JP2012062324A - ラタノプロストを有効成分とする澄明な点眼液 - Google Patents
ラタノプロストを有効成分とする澄明な点眼液 Download PDFInfo
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- JP2012062324A JP2012062324A JP2011279472A JP2011279472A JP2012062324A JP 2012062324 A JP2012062324 A JP 2012062324A JP 2011279472 A JP2011279472 A JP 2011279472A JP 2011279472 A JP2011279472 A JP 2011279472A JP 2012062324 A JP2012062324 A JP 2012062324A
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- Prior art keywords
- latanoprost
- bak
- concentration
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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
- A61K31/557—Eicosanoids, e.g. leukotrienes or prostaglandins
- A61K31/5575—Eicosanoids, e.g. leukotrienes or prostaglandins having a cyclopentane, e.g. prostaglandin E2, prostaglandin F2-alpha
-
- 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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- 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
- A61K47/186—Quaternary ammonium compounds, e.g. benzalkonium chloride or cetrimide
-
- 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
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- 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
- A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
-
- 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
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
-
- 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
-
- 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
- A61P27/04—Artificial tears; Irrigation solutions
-
- 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
- A61P27/06—Antiglaucoma agents or miotics
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Ophthalmology & Optometry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
【解決手段】0.001〜0.01%(W/V)の濃度のラタノプロストを有効成分とし、防腐剤として0.003〜0.01%(W/V)の濃度の、式[C6H5CH2N(CH3)2R]Cl(式中Rは炭素数12のアルキル基である)で表される塩化ベンザルコニウムを配合した、澄明な点眼液を提供する。
【選択図】なし
Description
結晶リン酸二水素ナトリウム0.2g、塩化ナトリウム0.8g、BAK−C120.01gを精製水約90mLに溶解し、1N水酸化ナトリウム水溶液でpHを6.7に調整し、精製水の追加で全量100mLとし、基剤を得た。ラタノプロスト5mgに基剤100mLを加え、約80℃の水浴中で加温しながら撹拌し、ラタノプロストを基剤に溶解させた。この溶液を室温に戻した後pHが6.7であることを確認した。
結晶リン酸二水素ナトリウム0.2g、塩化ナトリウム0.8g、BAK−C120.005gを精製水約90mLに溶解し、1N水酸化ナトリウム水溶液でpHを6.7に調整し、精製水の追加で全量100mLとし、基剤を得た。ラタノプロスト5mgに基剤100mLを加え、約80℃の水浴中で加温しながら撹拌し、ラタノプロストを基剤に溶解させた。この溶液を室温に戻した後pHが6.7であることを確認した。
1)比較処方1〜4を次のようにして調製した。
表3に比較処方1〜4の外観観察および残存率測定の結果を示す。ラタノプロストにBAKを0.02%または0.015%配合した比較処方1および2では、外観は無色透明で残存率も96.8〜99.4%であり配合変化は起こらなかった。しかし、BAK0.01%または0.005%配合した比較処方3および4は、白濁し、残存率も減少して配合変化が起こった。
上記実施例1−1について保存効力試験を行った。保存効力試験は、第十三改正日本薬局方の保存効力試験法に準拠して行った。
Claims (1)
- 0.001〜0.01%(W/V)の濃度のラタノプロストを有効成分とし、防腐剤として0.003〜0.01%(W/V)の濃度の、式[C6H5CH2N(CH3)2R]Cl(式中Rは炭素数12のアルキル基である)で表される塩化ベンザルコニウムを配合した、澄明な点眼液。
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2011279472A JP5087702B2 (ja) | 2002-09-09 | 2011-12-21 | ラタノプロストを有効成分とする澄明な点眼液 |
Applications Claiming Priority (7)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2002263030 | 2002-09-09 | ||
JP2002263035 | 2002-09-09 | ||
JP2002263039 | 2002-09-09 | ||
JP2002263035 | 2002-09-09 | ||
JP2002263039 | 2002-09-09 | ||
JP2002263030 | 2002-09-09 | ||
JP2011279472A JP5087702B2 (ja) | 2002-09-09 | 2011-12-21 | ラタノプロストを有効成分とする澄明な点眼液 |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2008331735A Division JP5171606B2 (ja) | 2002-09-09 | 2008-12-26 | ラタノプロストを有効成分とする澄明な点眼液 |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2012062324A true JP2012062324A (ja) | 2012-03-29 |
JP5087702B2 JP5087702B2 (ja) | 2012-12-05 |
Family
ID=31982142
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2008331735A Expired - Fee Related JP5171606B2 (ja) | 2002-09-09 | 2008-12-26 | ラタノプロストを有効成分とする澄明な点眼液 |
JP2011279472A Expired - Fee Related JP5087702B2 (ja) | 2002-09-09 | 2011-12-21 | ラタノプロストを有効成分とする澄明な点眼液 |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2008331735A Expired - Fee Related JP5171606B2 (ja) | 2002-09-09 | 2008-12-26 | ラタノプロストを有効成分とする澄明な点眼液 |
Country Status (7)
Country | Link |
---|---|
US (2) | US8143312B2 (ja) |
EP (1) | EP1547599B1 (ja) |
JP (2) | JP5171606B2 (ja) |
KR (3) | KR101253941B1 (ja) |
AU (1) | AU2003261981A1 (ja) |
CA (3) | CA2707067C (ja) |
WO (1) | WO2004022063A1 (ja) |
Families Citing this family (21)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CA2496540C (en) * | 2002-08-23 | 2011-01-25 | Santen Pharmaceutical Co., Ltd. | Stable ophthalmic solution comprising latanoprost as active ingredient |
US7074827B2 (en) | 2002-10-24 | 2006-07-11 | Sucampo Ag (Usa) Inc. | Method for treating ocular hypertension and glaucoma |
ATE412400T1 (de) | 2004-11-09 | 2008-11-15 | Novagali Pharma Sa | Öl-in-wasser-emulsion mit niedriger konzentration des kationischen mittels und positivem zetapotential |
GB0501192D0 (en) | 2005-01-20 | 2005-03-02 | Resolution Chemicals Ltd | Stable prostaglandin-containing compositions |
US7851504B2 (en) | 2005-03-16 | 2010-12-14 | Allergan, Inc. | Enhanced bimatoprost ophthalmic solution |
AU2011211356B2 (en) * | 2005-03-16 | 2014-06-05 | Allergan, Inc. | Enhanced bimatoprost ophthalmic solution |
US9241918B2 (en) | 2005-03-16 | 2016-01-26 | Allergan, Inc. | Enhanced bimatoprost ophthalmic solution |
US20100120908A1 (en) * | 2007-02-07 | 2010-05-13 | Teika Pharmaceutical Co., Ltd | Eye drop preparation comprising latanoprost |
EP1985298A1 (en) | 2007-04-24 | 2008-10-29 | Azad Pharma AG | Ophtalmic oil-in-water emulsions containing prostaglandins |
US9579341B2 (en) | 2007-05-16 | 2017-02-28 | Johnson & Johnson Consumer Inc. | Preserved compositions containing hyaluronic acid or a pharmaceutically-acceptable salt thereof and related methods |
US8609634B2 (en) | 2007-05-16 | 2013-12-17 | Mcneil-Ppc, Inc. | Preserved compositions containing hyaluronic acid or a pharmaceutically-acceptable salt thereof and related methods |
KR101529093B1 (ko) * | 2007-08-29 | 2015-06-16 | 와카모토 세이야꾸 가부시끼가이샤 | 라타노프로스트 함유 수성 의약 조성물 |
TWI544927B (zh) | 2008-03-17 | 2016-08-11 | 愛爾康研究有限公司 | 具有低濃度的表面活性劑以促進治療劑之生物可利用性的藥學組成物 |
EP2127638A1 (en) | 2008-05-30 | 2009-12-02 | Santen Pharmaceutical Co., Ltd | Method and composition for treating ocular hypertension and glaucoma |
EP2228058A1 (en) | 2009-03-04 | 2010-09-15 | Novagali Pharma S.A. | Anionic oil-in-water emulsion containing prostaglandins and uses thereof |
WO2010119305A1 (en) * | 2009-04-14 | 2010-10-21 | Abdi Ibrahim Ilac Sanayi Ve Ticaret Anonim Sirketi | Using of quaternary ammonium compounds in dissolving of latanoprost |
DE102009021372A1 (de) * | 2009-05-14 | 2010-11-18 | Ursapharm Arzneimittel Gmbh | Phosphatfreie pharmazeutische Zusammensetzung zur Glaukombehandlung |
EP2389939A1 (en) | 2010-05-28 | 2011-11-30 | Novagali Pharma S.A. | Use of prostaglandins F2alpha and analogues for the healing of corneal and conjunctival lesions |
US9522153B2 (en) | 2009-12-22 | 2016-12-20 | Allergan, Inc. | Compositions and methods for lowering intraocular pressure |
FR2962044B1 (fr) * | 2010-04-21 | 2013-02-22 | Horus Pharma | Emulsion lacrymimetique |
EP2952189B1 (en) | 2013-01-31 | 2019-09-18 | Senju Pharmaceutical Co., Ltd. | Clear aqueous solution |
Citations (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPS62277323A (ja) * | 1986-02-19 | 1987-12-02 | Sankyo Co Ltd | フマル酸ケトチフエン含有点眼液の製法 |
JPH01246227A (ja) * | 1988-03-28 | 1989-10-02 | Santen Pharmaceut Co Ltd | 塩化ベンザルコニウム含有水性製剤の配合禁忌防止方法 |
JPH06316525A (ja) * | 1992-12-21 | 1994-11-15 | Alcon Lab Inc | 緑内障治療用プロスタグランジン組成物 |
JPH1171344A (ja) * | 1996-12-26 | 1999-03-16 | Santen Pharmaceut Co Ltd | ジフルオロプロスタグランジン誘導体およびその用途 |
US6166073A (en) * | 1995-12-22 | 2000-12-26 | Alcon Laboratories, Inc. | Combinations of DP and FP type prostaglandins for lowering IOP |
US20020103255A1 (en) * | 1997-12-19 | 2002-08-01 | Hellberg Mark R. | Use of non-steroidal anti-inflammatory agents in combination with prostaglandin FP receptor agonists to treat glaucoma and ocular hypertension |
JP2003292442A (ja) * | 2002-01-29 | 2003-10-15 | Santen Pharmaceut Co Ltd | ブナゾシンとプロスタグランジン類からなる緑内障治療剤 |
Family Cites Families (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP0569046B1 (en) | 1988-09-06 | 2002-11-13 | Pharmacia Aktiebolag | Prostaglandin derivatives for the treatment of glaucoma or ocular hypertension |
US5631287A (en) * | 1994-12-22 | 1997-05-20 | Alcon Laboratories, Inc. | Storage-stable prostaglandin compositions |
EP0998277A1 (en) * | 1997-05-30 | 2000-05-10 | Merck & Co., Inc. (a New Jersey corp.) | Ophthalmic compositions for treating ocular hypertension |
WO2000004898A1 (en) * | 1998-07-21 | 2000-02-03 | Merck & Co., Inc. | Ophthalmic compositions for treating ocular hypertension |
JP3876355B2 (ja) * | 2000-09-13 | 2007-01-31 | 参天製薬株式会社 | 点眼液 |
CA2496540C (en) * | 2002-08-23 | 2011-01-25 | Santen Pharmaceutical Co., Ltd. | Stable ophthalmic solution comprising latanoprost as active ingredient |
-
2003
- 2003-09-08 KR KR1020127011155A patent/KR101253941B1/ko not_active IP Right Cessation
- 2003-09-08 KR KR1020057003916A patent/KR20050057251A/ko not_active Application Discontinuation
- 2003-09-08 EP EP03794272.9A patent/EP1547599B1/en not_active Expired - Lifetime
- 2003-09-08 CA CA2707067A patent/CA2707067C/en not_active Expired - Fee Related
- 2003-09-08 KR KR1020117001951A patent/KR101182496B1/ko not_active IP Right Cessation
- 2003-09-08 AU AU2003261981A patent/AU2003261981A1/en not_active Abandoned
- 2003-09-08 WO PCT/JP2003/011402 patent/WO2004022063A1/ja active Application Filing
- 2003-09-08 CA CA2707068A patent/CA2707068A1/en not_active Abandoned
- 2003-09-08 CA CA2498233A patent/CA2498233C/en not_active Expired - Fee Related
- 2003-09-08 US US10/526,822 patent/US8143312B2/en not_active Expired - Fee Related
-
2008
- 2008-12-26 JP JP2008331735A patent/JP5171606B2/ja not_active Expired - Fee Related
-
2010
- 2010-08-26 US US12/807,045 patent/US8183291B2/en not_active Expired - Fee Related
-
2011
- 2011-12-21 JP JP2011279472A patent/JP5087702B2/ja not_active Expired - Fee Related
Patent Citations (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPS62277323A (ja) * | 1986-02-19 | 1987-12-02 | Sankyo Co Ltd | フマル酸ケトチフエン含有点眼液の製法 |
JPH01246227A (ja) * | 1988-03-28 | 1989-10-02 | Santen Pharmaceut Co Ltd | 塩化ベンザルコニウム含有水性製剤の配合禁忌防止方法 |
JPH06316525A (ja) * | 1992-12-21 | 1994-11-15 | Alcon Lab Inc | 緑内障治療用プロスタグランジン組成物 |
US6166073A (en) * | 1995-12-22 | 2000-12-26 | Alcon Laboratories, Inc. | Combinations of DP and FP type prostaglandins for lowering IOP |
JPH1171344A (ja) * | 1996-12-26 | 1999-03-16 | Santen Pharmaceut Co Ltd | ジフルオロプロスタグランジン誘導体およびその用途 |
US20020103255A1 (en) * | 1997-12-19 | 2002-08-01 | Hellberg Mark R. | Use of non-steroidal anti-inflammatory agents in combination with prostaglandin FP receptor agonists to treat glaucoma and ocular hypertension |
JP2003292442A (ja) * | 2002-01-29 | 2003-10-15 | Santen Pharmaceut Co Ltd | ブナゾシンとプロスタグランジン類からなる緑内障治療剤 |
Also Published As
Publication number | Publication date |
---|---|
KR20110025844A (ko) | 2011-03-11 |
JP5087702B2 (ja) | 2012-12-05 |
KR101253941B1 (ko) | 2013-04-16 |
WO2004022063A1 (ja) | 2004-03-18 |
JP2009102373A (ja) | 2009-05-14 |
CA2707067A1 (en) | 2004-03-18 |
JP5171606B2 (ja) | 2013-03-27 |
EP1547599A4 (en) | 2010-06-30 |
US8143312B2 (en) | 2012-03-27 |
CA2707067C (en) | 2013-07-16 |
EP1547599A1 (en) | 2005-06-29 |
KR20050057251A (ko) | 2005-06-16 |
US8183291B2 (en) | 2012-05-22 |
CA2707068A1 (en) | 2004-03-18 |
CA2498233A1 (en) | 2004-03-18 |
AU2003261981A1 (en) | 2004-03-29 |
KR101182496B1 (ko) | 2012-09-12 |
US20100331407A1 (en) | 2010-12-30 |
US20060069162A1 (en) | 2006-03-30 |
CA2498233C (en) | 2012-08-14 |
KR20120051098A (ko) | 2012-05-21 |
EP1547599B1 (en) | 2017-11-01 |
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R250 | Receipt of annual fees |
Free format text: JAPANESE INTERMEDIATE CODE: R250 |
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LAPS | Cancellation because of no payment of annual fees |