JP2021050191A - 爪及び爪周り用医薬組成物 - Google Patents
爪及び爪周り用医薬組成物 Download PDFInfo
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- JP2021050191A JP2021050191A JP2019224820A JP2019224820A JP2021050191A JP 2021050191 A JP2021050191 A JP 2021050191A JP 2019224820 A JP2019224820 A JP 2019224820A JP 2019224820 A JP2019224820 A JP 2019224820A JP 2021050191 A JP2021050191 A JP 2021050191A
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Landscapes
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Abstract
Description
項1.
(A)抗真菌剤;
(B)ビニル系高分子、アクリル系高分子、デンプン系高分子、デキストラン、デキストリン脂肪酸エステル、カゼイン、ジメチルジステアリルアンモニウムヘクトライト、(アクリロイルジメチルタウリンアンモニウム/ビニルピロリドン)コポリマー、ジステアリン酸ポリエチレングリコール、トリイソステアリン酸エチレングリコール、トリイソステアリン酸ポリオキシエチレン(20)メチルグルコシド、ベントナイト、ヘクトライト、アルギン酸及び又はその塩、アルギン酸プロピレングリコールエステル及び多価アルコールからなる群より選択される少なくとも1種又は2種;及び
(C)抗炎症剤、局所麻酔剤、殺菌剤、及び抗ヒスタミン剤からなる群から選択される1種又は2種以上の化合物を含有する爪及び/又は爪周り用医薬組成物。
項2.
爪及び/又は爪周りが、爪溝及び/又は黄線部付近の溝である、項1に記載の医薬組成物。
項3.
前記(A)抗真菌剤が、アミン系抗真菌剤である、項1又は2に記載の医薬組成物。項4.
前記(A)抗真菌剤が、テルビナフィン及びその塩からなる群より選択される少なくとも1種である、項3に記載の医薬組成物。
項5.
前記(B)成分が、ポリビニルアルコール、ポリビニルピロリドン、ポリエチレングリコール、グリセリン、1,3−ブチレングリコール、アクリル酸メチル・アクリル酸−2−エチルヘキシルコポリマー及びカルボキシビニルポリマーからなる群より選択される少なくとも1種の増粘性高分子又は多価アルコールを含む、項1〜4のいずれか1項に記載の医薬組成物。
項6.
さらに、エタノールを含有する、項1〜5のいずれか1項に記載の医薬組成物。
項7.
前記エタノールの含有量が、組成物全量に対して20質量%以上である、項6記載の医薬組成物。
項8.
液剤である、項1〜7のいずれか1項に記載の医薬組成物。
抗真菌剤とは、真菌の生育を阻害又は抑制するか、真菌を殺菌する機能を有する物質であり、真菌感染に起因する様々な疾患や症状を治療、予防、改善するために用いられている。
本発明の(B)増粘性高分子及び/又は多価アルコールとしては、以下の物質を用いることができ、これらであれば、特に制限されない。すなわち、ビニル系高分子、アクリル系高分子、デンプン系高分子、デキストラン、デキストリン脂肪酸エステル、カゼイン、ジメチルジステアリルアンモニウムヘクトライト、(アクリロイルジメチルタウリンアンモニウム/ビニルピロリドン)コポリマー、ジステアリン酸ポリエチレングリコール、トリイソステアリン酸エチレングリコール、トリイソステアリン酸ポリオキシエチレン(20)メチルグルコシド、ベントナイト、ヘクトライト、アルギン酸及び又はその塩、アルギン酸プロピレングリコールエステル、増粘多糖類等の増粘性高分子及び多価アルコールからなる群より選択される少なくとも1種であり得る。
本発明の(C)成分としては、以下が挙げられる。
すなわち、抗炎症剤、局所麻酔剤、殺菌剤、及び抗ヒスタミン剤からなる群から選択される1種又は2種以上の化合物である。
本発明の医薬組成物に用いられるエタノールは、医薬品、医薬部外品、化粧品等で用いられている等級、グレードであれば、特に制限されない。医薬組成物の原料として用いるエタノールは、例えば、95%エタノール、99%エタノール(無水エタノール)等を適宜用いることが可能である。
本明細書でいう「塩」は、例えば、有機塩と無機塩とが例示される。有機塩としては、アンモニウム、又はジエタノールアミン、トリエタノールアミン、エチレンジアミン等が例示され、無機塩としては、ナトリウム、カリウム、カルシウム、マグネシウム等との塩が挙げられる。また、例えば、塩酸、臭化水素酸、硫酸、硝酸、リン酸等の無機酸の塩;メタンスルホン酸、ベンゼンスルホン酸、パラトルエンスルホン酸、酢酸、プロピオン酸、酒石酸、フマル酸、マレイン酸、リンゴ酸、シュウ酸、コハク酸、クエン酸、安息香酸、マンデル酸、ケイ皮酸、乳酸、グリコール酸、グルクロン酸、アスコルビン酸、ニコチン酸、サリチル酸等の有機酸との塩;又はアスパラギン酸、グルタミン酸などの酸性アミノ酸との塩なども挙げられる。なお、「塩」には、塩の溶媒和物又は水和物を含んでいてもよい。特に(A)成分の塩の形態としては、特に限定はされないが、入手のしやすさの観点から、好ましくは無機酸の塩であり、より好ましくは塩酸塩又は硝酸塩などである。
本発明の医薬組成物を充填する容器は特に限定されない。医薬品外用剤、医薬部外品、化粧品用の容器として用いられるものであればよい。このような容器材質として、例えば、医薬組成物との接触面の一部又は全部、好ましくは全部が、ポリオレフィン樹脂、アクリル酸樹脂、ポリエステル、ポリカーボネート、フッ素樹脂、ポリ塩化ビニル、ポリアミド、ABS樹脂、AS樹脂、ポリアセタール、変性ポリフェニレンエーテル、ポリアリレート、ポリスルホン、ポリイミド、セルロースアセテート、アルミニウム、及びガラスからなる群より選ばれる少なくとも1種の材料で構成されている容器が挙げられる。
本発明の医薬組成物は、医薬品、医薬部外品等として幅広く利用可能な任意の形態で提供される。好ましくは、皮膚外用剤として利用可能な製剤として提供される。本発明の医薬組成物は、公知の形態であれば、特に限定されないが、本発明の効果をより顕著に奏する観点から、例えば、クリーム剤、液剤(ジェル状組成物を含む)、懸濁剤、乳剤、ローション剤、エアゾール剤、ミスト剤などの水性医薬組成物の形態で提供されることが好ましく、クリーム剤、液剤、懸濁剤、乳剤、ローション剤、ミスト剤であることがより好ましい。特には液剤であることが好まし。ここで、水性医薬組成物とは、組成物全量に占める水分又は水溶性溶媒の割合が10質量%以上である剤形を指し、製剤の安定性又は使用感の観点から、好ましくは、20質量%以上、さらに好ましくは30質量%以上の剤形を指す。
本発明の医薬組成物は、公知の方法により製造することができる。必要に応じて、滅菌工程やろ過工程を含めることができる。
本発明の医薬組成物は、本発明の効果を損なわない範囲で、医薬品、医薬部外品、化粧品等として用いられ得る、公知の基剤又は担体と共に混合して製剤化することができる。その他に、本発明の医薬組成物には、例えば、界面活性剤、油分、アルコール類、高級脂肪酸、防腐剤、抗酸化剤、酸化防止剤、清涼化剤、保存剤、キレート剤、pH調整剤、安定化剤、溶解補助剤、懸濁化剤、等張化剤、緩衝剤、香料、着色剤、色素等の添加剤を配合することができる。これらの添加剤は、1種を単独で又は2種以上を組み合わせて使用できる。
本発明の医薬組成物のpHは、(A)成分の種類、他の配合成分の種類及び含有量、製剤形態、使用方法等に応じて適宜設定され、生理学的又は薬学的に許容できる範囲であれば制限されないが、安全性の観点から、例えば、pH2〜9とすることができ、好ましくは、約3〜8、より好ましくは、約5〜7とすることができる。
本発明の医薬組成物の粘度は、製剤の扱いやすさの観点から、医薬組成物全量に対して、好ましくは1mPa・s〜10Pa・sであり、より好ましくは2mPa・s〜8Pa・s、さらに好ましくは3Pa・s〜4Pa・sである。なお、本明細書における粘度とは東機産業株式会社製RB80型粘度計、M3ロータを用いて回転速度12rpm、測定時間1分にて測定した際に得られた結果とする。
本発明の医薬組成物は、限定はされないが、好ましくは、水虫又はタムシ、カンジダ症などの治療に用いられる。本発明の医薬組成物は、爪及び爪周り、特には、爪溝及び/又は黄線部付近の溝の他、爪母、爪根、爪半月、爪甲、爪先、黄線、後爪郭、甘皮、側爪郭、爪床、爪下皮などの爪及び爪周り全般に使用することができ、水虫又はタムシの治療に用いられる。本発明の効果をより顕著に奏する観点から、特に好ましくは、溝及び/又は黄線部付近の有効成分の届きにくい箇所の水虫に適用され得る。
本発明では、(A)抗真菌剤、(B)増粘性高分子及び/又は多価アルコール、及び(C)成分を共存させることにより、これらを含有する医薬組成物について、特に、爪及び爪周りへ広がりを促進することができる。ここで、特に広がり促進は、本明細書中で、「伸展性」ともいう。本発明において、医薬組成物の「伸展性」とは、医薬組成物が、爪及び爪周り、特には、爪溝及び/又は黄線部付近の溝の他、爪母、爪根、爪半月、爪甲、爪先、黄線、後爪郭、甘皮、側爪郭、爪床、爪下皮などの爪及び爪周り全般へ行き渡ることを言う。このような広がりの促進のためには、上記の本発明の医薬組成物における各成分の濃度、pH、粘度、製剤の条件等と同様の条件を採用する。
本発明では、医薬組成物に、(A)抗真菌剤、(B)増粘性高分子及び/又は多価アルコール、及び(C)成分を共存させることにより、特に、爪及び爪周りに艶感及び/又は保湿感を付与することができる。本発明において、このような艶感又は保湿感を発揮するためには、上記の本発明の医薬組成物における各成分の濃度、pH、粘度、製剤等の条件と同様の条件を採用する。
表1〜表5に示す実施例及び比較例の組成の医薬組成物(液剤)を、常法に従って調製した。次に、実施例及び比較例の組成物の表面張力を測定した。すなわち、各組成物をそれぞれ適量取り、毛管上昇方式表面張力計(キャピラリサイズ φ6×160mm、キャピラリ内径サイズφ0.5mm; アズワン製、型番2380−05−10)による測定に供した。所定の比較例に対する各実施例の表面張力低下率を式1に従って算出した。有効数字は二桁とした。結果を表1〜5に合わせて示す。表面張力が低いほど組成物は伸展するため、患部への適用後より適切に真菌へ薬剤を届けることができる。
式1:表面張力低下率 = (比較例の表面張力―各比較例に対応した実施例又は参考例の表面張力)/比較例の表面張力×100(%)
表6に示す実施例及び比較例の組成の医薬組成物(液剤)を、常法に従って調製した。次に、実施例及び比較例の組成物の表面張力を試験例1と同様の手法で測定した。各試験例において、各比較例に対する各実施例の表面張力低下率を式1に従って算出した。有効数字は二桁とした。結果を表6に合わせて示す。表面張力が低いほど組成物は伸展するため、患部への適用により、適切に真菌へ薬剤を届けることができる。
被験者5名について、表7に示す実施例及び比較例の医薬組成物(液剤)を、爪及び爪周りに適量塗布し、塗布直後あるいは塗布30分後の、艶感、伸展性、及び保湿感をVAS(Visual Analogue Scale)法によって評価した。すなわち、各質問項目について長さ100mmの線分の左端から回答した斜線位置までの長さを測定し、回答値とした。艶感の場合、塗布30分後の爪の状態について、「全く感じない」を0mm(線分の左端)としての回答、「光り輝いて見えるほど強く感じる」を100mm(線分の右端)としての回答と定め、各組成物の艶感がどの程度か評価した。製剤の伸展性の場合、塗布直後の爪周りの製剤の状態について「全く伸展しない」を0mm(線分の左端)としての回答、「隅々まで伸展した」を100mm(線分の右端)としての回答と定め、各組成物の伸展性がどの程度か評価した。保湿感の場合、塗布30分後の爪及び爪周りの状態について「全く感じない」を0mm(線分の左端)としての回答、「非常に強く感じる」を100mm(線分の右端)としての回答と定め、各組成物の保湿感がどの程度か評価した。被験者には、各組成物の組成を伏せて実施した。結果を表7に合わせて示す。
表9に示す実施例及び比較例の組成の医薬組成物(液剤)を、常法に従って調製した。次に、実施例及び比較例の組成物の表面張力を試験例1と同様の手法で測定した。各試験例において、各比較例に対する各実施例の表面張力低下率を式1に従って算出した。有効数字は二桁とした。結果を表8に合わせて示す。表面張力が低いほど組成物は伸展するため、患部への適用により、適切に真菌へ薬剤を届けることができる。
表10に示す実施例及び比較例の組成の液剤(ジェル状組成物)である医薬組成物を、常法に従って調製した。次に、実施例及び比較例の組成物の表面張力を試験例1と同様の手法で測定した。各試験例において、各比較例に対する各実施例の表面張力低下率を式1に従って算出した。有効数字は二桁とした。結果を表10に合わせて示す。表面張力が低いほど組成物は伸展するため、患部への適用により、適切に真菌へ薬剤を届けることができる。
Claims (8)
- (A)抗真菌剤;
(B)ビニル系高分子、アクリル系高分子、デンプン系高分子、デキストラン、デキストリン脂肪酸エステル、カゼイン、ジメチルジステアリルアンモニウムヘクトライト、(アクリロイルジメチルタウリンアンモニウム/ビニルピロリドン)コポリマー、ジステアリン酸ポリエチレングリコール、トリイソステアリン酸エチレングリコール、トリイソステアリン酸ポリオキシエチレン(20)メチルグルコシド、ベントナイト、ヘクトライト、アルギン酸及び又はその塩、アルギン酸プロピレングリコールエステル及び多価アルコールからなる群より選択される少なくとも1種又は2種;及び
(C)抗炎症剤、局所麻酔剤、殺菌剤、及び抗ヒスタミン剤からなる群から選択される1種又は2種以上の化合物を含有する爪及び/又は爪周り用医薬組成物。 - 爪及び/又は爪周りが、爪溝及び/又は黄線部付近の溝である、請求項1に記載の医薬組成物。
- 前記(A)抗真菌剤が、アミン系抗真菌剤である、請求項1又は2に記載の医薬組成物。
- 前記(A)抗真菌剤が、テルビナフィン及びその塩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3に記載の医薬組成物。
- 前記(B)成分が、ポリビニルアルコール、ポリビニルピロリドン、ポリエチレングリコール、グリセリン、1,3−ブチレングリコール、アクリル酸メチル・アクリル酸−2−エチルヘキシルコポリマー及びカルボキシビニルポリマーからなる群より選択される少なくとも1種の増粘性高分子又は多価アルコールを含む、請求項1〜4のいずれか1項に記載の医薬組成物。
- さらに、エタノールを含有する、請求項1〜5のいずれか1項に記載の医薬組成物。
- 前記エタノールの含有量が、組成物全量に対して20質量%以上である、請求項6記載の医薬組成物。
- 液剤である、請求項1〜7のいずれか1項に記載の医薬組成物。
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