JP2017132764A - シリコーンハイドロゲルカラーコンタクトレンズ用眼科組成物 - Google Patents
シリコーンハイドロゲルカラーコンタクトレンズ用眼科組成物 Download PDFInfo
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- JP2017132764A JP2017132764A JP2017012469A JP2017012469A JP2017132764A JP 2017132764 A JP2017132764 A JP 2017132764A JP 2017012469 A JP2017012469 A JP 2017012469A JP 2017012469 A JP2017012469 A JP 2017012469A JP 2017132764 A JP2017132764 A JP 2017132764A
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- ophthalmic composition
- contact lens
- silicone hydrogel
- lens
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Abstract
Description
[1]
テルペノイドを含有する、シリコーンハイドロゲルカラーコンタクトレンズ用眼科組成物;
[2]
上記テルペノイドが、非環式モノテルペン及び環式モノテルペンからなる群より選択される少なくとも1種である、[1]に記載のシリコーンハイドロゲルカラーコンタクトレンズ用眼科組成物;
[3]
上記テルペノイドの総含有量が、上記眼科組成物の総量に対して、0.00001〜1w/v%である、[1]又は[2]に記載のシリコーンハイドロゲルカラーコンタクトレンズ用眼科組成物;
[4]
さらに界面活性剤を含有する[1]〜[3]のいずれかに記載のシリコーンハイドロゲルカラーコンタクトレンズ用眼科組成物;
[5]
上記テルペノイドの総含有量1質量部に対して、上記界面活性剤の総含有量が0.01〜150質量部である[1]〜[4]のいずれかに記載のシリコーンハイドロゲルカラーコンタクトレンズ用眼科組成物;
[6]
眼科組成物にテルペノイドを配合することを含む、シリコーンハイドロゲルカラーコンタクトレンズ装用時の目の充血改善作用を該眼科組成物に付与する方法;等を提供するものである。
本発明の眼科組成物は、テルペノイドを含有することにより、シリコーンハイドロゲルカラーコンタクトレンズ用として好適に用いられる。
本発明の眼科組成物において、テルペノイドの他に好ましい成分を追加する場合の好ましい組み合わせを以下表1に例示する。但し、本発明は、本発明の効果を奏する限り、これらの組合せに限定されるものではない。
充血除去剤:例えば、α−アドレナリン作動薬、具体的には、エピネフリン、塩酸エピネフリン、塩酸エフェドリン、塩酸オキシメタゾリン、塩酸テトラヒドロゾリン、塩酸ナファゾリン、塩酸フェニレフリン、塩酸メチルエフェドリン、酒石酸水素エピネフリン、硝酸ナファゾリン等。これらはd体、l体又はdl体のいずれでもよい。
殺菌剤:例えば、アクリノール、セチルピリジニウム、塩酸クロルヘキシジン、グルコン酸クロルヘキシジン、塩酸ポリヘキサメチレンビグアニド等。
ビタミン類:例えば、フラビンアデニンジヌクレオチドナトリウム、塩酸ピリドキシン、シアノコバラミン、パンテノール、パントテン酸カルシウム、酢酸レチノール、パルミチン酸レチノール、酢酸トコフェロール等。
アミノ酸類:例えば、アミノエチルスルホン酸等。
消炎剤:例えば、グリチルレチン酸、サリチル酸メチル、サリチル酸グリコール、アズレンスルホン酸ナトリウム、アラントイン、ε―アミノカプロン酸、トラネキサム酸、塩化ベルベリン、塩化リゾチーム、グリチルリチン酸ニカリウム、インドメタシン、プラノプロフェン、イブプロフェン、イブプロフェンピコノール、ブフェキサマク、フルフェナム酸ブチル、ベンダザック、ピロキシカム、ケトプロフェン、フェルビナク等。
収斂剤:例えば、亜鉛華、乳酸亜鉛、硫酸亜鉛等。
局所麻酔薬成分:例えば、クロロブタノール、塩酸オキシブプロカイン、塩酸コカイン、塩酸コルネカイン、塩酸ジブカイン、塩酸テトラカイン、塩酸パラブチルアミノ安息香酸ジエチルアミノエチル、塩酸ピペロカイン、塩酸プロカイン、塩酸プロパラカイン、塩酸ヘキソチオカイン、塩酸リドカイン等。
その他:例えば、メチル硫酸ネオスチグミン、スルファメトキサゾール、スルファメトキサゾールナトリウム、紫根、セイヨウトチノキ、及びこれらの塩等。
担体:水、含水エタノール等の水性担体。
糖類:例えば、グルコース、シクロデキストリン等。
等張化剤:亜硫酸水素ナトリウム、亜硫酸ナトリウム等。
pH調節剤:例えば、水酸化カリウム、水酸化カルシウム、水酸化マグネシウム、硫酸、ポリリン酸、プロピオン酸、シュウ酸、グルコン酸、フマル酸、乳酸、酒石酸、リンゴ酸、コハク酸、グルコノラクトン、酢酸アンモニウム等。安定化剤:例えば、ナトリウムホルムアルデヒドスルホキシレート(ロンガリット)、亜硫酸水素ナトリウム、亜硫酸ナトリウム、ピロ亜硫酸ナトリウム、モノステアリン酸アルミニウム、モノステアリン酸グリセリン等。
キレート剤:例えば、エチレンジアミン二酢酸(EDDA)、エチレンジアミン三酢酸、エチレンジアミン四酢酸(エデト酸、EDTA)、N−(2−ヒドロキシエチル)エチレンジアミン三酢酸(HEDTA)、ジエチレントリアミン五酢酸(DTPA)等。
防腐剤、又は抗菌剤:例えば、安息香酸ナトリウム、エタノール、ソルビン酸、ソルビン酸カリウム、デヒドロ酢酸ナトリウム、パラオキシ安息香酸メチル、パラオキシ安息香酸エチル、パラオキシ安息香酸プロピル、パラオキシ安息香酸ブチル、硫酸オキシキノリン、フェネチルアルコール、ベンジルアルコール、ビグアニド化合物(具体的には、ポリクオタニウム等)、グローキル(ローディア社製 商品名)等。
本発明の眼科組成物のpHについては、医薬上、薬理学的に(製薬上)又は生理学的に許容される範囲内であれば特に限定されるものではないが、一例としては、pHが4.0〜9.5、好ましくは4.5〜9.0、より好ましくは、5.0〜8.5、更に好ましくは5.5〜8.0、特に好ましくは6.0〜8.0となる範囲が挙げられる。
本発明の眼科組成物は、慣用の方法で調製できる。例えば、テルペノイドや必要により他の成分を、水性担体に分散させた後、ホモジナイザーなどを用いて均一化、溶解又は乳化させ、pH調節剤によりpHを調節することにより調製すればよい。
本発明の眼科組成物は、その剤型については、眼科分野で使用可能である限り特に制限されないが、例えば、液状、軟膏状等が挙げられる。これらの中でも、液状が好ましい。また液状の中でも水性液状が好ましい。本発明の眼科組成物を水性液状にする場合、医薬上、薬理学的に(製薬上)又は生理学的に許容される水を水性担体として使用すればよく、このような水として、具体的には、蒸留水、常水、精製水、滅菌精製水、注射用水、注射用蒸留水等が例示される。これらの定義は第一五改正日本薬局方に基づく。本明細書において、水性液状とは、水を含有する液状の形態を意味し、通常は、眼科組成物中に水を1%以上、好ましくは5%以上、より好ましくは20%以上、更に好ましくは50%以上、より更に好ましくは70%以上、より更に好ましくは80%以上を含有するものを意味する。
シリコーンハイドロゲルカラーコンタクトレンズを本発明の眼科組成物と接触させることによって、レンズの着色部分への花粉粒子の付着量を低減させることが可能である。本発明は、花粉粒子付着抑制作用により、シリコーンハイドロゲルカラーコンタクトレンズへの花粉粒子付着抑制剤として好適に用いられ得る。
本発明の眼科組成物が点眼剤として用いられる場合、1滴あたりの滴下量が5〜50μLとなるように設計され得る。点眼剤の1滴あたりの滴下量が、結膜嚢の容量内である5〜50μLとなるように設計されることによって、装用されているシリコーンハイドロゲルカラーコンタクトレンズの全体に点眼剤が行き渡り、本発明の効果が奏される。また、1滴あたりの滴下量は、7〜45μLとなるように設計されていることが好ましく、10〜30μLとなるように設計されていることがさらに好ましい。シリコーンハイドロゲルカラーコンタクトレンズは、レンズに美的装飾を施したり、瞳を大きく見せるために、着色部分を大きくした結果、レンズの直径がクリアタイプのレンズの直径より大きくなる場合がある。このようなシリコーンハイドロゲルカラーコンタクトレンズにおいても十分な一滴量とする観点から、1滴あたりの滴下量は、25μL以上となるように設計することが可能であり、30μL以上が好ましく、35μL以上がより好ましく、40μL以上が更に好ましく、45μL以上が特に好ましく、50μL以上が最も好ましい。
本発明の眼科組成物がマルチドーズ型の点眼剤及び又は装着液として用いられる場合、内容積が4〜30mLである容器に充填されていることが好ましく、5〜25mLである容器に充填されていることがさらに好ましく、6〜18mLである容器に充填されていることが特に好ましい。
本発明の眼科組成物が充填される容器は、プラスチック製が好ましい。プラスチックの構成材質は、特に制限されないが、例えば、ポリエチレンテレフタレート、ポリブチレンテレフタレート、ポリエチレンナフタレート、ポリアリレート、ポリカーボネート、ポリエチレン、ポリプロピレン、ポリイミド、エラストマーの何れか1種、これらの共重合体、又はこれらの2種以上の混合体が挙げられる。成形性や耐性の観点から、ポリエチレンテレフタレート、ポリアリレート、ポリエチレンナフタレート、これらの共重合体、又はこれらの2種以上の混合体が好ましく、特にポリエチレンテレフタレートを含有する容器が好ましい。
本発明は、本発明の作用を利用して、別の観点から、テルペノイドを含有する眼科組成物を、シリコーンハイドロゲルカラーコンタクトレンズに接触させることを特徴とする、シリコーンハイドロゲルカラーコンタクトレンズへの花粉粒子の付着を抑制する方法を提供することができる。
下記表2のコンタクトレンズを用いて、各コンタクトレンズに対する花粉付着について評価した。
[式1−1]
花粉付着量=コンタクトレンズ片浸漬前の花粉溶液中の花粉粒子の数−コンタクトレンズ片浸漬後の花粉溶液中の花粉粒子の数
[式1−2]
花粉付着抑制率(%)={(試験液1に浸漬したシリコーンハイドロゲルクリアコンタクトレンズへの花粉付着量/試験液1に浸漬したシリコーンハイドロゲルカラーコンタクトレンズへの花粉付着量)−1}×100
上記試験例1−1と同じ方法により、上記表2のレンズ1、レンズ2、及びレンズ4を用いて、下記表4に示す試験液を適用した場合における、花粉付着量を求めた。各試験液は常法により調製した眼科組成物である。花粉付着量の算出には上記[式1−1]を用いた。
[式1−3]
花粉付着抑制率(%)={(試験液1に浸漬したコンタクトレンズに対する花粉付着量/各試験液に浸漬したコンタクトレンズに対する花粉付着量)−1}×100
上記試験例1−1と同じ方法により、上記表2のレンズ3を用いて、下記表5に示す試験液を適用した場合における、花粉付着量を求めた。各試験液は常法により調製した眼科組成物である。花粉付着量の算出には上記[式1−1]を用いた。
下記表6のコンタクトレンズを用いて、各コンタクトレンズに対するアメーバ付着について評価した。
[式2−1]
アメーバ付着抑制率(%)={(試験液7に浸漬したシリコーンハイドロゲルクリアコンタクトレンズへのアメーバ付着数/試験液7に浸漬したシリコーンハイドロゲルカラーコンタクトレンズへのアメーバ付着数)−1}×100
上記試験例2−1と同じ方法により、上記表6の各コンタクトレンズを用いて、下記表8に示す試験液を適用した場合における、アメーバ付着量を求めた。各試験液は常法により調製した眼科組成物である。
[式2−2]
アメーバ付着抑制率(%)={(試験液7に浸漬したコンタクトレンズに対するアメーバ付着量/各試験液に浸漬したコンタクトレンズに対するアメーバ付着量)−1}×100
下記表9に示す各試験液を常法により調製し、ポリエチレンテレフタレート製点眼容器に充填した。シリコーンハイドロゲルカラーコンタクトレンズを装用している被験者7名に、下記表9に示す自覚症状についてVAS(Visual analogue scale)法による自覚症状アンケートを行った。被験レンズは、AIR OPTIX COLORS Honey(Alcon Laboratories社)を用いた。自覚症状アンケートは、レンズ装着後5分以上経過してレンズ装用に慣れたことを確認してから行なった(点眼前)。次に、製剤を左右眼に1滴ずつ点眼させ、5分後に同様にVAS法による自覚症状アンケートを行った(点眼後)。この操作を、試験液1及び試験液3についてそれぞれ実施した。自覚症状アンケートは、10cmの線が引いてある自覚症状調査シート上に、最も感じる場合を10cm、全く感じられない場合を0cmとした。被験者が付けた印までの長さを測定し、VAS値とした。
[式3−1]
VAS値の変化量=点眼前のVAS値−点眼後のVAS値
[式3−2]
VAS値の変化量=点眼後のVAS値−点眼前のVAS値
[式3−3]
自覚症状のVAS値改善率(%)={(試験液3の自覚症状のVAS値変化量/試験液1の自覚症状のVAS値変化量)−1}×100
下記表10〜表13に示す各試験液を常法により調製し、ポリエチレンテレフタレート製点眼容器に充填した。容器の滴下口に対して垂直方向の容器幅は下記表10〜表13に示す通りである。本明細書において、容器幅とは、滴下ノズルのある面から容器を見た場合(滴下ノズルの先端の延長線上から、容器を見た場合)の容器外観の最大長をいう。また、容器幅とは、被験者が試験液を容器から眼へ滴下する時に視認する容器外観の最大長であるともいえる。被験者3名に、被験レンズ装着後5分以上経過してレンズ装用に慣れたことを確認し、左右眼に1滴ずつ試験液を点眼させた。点眼は、試験液の滴下時に滴下ノズルを視認しながら行なった。なお、各試験液を収容した容器は、同形状の滴下ノズルを使用しているため、いずれの容器であっても滴下量は同量である。さらに、各試験液において、試験液の重量、収容容器の重量、及び滴下ノズルの重量の総重量の誤差が±5%となるように調整し、被験者が容器を持った感触が同程度であることを確認した。
「液滴を作りにくい使用感」とは、眼内の意図する位置に試験液の液滴を着液させるために容器から液滴を押し出す操作を行いにくいと感じる使用感とした。
「レンズが視界をさえぎる使用感」とは、滴下ノズルを視認しながら試験液を滴下する時に、コンタクトレンズの着色部が視界に入り、視界をさえぎると感じる使用感とした。
「清涼感」とは、滴下した試験液が目と接触した時に感じる冷感を清涼感とした。
「点しにくい使用感」とは、上を向いた姿勢で点眼容器や滴下ノズルの位置を確認し、試験液が眼内に着液するまでの操作を行いにくいと感じる、総合評価としての使用感とした。
[式4−1]
VAS値改善率(%)={1−(レンズ4のVAS平均値/レンズ2のVAS平均値)}×100
[式4−2]
VAS値改善率(%)={1−(各試験液のVAS平均値/対応する試験液のVAS平均値)}×100
[式4−3]
清涼感のVAS値改善率(%)={1−(対応する試験液のVAS平均値/各試験液のVAS平均値)}×100
下記表14〜表16に記載の処方で、点眼剤(製剤例1〜49)、コンタクトレンズ装着液(製剤例50〜52)、コンタクトレンズ用多目的溶液(製剤例53、54)を調製した。表中の単位は、表中に記載があるもの以外は全て(w/v%)である。
Claims (6)
- テルペノイドを含有する、シリコーンハイドロゲルカラーコンタクトレンズ用眼科組成物。
- 前記テルペノイドが、非環式モノテルペン及び環式モノテルペンからなる群より選択される少なくとも1種である、請求項1に記載のシリコーンハイドロゲルカラーコンタクトレンズ用眼科組成物。
- 前記テルペノイドの総含有量が、前記眼科組成物の総量に対して、0.00001〜1w/v%である、請求項1又は2に記載のシリコーンハイドロゲルカラーコンタクトレンズ用眼科組成物。
- さらに界面活性剤を含有する、請求項1〜3のいずれか1項に記載のシリコーンハイドロゲルカラーコンタクトレンズ用眼科組成物。
- 前記テルペノイドの総含有量1質量部に対して、前記界面活性剤の総含有量が0.01〜150質量部である請求項1〜4のいずれか1項に記載のシリコーンハイドロゲルカラーコンタクトレンズ用眼科組成物。
- 眼科組成物にテルペノイドを配合することを含む、シリコーンハイドロゲルカラーコンタクトレンズ装用時の目の充血改善作用を該眼科組成物に付与する方法。
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