JP5643092B2 - コンタクトレンズのパッケージング溶液 - Google Patents
コンタクトレンズのパッケージング溶液 Download PDFInfo
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- JP5643092B2 JP5643092B2 JP2010522932A JP2010522932A JP5643092B2 JP 5643092 B2 JP5643092 B2 JP 5643092B2 JP 2010522932 A JP2010522932 A JP 2010522932A JP 2010522932 A JP2010522932 A JP 2010522932A JP 5643092 B2 JP5643092 B2 JP 5643092B2
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- packaging solution
- contact lens
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Classifications
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B25/00—Packaging other articles presenting special problems
- B65B25/008—Packaging other articles presenting special problems packaging of contact lenses
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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
- A61L12/02—Methods or apparatus for disinfecting or sterilising contact lenses; Accessories therefor using physical phenomena, e.g. electricity, ultrasonics or ultrafiltration
- A61L12/04—Heat
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- G—PHYSICS
- G02—OPTICS
- G02B—OPTICAL ELEMENTS, SYSTEMS OR APPARATUS
- G02B1/00—Optical elements characterised by the material of which they are made; Optical coatings for optical elements
- G02B1/04—Optical elements characterised by the material of which they are made; Optical coatings for optical elements made of organic materials, e.g. plastics
- G02B1/041—Lenses
- G02B1/043—Contact lenses
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- G—PHYSICS
- G02—OPTICS
- G02C—SPECTACLES; SUNGLASSES OR GOGGLES INSOFAR AS THEY HAVE THE SAME FEATURES AS SPECTACLES; CONTACT LENSES
- G02C7/00—Optical parts
- G02C7/02—Lenses; Lens systems ; Methods of designing lenses
- G02C7/04—Contact lenses for the eyes
Description
断りない限り、本明細書で使用されるすべての専門用語は、本発明が属する技術分野の当業者によって一般に理解されるものと同じ意味を有する。一般に、本明細書で使用される術語及び実験手順は当該技術で周知であり、一般に使用されている。これらの手順には、当該技術及び種々の一般的参考文献で提供されているような従来法が使用される。ある語が単数形で記載されている場合、本発明者らはその語の複数形をも考慮している。本明細書で使用される術語及び以下に記載する実験手順は、当該技術で周知であり、一般に使用されているものである。本開示を通して使用される以下の用語は、断りない限り、以下の意味を有するものと理解されなければならない。
a.本明細書で使用されるポリマー材料(モノマー又はマクロマー材料を含む)の「分子量」とは、断りない限り、又は試験条件がそうではないことを指示しない限り、数平均分子量をいう。
b.レンズに関していう「視認用色付け」とは、装用者がレンズ貯蔵、消毒又は洗浄パッケージ内の透明な溶液中のレンズを容易に見つけることを可能にするためのレンズの染色(又は着色)をいう。レンズの視認用色付けに染料及び/又は顔料を使用することができるということは当該技術で周知である。
レンズパッケージング溶液
コポリマー845をISPから、PEG400(Sentry Carbowax 400)をDowから入手した。表1に示すように1Lの水中で様々な成分を溶解させることによって、溶液を調整した。ここで、HECは成分の一つとして用いられ、溶液はHECを溶解させるために約80℃で調製した。
Advancedマイクロオスモメーターモデル3300を各パッケージング溶液のオスモル濃度を決定するために用いた(各溶液に対し2つの独立した実験結果を平均した)。パッケージング溶液の粘度は、Brookfield Viscometerを用いて、異なる回転速度(3rpm、6rpm及び12rpm)での3回の測定の平均によって得た。各パッケージング溶液のpH値は、Fisher Acumet 25 pH計(各溶液に対し2つの独立した実験結果を平均した)を用いた。結果を表2にまとめた。
細胞毒性評価
実施例1で調製した各パッケージング溶液についての、24時間暴露時での細胞毒性の試験をL−929(L929)マウス繊維芽細胞を用いて行った。アラマーブルー試験(AB)並びにニュートラルレッド取り込み及び放出試験(NRUR)を溶液の細胞毒性評価に用いた。96Wellプレート型中にて試験サンプルの溶液を1:1、1:3及び1:7に希釈し(最終的な溶液濃度は50、25、12.5%)細胞単層を24時間曝露した。この試験では、、対照と比較しての、初期の曝露及び試験溶液を用いてのインキュベーション後の制御された環境での成長した細胞を、生存及び成長力についてモニターした。10ppmにおけるBAKを陽性対照として用いた。
溶液調製
種々の溶液を、表3に示すようにリン酸緩衝生理食塩水中で種々の成分を溶解させることで調製した。各溶液はHPMCを溶解させるために約80℃で調製した。濃度、pH及びオスモル濃度を、実施例1に記載の方法によって測定し、結果を表3にまとめた。
O2OPTIX(商標)レンズを、パッケージング溶液(Y1,Y2、Y3、及びY4の一つ)を含むブリスタパッケージにパッケージングし、封止し、オートクレーブ処理を行った。
緩衝生理食塩水(対照)、Y1、Y2、Y3又はY4のパッケージング溶液中に包装されたレンズの、イオン透過性、酸素透過性、反射指数、光透過率、水分含有量、弾性率に有意な変化はみられない。試験の行われた溶液に包装された全てのレンズは細胞毒性試験に合格した。本発明におけるパッケージング溶液中に包装されたレンズの、水の接触角(3つのレンズに対する計測の平均)、脂質取り込み、及びタンパク質取り込みを表にまとめた。
市販されているNight&Dayレンズの他にAcuvue Advance及びO2Optixをパッケージング食塩水から取り出し、パッケージング溶液(下記)で3度すすいだ後、パッケージング溶液に一晩浸した。翌日にレンズを10μg/mLのホスホチジルエタノールアミンを加えた新しい24wellプレートに置き、再度一晩浸した。24時間後レンズを34.5℃のインキュベーション及びアルミニウムホイルから動かし、緩衝液を3度交換し、1mLのリン酸緩衝生理食塩水(PBS)を加えた新しい24wellプレートに置き、Victor II Wallacにて測定した。
1%アミノコート
PBS中0.25%HEC
0.5%コポリマー845
PBS中2%PVP
PBS中0.1%HEC及び1%PVP
PBS中1%PEG400及び2%PVP
PBS中1%PEG400及び2%PVA
PBS中0.5%PEG400及び1%K90PVP
PBS中0.5%PEG400及び2%K90PVP
PBS中0.25%PEG400及び1%K90PVP
PBS中0.25%PEG400及び2%K90PVP
PBS中0.5%コポリマー845及び0.5%アミノコート
PBS中0.5%コポリマー845及び0.5%PEG400
PBS中0.1%ヒドロキシプロピルグァーガム
対照標準PBS
パッケージング溶液(下記)を、吸収生産工程(imbibed production process)(プラズマ処理後の乾燥レンズのための水和溶液としてパッケージング溶液を使用することによって、レンズにパッケージング溶液を「吸収」させた工程)及びレンズの湿潤性試験にて用いた。吸収生産工程において、パッケージング溶液はまた、一杯の生理食塩水(すなわち、レンズパッケージ内に)のために用いられた。
1P.生理食塩水パッケージングに2%コリドンK90を添加
2P.生理食塩水パッケージングに1%コポリマー845を添加
3P.標準生産ラインの生理食塩水中に包装されたNight&Day対照レンズ
4P.プラズマ処理を施した後、2%コリドンK90に浸して包装された乾燥レンズ
5P.プラズマ処理を施した後、1%コポリマー845に浸して包装された乾燥レンズ
6P.生理食塩水パッケージに0.25%PEG4000/1%コリドンK90を添加
7P.生理食塩水パッケージに0.5%コポリマー845/0.5%PEG400を添加
8P.プラズマ処理を施した後、0.25%PEG4000/1%コリドンK90に浸して包装された乾燥レンズ
9P.プラズマ処理を施した後、0.5%コポリマー845/0.5%PEG400に浸して包装された乾燥レンズ
Claims (8)
- パッケージング溶液及びパッケージング溶液に浸漬されたシリコーンヒドロゲルコンタクトレンズを含む、封止され、滅菌されたパッケージを含む、眼科用製品であって、
ここで、パッケージング溶液は、
ビニルピロリドンとジメチルアミノエチルメタクリレートとのコポリマー;
600以下の平均分子量を有するポリエチレングリコール;
α−オキソ多酸又はその塩;及び
0.001重量%〜2重量%の一つ以上の緩衝剤を含み、
パッケージング溶液は、200〜450mOsm/kgのオスモル濃度を有し、パッケージング溶液は、25℃で1.2〜2.5センチポアズの粘度を有し、6.0〜8.0のpHを有し、そして、パッケージング溶液中のギ酸の量が、α−オキソ多酸又はその塩なしの溶液中で検出される量の80%以下である、眼科用製品。 - α−オキソ多酸が、クエン酸、2−ケトグルタル酸及びリンゴ酸からなる群より選択される、請求項1記載の眼科用製品。
- α−オキソ多酸が、クエン酸である、請求項1又は2記載の眼科用製品。
- ヒドロゲルコンタクトレンズが、その中に一つ以上の浸出可能な潤滑剤を含む、請求項1〜3いずれか1項記載の眼科用製品。
- 装用者の初期不快感を緩和しうる、ソフトコンタクトレンズを製造する方法であって、
a)パッケージング溶液を含む容器に、シリコーンヒドロゲルコンタクトレンズをパッケージングすることであって、ここで
パッケージング溶液は、ビニルピロリドンとジメチルアミノエチルメタクリレートとのコポリマーを含み、
パッケージング溶液は、さらに、600以下の平均分子量を有するポリエチレングリコール、α−オキソ多酸又はその塩、及び、0.001重量%〜2重量%の一つ以上の緩衝剤を含み、
パッケージング溶液は、200〜450mOsm/kgのオスモル濃度を有し、パッケージング溶液は、25℃で1.2〜2.5センチポアズの粘度を有し、パッケージング溶液は、6.0〜8.0のpHを有し、そして、パッケージング溶液中のギ酸の量が、α−オキソ多酸又はその塩なしの溶液中で検出される量の80%以下であること:ならびに
b)パッケージング中のシリコーンヒドロゲルコンタクトレンズを滅菌してソフトコンタクトレンズを得ること
により、シリコーンヒドロゲルコンタクトレンズに、湿潤性の増加、摩擦の減少、レンズのクッションによる初期のコンディショニング、及び/又はレンズ上への沈着物の付着性の減少を提供する工程を含む方法。 - α−オキソ多酸が、クエン酸、2−ケトグルタル酸及びリンゴ酸からなる群より選択される、請求項5記載の方法。
- α−オキソ多酸が、クエン酸である、請求項6記載の方法。
- シリコーンヒドロゲルコンタクトレンズが、その中に一つ以上の浸出可能な潤滑剤を含む、請求項5〜7いずれか1項記載の方法。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US96933707P | 2007-08-31 | 2007-08-31 | |
US60/969,337 | 2007-08-31 | ||
PCT/US2008/010146 WO2009032122A1 (en) | 2007-08-31 | 2008-08-27 | Contact lens packaging solutions |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
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JP2014151165A Division JP5821140B2 (ja) | 2007-08-31 | 2014-07-24 | コンタクトレンズのパッケージング溶液 |
Publications (3)
Publication Number | Publication Date |
---|---|
JP2010538321A JP2010538321A (ja) | 2010-12-09 |
JP2010538321A5 JP2010538321A5 (ja) | 2011-07-21 |
JP5643092B2 true JP5643092B2 (ja) | 2014-12-17 |
Family
ID=40260610
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
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JP2010522932A Expired - Fee Related JP5643092B2 (ja) | 2007-08-31 | 2008-08-27 | コンタクトレンズのパッケージング溶液 |
JP2014151165A Expired - Fee Related JP5821140B2 (ja) | 2007-08-31 | 2014-07-24 | コンタクトレンズのパッケージング溶液 |
Family Applications After (1)
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JP2014151165A Expired - Fee Related JP5821140B2 (ja) | 2007-08-31 | 2014-07-24 | コンタクトレンズのパッケージング溶液 |
Country Status (7)
Country | Link |
---|---|
US (2) | US8689971B2 (ja) |
EP (1) | EP2188655B1 (ja) |
JP (2) | JP5643092B2 (ja) |
KR (1) | KR101535692B1 (ja) |
AT (1) | ATE540327T1 (ja) |
CA (1) | CA2692831C (ja) |
WO (1) | WO2009032122A1 (ja) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
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JP2014222362A (ja) * | 2007-08-31 | 2014-11-27 | ノバルティス アーゲー | コンタクトレンズのパッケージング溶液 |
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JP2014222362A (ja) * | 2007-08-31 | 2014-11-27 | ノバルティス アーゲー | コンタクトレンズのパッケージング溶液 |
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WO2009032122A1 (en) | 2009-03-12 |
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US8689971B2 (en) | 2014-04-08 |
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ATE540327T1 (de) | 2012-01-15 |
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EP2188655A1 (en) | 2010-05-26 |
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US9162784B2 (en) | 2015-10-20 |
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CA2692831A1 (en) | 2009-03-12 |
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