JP2022176963A - 眼科組成物 - Google Patents
眼科組成物 Download PDFInfo
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- JP2022176963A JP2022176963A JP2022129922A JP2022129922A JP2022176963A JP 2022176963 A JP2022176963 A JP 2022176963A JP 2022129922 A JP2022129922 A JP 2022129922A JP 2022129922 A JP2022129922 A JP 2022129922A JP 2022176963 A JP2022176963 A JP 2022176963A
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- ophthalmic composition
- cyclic olefin
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- 239000011736 potassium bicarbonate Substances 0.000 description 1
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- 235000011082 potassium citrates Nutrition 0.000 description 1
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- 230000008569 process Effects 0.000 description 1
- 235000010232 propyl p-hydroxybenzoate Nutrition 0.000 description 1
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Abstract
Description
(A)界面活性成分、及び(B)緩衝剤を含有する眼科組成物であって、該眼科組成物と接する部分の一部又は全部が環状オレフィン類を含有する樹脂で形成された容器に収容してなる眼科組成物。
[2]
容器を形成する樹脂がポリエチレンを更に含有する、[1]に記載の眼科組成物。
[3]
(A)界面活性成分を2種以上含有する、[1]又は[2]に記載の眼科組成物。
[4]
眼科組成物の総量を基準として、(A)成分の総含有量が、0.00001~10w/v%である、[1]~[3]のいずれかに記載の眼科組成物。
[5]
(A)成分の総含有量1質量部に対して、(B)成分の総含有量が、0.001~8000質量部である、[1]~[4]のいずれかに記載の眼科組成物。
[6]
眼科組成物のpHが、4.0~9.5である、[1]~[5]のいずれかに記載の眼科組成物。
[7]
眼科組成物の総量を基準として、水の含有量が、80w/v%以上100w/v%未満である、[1]~[6]のいずれかに記載の眼科組成物。
[8]
環状オレフィン類を含有する樹脂で形成された容器の波長400~700nmの可視光領域における光透過率の最大値が、50%以上である、[1]~[7]のいずれかに記載の眼科組成物。
[9]
1滴あたりの滴下量が1~99μLである、[1]~[8]のいずれかに記載の眼科組成物。
[10]
使用回数が少数回又は単回である、[1]~[9]のいずれかに記載の眼科組成物。
[11]
眼科組成物に、(A)界面活性成分、及び(B)緩衝剤を配合することを含む、該眼科組成物に環状オレフィン類を含有する樹脂に対する濡れ抑制作用を付与する方法。
[12]
環状オレフィン類を含有する樹脂で形成された容器に収容されてなる眼科組成物に、2種以上の(A)界面活性成分、及び(B)緩衝剤を配合することを含む、該眼科組成物ににおいの変化抑制作用を付与する方法。
本実施形態に係る眼科組成物は、(A)界面活性成分(単に「(A)成分」とも表記する。)、及び(B)緩衝剤(単に「(B)成分」とも表記する。)を含有する。
界面活性成分は、非イオン界面活性剤、及び多価アルコールを含み、医薬上、薬理学的に(製薬上)又は生理学的に許容されるものであれば、特に制限されない。
緩衝剤としては、無機緩衝剤及び有機緩衝剤を含み、医薬上、薬理学的に(製薬上)又は生理学的に許容されるものであれば、特に制限されない。
抗アレルギー剤:例えば、クロモグリク酸ナトリウム、トラニラスト、ペミロラストカリウム、アシタザノラスト等。
ステロイド剤:例えば、プロピオン酸フルチカゾン、フランカルボン酸フルチカゾン、フランカルボン酸モメタゾン、プロピオン酸ベクロメタゾン、フルニソリド等。
消炎剤:例えば、グリチルレチン酸、グリチルリチン酸二カリウム、プラノプロフェン、サリチル酸メチル、サリチル酸グリコール、アラントイン、トラネキサム酸、ε-アミノカプロン酸、ベルベリン、アズレンスルホン酸ナトリウム、塩化リゾチーム、硫酸亜鉛、乳酸亜鉛、甘草等。
充血除去剤:塩酸テトラヒドロゾリン、硝酸テトラヒドロゾリン、塩酸ナファゾリン、硝酸ナファゾリン、エピネフリン、塩酸エピネフリン、塩酸エフェドリン、塩酸フェニレフリン、dl-塩酸メチルエフェドリン等。
眼筋調節薬剤:例えば、アセチルコリンと類似した活性中心を有するコリンエステラーゼ阻害剤、具体的にはメチル硫酸ネオスチグミン、トロピカミド、ヘレニエン、硫酸アトロピン等。
収斂剤:例えば、亜鉛華、乳酸亜鉛、硫酸亜鉛等。
局所麻酔剤:例えば、リドカイン、プロカイン等。
その他:レバミピド等。
代表的な成分として次の添加物が挙げられる。
担体:例えば、水、含水エタノール等の水性溶媒。
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(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。
基剤:例えば、オクチルドデカノール、酸化チタン、臭化カリウム、プラスチベース等。
pH調節剤:塩酸、酢酸、水酸化ナトリウム、水酸化カリウム、水酸化カルシウム、水酸化マグネシウム、トリエタノールアミン、ジイソプロパノールアミン等。
安定化剤: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、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、シクロデキストリン、モノエタノールアミン等。
陰イオン界面活性剤:ポリオキシエチレンアルキルエーテルリン酸塩、ポリオキシエチレンアルキルエーテル硫酸塩、アルキルベンゼンスルホン酸塩、アルキル硫酸塩、N-アシルタウリン塩等。
両性界面活性剤:ラウリルジメチルアミノ酢酸ベタイン等。
本実施形態に係る眼科組成物は、該眼科組成物と接する部分の一部又は全部が環状オレフィン類を含有する樹脂(単に「環状オレフィン類含有樹脂」とも表記する。)で形成された容器に収容して提供される。
本実施形態に係る眼科組成物は、環状オレフィン類を含有する樹脂に対する濡れが抑制されている。したがって、本発明の一実施形態として、眼科組成物に、(A)界面活性成分、及び(B)緩衝剤を配合することを含む、該眼科組成物に環状オレフィン類を含有する樹脂に対する濡れ抑制作用を付与する方法が提供される。また、本発明の別の実施形態として、眼科組成物に、(A)界面活性成分、及び(B)緩衝剤を配合することを含む、該眼科組成物に環状オレフィン類を含有する樹脂に対する濡れを抑制する方法が提供される。
本実施形態に係る、環状オレフィン類を含有する樹脂で形成された容器に収容されてなる眼科組成物は、2種以上の(A)界面活性成分を含有すると、臭気が抑制されている等、においの変化が抑制されている。したがって、本発明の一実施形態として、環状オレフィン類を含有する樹脂で形成された容器に収容されてなる眼科組成物に、2種以上の(A)界面活性成分、及び(B)緩衝剤を配合することを含む、該眼科組成物ににおいの変化抑制作用を付与する方法が提供される。また、本発明の別の実施形態として、環状オレフィン類を含有する樹脂で形成された容器に収容されてなる眼科組成物に、2種以上の(A)界面活性成分、及び(B)緩衝剤を配合することを含む、該眼科組成物のにおいの変化を抑制する方法が提供される。
接触角計DM-501(協和界面科学株式会社製)を用いて、同接触角計の拡張/収縮法の測定手順に従い、各試験液の動的接触角(前進角)を測定した。動的接触角(前進角)は、固体と液体の界面が運動する際の接触角である。
表1に示す各処方を常法により調製し、試験液とした。表1における各成分の含有量の単位はw/v%である。なお、各試験における(A)成分液は、表1に示す(A)成分を表1に示す含有量で含有した処方である(残部は精製水)。
[式1]動的接触角の変化率(%)={((A)成分液とCOCの動的接触角/(A)成分液とLDPEの動的接触角)-1}×100
表2~7に示す各試験例の試験液を常法により調製した。表2~7における各成分の単位はw/v%である。なお、対応する処方液とは、各試験液の処方から(A)成分以外の成分を除き、塩酸及び水酸化ナトリウム適量によりpHを調整した処方である(残部は精製水)。また、容器材質は、環状オレフィンコポリマー(COC;TOPAS8007(ポリプラスチックス社製))、又はCOC90w/w%及び低密度ポリエチレン(LDPE)10w/w%を含有する容器材質である。
[式2]動的接触角の変化率(%)={(試験例の試験液の動的接触角/対応する処方液のCOCの動的接触角)-1}×100
表8~13に示す各試験例の試験液を常法により調製した。表8~13における各成分の単位はw/v%である。容器材質は、環状オレフィンコポリマー(COC;TOPAS8007(ポリプラスチックス社製))を含有する容器材質である。
[式3]動的接触角の変化率(%)={(試験例の試験液の動的接触角/対応する試験液の動的接触角)-1}×100
なお、対応する試験液とは、試験例3-2~3-11については試験例3-1、試験例3-13~3-17については試験例3-12、試験例3-19~3-22については試験例3-18、試験例3-24~3-29については試験例3-23、試験例3-31~3-35については試験例3-30、試験例3-37~3-39については試験例3-36、試験例3-41~3-43については試験例3-40、試験例3-45~3-47については試験例3-44、試験例3-49~3-55については試験例3-48、試験例3-57~3-63については試験例3-56、試験例3-65及び3-66については試験例3-64である。
表14に示す各試験例の試験液を常法により調製し、5mL容量のガラス製アンプル管に1mLずつ充填した。表14における各成分の単位はw/v%である。なお、対応する処方液とは、各試験液の処方から(A)成分以外の成分を除き、塩酸及び水酸化ナトリウム適量によりpHを調整した処方である(残部は精製水)。さらに横2mm、縦20mm、厚さ0.2mmの容器材質片を1個ずつ浸漬させ、速やかに密封した。容器材質は、環状オレフィンコポリマー(COC;TOPAS8007(ポリプラスチックス社製))である。次に、恒温槽にて60℃で静置する熱処理を行った。熱処理の期間は表14に示す通りとした。その後、においに敏感な被験者4名の腕に、熱処理前後の各試験液20μLを滴下し、指で直径約2cmの円状に広げてにおいを嗅ぎ、VAS(Visual Analog Scale)法により評価した。すなわち、「臭気」について、10cmの直線の両端において、「全く感じない」を0mm、「とても感じる」を100mmとし、各試験液の臭いに相当する直線上の一点を被験者に示させた。0mmの点からの距離(mm)を測定して、4名の平均値を算出し、試験液のVAS値とした。次いで、下記[式4-1]により、熱処理前後のVAS変化値を算出した。その後、下記[式4-2]により、対応する処方液に対する試験例の試験液の臭い改善率を算出した。算出した結果は、表14に示す。
[式4-1]VAS変化値=熱処理前の試験液のVAS値-熱処理後の試験液のVAS値
[式4-2]臭い改善率(%)={1-(各試験例のVAS変化値/対応する処方液のVAS変化値)}×100
表15~17に示す各試験例の試験液を常法により調製し、5mL容量のガラス製アンプル管に1mLずつ充填した。表15~17における各成分の単位はw/v%である。各試験液に横2mm、縦20mm、厚さ0.2mmの容器材質片を1個ずつ浸漬させ、速やかに密封した。容器材質は、環状オレフィンコポリマー(COC;TOPAS8007(ポリプラスチックス社製))である。次に、恒温槽にて60℃で静置する熱処理を行った。熱処理の期間は表15~17に示す通りとした。その後、においに敏感な被験者4名の腕に、熱処理後の各試験液20μLを滴下し、指で直径約2cmの円状に広げてにおいを嗅ぎ、VAS(Visual Analog Scale)法により評価した。すなわち、「臭気」について、10cmの直線の両端において、「全く感じない」を0mm、「とても感じる」を100mmとし、各試験液の臭いに相当する直線上の一点を被験者に示させた。0mmの点からの距離(mm)を測定して、4名の平均値を算出し、試験液のVAS値とした。次いで、下記[式5]により、対応する試験例に対する試験例の試験液の臭いの改善率を算出した。算出した結果は、表15~17に示す。
[式5]臭い改善率(%)={1-(熱処理後の試験例のVAS値/熱処理後の対応する試験液のVAS値)}×100
表19に示す各試験例の試験液を常法により調製した。表19における各成分の単位はw/v%である。また、容器材質として、表18に示す環状オレフィンコポリマー(COC;TOPAS8007(ポリプラスチックス社製))を含有する樹脂(容器材質A)、及びCOCと低密度ポリエチレン(LDPE)又は直鎖状低密度ポリエチレン(LLDPE)を含有する樹脂(容器材質B、C、D及びE)を用いた。表18において、容器材質に含まれる各構成成分の単位はw/w%である。
[式6]動的接触角の変化率(%)={(試験例の試験液の動的接触角/対応する処方液の容器材質Aに接触した動的接触角)-1}×100
なお、対応する試験液とは、試験例6-1及び6-2については試験例3-1、試験例6-3については試験例3-48、試験例6-4及び6-5については試験例3-56である。対応する処方液の動的接触角を求めるに際しては容器材質Aを使用した。
表20に示す各試験例の試験液を常法により調製した。表20における各成分の単位はw/v%である。また、容器材質は、試験例6の表18に示す容器材質を用いた。
[式7]動的接触角の変化率(%)={(試験例の試験液の動的接触角/対応する処方液の容器材質Cに接触した動的接触角)-1}×100
なお、対応する処方液とは、各試験液の処方から(B)成分を除き、塩酸及び水酸化ナトリウム適量によりpHを調整した処方である(残部は精製水)。対応する処方液の動的接触角を求めるに際しては容器材質Cを使用した。
表21に示す各試験例の試験液を常法により調製した。表21における各成分の単位はw/v%である。また、容器材質は、試験例6の表18に示す容器材質を用いた。
[式8]動的接触角の変化率(%)={(試験例の試験液の動的接触角/対応する処方液の容器材質Aに接触した動的接触角)-1}×100
なお、対応する処方液とは、各試験液の処方において(A)成分及び(B)成分のみを含有し、塩酸及び水酸化ナトリウム適量によりpHを調整した処方である(残部は精製水)。対応する処方液の動的接触角を求めるに際しては容器材質Aを使用した。
表22に示す各試験例の試験液を常法により調製し、5mL容量のガラス製アンプル管に1mLずつ充填した。表22における各成分の単位はw/v%である。各試験液に横2mm、縦20mm、厚さ0.2mmの容器材質片を1個ずつ浸漬させ、速やかに密封した。容器材質は、試験例6の表18に示す容器材質を用いた。次に、恒温槽にて60℃で静置する熱処理を行った。熱処理の期間は表22に示す通りとした。その後、においに敏感な被験者4名の腕に、熱処理後の各試験液20μLを滴下し、指で直径約2cmの円状に広げてにおいを嗅ぎ、VAS(Visual Analog Scale)法により評価した。すなわち、「臭気」について、10cmの直線の両端において、「全く感じない」を0mm、「とても感じる」を100mmとし、各試験液の臭いに相当する直線上の一点を被験者に示させた。0mmの点からの距離(mm)を測定して、4名の平均値を算出し、試験液のVAS値とした。次いで、下記[式9]により、対応する試験例に対する試験例の試験液の臭いの改善率を算出した。算出した結果は、表22に示す。
[式9]臭い改善率(%)={1-(熱処理後の試験例のVAS値/熱処理後の対応する試験液のVAS値)}×100
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- (A)界面活性成分、及び(B)緩衝剤を含有する眼科組成物であって、該眼科組成物と接する部分の一部又は全部が環状オレフィン類を含有する樹脂で形成された容器に収容してなる眼科組成物。
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