P27/16—Otologicals
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
Abstract
Description
Claims (1)
- 【特許請求の範囲】 1.眼科用もしくは耳鼻咽喉科用の抗炎症に使用される組成物であって、 (A)治療量のコルチコステロイドと、 (B)水性溶剤中の非イオン系ポリマーと、 (C)非イオン系界面活性剤と、 (D)非イオン系トニシティー剤(tonicity agent)とを含む組成物。 2.(A):(B):(C)のモル比が約1:20:0.05から約1:0.0 5:1である、請求項1に記載の組成物。 3.コルチコステロイドが抗炎症性を有するソフトステロイドからなるグループ より選択され、その量が約0.2から2重量%である、請求項1に記載の組成物 。 4.コルチコステロイドがロテプレドノールエタボナート(loteprednol etabon ate)であり、かつその量が約0.5から1重量%である、請求項1に記載の組 成物。 5.前記非イオン系ポリマーが、ポリビニルピロリドン、ポリビニルアルコール 、デキストリン及びシクロデキストリンからなるグループから選択された水に可 溶のポリマーであって、かつその量が約0.2から2重量%である、請求項1に 記載の組成物。 6.前記非イオン系ポリマーがポリビニルピロリドンであり、かつその量が約0 .4から1重量%である、請求項1に記載の組成物。 7.前記非イオン系界面活性剤がチロキサポールであり、かつその量が約0.1 から0.6重量%である、請求項8に記載の組成物。 8.請求項1の組成物は、更に等張性を得るために十分な量の非イオン系トニシ ティー剤(tonicity agent)を含む。 9.非イオン系トニシティー剤が、約1.05から5.75重量%であり、かつ 非イオン系界面活性剤が約0.05から1重量%である、請求項8に記載の組成 物。 10.前記非イオン系トニシティー剤が非イオン系のジオールで、かつその量が 約1.5から4重量%である、請求項8に記載の組成物。 11.前記ジオールがグリセロールもしくはマンニトールである、請求項10に 記載の組成物。 12.請求項1の組成物は更に、前記組成物中に微生物の生成を阻止するために 保存剤及びその混合物を含み、その量は約0.0001から0.025重量%で ある。 13.前記保存剤が、塩化ベンザルコニウム、ジソディウムエデテート(disodi um edetate)及びそれらの混合物からなるグループより選択される、請求項12 に記載の組成物。 14.前記保存剤が塩化ベンザルコニウム及びジソディウムエデテートの混合物 である、請求項12に記載の組成物。 15.前記コルチコステロイドと混合される追加の治療薬を更に含む、請求項1 に記載の組成物であって、前記追加の治療薬は、ベタキサロール(betaxalol) 、アテノロール(athenolol)、リボバノロール(livobanolol)、エピネネフリ ン(epinenephrin)、ジピバリール(dipivalyl)、オキソノロール(oxonolol )、アセタジルミド系(acetazilumide-base)、メタザロミド(methazalomide )、ト ブラマイシン、ゲンタマイシン、ピロキシカム、インドメタシン、ナプロキセン 、フェニルブタゾン、イブプロフェン及びジクロフェナック酸からなるグループ より選択される。 16.前記コルチコステロイドは、約15μm以下の粒子径を有する、請求項1 に記載の組成物。 17.眼科用及び耳鼻咽喉科用の抗炎症に使用される組成物であって、 水性溶剤中に非イオン系ポリマーと、等張性を生ずるのに効果的な量の非イオ ン系トニシティー剤と、水性溶剤中にポリマーとトニシティー剤を保持するのに 十分な量の非イオン系界面活性剤とを含んだ、組成物。 18.非イオン系ポリマーの量は約0.2から2重量%であり、非イオン系トニ シティー剤の量は約1.05から5.75重量%であり、かつ非イオン系界面活 性剤の量は、約0.05から1重量%である、請求項17に記載の組成物。 19.請求項17に記載の組成物は更に、約0.0001から0.025重量% の、塩化ベンザルコニウム、ジソディウムエデテート及びそれらの混合物からな る保存剤を含む。 20.非イオン系ポリマーはポリビニルピロリドンであり、かつその量は約0. 4から1重量%であり、非イオン系トニシティー剤はジオールであり、かつその 量は約2から2.8重量%であり、非イオン系界面活性剤はチロキサポールであ り、かつその量は約0.1から0.6重量%である、請求項17に記載の組成物 。 21.非イオン系トニシティー剤がグリセロールもしくはマンニトールであり、 さらに治療量のコルチコステロイドが含まれ、これらのコルチコステロイドと非 イオン系ポリマーと非イオン系界面活性剤のモル比が、約1:20:0.05か ら約1:0.05:1である、請求項20に記載の組成物。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US142,743 | 1993-10-25 | ||
US08/142,743 US5540930A (en) | 1993-10-25 | 1993-10-25 | Suspension of loteprednol etabonate for ear, eye, or nose treatment |
PCT/US1994/012059 WO1995011669A1 (en) | 1993-10-25 | 1994-10-21 | Suspension of loteprednol etabonate |
Publications (2)
Publication Number | Publication Date |
---|---|
JPH09504294A true JPH09504294A (ja) | 1997-04-28 |
JP3570720B2 JP3570720B2 (ja) | 2004-09-29 |
Family
ID=22501105
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP51272595A Expired - Fee Related JP3570720B2 (ja) | 1993-10-25 | 1994-10-21 | 耳、眼もしくは鼻の治療に使用されるロテプレドノールエタボナートの懸濁剤 |
Country Status (17)
Country | Link |
---|---|
US (2) | US5540930A (ja) |
EP (1) | EP0730443B1 (ja) |
JP (1) | JP3570720B2 (ja) |
KR (1) | KR100341497B1 (ja) |
AT (1) | ATE217523T1 (ja) |
AU (1) | AU697617B2 (ja) |
BR (1) | BR9407958A (ja) |
CA (1) | CA2174550C (ja) |
DE (1) | DE69430635T2 (ja) |
DK (1) | DK0730443T3 (ja) |
ES (1) | ES2179851T3 (ja) |
HU (1) | HU227316B1 (ja) |
IL (1) | IL111402A (ja) |
NZ (1) | NZ275749A (ja) |
PT (1) | PT730443E (ja) |
SG (1) | SG48768A1 (ja) |
WO (1) | WO1995011669A1 (ja) |
Cited By (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2006513217A (ja) * | 2002-12-20 | 2006-04-20 | コントロール・デリバリー・システムズ・インコーポレイテッド | 眼内用途のためのステロイド組成物 |
JP2007510723A (ja) * | 2003-11-03 | 2007-04-26 | ノートン ヘルスケアー リミテッド | ドライパウダー吸入器で使用するためのソフトステロイド組成物 |
JP2010507566A (ja) * | 2006-10-26 | 2010-03-11 | 大塚製薬株式会社 | レバミピド含有水性懸濁液剤及びその製造方法 |
JP2012087151A (ja) * | 2003-10-31 | 2012-05-10 | Bausch & Lomb Inc | ロテプレドノールエタボネートおよびトブラマイシンの局所眼科用懸濁液 |
JP2015519331A (ja) * | 2012-05-03 | 2015-07-09 | カラ ファーマシューティカルズ インコーポレイテッド | 改善された粘膜輸送を示す医薬用ナノ粒子 |
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- 1994-10-21 CA CA002174550A patent/CA2174550C/en not_active Expired - Lifetime
- 1994-10-21 HU HU9601081A patent/HU227316B1/hu unknown
- 1994-10-21 WO PCT/US1994/012059 patent/WO1995011669A1/en active IP Right Grant
- 1994-10-21 AT AT94930831T patent/ATE217523T1/de active
- 1994-10-21 ES ES94930831T patent/ES2179851T3/es not_active Expired - Lifetime
- 1994-10-21 DK DK94930831T patent/DK0730443T3/da active
- 1994-10-21 JP JP51272595A patent/JP3570720B2/ja not_active Expired - Fee Related
- 1994-10-21 EP EP94930831A patent/EP0730443B1/en not_active Expired - Lifetime
- 1994-10-21 KR KR1019960702130A patent/KR100341497B1/ko not_active IP Right Cessation
- 1994-10-21 BR BR9407958A patent/BR9407958A/pt not_active Application Discontinuation
- 1994-10-21 NZ NZ275749A patent/NZ275749A/en not_active IP Right Cessation
- 1994-10-21 DE DE69430635T patent/DE69430635T2/de not_active Expired - Lifetime
- 1994-10-21 PT PT94930831T patent/PT730443E/pt unknown
- 1994-10-21 AU AU79835/94A patent/AU697617B2/en not_active Ceased
- 1994-10-25 IL IL11140294A patent/IL111402A/xx not_active IP Right Cessation
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Cited By (7)
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JP2006513217A (ja) * | 2002-12-20 | 2006-04-20 | コントロール・デリバリー・システムズ・インコーポレイテッド | 眼内用途のためのステロイド組成物 |
JP2012087151A (ja) * | 2003-10-31 | 2012-05-10 | Bausch & Lomb Inc | ロテプレドノールエタボネートおよびトブラマイシンの局所眼科用懸濁液 |
JP2007510723A (ja) * | 2003-11-03 | 2007-04-26 | ノートン ヘルスケアー リミテッド | ドライパウダー吸入器で使用するためのソフトステロイド組成物 |
JP2010507566A (ja) * | 2006-10-26 | 2010-03-11 | 大塚製薬株式会社 | レバミピド含有水性懸濁液剤及びその製造方法 |
US8772317B2 (en) | 2006-10-26 | 2014-07-08 | Otsuka Pharmaceutical Co., Ltd. | Aqueous pharmaceutical suspensions containing rebamipide and manufacturing process thereof |
JP2015519331A (ja) * | 2012-05-03 | 2015-07-09 | カラ ファーマシューティカルズ インコーポレイテッド | 改善された粘膜輸送を示す医薬用ナノ粒子 |
JP2020015758A (ja) * | 2012-05-03 | 2020-01-30 | カラ ファーマシューティカルズ インコーポレイテッド | 改善された粘膜輸送を示す医薬用ナノ粒子 |
Also Published As
Publication number | Publication date |
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IL111402A0 (en) | 1994-12-29 |
AU7983594A (en) | 1995-05-22 |
EP0730443A4 (en) | 1997-11-05 |
IL111402A (en) | 2000-12-06 |
EP0730443B1 (en) | 2002-05-15 |
HU9601081D0 (en) | 1996-06-28 |
SG48768A1 (en) | 1998-05-18 |
CA2174550A1 (en) | 1995-05-04 |
US5747061A (en) | 1998-05-05 |
PT730443E (pt) | 2002-11-29 |
HUT74882A (en) | 1997-02-28 |
KR100341497B1 (ko) | 2002-12-05 |
WO1995011669A1 (en) | 1995-05-04 |
HU227316B1 (en) | 2011-03-28 |
KR960705541A (ko) | 1996-11-08 |
US5540930A (en) | 1996-07-30 |
EP0730443A1 (en) | 1996-09-11 |
JP3570720B2 (ja) | 2004-09-29 |
BR9407958A (pt) | 1996-11-26 |
DK0730443T3 (da) | 2002-09-09 |
CA2174550C (en) | 2002-10-01 |
ES2179851T3 (es) | 2003-02-01 |
AU697617B2 (en) | 1998-10-15 |
DE69430635D1 (de) | 2002-06-20 |
DE69430635T2 (de) | 2003-01-02 |
ATE217523T1 (de) | 2002-06-15 |
NZ275749A (en) | 1998-02-26 |
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