JP6921757B2 - 眼科組成物 - Google Patents
眼科組成物 Download PDFInfo
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- JP6921757B2 JP6921757B2 JP2017553786A JP2017553786A JP6921757B2 JP 6921757 B2 JP6921757 B2 JP 6921757B2 JP 2017553786 A JP2017553786 A JP 2017553786A JP 2017553786 A JP2017553786 A JP 2017553786A JP 6921757 B2 JP6921757 B2 JP 6921757B2
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- 229920001230 polyarylate Polymers 0.000 description 1
- 229920000515 polycarbonate Polymers 0.000 description 1
- 239000004417 polycarbonate Substances 0.000 description 1
- 239000011112 polyethylene naphthalate Substances 0.000 description 1
- 229920001721 polyimide Polymers 0.000 description 1
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 description 1
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 description 1
- 235000010483 polyoxyethylene sorbitan monopalmitate Nutrition 0.000 description 1
- 239000000249 polyoxyethylene sorbitan monopalmitate Substances 0.000 description 1
- 235000010989 polyoxyethylene sorbitan monostearate Nutrition 0.000 description 1
- 239000001818 polyoxyethylene sorbitan monostearate Substances 0.000 description 1
- 235000010988 polyoxyethylene sorbitan tristearate Nutrition 0.000 description 1
- 239000001816 polyoxyethylene sorbitan tristearate Substances 0.000 description 1
- 229940068977 polysorbate 20 Drugs 0.000 description 1
- 229940101027 polysorbate 40 Drugs 0.000 description 1
- 229940113124 polysorbate 60 Drugs 0.000 description 1
- 229940099511 polysorbate 65 Drugs 0.000 description 1
- 229960003975 potassium Drugs 0.000 description 1
- 229910052700 potassium Inorganic materials 0.000 description 1
- 239000011591 potassium Substances 0.000 description 1
- 235000011056 potassium acetate Nutrition 0.000 description 1
- 229960004109 potassium acetate Drugs 0.000 description 1
- 229940068988 potassium aspartate Drugs 0.000 description 1
- 239000011736 potassium bicarbonate Substances 0.000 description 1
- 235000015497 potassium bicarbonate Nutrition 0.000 description 1
- 229910000028 potassium bicarbonate Inorganic materials 0.000 description 1
- 229910000027 potassium carbonate Inorganic materials 0.000 description 1
- 235000011181 potassium carbonates Nutrition 0.000 description 1
- 239000001508 potassium citrate Substances 0.000 description 1
- 229960002635 potassium citrate Drugs 0.000 description 1
- QEEAPRPFLLJWCF-UHFFFAOYSA-K potassium citrate (anhydrous) Chemical compound [K+].[K+].[K+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O QEEAPRPFLLJWCF-UHFFFAOYSA-K 0.000 description 1
- 235000011082 potassium citrates Nutrition 0.000 description 1
- TYJJADVDDVDEDZ-UHFFFAOYSA-M potassium hydrogencarbonate Chemical compound [K+].OC([O-])=O TYJJADVDDVDEDZ-UHFFFAOYSA-M 0.000 description 1
- 229940086066 potassium hydrogencarbonate Drugs 0.000 description 1
- JVUYWILPYBCNNG-UHFFFAOYSA-N potassium;oxido(oxo)borane Chemical compound [K+].[O-]B=O JVUYWILPYBCNNG-UHFFFAOYSA-N 0.000 description 1
- 229960003101 pranoprofen Drugs 0.000 description 1
- ZUFQODAHGAHPFQ-UHFFFAOYSA-N pyridoxine hydrochloride Chemical compound Cl.CC1=NC=C(CO)C(CO)=C1O ZUFQODAHGAHPFQ-UHFFFAOYSA-N 0.000 description 1
- 229960004172 pyridoxine hydrochloride Drugs 0.000 description 1
- 235000019171 pyridoxine hydrochloride Nutrition 0.000 description 1
- 239000011764 pyridoxine hydrochloride Substances 0.000 description 1
- MIXMJCQRHVAJIO-TZHJZOAOSA-N qk4dys664x Chemical compound O.C1([C@@H](F)C2)=CC(=O)C=C[C@]1(C)[C@@H]1[C@@H]2[C@@H]2C[C@H]3OC(C)(C)O[C@@]3(C(=O)CO)[C@@]2(C)C[C@@H]1O.C1([C@@H](F)C2)=CC(=O)C=C[C@]1(C)[C@@H]1[C@@H]2[C@@H]2C[C@H]3OC(C)(C)O[C@@]3(C(=O)CO)[C@@]2(C)C[C@@H]1O MIXMJCQRHVAJIO-TZHJZOAOSA-N 0.000 description 1
- 230000001105 regulatory effect Effects 0.000 description 1
- 229960000342 retinol acetate Drugs 0.000 description 1
- 235000019173 retinyl acetate Nutrition 0.000 description 1
- 239000011770 retinyl acetate Substances 0.000 description 1
- 229940108325 retinyl palmitate Drugs 0.000 description 1
- 235000019172 retinyl palmitate Nutrition 0.000 description 1
- 239000011769 retinyl palmitate Substances 0.000 description 1
- XWGJFPHUCFXLBL-UHFFFAOYSA-M rongalite Chemical compound [Na+].OCS([O-])=O XWGJFPHUCFXLBL-UHFFFAOYSA-M 0.000 description 1
- 235000019719 rose oil Nutrition 0.000 description 1
- 239000010666 rose oil Substances 0.000 description 1
- 239000004576 sand Substances 0.000 description 1
- HFHDHCJBZVLPGP-UHFFFAOYSA-N schardinger α-dextrin Chemical compound O1C(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(O)C2O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC2C(O)C(O)C1OC2CO HFHDHCJBZVLPGP-UHFFFAOYSA-N 0.000 description 1
- UQDJGEHQDNVPGU-UHFFFAOYSA-N serine phosphoethanolamine Chemical compound [NH3+]CCOP([O-])(=O)OCC([NH3+])C([O-])=O UQDJGEHQDNVPGU-UHFFFAOYSA-N 0.000 description 1
- 239000000377 silicon dioxide Substances 0.000 description 1
- 239000011734 sodium Substances 0.000 description 1
- 229910052708 sodium Inorganic materials 0.000 description 1
- GQTHJBOWLPZUOI-FJXQXJEOSA-M sodium D-pantothenate Chemical compound [Na+].OCC(C)(C)[C@@H](O)C(=O)NCCC([O-])=O GQTHJBOWLPZUOI-FJXQXJEOSA-M 0.000 description 1
- 239000001632 sodium acetate Substances 0.000 description 1
- 235000017281 sodium acetate Nutrition 0.000 description 1
- 229960004249 sodium acetate Drugs 0.000 description 1
- WXMKPNITSTVMEF-UHFFFAOYSA-M sodium benzoate Chemical compound [Na+].[O-]C(=O)C1=CC=CC=C1 WXMKPNITSTVMEF-UHFFFAOYSA-M 0.000 description 1
- 239000004299 sodium benzoate Substances 0.000 description 1
- 235000010234 sodium benzoate Nutrition 0.000 description 1
- 229960003885 sodium benzoate Drugs 0.000 description 1
- 229910000030 sodium bicarbonate Inorganic materials 0.000 description 1
- 235000017557 sodium bicarbonate Nutrition 0.000 description 1
- 229910000029 sodium carbonate Inorganic materials 0.000 description 1
- 235000017550 sodium carbonate Nutrition 0.000 description 1
- 229940074545 sodium dihydrogen phosphate dihydrate Drugs 0.000 description 1
- HRZFUMHJMZEROT-UHFFFAOYSA-L sodium disulfite Chemical compound [Na+].[Na+].[O-]S(=O)S([O-])(=O)=O HRZFUMHJMZEROT-UHFFFAOYSA-L 0.000 description 1
- 229940010747 sodium hyaluronate Drugs 0.000 description 1
- 229940079827 sodium hydrogen sulfite Drugs 0.000 description 1
- 235000010267 sodium hydrogen sulphite Nutrition 0.000 description 1
- 235000010262 sodium metabisulphite Nutrition 0.000 description 1
- 229940068459 sodium pantothenate Drugs 0.000 description 1
- 239000001488 sodium phosphate Substances 0.000 description 1
- 229940001482 sodium sulfite Drugs 0.000 description 1
- 235000010265 sodium sulphite Nutrition 0.000 description 1
- AKHNMLFCWUSKQB-UHFFFAOYSA-L sodium thiosulfate Chemical compound [Na+].[Na+].[O-]S([O-])(=O)=S AKHNMLFCWUSKQB-UHFFFAOYSA-L 0.000 description 1
- 235000019345 sodium thiosulphate Nutrition 0.000 description 1
- YWIVKILSMZOHHF-QJZPQSOGSA-N sodium;(2s,3s,4s,5r,6r)-6-[(2s,3r,4r,5s,6r)-3-acetamido-2-[(2s,3s,4r,5r,6r)-6-[(2r,3r,4r,5s,6r)-3-acetamido-2,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-2-carboxy-4,5-dihydroxyoxan-3-yl]oxy-5-hydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-3,4,5-trihydroxyoxane-2- Chemical compound [Na+].CC(=O)N[C@H]1[C@H](O)O[C@H](CO)[C@@H](O)[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@@H]([C@@H](O[C@H]3[C@@H]([C@@H](O)[C@H](O)[C@H](O3)C(O)=O)O)[C@H](O)[C@@H](CO)O2)NC(C)=O)[C@@H](C(O)=O)O1 YWIVKILSMZOHHF-QJZPQSOGSA-N 0.000 description 1
- LARLNXOUTTUXPN-UHFFFAOYSA-N sodium;(4-aminophenyl)sulfonyl-(5-methyl-1,2-oxazol-3-yl)azanide Chemical compound [Na+].O1C(C)=CC([N-]S(=O)(=O)C=2C=CC(N)=CC=2)=N1 LARLNXOUTTUXPN-UHFFFAOYSA-N 0.000 description 1
- GEYJUFBPCGDENK-UHFFFAOYSA-M sodium;3,8-dimethyl-5-propan-2-ylazulene-1-sulfonate Chemical compound [Na+].CC(C)C1=CC=C(C)C2=C(S([O-])(=O)=O)C=C(C)C2=C1 GEYJUFBPCGDENK-UHFFFAOYSA-M 0.000 description 1
- 239000002904 solvent Substances 0.000 description 1
- 239000000600 sorbitol Substances 0.000 description 1
- 235000010356 sorbitol Nutrition 0.000 description 1
- 235000012424 soybean oil Nutrition 0.000 description 1
- 239000003549 soybean oil Substances 0.000 description 1
- 229940032094 squalane Drugs 0.000 description 1
- 239000003381 stabilizer Substances 0.000 description 1
- 238000004659 sterilization and disinfection Methods 0.000 description 1
- 150000003431 steroids Chemical class 0.000 description 1
- 229940086735 succinate Drugs 0.000 description 1
- KDYFGRWQOYBRFD-UHFFFAOYSA-L succinate(2-) Chemical compound [O-]C(=O)CCC([O-])=O KDYFGRWQOYBRFD-UHFFFAOYSA-L 0.000 description 1
- 150000008163 sugars Chemical class 0.000 description 1
- 229960005404 sulfamethoxazole Drugs 0.000 description 1
- 125000000020 sulfo group Chemical group O=S(=O)([*])O[H] 0.000 description 1
- BDHFUVZGWQCTTF-UHFFFAOYSA-M sulfonate Chemical compound [O-]S(=O)=O BDHFUVZGWQCTTF-UHFFFAOYSA-M 0.000 description 1
- 150000003460 sulfonic acids Chemical class 0.000 description 1
- 150000003467 sulfuric acid derivatives Chemical class 0.000 description 1
- JLKIGFTWXXRPMT-UHFFFAOYSA-N sulphamethoxazole Chemical compound O1C(C)=CC(NS(=O)(=O)C=2C=CC(N)=CC=2)=N1 JLKIGFTWXXRPMT-UHFFFAOYSA-N 0.000 description 1
- 229940095064 tartrate Drugs 0.000 description 1
- XOAAWQZATWQOTB-UHFFFAOYSA-N taurine Chemical compound NCCS(O)(=O)=O XOAAWQZATWQOTB-UHFFFAOYSA-N 0.000 description 1
- 229940021790 tetrahydrozoline hydrochloride Drugs 0.000 description 1
- BJORNXNYWNIWEY-UHFFFAOYSA-N tetrahydrozoline hydrochloride Chemical compound Cl.N1CCN=C1C1C2=CC=CC=C2CCC1 BJORNXNYWNIWEY-UHFFFAOYSA-N 0.000 description 1
- SVQFLMKSDLCPAY-UHFFFAOYSA-N tetrahydrozoline nitrate Chemical compound O[N+]([O-])=O.N1CCN=C1C1C2=CC=CC=C2CCC1 SVQFLMKSDLCPAY-UHFFFAOYSA-N 0.000 description 1
- 229960000337 tetryzoline Drugs 0.000 description 1
- 235000010384 tocopherol Nutrition 0.000 description 1
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- 239000011732 tocopherol Substances 0.000 description 1
- 229940042585 tocopherol acetate Drugs 0.000 description 1
- GYDJEQRTZSCIOI-LJGSYFOKSA-N tranexamic acid Chemical compound NC[C@H]1CC[C@H](C(O)=O)CC1 GYDJEQRTZSCIOI-LJGSYFOKSA-N 0.000 description 1
- 229960000401 tranexamic acid Drugs 0.000 description 1
- 229960005342 tranilast Drugs 0.000 description 1
- NZHGWWWHIYHZNX-CSKARUKUSA-N tranilast Chemical compound C1=C(OC)C(OC)=CC=C1\C=C\C(=O)NC1=CC=CC=C1C(O)=O NZHGWWWHIYHZNX-CSKARUKUSA-N 0.000 description 1
- WYXIGTJNYDDFFH-UHFFFAOYSA-Q triazanium;borate Chemical compound [NH4+].[NH4+].[NH4+].[O-]B([O-])[O-] WYXIGTJNYDDFFH-UHFFFAOYSA-Q 0.000 description 1
- 229910000404 tripotassium phosphate Inorganic materials 0.000 description 1
- 235000019798 tripotassium phosphate Nutrition 0.000 description 1
- LENZDBCJOHFCAS-UHFFFAOYSA-N tris Chemical compound OCC(N)(CO)CO LENZDBCJOHFCAS-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
- 235000019801 trisodium phosphate Nutrition 0.000 description 1
- 229960004791 tropicamide Drugs 0.000 description 1
- 229940088594 vitamin Drugs 0.000 description 1
- 235000013343 vitamin Nutrition 0.000 description 1
- 239000011782 vitamin Substances 0.000 description 1
- 229930003231 vitamin Natural products 0.000 description 1
- 239000000341 volatile oil Substances 0.000 description 1
- 239000008215 water for injection Substances 0.000 description 1
- 229920003169 water-soluble polymer Polymers 0.000 description 1
- 239000003871 white petrolatum Substances 0.000 description 1
- 239000000811 xylitol Substances 0.000 description 1
- 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
- 239000011576 zinc lactate Substances 0.000 description 1
- 235000000193 zinc lactate Nutrition 0.000 description 1
- 229940050168 zinc lactate Drugs 0.000 description 1
- 239000011787 zinc oxide Substances 0.000 description 1
- 229960001296 zinc oxide Drugs 0.000 description 1
- NWONKYPBYAMBJT-UHFFFAOYSA-L zinc sulfate Chemical compound [Zn+2].[O-]S([O-])(=O)=O NWONKYPBYAMBJT-UHFFFAOYSA-L 0.000 description 1
- 229960001763 zinc sulfate Drugs 0.000 description 1
- 229910000368 zinc sulfate Inorganic materials 0.000 description 1
- 239000004711 α-olefin Substances 0.000 description 1
- GVJHHUAWPYXKBD-IEOSBIPESA-N α-tocopherol Chemical compound OC1=C(C)C(C)=C2O[C@@](CCC[C@H](C)CCC[C@H](C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-IEOSBIPESA-N 0.000 description 1
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Description
[1]ポリビニルピロリドンK90(A)と、油性成分およびポリエチレングリコールからなる群より選択される少なくとも一種(B)とを含有する、眼科組成物。
[2]上記(B)成分の油性成分が植物油である、[1]記載の眼科組成物。
[3]上記(B)成分のポリエチレングリコールの重量平均分子量が100〜100000である、[1]または[2]記載の眼科組成物。
[4]上記(A)成分のポリビニルピロリドンK90の含有量が、眼科組成物の総量を基準として、0.001〜10w/v%である、[1]〜[3]のいずれかに記載の眼科組成物。
[5]コンタクトレンズ用である、[1]〜[4]のいずれかに記載の眼科組成物。
[6]上記コンタクトレンズがソフトコンタクトレンズである、[5]記載の眼科組成物。
[7]眼科組成物に、ポリビニルピロリドンK90(A)と、油性成分またはポリエチレングリコールからなる群より選択される少なくとも一種(B)とを含有させる工程を含む、眼科組成物に、摩擦低減作用を付与する方法。
本明細書において、特に記載のない限り、略号「POE」はポリオキシエチレンを意味する。
本明細書において、特に記載のない限り、略号「POP」はポリオキシプロピレンを意味する。
本発明の眼科組成物は、ポリビニルピロリドンK90(A)と、油性成分およびポリエチレングリコールからなる群より選択される少なくとも一種(B)とを含有するものである。
K=(1.5logηrel−1)/(0.15+0.003c)+[300clogηrel+(c+1.5clogηrel)2]1/2/(0.15c+0.003c2)…(1)
ηrel:ポリビニルピロリドン水溶液の水に対する相対粘度
c:ポリビニルピロリドン水溶液中のポリビニルピロリドン濃度(%)
抗ヒスタミン剤:例えば、イプロヘプチン、ジフェンヒドラミン、マレイン酸クロルフェニラミン、フマル酸ケトチフェン、塩酸オロパタジン、塩酸レボカバスチン等。
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。
充血除去剤:例えば、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。
消炎剤:例えば、グリチルレチン酸、グリチルリチン酸、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、リゾチーム、甘草等。
収斂剤:例えば、亜鉛華、乳酸亜鉛、硫酸亜鉛等。
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、シアノコバラミン、塩酸ピリドキシン、パンテノール、パントテン酸カルシウム、パントテン酸ナトリウム、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。
局所麻酔剤:例えば、リドカイン等。
その他:例えば、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等。
担体:例えば、水、含水エタノール等の水性担体。
糖類:例えば、シクロデキストリン等。
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)、トコフェロール、ピロ亜硫酸ナトリウム、モノエタノールアミン、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、ジブチルヒドロキシトルエン、エデト酸ナトリウム、亜硫酸水素ナトリウム、亜硫酸ナトリウム等。
陰イオン界面活性剤:例えば、アルキルベンゼンスルホン酸塩、アルキル硫酸塩、ポリオキシエチレンアルキル硫酸塩、α−スルホ脂肪酸エステル塩、α−オレフィンスルホン酸等。
本実施形態に係る眼科組成物は、瞬目時やコンタクトレンズ装用時の、該眼科組成物と接触する対象部分(結膜[眼瞼縁の結膜:lid wiper]を含む)、角膜、コンタクトレンズ(表面[装用時に外界に接する面]、裏面[装用時に眼球に接する面]およびエッジ部分を含む)等における、摩擦抵抗が低減されて滑らかになるため、不快感が軽減され、良好な使用感が得られるという効果を奏する。したがって、本発明の一実施形態として、ポリビニルピロリドンK90(A)と、油性成分およびポリエチレングリコールからなる群より選択される少なくとも一種(B)とを含む眼科組成物からなる、摩擦の低減剤(好ましくは、コンタクトレンズ装用中の摩擦の低減剤)が提供される。
表1〜表5における各成分量の単位は、全て「w/v%」である。
[実施例1、比較例1]
後記の表1に示す処方(実施例1−1、1−2、比較例1−1)にしたがい、各眼科組成物を調製し、内容積14.2mLのポリエチレンテレフタレート製点眼容器に13mL無菌充填した。充填後、点眼容器にポリエチレン製ノズルを装着し、裸眼の被験者4名に、各眼科組成物を、左右の眼に点眼させた。そして、点眼後すぐに、下記の方法にしたがって、点眼後のべたつきをVAS(Visual analog scale:視覚的評価スケール)によって評価させ、べたつきの改善率(%)を求めた。その結果を後記の表1に併せて示した。なお、本発明の「べたつき」とは、セルロース等の糖類に由来する、粘性に起因して発生する「粘つき」とは異なり、膜が張ったような感じに伴うべたべたとした感触をいう。
100mmの線が引いてある自覚症状調査シート上に、べたつきが全く感じられない場合を0mm、強く感じる場合を100mmとして、被験者が感じた項目の程度のところに印を付けた。この長さ(mm)をVAS値とした。すなわち、VAS値が高いほど、べたつきの自覚スコアが高いということになる。そして、VASの平均値を求め、下記の式(2)にしたがって、比較例1−1に対するべたつきの改善率を算出した。
べたつきの改善率(%)=(比較例1−1のスコアの平均値−各実施例のスコアの平均値)/比較例1−1のスコアの平均値×100 ……(2)
[実施例2、比較例2]
ソフトコンタクトレンズ(製品名:プロクリアワンデー(オマフィルコンA(omafilconA))、米国食品医薬品局(FDA)基準によるソフトコンタクトレンズ分類:グループII、クーパービジョン社製)一枚を、リン酸緩衝生理食塩水(塩化ナトリウム:0.83w/v%、リン酸水素ナトリウム12水和物:0.5993w/v%、リン酸二水素ナトリウム2水和物:0.0528w/v%)ですすぎ、表面に付着した余分な液を拭き取った後に、下記の表2に示す処方の各眼科組成物(実施例2−1、2−2、比較例2−1、2−2、2−3、2−4、2−5)中に10秒間浸漬させた。その後、摩擦感テスター(Tribomaster TL201Ts、トリニティラボ社製)の接触子にソフトコンタクトレンズを接着させた。一方、生理食塩水に1時間浸漬した人工皮革を摩擦感テスターの移動テーブルに張り付け、人工皮革上に生理食塩水4mLを、接触子が移動しうる全面に充分に行き渡るように広げた。つぎに測定ユニットに20gの錘を装着した。ソフトコンタクトレンズを接着させた接触子を、測定ユニットに取り付け、1秒あたり100回、20秒間測定を行った。測定開始後5〜20秒の測定結果から得られた動摩擦係数の平均値を算出し、その製剤の動摩擦係数(μk)とした。下記の式(3)にしたがい、下記の表2に示す対照例の動摩擦係数を基準として、他の動摩擦係数が低下した割合を算出し、摩擦低減率(%)とした。その結果を、下記の表2に併せて示す。また、縦軸を対照例に対する摩擦低減率(%)として、実施例2−1、2−2と、比較例2−1、2−2、2−3、2−4、2−5とを対比して示す棒グラフを作成し、図1に示す。
摩擦低減率(%)=(対照例の摩擦係数−各製剤例の動摩擦係数)/対照例の動摩擦係数×100 ……(3)
[実施例3、比較例3]
後記の表3に示す処方(実施例3、比較例3)にしたがい、各眼科組成物を調製し、内容積14.2mLのポリエチレンテレフタレート製点眼容器に13mL無菌充填した。充填後、点眼容器にポリエチレン製ノズルを装着し、裸眼の被験者3名に、各眼科組成物を、左右の眼にそれぞれ1滴ずつ点眼させた。そして、下記の方法にしたがって、点眼後の使用感を項目ごとにVAS(Visual analog scale:視覚的評価スケール)によって評価させ、スコアの変化率を求めた。その結果を後記の表3に併せて示した。なお、試験は被験者の左右の目の状態に差がないことを確認した後に実施した。
100mmの線が引いてある自覚症状調査シート上に、点眼直後のべたつきが全く感じられない場合を0mm、べたつきをとても強く感じる場合を100mm、点眼10分後の滞留感を全く感じない場合を0mm、滞留感をとても強く感じる場合を100mmとして、被験者が感じた項目の程度のところに印を付けた。この長さ(mm)をVAS値とした。すなわち、べたつきに関してはVAS値が低いほど、べたつきの自覚スコアが低く、10分後の滞留感についてはVAS値が高いほど、滞留感の自覚スコアが高いことを表す。そして、VASの平均値を求め、下記の式(4)にしたがって、比較例3に対する実施例3のスコアの変化率を算出した。例えば、べたつき感の評価では、実施例3の方が比較例3よりもべたつき感が改善し、自覚スコアが低くなっているため、式(4)において、(実施例のスコアの平均値−比較例のスコアの平均値)の値が−(マイナス)となり、変化率(%)も−(マイナス)となる。なお、本発明において、「滞留感」とは、眼科組成物が目に留まっている感触をいい、滞留感が向上することは、所望の薬効や清涼感を持続させるために有効である。
スコアの変化率(%)=(実施例のスコアの平均値−対応する比較例のスコアの平均値)/対応する比較例のスコアの平均値×100 ……(4)
[実施例4、比較例4]
後記の表4に示す処方(実施例4、比較例4)にしたがい、各眼科組成物を調製し、内容積14.2mLのポリエチレンテレフタレート製点眼容器に13mL無菌充填した。充填後、点眼容器にポリエチレン製ノズルを装着し、裸眼の被験者3名に、各眼科組成物を、左右の眼にそれぞれ1滴ずつ点眼させた。そして、下記の方法にしたがって、点眼後の使用感を項目ごとにVAS(Visual analog scale:視覚的評価スケール)によって評価させ、スコアの変化率を求めた。その結果を後記の表4に併せて示した。なお、試験は被験者の左右の目の状態に差がないことを確認した後に実施した。
100mmの線が引いてある自覚症状調査シート上に、点眼10分後において、目のべたつきが全く感じられない場合を0mm、べたつきをとても強く感じる場合を100mm、目の乾きを感じない場合を0mm、目の乾きをとても強く感じる場合を100mmとして、被験者が感じた項目の程度のところに印を付けた。この長さ(mm)をVAS値とした。すなわち、べたつきに関してはVAS値が低いほど、べたつきの自覚スコアが低く、目の乾きについては、VAS値が低いほど、目の乾きの自覚スコアが低いということになる。そして、VASの平均値を求め、前記の式(4)にしたがって、比較例4に対する実施例の自覚スコアの変化率を算出した。
[実施例5、比較例5]
後記の表5に示す処方(実施例5、比較例5)にしたがい、各眼科組成物を調製し、内容積14.2mLのポリエチレンテレフタレート製点眼容器に13mL無菌充填した。充填後、点眼容器にポリエチレン製ノズルを装着し、裸眼の被験者3名に、各眼科組成物を、左右の眼にそれぞれ1滴ずつ点眼させた。そして、下記の方法にしたがって、点眼後の使用感を項目ごとにVAS(Visual analog scale:視覚的評価スケール)によって評価させ、スコアの変化率を求めた。その結果を後記の表5に併せて示した。なお、試験は被験者の左右の目の状態に差がないことを確認した後に実施した。
100mmの線が引いてある自覚症状調査シート上に、点眼直後において、べたつきが全く感じられない場合を0mm、とても強く感じる場合を100mm、霧視があり大変見づらい場合を0mm、霧視がなく見やすい場合を100mm、異物感が全く感じられない場合を0mm、とても強く感じる場合を100mm、コロコロする感じが全く感じられない場合を0mm、とても強く感じる場合を100mmとして、被験者が感じた項目の程度のところに印を付けた。この長さ(mm)をVAS値とした。すなわち、べたつきに関してはVAS値が低いほど、べたつきの自覚スコアが低く、見やすさ(霧視の起こりにくさ)ついては、VAS値が高いほど、見やすさの自覚スコアが高く、異物感、コロコロする感じについては、VAS値が低いほど、異物感、コロコロする感じの自覚スコアが低いということになる。そして、VASの平均値を求め、上記式(4)にしたがって、比較例5に対する実施例の自覚スコアの変化率を算出した。
なお、処方例1〜25の点眼剤をポリエチレンテレフタレート製容器に充填し、ポリエチレン製のノズルを装着したものを製剤例1〜25とした。また、処方例1〜25の点眼剤をポリエチレンテレフタレート製容器に充填し、ポリブチレンテレフタレート製のノズルを装着したものを製剤例26〜50とした。さらに、処方例26の洗眼剤をポリエチレンテレフタレート製容器に充填したものを製剤例51とし、処方例27のコンタクトレンズ消毒・洗浄・保存液を高密度ポリエチレン製容器に充填したものを製剤例52、処方例28のコンタクトレンズ装着液をポリエチレンテレフタレート製容器に充填したものを製剤例53とした。そして、処方例27のコンタクトレンズ消毒・洗浄・保存液を、ポリプロピレン製容器に充填したものを製剤例54とし、ポリエチレンテレフタレート製容器に充填したものを製剤例55とした。
Claims (4)
- ポリビニルピロリドンK90(A)と、ゴマ油およびヒマシ油の少なくとも一種である油性成分(B)とを含有する眼科組成物であって、
上記(A)成分のポリビニルピロリドンK90の含有量が、眼科組成物の総量を基準として、0.005〜1w/v%であり、
上記(B)成分の油性成分の含有量が、眼科組成物の総量を基準として、0.001〜0.1w/v%である、眼科組成物。 - コンタクトレンズ用である、請求項1記載の眼科組成物。
- 上記コンタクトレンズがソフトコンタクトレンズである、請求項2記載の眼科組成物。
- 眼科組成物に、ポリビニルピロリドンK90(A)と、ゴマ油およびヒマシ油の少なくとも一種である油性成分(B)とを含有させる工程を含み、
上記(A)成分のポリビニルピロリドンK90の含有量が、眼科組成物の総量を基準として、0.005〜1w/v%であり、
上記(B)成分の油性成分の含有量が、眼科組成物の総量を基準として、0.001〜0.1w/v%である、眼科組成物に摩擦低減作用を付与する方法。
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