JP2017197524A - 眼科組成物 - Google Patents
眼科組成物 Download PDFInfo
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- JP2017197524A JP2017197524A JP2017080069A JP2017080069A JP2017197524A JP 2017197524 A JP2017197524 A JP 2017197524A JP 2017080069 A JP2017080069 A JP 2017080069A JP 2017080069 A JP2017080069 A JP 2017080069A JP 2017197524 A JP2017197524 A JP 2017197524A
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- XBFJAVXCNXDMBH-UHFFFAOYSA-N tetracyclo[6.2.1.1(3,6).0(2,7)]dodec-4-ene Chemical compound C1C(C23)C=CC1C3C1CC2CC1 XBFJAVXCNXDMBH-UHFFFAOYSA-N 0.000 description 1
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- OGIDPMRJRNCKJF-UHFFFAOYSA-N titanium oxide Inorganic materials [Ti]=O OGIDPMRJRNCKJF-UHFFFAOYSA-N 0.000 description 1
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- WYXIGTJNYDDFFH-UHFFFAOYSA-Q triazanium;borate Chemical compound [NH4+].[NH4+].[NH4+].[O-]B([O-])[O-] WYXIGTJNYDDFFH-UHFFFAOYSA-Q 0.000 description 1
- 235000013337 tricalcium citrate Nutrition 0.000 description 1
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- BSVBQGMMJUBVOD-UHFFFAOYSA-N trisodium borate Chemical compound [Na+].[Na+].[Na+].[O-]B([O-])[O-] BSVBQGMMJUBVOD-UHFFFAOYSA-N 0.000 description 1
- RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical compound [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O RYFMWSXOAZQYPI-UHFFFAOYSA-K 0.000 description 1
- 229910000406 trisodium phosphate Inorganic materials 0.000 description 1
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- 235000019158 vitamin B6 Nutrition 0.000 description 1
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- 239000003871 white petrolatum Substances 0.000 description 1
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- 235000010447 xylitol Nutrition 0.000 description 1
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 description 1
- 229960002675 xylitol Drugs 0.000 description 1
- 239000011787 zinc oxide Substances 0.000 description 1
- 235000014692 zinc oxide Nutrition 0.000 description 1
- 239000004711 α-olefin Substances 0.000 description 1
- 239000002076 α-tocopherol Substances 0.000 description 1
- 235000004835 α-tocopherol Nutrition 0.000 description 1
- 239000011590 β-tocopherol Substances 0.000 description 1
- 235000007680 β-tocopherol Nutrition 0.000 description 1
- 239000002478 γ-tocopherol Substances 0.000 description 1
- QUEDXNHFTDJVIY-DQCZWYHMSA-N γ-tocopherol Chemical compound OC1=C(C)C(C)=C2O[C@@](CCC[C@H](C)CCC[C@H](C)CCCC(C)C)(C)CCC2=C1 QUEDXNHFTDJVIY-DQCZWYHMSA-N 0.000 description 1
Landscapes
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
Description
(A)テルペノイド、トコフェロール類、並びにベンジルアンモニウム化合物及びその塩からなる群より選択される1種以上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]
(B)緩衝剤を更に含有する、[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、0.00001〜1.0w/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、1〜7000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)テルペノイド、トコフェロール類、並びにベンジルアンモニウム化合物及びその塩からなる群より選択される1種以上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、(A)テルペノイド、トコフェロール類、並びにベンジルアンモニウム化合物及びその塩からなる群より選択される1種以上、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)テルペノイド、トコフェロール類、並びにベンジルアンモニウム化合物及びその塩からなる群より選択される1種以上(単に「(A)成分」とも表記する。)を含有する。
テルペノイドは、環式テルペン及び非環式テルペンを含み、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。
本実施形態に係る眼科組成物は、更に(B)緩衝剤(単に「(B)成分」とも表記する。)を含有することが好ましい。眼科組成物が(B)成分を更に含有することで、本発明による効果がより顕著に奏される。また、眼科組成物が(B)成分を更に含有することで、(A)成分を含有する眼科組成物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された場合であっても、芳香性を保持し、或いは臭気を改善する等、においの変化を抑制する効果を奏する。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、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)テルペノイド、トコフェロール類、並びにベンジルアンモニウム化合物及びその塩からなる群より選択される1種以上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)テルペノイド、トコフェロール類、並びにベンジルアンモニウム化合物及びその塩からなる群より選択される1種以上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、(B)成分を更に含有すると、芳香性が保持されており、又は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、(A)テルペノイド、トコフェロール類、並びにベンジルアンモニウム化合物及びその塩からなる群より選択される1種以上、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、(A)テルペノイド、トコフェロール類、並びにベンジルアンモニウム化合物及びその塩からなる群より選択される1種以上、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1〜3に示す各試験例の試験液を常法により調製した。表1〜3における各成分の単位はw/v%である。
[式1]動的接触角の変化率(%)={(試験液の動的接触角/対応する処方液の動的接触角)−1}×100
なお、対応する処方液とは、各試験液の処方から(A)成分を除いた処方であり、試験例1−2については試験例1−1、試験例1−4については試験例1−3、試験例1−6については試験例1−5、試験例1−8については試験例1−7、試験例1−10については試験例1−9、試験例1−12については試験例1−11、試験例1−14及び1−15については試験例1−13、試験例1−17については試験例1−16、試験例1−19〜1−22については試験例1−18、試験例1−24及び1−25については試験例1−23、試験例1−27については試験例1−26、試験例1−29については試験例1−28、試験例1−31については試験例1−30である。
表4に示す各試験例の試験液、及び各試験例に対応する処方液を常法により調製した。表4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、いずれも環状オレフィンコポリマー(COC)である。
[式2]動的接触角の変化率(%)={(各試験例の試験液の動的接触角/対応する処方液の動的接触角)−1}×100
表5〜7に示す各試験例の試験液を常法により調製した。表5〜7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)成分及びエタノールを除いた処方である。なお、試験例3−6〜試験例3−8については対応する処方液を試験例3−5とした。また、容器材質は、いずれも環状オレフィンコポリマー(COC)である。
[式3]動的接触角の変化率(%)={(各試験例の試験液の動的接触角/対応する処方液の動的接触角)−1}×100
表8〜10に示す各試験例の試験液を常法により調製した。表8〜10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)成分を除いた処方である。また、容器材質は、いずれも環状オレフィンコポリマー(COC)である。
[式4]動的接触角の変化率(%)={(各試験例の試験液の動的接触角/対応する処方液の動的接触角)−1}×100
表11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11における各成分の単位はw/v%である。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℃、5時間静置する熱処理を行った。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、「芳香性」について、100mm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、各試験液の芳香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5−1]により、熱処理前後のVAS変化値を算出した。その後、下記[式5−2]により、容器材質を浸漬しない試験例5−1に対する試験例の試験液の芳香性の保持率を算出した。算出した結果は、表11に示す。
[式5−1]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5−2]芳香性の保持率(%)={1−(各試験例のVAS変化値/試験例5−1のVAS変化値)}×100
表12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12における各成分の単位はw/v%である。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))、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。次に、恒温槽にて70℃、2日間静置する熱処理を行った。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、100mm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、各試験液の臭気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6]により、熱処理前後の臭いの改善率を算出した。算出した結果は、表12に示す。
[式6]臭いの改善率(%)={1−(熱処理後の試験液のVAS値/熱処理前の試験液のVAS値)}×100
表13〜16に示す各試験例の試験液を常法により調製した。表13〜16における各成分の単位はw/v%である。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))を含有する樹脂、又はCOCと低密度ポリエチレン(LDPE)若しくは直鎖状低密度ポリエチレン(LLDPE)を含有する樹脂であり、表13〜16における容器材質に含まれる各構成成分の単位はw/w%である。
[式7]動的接触角の変化率(%)={(試験液の動的接触角/対応する処方液の動的接触角)−1}×100
なお、対応する処方液とは、試験例7−1〜7−6については試験例1−13、試験例7−8及び7−9については試験例7−7、試験例7−10〜7−12については試験例1−13、試験例7−14〜7−17については試験例7−13、試験例7−19〜7−24については試験例7−18、試験例7−26〜7−28については試験例7−25、試験例7−30〜7−32については試験例7−29である。
表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17における各成分の単位はw/v%である。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))を含有する樹脂、又はCOCと低密度ポリエチレン(LDPE)若しくは直鎖状低密度ポリエチレン(LLDPE)を含有する樹脂であり、表17における容器材質に含まれる各構成成分の単位はw/w%である。次に、恒温槽にて60℃、5時間静置する熱処理を行った。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、「芳香性」について、100mm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、各試験液の芳香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8−1]により、熱処理前後のVAS変化値を算出した。その後、下記[式8−2]により、容器材質を浸漬しない試験例8−1に対する試験例の試験液の芳香性の保持率を算出した。算出した結果は、表17に示す。
[式8−1]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8−2]芳香性の保持率(%)={1−(各試験例のVAS変化値/試験例8−1のVAS変化値)}×100
表18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18における各成分の単位はw/v%である。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))を含有する樹脂、又はCOCと低密度ポリエチレン(LDPE)若しくは直鎖状低密度ポリエチレン(LLDPE)を含有する樹脂であり、表18における容器材質に含まれる各構成成分の単位はw/w%である。次に、恒温槽にて70℃、2日間静置する熱処理を行った。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、100mm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、各試験液の臭気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、熱処理前後の臭いの改善率を算出した。算出した結果は、表18に示す。
[式9]臭いの改善率(%)={1−(熱処理後の試験液のVAS値/熱処理前の試験液のVAS値)}×100
Claims (6)
- (A)テルペノイド、トコフェロール類、並びにベンジルアンモニウム化合物及びその塩からなる群より選択される1種以上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。
- 容器を形成する樹脂がポリエチレンを更に含有する、請求項1に記載の眼科組成物。
- (B)緩衝剤を更に含有する、請求項1又は2に記載の眼科組成物。
- 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、請求項1〜3のいずれか1項に記載の眼科組成物。
- 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、請求項1〜4のいずれか1項に記載の眼科組成物。
- 眼科組成物に、(A)テルペノイド、トコフェロール類、並びにベンジルアンモニウム化合物及びその塩からなる群より選択される1種以上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。
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