JP2016027025A - 局所粘膜適用水性組成物 - Google Patents
局所粘膜適用水性組成物 Download PDFInfo
- Publication number
- JP2016027025A JP2016027025A JP2015128757A JP2015128757A JP2016027025A JP 2016027025 A JP2016027025 A JP 2016027025A JP 2015128757 A JP2015128757 A JP 2015128757A JP 2015128757 A JP2015128757 A JP 2015128757A JP 2016027025 A JP2016027025 A JP 2016027025A
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- JP
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- Prior art keywords
- aqueous composition
- mucosa
- acid
- topical
- present
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
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- 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
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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
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- NWONKYPBYAMBJT-UHFFFAOYSA-L zinc sulfate Chemical compound [Zn+2].[O-]S([O-])(=O)=O NWONKYPBYAMBJT-UHFFFAOYSA-L 0.000 description 1
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- 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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Abstract
Description
充血除去剤:塩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、塩酸メチルエフェドリン等。
殺菌剤: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: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、酢酸レチノール、パルミチン酸レチノール、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、酢酸トコフェロール等。
アミノ酸類:アミノエチルスルホン酸、コンドロイチン硫酸ナトリウム等。
消炎剤:グリチルリチン酸二カリウム、アラントイン、塩化ベルベリン、硫酸ベルベリン、塩化リゾチーム、アズレンスルホン酸ナトリウム、インドメタシン、プラノプロフェン、イブプロフェン、等。
収斂剤:亜鉛華、乳酸亜鉛、硫酸亜鉛等。
その他: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、スルフイソキサゾール、スルフイソミジンナトリウム、ヒアルロン酸ナトリウム、メチル硫酸ネオスチグミン等。
増粘剤:ヒドロキシプロピルメチルセルロース、ヒドロキシエチルセルロース、メチルセルロース、カルボキシメチルセルロースナトリウム、ジェランガム、アルギン酸等。
糖アルコール類:キシリトール、ソルビトール、マンニトールなど。これらはd体、l体又はdl体のいずれでもよい。
糖類:ブドウ糖など。
等張化剤:亜硫酸水素ナトリウム、亜硫酸ナトリウム、塩化カリウム、塩化カルシウム、塩化ナトリウム、塩化マグネシウム等。
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、等。
安定化剤:ジブチルヒドロキシトルエン、ブチルヒドロキシアニソール、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等。
キレート剤:アスコルビン酸、エデト酸四ナトリウム、エデト酸ナトリウム、等。
防腐剤:塩酸アルキルジアミノエチルグリシン、安息香酸ナトリウム、エタノール、塩化ベンザルコニウム、塩化ベンゼトニウム、グルコン酸クロルヘキシジン、塩化亜鉛、クロロブタノール、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、塩酸ポリヘキサニド(ポリヘキサメチレンビグアニド)等)、グローキル(ローディア社製商品名)等。
油類:ゴマ油、ヒマシ油、ダイズ油、オリーブ油等の植物油、スクワラン等の動物油、流動パラフィン、ワセリン等の鉱物油等。
ここで、コンタクトレンズは、ハードコンタクトレンズ、酸素透過性ハードコンタクトレンズ、およびソフトコンタクトレンズのいずれも指す。
なお、表1〜3における各成分量の単位は、w/v%である。
表1に示す組成の眼粘膜適用組成物を常法に従って調製した。具体的には、各成分を100mL容量ビーカーに量り取り、必要量の蒸留水を添加した。加温しながら攪拌し、室温にて最終pHを調節し、均一な製剤を得た。ここで、レバミピドとしては、日本薬局方適合のレバミピドを用いた。
(式I)濁度相対値(%)=[(各眼粘膜適用組成物の濁度)/(基準となる比較例の濁度)]×100
表2に示す組成の眼粘膜適用組成物を、試験例1と同様に調製した。
調製した各眼粘膜適用組成物を10mL容量ガラス製ヘッドスペースバイアルに5mLずつ充填し、光安定性試験装置(「LT-120A-WCD」、ナガノサイエンス社製)を用いて、D65蛍光ランプを光源として、室温25℃の下、4000lxの光を照射することにより、積算照射量66.17万lx・hの光を曝光した。その後、各眼粘膜適用組成物を転倒混和後に以下の基準に従って析出物の有無を確認し、試験例1と同様に濁度測定により白濁度を評価した。
50cm離れた場所から観察し、結晶が20個以上確認できる ×
50cm離れた場所から観察し、結晶が10〜20個確認できる △
50cm離れた場所から観察し、確認できる結晶が10個以下である ○
表3に示す組成の眼粘膜適用組成物(点眼剤)を、試験例1と同様に調製した。
(式II)改善率(%)={1−(各試験例の動的接触角の平均値/対応する比較例の動的接触角の平均値)}×100
対応する比較例とは、(A)成分と(B)成分の両方を含有しない水性組成物を意味する。具体的には、実施例3については比較例3である。
下記表4〜表7に記載の処方で、点眼剤(製剤例1〜19、22〜28)、口腔用スプレー剤(製剤例20)、含嗽液(製剤例21)が調製され、以下に記載の容器に収容される。表4〜7の製剤例中、塩酸及び水酸化ナトリウムはpH調整に用いられ、局所粘膜適用水性組成物が表4〜7に記載のpHとなるように加えられる。精製水は各液剤の全量が100mLとなるよう加えられる。
尚、下記表4〜表7における各成分量の単位は、w/v%である。
製剤例4、7、14、15、19はPP容器に収容。製剤例12はPEN容器に収容。
製剤例1〜12、14〜19、22〜25、27〜28はPE製のノズルを、製剤例13、26はPBT製のノズルを装着した。
Claims (7)
- (A)レバミピド、レバミピド誘導体、及びそれらの塩からなる群より選択される少なくとも1種、並びに
(B)テルペノイド
を含有する、局所粘膜適用水性組成物。 - 前記テルペノイドが、メントール、メントン、カンフル、ボルネオール、およびゲラニオール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記載の局所粘膜適用水性組成物。
- さらに、ビニル系高分子、アミン類、多価アルコール、およびカフェインからなる群より選択される少なくとも1種の溶解補助剤を含有する請求項1または2記載の局所粘膜適用水性組成物。
- さらに、緩衝剤を含有する請求項1〜3のいずれか1項記載の局所粘膜適用水性組成物。
- さらに、界面活性剤を含有する請求項1〜4のいずれか1項記載の局所粘膜適用水性組成物。
- 眼粘膜用である、請求項1〜5のいずれか1項記載の局所粘膜適用水性組成物。
- 局所粘膜適用水性組成物中に、(A)レバミピド、レバミピド誘導体、及びそれらの塩からなる群より選択される少なくとも1種、並びに(B)テルペノイドを共存させることで、析出を抑制する方法。
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JP2016027039A (ja) * | 2014-07-03 | 2016-02-18 | ロート製薬株式会社 | 局所粘膜用水性組成物 |
JP2020002123A (ja) * | 2018-06-26 | 2020-01-09 | ダエウー ファーマシューティカル インダストリー カンパニー リミテッドDaewoo Pharmaceutical Ind. Co., Ltd. | レバミピドを含有するドライアイ治療用水溶性多回用点眼剤組成物、並びにその可溶化及び安定化方法 |
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JP2016027039A (ja) * | 2014-07-03 | 2016-02-18 | ロート製薬株式会社 | 局所粘膜用水性組成物 |
JP2020002123A (ja) * | 2018-06-26 | 2020-01-09 | ダエウー ファーマシューティカル インダストリー カンパニー リミテッドDaewoo Pharmaceutical Ind. Co., Ltd. | レバミピドを含有するドライアイ治療用水溶性多回用点眼剤組成物、並びにその可溶化及び安定化方法 |
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