JP5258139B2 - ビタミンbの形態を含有する改良した眼科用およびコンタクトレンズ用溶液 - Google Patents
ビタミンbの形態を含有する改良した眼科用およびコンタクトレンズ用溶液 Download PDFInfo
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- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
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- A61K31/16—Amides, e.g. hydroxamic acids
- A61K31/164—Amides, e.g. hydroxamic acids of a carboxylic acid with an aminoalcohol, e.g. ceramides
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/16—Amides, e.g. hydroxamic acids
- A61K31/17—Amides, e.g. hydroxamic acids having the group >N—C(O)—N< or >N—C(S)—N<, e.g. urea, thiourea, carmustine
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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
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
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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
- A61K31/327—Peroxy compounds, e.g. hydroperoxides, peroxides, peroxyacids
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/4164—1,3-Diazoles
- A61K31/4172—Imidazole-alkanecarboxylic acids, e.g. histidine
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/40—Peroxides
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- A—HUMAN NECESSITIES
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- 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
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L12/00—Methods or apparatus for disinfecting or sterilising contact lenses; Accessories therefor
- A61L12/08—Methods or apparatus for disinfecting or sterilising contact lenses; Accessories therefor using chemical substances
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L12/00—Methods or apparatus for disinfecting or sterilising contact lenses; Accessories therefor
- A61L12/08—Methods or apparatus for disinfecting or sterilising contact lenses; Accessories therefor using chemical substances
- A61L12/086—Container, accessories or devices therefor
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L12/00—Methods or apparatus for disinfecting or sterilising contact lenses; Accessories therefor
- A61L12/08—Methods or apparatus for disinfecting or sterilising contact lenses; Accessories therefor using chemical substances
- A61L12/12—Non-macromolecular oxygen-containing compounds, e.g. hydrogen peroxide or ozone
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L12/00—Methods or apparatus for disinfecting or sterilising contact lenses; Accessories therefor
- A61L12/08—Methods or apparatus for disinfecting or sterilising contact lenses; Accessories therefor using chemical substances
- A61L12/12—Non-macromolecular oxygen-containing compounds, e.g. hydrogen peroxide or ozone
- A61L12/124—Hydrogen peroxide; Peroxy compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L12/00—Methods or apparatus for disinfecting or sterilising contact lenses; Accessories therefor
- A61L12/08—Methods or apparatus for disinfecting or sterilising contact lenses; Accessories therefor using chemical substances
- A61L12/14—Organic compounds not covered by groups A61L12/10 or A61L12/12
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L12/00—Methods or apparatus for disinfecting or sterilising contact lenses; Accessories therefor
- A61L12/08—Methods or apparatus for disinfecting or sterilising contact lenses; Accessories therefor using chemical substances
- A61L12/14—Organic compounds not covered by groups A61L12/10 or A61L12/12
- A61L12/141—Biguanides, e.g. chlorhexidine
- A61L12/142—Polymeric biguanides
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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
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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
- A61P27/02—Ophthalmic agents
- A61P27/04—Artificial tears; Irrigation solutions
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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
- A61P31/10—Antimycotics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
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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
- A61K47/06—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
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- Apparatus For Disinfection Or Sterilisation (AREA)
- Eyeglasses (AREA)
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Description
本願は、2000年11月8日に出願された米国仮特許出願出願番号60/246,689号、2000年11月8日に出願された米国仮特許出願出願番号60/246,707号、2000年11月8日に出願された米国仮特許出願出願番号60/246,708号、および2000年11月8日に出願された米国仮特許出願出願番号60/246,709号の利益を主張する。
本発明は眼科用溶液およびその用途の分野に関する。特に、本発明は、コンタクトレンズ洗浄用溶液、コンタクトレンズすすぎおよび保存溶液、眼に対して活性の医薬剤を送達するための溶液、眼科用具を殺菌するための溶液等に関する。
本発明は眼科用溶液の分野に関し、特に長期間使用後の防腐効力および心地よさの態様に関する。これらの眼科用溶液は一定の期間にわたって使用され、一般薬(OTC製品)として入手できる。溶液は、例えば、眼に活性医薬剤を送達するような角膜組織に直接接触するのに使用されるか、コンタクトレンズのような角膜組織と接触しうる器具の洗浄、コンディショニングまたは保存のような間接的に使用され、これらの溶液が細菌またはその他の微生物感染源を導入しないことを保証する必要性がある。したがって、多くの溶液が購入され、開放され、使用され、封をされ、そして次に再使用されるので、溶液中の微生物の生存性を減少させ、使用者による溶液の汚染の機会を少なくするために防腐剤を含有させる。
本発明は選択ビタミンB類、すなわち、ピリドキシンおよびその塩類、ならびにチアミンおよびその塩類を使用する改良された眼科用溶液に関し、溶液をより効果的に防腐処理をし、コンタクトレンズ上にカチオン性防腐剤が沈着するのを一定程度減少させることを目的とする。ここで、眼科用溶液は、クリーナーのようなコンタクトレンズ処理溶液、浸漬溶液、コンディショニング溶液ならびにレンズ保存液、さらに湿潤溶液および眼のコンディションの処置のための眼内溶液等を含むと理解される。
本明細書中で具体的に記載される溶液は、0.001〜約1%の選択ビタミンB類、すなわち、ピリドキシンおよびその塩類、ならびにチアミンおよびその塩類と、張性剤、バッファー、防腐剤、界面活性剤、および抗微生物剤のような眼科用溶液に有用なその他の活性成分とを組合せて含有する。
本発明の溶液は、バッファー、張性剤(tonicity agents)、粘滑薬、湿潤剤、防腐剤、金属イオン封鎖剤(キレート化剤)、界面活性剤、および酵素(これらに限定されない)を含む他の添加剤をさらに含有できる。
本発明の代表的な水性溶液は、レンズ洗浄または眼に潤滑を与えるのを補助する張性剤、界面活性剤および粘性導入剤のような上述した活性成分の基本的で新規な特性に影響を与えない追加の成分を含有できる。適切な張性剤には塩化ナトリウム、塩化カリウム、グリセリンまたはその混合物等がある。溶液の張性は典型的には溶液1kg当たりおおよそ240〜310ミリオスモル(mOsm/kg)に調整され、溶液を眼組織とそして親水性コンタクトレンズと相容性にする。一実施態様では、溶液は0.01〜0.2重量%の塩化ナトリウムを含有する。重要な因子は、約0.2モルパーセント以下の塩化物濃度を供給するよりも大きくない程度にこのような添加剤の濃度を維持することである。
ピリドキシンHCl(Spectrum)およびチアミンHCl(Fisher)を含有する製剤を0.2%ホスフェートバッファー中で調製した。溶液を塩化ナトリウムで等張とし、0.0001%のポリヘキサメチレンビグアニドで防腐処理をした。1N水酸化ナトリウムまたは1N塩酸でpHを7.2に調整した。溶液のインビトロ殺微生物活性を、室温で4時間10mlの各溶液にC. albicansを露出することにより決定した。次いで、各溶液のアリコットを寒天プレート上に順次希釈し、上昇させた温度で48時間インキュベートした。インキュベート時間の結果、コローニーの展開についてプレートを試験した。接種コントロールに対する比較に基づいて対数減少を決定した。下記の表はインビトロ検討の結果を与える。
実施例2 デクスパンテノールを含有する製剤
デクスパンテノールを含有する製剤を0.2%ホスフェートバッファー中で調製した。溶液を塩化ナトリウムで等張とし、0.0001%のポリヘキサメチレンビグアニドで防腐処理をした。1N水酸化ナトリウムまたは1N塩酸でpHを7.2に調整した。溶液のインビトロ殺微生物活性を、室温で4時間10mlの各溶液にC. albicansを露出することにより決定した。次いで、各溶液のアリコットを寒天プレート上に順次希釈し、上昇させた温度で48時間インキュベートした。インキュベート時間の結果、コローニーの展開についてプレートを試験した。接種コントロールに対する比較に基づいて対数減少を決定した。下記の表はインビトロ検討の結果を与える。
Claims (9)
- 0.001〜10重量%の、チアミン(B1)、デクスパンテノール、およびパントテン酸(B5)からなる群から選択される防腐剤増強剤、ならびに少なくとも0.0001重量%のカチオン性防腐剤を含むコンタクトレンズ処理溶液。
- 前記カチオン性防腐剤の濃度が1〜100ppmである、請求項1に記載のコンタクトレンズ処理溶液。
- 生理学的適合性バッファーをさらに含む請求項1に記載のコンタクトレンズ処理溶液。
- 0.01%〜5.0%のグリセリンをさらに含む請求項1に記載のコンタクトレンズ処理溶液。
- 0.01%〜2.0%のデカン二酸をさらに含む請求項1に記載のコンタクトレンズ処理溶液。
- ポリソルベート界面活性剤、ポリオキシエチレン界面活性剤、ホスホネート、サポニンおよびポリエトキシル化ひまし油からなる群から選択される湿潤剤をさらに含む請求項1に記載のコンタクトレンズ処理溶液。
- エチレンジアミン四酢酸、ホスホネート、シトレート、グルコネートおよびタートレートからなる群から選択される金属イオン封鎖剤をさらに含む請求項1に記載のコンタクトレンズ処理溶液。
- 前記カチオン性防腐剤はポリヘキサメチレンビグアニドである請求項1に記載のコンタクトレンズ処理溶液。
- コンタクトレンズと請求項1に記載のコンタクトレンズ処理溶液とを接触させる工程を含むコンタクトレンズ処理方法。
Applications Claiming Priority (9)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US24668900P | 2000-11-08 | 2000-11-08 | |
US24670700P | 2000-11-08 | 2000-11-08 | |
US24670900P | 2000-11-08 | 2000-11-08 | |
US24670800P | 2000-11-08 | 2000-11-08 | |
US60/246,708 | 2000-11-08 | ||
US60/246,707 | 2000-11-08 | ||
US60/246,689 | 2000-11-08 | ||
US60/246,709 | 2000-11-08 | ||
PCT/US2001/046841 WO2002062260A2 (en) | 2000-11-08 | 2001-11-08 | Improved ophthalmic and contact lens solutions containing forms of vitamin b |
Related Child Applications (2)
Application Number | Title | Priority Date | Filing Date |
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JP2010121081A Division JP5301498B2 (ja) | 2000-11-08 | 2010-05-27 | ビタミンbの形態を含有する改良した眼科用およびコンタクトレンズ用溶液 |
JP2013010972A Division JP5868338B2 (ja) | 2000-11-08 | 2013-01-24 | ビタミンbの形態を含有する改良した眼科用およびコンタクトレンズ用溶液 |
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Publication Number | Publication Date |
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JP2004526186A JP2004526186A (ja) | 2004-08-26 |
JP2004526186A5 JP2004526186A5 (ja) | 2006-08-10 |
JP5258139B2 true JP5258139B2 (ja) | 2013-08-07 |
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Family Applications (6)
Application Number | Title | Priority Date | Filing Date |
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JP2002542434A Pending JP2004525865A (ja) | 2000-11-08 | 2001-11-08 | 過酸化物源およびカチオン性ポリマー防腐剤を含有する改良した眼科用およびコンタクトレンズ用溶液 |
JP2002562269A Expired - Fee Related JP5258139B2 (ja) | 2000-11-08 | 2001-11-08 | ビタミンbの形態を含有する改良した眼科用およびコンタクトレンズ用溶液 |
JP2002540667A Expired - Fee Related JP4580143B2 (ja) | 2000-11-08 | 2001-11-08 | 眼科用溶液中のl−ヒスチジン |
JP2010121081A Expired - Fee Related JP5301498B2 (ja) | 2000-11-08 | 2010-05-27 | ビタミンbの形態を含有する改良した眼科用およびコンタクトレンズ用溶液 |
JP2013010972A Expired - Fee Related JP5868338B2 (ja) | 2000-11-08 | 2013-01-24 | ビタミンbの形態を含有する改良した眼科用およびコンタクトレンズ用溶液 |
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