JP5442919B2 - キレート化剤を含む、オートクレーブで処理できる医薬組成物 - Google Patents
キレート化剤を含む、オートクレーブで処理できる医薬組成物 Download PDFInfo
- Publication number
- JP5442919B2 JP5442919B2 JP2000539830A JP2000539830A JP5442919B2 JP 5442919 B2 JP5442919 B2 JP 5442919B2 JP 2000539830 A JP2000539830 A JP 2000539830A JP 2000539830 A JP2000539830 A JP 2000539830A JP 5442919 B2 JP5442919 B2 JP 5442919B2
- Authority
- JP
- Japan
- Prior art keywords
- cyclodextrin
- composition
- ophthalmic
- edta
- chloride
- 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.)
- Expired - Lifetime
Links
Classifications
-
- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
-
- 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
-
- 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
Description
試験組成物を、15分又はそれ以上の間、120℃又はそれ以上まで加熱すること(ここで、該組成物は、水性である):によって特徴づけられる、標準化された温度加熱方法に関する。該水性組成物は、密閉した容器の中に置かれ、その容器は、典型的には、プラスティックか、あるいはガラスのボトルである。好ましいボトルの材料は、ポリプロピレンン(PP)である。オートクレーブ処理中の圧力は、典型的には、1バール(bar)又はそれ以上である。
10ml白色PP−ボトル中のサンプル
ケトチフェン0.025%目薬
5mlの白色PP−ボトル中のサンプル
Claims (7)
- 密閉した容器の中でオートクレーブ処理をする間に、水性眼科用組成物中の眼科用薬剤が分解することを防ぐための、EDTA、デスフェラル及びデクエストからなる群から選択される安定剤の使用であって、ここで、眼科用薬剤が、ケトチフェン及びデキサメタゾンから選ばれ、かつ、組成物が、塩化セパゾニウム、臭化セチルトリメチルアンモニウム(セトリミド)、塩化セチルピリジニウム、塩化ベンズオキソニウム、塩化ベンゼトニウム、臭化ドミフェン(ブラドソール(登録商標))、及び塩化ベンザルコニウムからなる群から選択される保存剤をさらに含む、使用。
- オートクレーブ処理が、密閉した容器において、120℃又はそれ以上で、15分又はそれ以上の間、かつ、1バール又はそれ以上で、行われる、請求項1記載の使用。
- 安定剤が、EDTA又はデクエストである、請求項1又は2記載の使用。
- 組成物が、緩衝液、キャリヤー、可溶化剤、保存剤、張度増強剤及び充填剤からなる群から選択される、1以上の賦形剤をさらに含む、請求項1〜3のいずれか1項記載の使用。
- 組成物が、α−シクロデキストリン、β−シクロデキストリン、γ−シクロデキストリン、ヒドロキシプロピル−β−シクロデキストリン、ヒドロキシプロピル−γ−シクロデキストリン、ジメチル−β−シクロデキストリン及びジメチル−γ−シクロデキストリンの群から選択されるシクロデキストリンをさらに含む、請求項1〜4のいずれか1項記載の使用。
- キャリヤーが、水、セルロース誘導体、中性カルボポール、及びこれらの混合物から選択される、請求項4記載の使用。
- 密閉した容器の中でオートクレーブ処理をする間に、水性眼科用組成物中の眼科用薬剤が分解することを防ぐための、EDTAである安定剤の使用であって、ここで、眼科用薬剤がフマル酸水素ケトチフェンであり、かつ、組成物がフマル酸水素ケトチフェン0.0345重量%、グリセロール2.125重量%、塩化ベンザルコニウム0.01重量%、EDTA0.05重量%及び水を含む、使用。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP98810016.0 | 1998-01-15 | ||
EP98810016A EP0938896A1 (en) | 1998-01-15 | 1998-01-15 | Autoclavable pharmaceutical compositions containing a chelating agent |
PCT/EP1999/000160 WO1999036055A1 (en) | 1998-01-15 | 1999-01-13 | Autoclavable pharmaceutical compositions containing a chelating agent |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2011085446A Division JP5587237B2 (ja) | 1998-01-15 | 2011-04-07 | キレート化剤を含む、オートクレーブで処理できる医薬組成物 |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2002509101A JP2002509101A (ja) | 2002-03-26 |
JP5442919B2 true JP5442919B2 (ja) | 2014-03-19 |
Family
ID=8235893
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2000539830A Expired - Lifetime JP5442919B2 (ja) | 1998-01-15 | 1999-01-13 | キレート化剤を含む、オートクレーブで処理できる医薬組成物 |
JP2011085446A Expired - Lifetime JP5587237B2 (ja) | 1998-01-15 | 2011-04-07 | キレート化剤を含む、オートクレーブで処理できる医薬組成物 |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2011085446A Expired - Lifetime JP5587237B2 (ja) | 1998-01-15 | 2011-04-07 | キレート化剤を含む、オートクレーブで処理できる医薬組成物 |
Country Status (12)
Country | Link |
---|---|
US (2) | US6468548B1 (ja) |
EP (4) | EP0938896A1 (ja) |
JP (2) | JP5442919B2 (ja) |
AT (2) | ATE491434T1 (ja) |
AU (1) | AU742920B2 (ja) |
CA (1) | CA2315767C (ja) |
CY (1) | CY1111126T1 (ja) |
DE (2) | DE69943051D1 (ja) |
DK (2) | DK1172098T3 (ja) |
ES (2) | ES2198127T3 (ja) |
PT (2) | PT1172098E (ja) |
WO (1) | WO1999036055A1 (ja) |
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AU775832B2 (en) * | 1998-01-15 | 2004-08-19 | Novartis Ag | Ophthalmic composition |
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US6777429B1 (en) | 1999-07-23 | 2004-08-17 | Novartis Ag | Ophthalmic composition |
JP2001158750A (ja) * | 1999-12-02 | 2001-06-12 | Lion Corp | 眼科用組成物及び抗アレルギー薬の持続性向上方法 |
WO2001052812A1 (de) * | 2000-01-20 | 2001-07-26 | Dr. Gerhard Mann Chem.-Pharm. Fabrik Gmbh | Diclofenamid suspensionsgel |
DE60117043T2 (de) * | 2000-11-22 | 2006-07-13 | Rxkinetix, Inc., Louisville | Behandlung von mukositis |
US20040214797A1 (en) * | 2001-05-07 | 2004-10-28 | Allergan, Inc. | Preserved pharmaceutical compositions comprising cyclodextrins |
AR034372A1 (es) * | 2001-06-08 | 2004-02-18 | Novartis Ag | Composiciones farmaceuticas |
WO2002100436A2 (en) * | 2001-06-08 | 2002-12-19 | Novartis Ag | Ophthalmic once-a-day composition |
ATE547122T1 (de) * | 2001-11-21 | 2012-03-15 | Novartis Pharma Gmbh | Zusammensetzung zur stabilisierung von hyaluronsäure |
DE10222561B4 (de) * | 2002-05-17 | 2009-12-10 | Dr. Franz Köhler Chemie GmbH | Protektive Lösung zur Verhinderung von Ischämieschäden |
ES2685436T3 (es) * | 2002-12-09 | 2018-10-09 | Abraxis Bioscience, Llc | Composiciones y procedimientos para administración de agentes farmacológicos |
EP1454636A1 (en) * | 2003-03-04 | 2004-09-08 | Dompé S.P.A. | Sterilization of glucocorticoid drug particles for pulmonary delivery |
US6933289B2 (en) * | 2003-07-01 | 2005-08-23 | Allergan, Inc. | Inhibition of irritating side effects associated with use of a topical ophthalmic medication |
US20050101582A1 (en) | 2003-11-12 | 2005-05-12 | Allergan, Inc. | Compositions and methods for treating a posterior segment of an eye |
US20050234018A1 (en) * | 2004-04-15 | 2005-10-20 | Allergan, Inc. | Drug delivery to the back of the eye |
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CA2585266C (en) * | 2004-10-25 | 2010-10-19 | Bausch & Lomb Incorporated | Ophthalmic compositions and methods of using the same |
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US20060089384A1 (en) * | 2004-10-25 | 2006-04-27 | Minno George E | Ophthalmic compositions and methods of using the same |
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US20060186005A1 (en) * | 2005-02-24 | 2006-08-24 | Sina Ebnesajjad | Terminally sterilizing pharmaceutical package |
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US20070048388A1 (en) * | 2005-08-26 | 2007-03-01 | Fu-Pao Tsao | Stabilized and preserved ketotifen ophthalmic compositions |
US20070048389A1 (en) * | 2005-08-26 | 2007-03-01 | Fu-Pao Tsao | Stabilized and preserved ketotifen ophthalmic compositions |
US20070077302A1 (en) * | 2005-09-30 | 2007-04-05 | Azaam Alli | Methods for stabilizing ophthalmic compositions |
PT1965787E (pt) * | 2005-11-30 | 2013-07-05 | Endo Pharmaceuticals Inc | Tratamento de xerostomia com um antioxidante que contém enxofre |
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US10174006B2 (en) * | 2013-06-06 | 2019-01-08 | Novartis Ag | Topical aqueous ophthalmic compositions containing a 1H-indole-1-carboxamide derivative and use thereof for treatment of ophthalmic disease |
WO2015105135A1 (ja) * | 2014-01-10 | 2015-07-16 | 参天製薬株式会社 | ピリジルアミノ酢酸化合物含有医薬組成物 |
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-
1998
- 1998-01-15 EP EP98810016A patent/EP0938896A1/en not_active Withdrawn
-
1999
- 1999-01-13 DE DE69943051T patent/DE69943051D1/de not_active Expired - Lifetime
- 1999-01-13 WO PCT/EP1999/000160 patent/WO1999036055A1/en active IP Right Grant
- 1999-01-13 EP EP10180311A patent/EP2281554A1/en not_active Ceased
- 1999-01-13 AT AT01124282T patent/ATE491434T1/de active
- 1999-01-13 DE DE69907137T patent/DE69907137T2/de not_active Expired - Lifetime
- 1999-01-13 EP EP99906123A patent/EP1047406B1/en not_active Expired - Lifetime
- 1999-01-13 PT PT01124282T patent/PT1172098E/pt unknown
- 1999-01-13 JP JP2000539830A patent/JP5442919B2/ja not_active Expired - Lifetime
- 1999-01-13 PT PT99906123T patent/PT1047406E/pt unknown
- 1999-01-13 EP EP01124282A patent/EP1172098B1/en not_active Expired - Lifetime
- 1999-01-13 DK DK01124282.3T patent/DK1172098T3/da active
- 1999-01-13 AU AU26169/99A patent/AU742920B2/en not_active Expired
- 1999-01-13 CA CA002315767A patent/CA2315767C/en not_active Expired - Lifetime
- 1999-01-13 ES ES99906123T patent/ES2198127T3/es not_active Expired - Lifetime
- 1999-01-13 AT AT99906123T patent/ATE238036T1/de active
- 1999-01-13 DK DK99906123T patent/DK1047406T3/da active
- 1999-01-13 ES ES01124282T patent/ES2356229T3/es not_active Expired - Lifetime
-
2000
- 2000-07-14 US US09/616,151 patent/US6468548B1/en not_active Expired - Lifetime
-
2001
- 2001-12-10 US US10/016,361 patent/US6776982B2/en not_active Expired - Lifetime
-
2011
- 2011-01-21 CY CY20111100067T patent/CY1111126T1/el unknown
- 2011-04-07 JP JP2011085446A patent/JP5587237B2/ja not_active Expired - Lifetime
Also Published As
Publication number | Publication date |
---|---|
ES2198127T3 (es) | 2004-01-16 |
DK1047406T3 (da) | 2003-07-21 |
AU2616999A (en) | 1999-08-02 |
EP1172098B1 (en) | 2010-12-15 |
CY1111126T1 (el) | 2015-06-11 |
ES2356229T3 (es) | 2011-04-06 |
WO1999036055A1 (en) | 1999-07-22 |
CA2315767C (en) | 2008-10-28 |
JP5587237B2 (ja) | 2014-09-10 |
DK1172098T3 (da) | 2011-03-14 |
JP2002509101A (ja) | 2002-03-26 |
ATE491434T1 (de) | 2011-01-15 |
US6468548B1 (en) | 2002-10-22 |
AU742920B2 (en) | 2002-01-17 |
DE69943051D1 (de) | 2011-01-27 |
EP0938896A1 (en) | 1999-09-01 |
US6776982B2 (en) | 2004-08-17 |
EP1172098A1 (en) | 2002-01-16 |
EP2281554A1 (en) | 2011-02-09 |
DE69907137T2 (de) | 2003-11-27 |
ATE238036T1 (de) | 2003-05-15 |
EP1047406B1 (en) | 2003-04-23 |
EP1047406A1 (en) | 2000-11-02 |
DE69907137D1 (de) | 2003-05-28 |
JP2011168601A (ja) | 2011-09-01 |
PT1172098E (pt) | 2011-02-01 |
PT1047406E (pt) | 2003-08-29 |
CA2315767A1 (en) | 1999-07-22 |
US20020165254A1 (en) | 2002-11-07 |
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