JP2007137869A - 直腸、尿道および膣適用用半固形状製剤。 - Google Patents
直腸、尿道および膣適用用半固形状製剤。 Download PDFInfo
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- JP2007137869A JP2007137869A JP2006255115A JP2006255115A JP2007137869A JP 2007137869 A JP2007137869 A JP 2007137869A JP 2006255115 A JP2006255115 A JP 2006255115A JP 2006255115 A JP2006255115 A JP 2006255115A JP 2007137869 A JP2007137869 A JP 2007137869A
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Abstract
【解決手段】製剤中に溶解し、且つ、ゲル化していないジェランガムを含有することを特徴とする直腸,尿道および膣適用用半固形状製剤。
【選択図】なし
Description
(1)製剤中に溶解し、且つ、ゲル化していないジェランガムを含有することを特徴とする、半固形状製剤。
(2)pHが4〜8であることを特徴とする、上記(1)に記載の半固形状製剤。
(3)更に増粘安定剤を含有する上記(1)又は(2)に記載の半固形状製剤。
(4)上記増粘安定剤がカルボキシビニルポリマー、アルギン酸、キサンタンガム、トラガントガム、アラビアゴム、寒天、カラギーナン、ゼラチン、ヒドロキシプロピルセルロース、カルボキシメチルセルロース、ポリビニルピロリドンおよびそれらの塩又は誘導体からなる群から選ばれる1種または2種以上である上記(3)に記載の半固形状製剤。
(5)更にキレート化剤を含有する上記(1)〜(4)のいずれかに記載の半固形状製剤。
(6)上記半固形状製剤が、水性ゲル剤あるいはクリーム剤である上記(1)〜(5)のいずれかに記載の半固形状製剤。
(7)上記半固形状製剤が、直腸、尿道及び/又は膣適用用である上記(1)〜(6)のいずれかに記載の半固形状製剤。
(8)上記半固形状製剤の粘度が10〜5000mPa・sの範囲である上記(1)〜(7)のいずれかに記載の半固形状製剤。
ここで、ジェランガムが、製剤中に溶解し、且つ、ゲル化していない状態を維持するためには、ジェランガムのゲル化を促進する成分を配合しないことが好ましい。そのような成分としては、例えばカルシウムイオン、マグネシウムイオン、アルミニウムイオン、鉄イオン、銅イオン、ナトリウムイオン、カリウムイオン、アンモニウムイオン等のカチオン性イオン等が挙げられる。
なお、これまでに記載した成分については何ら限定されるものではない。
実施例1:粘稠ゲル剤
塩酸リドカイン 2.0g
ジェランガム 0.5g
クエン酸 0.2g
クエン酸ナトリウム 0.05g
エデト酸ニナトリウム 0.05g
ジイソプロパノールアミン 適量
防腐剤(パラベン類) 0.1g
1,3-ブチレングリコール 5g
精製水 全100g
実施例1にさらにアルギン酸ナトリウムを1.0%加えてゲル剤を得た。
酢酸ヒドロコルチゾン 0.5g
リドカイン 1g
塩酸ジフェンヒドラミン 2g
l-メントール 0.1g
クエン酸 0.6g
クエン酸ナトリウム 0.6g
ジェランガム 0.3g
カルボキシビニルポリマー 0.5g
アルギン酸ナトリウム 0.5%
水酸化ナトリウム 適量
防腐剤(パラベン類) 0.15g
エタノール 5g
1,3-ブチレングリコール 5g
精製水 全100g
酢酸ヒドロコルチゾン 0.5g
塩酸テトラヒドロゾリン 0.05g
塩酸リドカイン 3.0g
マレイン酸クロルフェニラミン 0.2g
l-メントール 0.05g
塩酸クロルヘキシジン 0.25g
アラントイン 1g
防腐剤(パラベン類) 0.15g
ジェランガム 0.2g
アルギン酸ナトリウム 0.5g
ヒドロキシエチルセルロース 0.5g
ポリオキシエチレン硬化ヒマシ油(60) 2.0g
クエン酸 0.225g
クエン酸ナトリウム 0.05g
ジイソプロパノールアミン 適量
エタノール 5g
1,3-ブチレングリコール 10g
精製水 全100g
酢酸ヒドロコルチゾン 0.5g
グリチルレチン酸 1.5g
塩酸テトラヒドロゾリン 0.05g
塩酸リドカイン 3.202g
マレイン酸クロルフェニラミン 0.2g
l-メントール 0.1
ビタミンE-アセテート 3.0
アラントイン 1g
プロピレングリコール 5.0g
グリセリン 5.0g
スクワレン 5.0g
ミリスチン酸オクチルドデシル 5.0g
セトステアリルアルコール 5.0g
ポリソルベート60 3.0g
ステアリン酸モノグリセリド 1.5g
ジメチルポリシロキサン 1.0g
ジェランガム 0.5g
クエン酸 0.2g
クエン酸ナトリウム 0.05g
エデト酸ナトリウム塩 0.05g
ジイソプロパノールアミン 適量
防腐剤(パラベン類) 適量
ジブチルヒドロキシトルエン 適量
精製水 全100g
酢酸プレドニゾロン 0.05g
グリチルレチン酸 1.5g
塩酸テトラヒドロゾリン 0.05g
塩酸リドカイン 3.202g
マレイン酸クロルフェニラミン 0.2g
塩化ベンザルコニウム 0.05
l-メントール 0.2
グリセリン 5.0g
1,3-ブチレングリコール 10.0g
スクワラン 10.0g
セタノール 3.0g
パルミチン酸イソプロピル 5.0g
ステアリン酸ポリオキシル 2.0g
ポリオキシエチレン硬化ヒマシ油(60) 2.0g
キサンタンガム 0.3g
ジェランガム 0.3g
ジメチルポリシロキサン 1.0g
クエン酸 0.2g
クエン酸ナトリウム 0.05g
エデト酸ナトリウム塩 0.05g
ジイソプロパノールアミン 適量
防腐剤(パラベン類) 適量
ジブチルヒドロキシトルエン 適量
精製水 全100g
硝酸ミコナゾール 1.0g
リドカイン 2.0g
グリチルリチン酸ニカリウム 0.5g
1,3-ブチレングリコール 5.0g
グリセリン 5.0g
流動パラフィン 7.0g
ミリスチン酸イソプロピル 3.0g
セトステアリルアルコール 5.0g
モノステアリン酸PEG(40) 2.5g
ステアリン酸モノグリセリド 2.5g
カルボキシルビニルポリマー 1.0g
ジェランガム 0.3g
ジメチルポリシロキサン 1.0g
クエン酸 0.2g
クエン酸ナトリウム 0.05g
エデト酸ナトリウム塩 0.05g
ジイソプロパノールアミン 適量
防腐剤(パラベン類) 適量
ジブチルヒドロキシトルエン 適量
精製水 全100g
硝酸ミコナゾール 1.0g
リドカイン 2.0g
グリチルリチン酸ニカリウム 0.5g
酢酸トコフェロール 1.0g
l-メントール 0.1g
塩化デカリニウム 0.1g
プロピレングリコール 5.0g
グリセリン 5.0g
スクワラン 5.0g
中鎖脂肪酸トリグリセリド 5.0g
セタノール 0.5g
モノステアリン酸ソルビタン 1.0g
POE(10)硬化ヒマシ油 1.0g
カルボキシルビニルポリマー 0.5g
ジェランガム 0.3g
ジメチルポリシロキサン 1.0g
クエン酸 0.2g
クエン酸ナトリウム 0.05g
エデト酸ナトリウム塩 0.05g
ジイソプロパノールアミン 適量
防腐剤(パラベン類) 適量
ジブチルヒドロキシトルエン 適量
精製水 全100g
(方法)
in vitro滞留性試験は直腸での製剤滞留性を動物を用いることなく評価できる方法で、坐剤の静止性を評価するのに用いられており、セルロース膜(ダイアライシスメンブラン36、長さ約30cm、和光純薬製)の周りに一定温度の水を還流させることで直腸圧を再現できる(ポンプ回転数:50rpm、圧:2.0kPa)。セルロース膜の最下部に製剤約2gを充填し、圧をかけると、経時的に製剤が上部へと移動していくので、一定時間後の製剤の移動距離や画分の重量から製剤の滞留性を評価できる。本試験では竹田理化製の薬剤溶解モデル試験用温・冷水供給装置を用いた。各製剤で、評価しやすい温度と時間を設定した。水性ゲル剤での試験は還流温度が37℃、試験時間は3分、クリーム剤では還流温度が50℃、試験時間は10分、油性軟膏剤では還流温度が37℃、試験時間は30分で実施した。なお、還流水には、体液モデルとして公知である人工鼻汁(5.35gNaCl、1.91gKCl、0.59gCaCl2・2H2O、0.13gMgCl2・6H2O、及び4.76gNa2B4O7・10H2Oを精製水に溶解し、全量を1000mlに調製)を用いた。
水性ゲル剤の滞留性について測定した結果を表4に示した。カルボキシビニルポリマーにジェランガムを配合(実施例9)することで、カルボキシビニルポリマー単独(比較例1)より移動距離が減少し、滞留性が飛躍的に増大していることが確認された。更にアルギン酸ナトリウムを加える(実施例10)ことで滞留性が増大された。なお、本例において、ジェランガムは溶解し、且つ、ゲル化していない状態で配合されている。
Claims (8)
- 製剤中に溶解し、且つ、ゲル化していないジェランガムを含有することを特徴とする、半固形状製剤。
- pHが4〜8であることを特徴とする、請求項1に記載の半固形状製剤。
- 更に増粘安定剤を含有することを特徴とする請求項1又は2に記載の半固形状製剤。
- 上記増粘安定剤がカルボキシビニルポリマー、アルギン酸、キサンタンガム、トラガントガム、アラビアゴム、寒天、カラギーナン、ゼラチン、ヒドロキシプロピルセルロース、カルボキシメチルセルロース、ポリビニルピロリドンおよびそれらの塩又は誘導体からなる群から選ばれる1種または2種以上である請求項3に記載の半固形状製剤。
- 更にキレート化剤を含有する請求項1〜4のいずれか1項に記載の半固形状製剤。
- 上記半固形状製剤が、水性ゲル剤あるいはクリーム剤である請求項1〜5のいずれか1項に記載の半固形状製剤。
- 上記半固形状製剤が、直腸、尿道及び/又は膣適用用である請求項1〜6のいずれか1項に記載の半固形状製剤。
- 上記半固形状製剤の粘度が10〜5000mPa・sの範囲である請求項1〜7のいずれか1項に記載の半固形状製剤。
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JP2011207781A (ja) * | 2010-03-29 | 2011-10-20 | Lion Corp | 口腔用軟膏 |
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JP2014185132A (ja) * | 2012-03-29 | 2014-10-02 | Kowa Company Ltd | ロキソプロフェンを含有する医薬組成物 |
WO2015099029A1 (ja) * | 2013-12-25 | 2015-07-02 | 参天製薬株式会社 | 注射剤およびデポ形成方法 |
JPWO2016104618A1 (ja) * | 2014-12-26 | 2017-10-05 | ニプロ株式会社 | 医療用皮膚外用剤 |
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JP2021515802A (ja) * | 2018-01-08 | 2021-06-24 | チー リウ | アネモシドb4の直腸粘膜投与製剤及びその製造方法 |
JP7214751B2 (ja) | 2018-01-08 | 2023-01-30 | チー リウ | アネモシドb4の直腸粘膜投与製剤及びその製造方法 |
IT201900000388A1 (it) * | 2019-01-10 | 2020-07-10 | L N Age S R L | Composizione per l'uso nel trattamento di lesioni vaginali, del glande ed anali |
JP7465066B2 (ja) | 2019-06-17 | 2024-04-10 | 小林製薬株式会社 | 乳化安定化剤 |
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