JP2011184319A - 貼付剤 - Google Patents
貼付剤 Download PDFInfo
- Publication number
- JP2011184319A JP2011184319A JP2010048888A JP2010048888A JP2011184319A JP 2011184319 A JP2011184319 A JP 2011184319A JP 2010048888 A JP2010048888 A JP 2010048888A JP 2010048888 A JP2010048888 A JP 2010048888A JP 2011184319 A JP2011184319 A JP 2011184319A
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- JP
- Japan
- Prior art keywords
- mass
- patch
- component
- polyacrylic acid
- salt
- 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
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- 229920002125 Sokalan® Polymers 0.000 claims abstract description 31
- 239000004584 polyacrylic acid Substances 0.000 claims abstract description 27
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- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims abstract description 16
- SECXISVLQFMRJM-UHFFFAOYSA-N N-Methylpyrrolidone Chemical compound CN1CCCC1=O SECXISVLQFMRJM-UHFFFAOYSA-N 0.000 claims abstract description 16
- 229910052751 metal Inorganic materials 0.000 claims abstract description 14
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- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 abstract description 15
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- -1 fatty acid ester Chemical class 0.000 description 29
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- RZRNAYUHWVFMIP-GDCKJWNLSA-N 3-oleoyl-sn-glycerol Chemical compound CCCCCCCC\C=C/CCCCCCCC(=O)OC[C@H](O)CO RZRNAYUHWVFMIP-GDCKJWNLSA-N 0.000 description 2
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- 235000004204 Foeniculum vulgare Nutrition 0.000 description 2
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- HEFNNWSXXWATRW-UHFFFAOYSA-N Ibuprofen Chemical compound CC(C)CC1=CC=C(C(C)C(O)=O)C=C1 HEFNNWSXXWATRW-UHFFFAOYSA-N 0.000 description 2
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- 239000005844 Thymol Substances 0.000 description 2
- YKTSYUJCYHOUJP-UHFFFAOYSA-N [O--].[Al+3].[Al+3].[O-][Si]([O-])([O-])[O-] Chemical compound [O--].[Al+3].[Al+3].[O-][Si]([O-])([O-])[O-] YKTSYUJCYHOUJP-UHFFFAOYSA-N 0.000 description 2
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- 229910052782 aluminium Inorganic materials 0.000 description 2
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- BWZOPYPOZJBVLQ-UHFFFAOYSA-K aluminium glycinate Chemical compound O[Al+]O.NCC([O-])=O BWZOPYPOZJBVLQ-UHFFFAOYSA-K 0.000 description 2
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- GDVKFRBCXAPAQJ-UHFFFAOYSA-A dialuminum;hexamagnesium;carbonate;hexadecahydroxide Chemical compound [OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[Mg+2].[Mg+2].[Mg+2].[Mg+2].[Mg+2].[Mg+2].[Al+3].[Al+3].[O-]C([O-])=O GDVKFRBCXAPAQJ-UHFFFAOYSA-A 0.000 description 2
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Abstract
【解決手段】(A)水難溶性非ステロイド系消炎鎮痛剤と、(B)N−メチル−2−ピロリドンと、(C)スメクタイト系粘土鉱物と、(D)非イオン性界面活性剤と、(E)グリセリン5〜25質量%と、(F)ポリアクリル酸、その塩又はその部分中和物と、(G)多価金属塩とを含有し、含水率が55〜80質量%である含水性膏体が、支持体に積層されてなる貼付剤。
【選択図】なし
Description
[1].(A)水難溶性非ステロイド系消炎鎮痛剤と、(B)N−メチル−2−ピロリドンと、(C)スメクタイト系粘土鉱物と、(D)非イオン性界面活性剤と、(E)グリセリン5〜25質量%と、(F)ポリアクリル酸、その塩又はその部分中和物と、(G)多価金属塩とを含有し、含水率が55〜80質量%である含水性膏体が、支持体に積層されてなる貼付剤。
[2].(B)/(C)で表される、含水性膏体中の(B)成分と(C)成分との含有質量比が8以下である[1]記載の貼付剤。
本発明の貼付剤は、(A)水難溶性非ステロイド系消炎鎮痛剤と、(B)N−メチル−2−ピロリドンと、(C)スメクタイト系粘土鉱物と、(D)非イオン性界面活性剤と、(E)グリセリン5〜25質量%と、(F)ポリアクリル酸、その塩又はその部分中和物と、(G)多価金属塩とを含有し、含水率が55〜80質量%である含水性膏体が、支持体に積層されてなる貼付剤である。
本発明において、「水難溶性薬物」とは、20℃の水に対する溶解度が0〜30mg/mLであり、好ましくは0〜10mg/mLである薬物を示す。水難溶性非ステロイド系消炎鎮痛剤としては、その種類は特に限定されず、具体的には、イブプロフェン、ナプロキセン、ケトプロフェン、アセトアミノフェン、インドメタシン、ブフェキサマック、アスピリン、ジクロフェナック、アルクロフェナック、フェンクロフェナック、フェルビナク、エトドラック、フルルビプロフェン、メフェナミック、メクロフェナミック、ピロキシカム等が挙げられ、1種単独で又は2種以上を適宜組み合わせて用いることができる。特に、本発明においては、ケトプロフェン、インドメタシン、フェルビナク、フルルビプロフェン等が好適に使用でき、顕著な皮膚透過性を示す。
N−メチル−2−ピロリドンを用いることで、(A)成分の消炎鎮痛剤を溶解し、皮膚透過性を高めることができる。(B)成分の含有量は、(A)成分含有量の1〜20倍(質量)が好ましく、2.5〜12倍がより好ましい。(B)成分の含有量が(A)成分含有量の1倍未満だとフェルビナクの溶解性が悪くなるおそれがあり、20倍を超えると、皮膚刺激等が生じるおそれがある。なお、表記倍率は、小数点第1位を四捨五入した値である。(B)成分の含有量は、含水性膏体中0.5〜10質量%が好ましく、2〜8質量%がより好ましい。
スメクタイト系粘土鉱物を用いることで、(A)成分の皮膚透過性を損なうことなく(B)成分配合によるべたつきを抑制することができる。スメクタイト系粘土鉱物として、具体的にはベントナイト、モンモリロナイト、バイデライト、ノントロナイト、サポナイト、ヘクトライト、ソーコナイト、スチブンサイト等を挙げることができ、これらは1種単独で又は2種以上を適宜組み合わせて用いられる。このようなスメクタイト系粘土鉱物は、天然より産出されるものとしては、例えばモンモリロナイトを含有する製品として、水澤化学工業(株)のベンクレーSL、(株)ホージュンのベントナイトW、ベンゲル、クニミネ工業(株)のクニピアG及びクニピアF、(株)ツチヨシアクティーのウエスタンボンド等、サポナイトを含有する製品として、クニミネ工業(株)のスメクトンSA、バンダービルド社のビーガムT、ビーガムHV、ビーガムF及びビーガムK等、ヘクトライトを含有する製品として、(株)ボルクレイ・ジャパンのヘクタブライト、ヘクタライト等が市販されている。また、合成スメクタイト系粘土鉱物も各種販売されており、水澤化学工業(株)社のイオナイト、コープケミカル(株)社からルーセンタイトSWN、SPN、SAN等が市販されている。
非イオン性界面活性剤を用いることで、(A)成分の消炎鎮痛剤を溶解させ、含水性膏体中に十分に混合させる作用をする。非イオン性界面活性剤は特に限定されず、従来使用されている合成及び天然界面活性剤であって、皮膚に対して安全なものを使用することができ、1種単独で又は2種以上を適宜組み合わせて用いることができる。
流動パラフィンのHLB値=((TS−10のHLB値(14.9)×使用質量%)+(SS−10のHLB値(4.7)×使用質量%))/100
流動パラフィンの所要HLB値は10.1〜10.3ぐらいである。
次に、未知の界面活性剤のHLBを、HLB値を求めた流動パラフィンを使って測定する。未知の界面活性剤が親水性であればSS−10と組み合わせ、親油性であればTS−10と組み合わせて、流動パラフィンを乳化し、安定性のあるところの最適割合を求め、未知の界面活性剤のHLB値をXとして前記計算式にあてはめて算出する。
乳化の処方は流動パラフィン40質量%、使用する界面活性剤は油相の10質量%、すなわち全体の4質量%、水が50質量%で行なう。界面活性剤4質量%は二つの界面活性剤の全量であり、界面活性剤の全量は一定にしておき、割合のみを変えて乳化できるところまで乳化する。界面活性剤の割合は0.1質量%ずつ変えて行なう。できたエマルジョンは水が蒸発しないようにふたをする。乳化が終わればできたエマルジョンをおのおの1質量%に希釈し、共栓付試験管に同じ量を取り、一昼夜放置し、クリーミング量、白濁度、下層の水分離等から判定し、最も安定性の良いものを最適割合とする。
グリセリンは、三価のアルコールで毒性が極めて低く吸湿性を有する液状成分であり、日本薬局方に適合するものを用いることができる。グリセリンは、保湿効果を有し、医薬品や化粧品では主に保湿・湿潤剤や保水剤として配合される他、粘度低下剤、皮膚保護剤、溶剤等としても配合される。本発明においては、保湿・湿潤剤や保水剤、ポリアクリル酸、その塩又はその部分中和物の可塑剤として機能する。
ポリアクリル酸、その塩又はその部分中和物は1種単独で又は2種以上を適宜組み合わせて用いることができる。ポリアクリル酸としてはいずれのものでも使用でき、その分子量及び直鎖状、分岐鎖状等の形状には特に制限はないが、重量平均分子量1万〜1000万のものを用いることが好ましい。特に、使用感が向上する点から、重量平均分子量1万〜50万未満、50万〜200万未満、200万〜700万のポリアクリル酸及びその塩を2種以上組み合わせると好適である。なお、通常のアクリル酸を重合して得られた重合体のほか、カルボキシビニルポリマー、例えば、カーボポール(商品名:米国ノベオン社製)、ジュンロンPW−110(商品名:東亞合成(株)製、粘度8000〜20000mPa・s(0.2質量%水溶液、25℃))等のアクリル酸重合体を一部架橋したものも好適に使用し得る。
(F)ポリアクリル酸、その塩又はその部分中和物と、(G)多価金属塩とを併用することにより、(F)成分を(G)成分で架橋させた架橋体となる。
下記方法で、貼付剤を得た。得られた貼付剤について下記評価を行った。結果を表1〜6中に併記した。
(A)フェルビナクを、(B)N−メチル−2−ピロリドン及び(D)成分等で溶解した液、(C)スメクタイト系粘度鉱物、(E)グリセリン、ポリアクリル酸、その塩又は部分中和物、多価金属塩及びその他成分を、高速/高せん断ミキサーを用いて、温度条件(25〜35℃)、攪拌条件(300〜700rpm)によって撹拌し、表1〜6に示す組成の含水性膏体を得た。直ちにこれを1枚(140×100mm)当り表1〜6に示す膏体量となるようにマルチフィラメント糸により編成された両面メリヤス編布の支持体に展延、裁断(140×100mm)し、貼付剤(湿布シート)を得た。
Hos:HR−1雌性ヘアレスマウス(7週齢)の背部から採取した皮膚を、37℃のリン酸緩衝液(pH7.4等張緩衝液)を循環させたフランツ型拡散セル(有効面積4.91cm2)に装着した。装着した皮膚上に、直径4.5cmの円に切り取った貼付剤をそれぞれ積層し、単位時間毎にセル内の試料(緩衝液)を採取した。
採取した試料は、高速液体クロマトグラフィー分析に供し、皮膚を透過した各薬物の量(薬物の皮膚透過量、μg/cm2)を求めた。評価は8時間後の薬物の皮膚透過量から以下の基準により判定した。なお、8時間後の皮膚透過量が多いことは、薬物の経皮吸収性に優れることを表す。60μg/cm2以上を良好と判断した。(A)成分の皮膚透過性を皮膚透過量に基づき、下記基準に従って示す。
[基準]
◎:皮膚透過量が、90μg/cm2以上
○:皮膚透過量が、60μg/cm2以上90μg/cm2未満
△:皮膚透過量が、30μg/cm2以上60μg/cm2未満
×:皮膚透過量が、30μg/cm2未満
健常成人10人の肘に、10cm×14cmに裁断した貼付剤を貼り、約1時間後剥離した際に、貼付部位に粘着剤が残ることによるべたつきを観察し、下記基準により評価した。10人の評価結果の合計点から、下記剥離後の皮膚のべたつき評価基準に基づき判定した結果を表に併記した。
[基準]
5:感じない
4:ややべたつきを感じる
3:べたつきを感じる
2:かなりべたつきを感じる
1:非常にべたつきを感じる
[剥離後の皮膚のべたつき評価基準]
◎:10人の評価結果の合計点が40点以上
○:10人の評価結果の合計点が30点以上40点未満
△:10人の評価結果の合計点が20点以上30点未満
×:10人の評価結果の合計点が20点未満
健常成人10人の肘に、10cm×14cmに裁断した貼付剤を貼り、8時間後の状態を、下記基準により評価した。10人の評価結果の合計点から、下記基準に基づき判定した結果を表に併記した。
[基準]
5:貼付剤のはがれ・めくれなし
4:貼付剤の周囲にはがれ・めくれあり(全体の20%未満)
3:貼付剤の周囲にはがれ・めくれあり(全体の20%以上40%未満)
2:貼付剤の周囲にはがれ・めくれあり(全体の40%以上60%未満)
1:貼付剤の周囲60%以上にはがれ・めくれあり又は剥がれ落ちた
[8時間後のはがれ・めくれ評価基準]
◎:10人の評価結果の合計点が40点以上
○:10人の評価結果の合計点が30点以上40点未満
△:10人の評価結果の合計点が20点以上30点未満
×:10人の評価結果の合計点が20点未満
上記実施例の製造方法に準じて、表7の組成の貼付剤を調製した。得られた貼付剤は、良好な皮膚透過性を有し、剥離後のべたつき、8時間後のはがれ・めくれもなかった。
モンモリロナイト:ベンクレーSL(水澤化学工業(株)製)
ポリアクリル酸:ジュリマーAC−108H(13.3%水溶液)(東亞合成(株)製)、重量平均分子量130万
ポリアクリル酸ナトリウム:アロンビスS(東亞合成(株)製)重量平均分子量は400〜500万
ポリアクリル酸部分中和物:アロンビスAH−106X(東亞合成(株)製)重量平均分子量400万〜500、中和度40モル%)
香料:ラベンダー油:ペパーミント油:ローズマリー油:オレンジ油=5:3:1:1(質量比)
実施例3のフェルビナク0.7%をフルルビプロフェン0.2%に変更する以外は同様に貼付剤を調製した。
実施例3のフェルビナク0.7%をフルルビプロフェン0.5%に変更する以外は同様に貼付剤を調製した。
実施例3のフェルビナク0.7%をケトプロフェン0.3%に変更する以外は同様に貼付剤を調製した。
実施例3のフェルビナク0.7%をケトプロフェン0.5%に変更する以外は同様に貼付剤を調製した。
Claims (2)
- (A)水難溶性非ステロイド系消炎鎮痛剤と、(B)N−メチル−2−ピロリドンと、(C)スメクタイト系粘土鉱物と、(D)非イオン性界面活性剤と、(E)グリセリン5〜25質量%と、(F)ポリアクリル酸、その塩又はその部分中和物と、(G)多価金属塩とを含有し、含水率が55〜80質量%である含水性膏体が、支持体に積層されてなる貼付剤。
- (B)/(C)で表される、含水性膏体中の(B)成分と(C)成分との含有質量比が8以下である請求項1記載の貼付剤。
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Cited By (3)
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JP2014028767A (ja) * | 2012-07-31 | 2014-02-13 | Lion Corp | 貼付剤 |
JP2015502430A (ja) * | 2012-02-29 | 2015-01-22 | ホリスター・インコーポレーテッドHollister Incorporated | 皮膚粘着医療製品用の緩衝粘着剤組成物および該組成物の製造方法 |
KR20170097689A (ko) * | 2014-12-22 | 2017-08-28 | 히사미쓰 세이야꾸 가부시키가이샤 | 파프제 |
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JPH11139964A (ja) * | 1997-11-04 | 1999-05-25 | Lion Corp | 含水系パップ剤組成物 |
JP2001064161A (ja) * | 1999-08-30 | 2001-03-13 | Lion Corp | 貼付剤 |
JP2002020274A (ja) * | 2000-06-12 | 2002-01-23 | San-A Seiyaku Kk | 非ステロイド性消炎鎮痛剤の外用貼付剤および外用貼付薬 |
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JPH11139964A (ja) * | 1997-11-04 | 1999-05-25 | Lion Corp | 含水系パップ剤組成物 |
JP2001064161A (ja) * | 1999-08-30 | 2001-03-13 | Lion Corp | 貼付剤 |
JP2002020274A (ja) * | 2000-06-12 | 2002-01-23 | San-A Seiyaku Kk | 非ステロイド性消炎鎮痛剤の外用貼付剤および外用貼付薬 |
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JP2015502430A (ja) * | 2012-02-29 | 2015-01-22 | ホリスター・インコーポレーテッドHollister Incorporated | 皮膚粘着医療製品用の緩衝粘着剤組成物および該組成物の製造方法 |
JP2014028767A (ja) * | 2012-07-31 | 2014-02-13 | Lion Corp | 貼付剤 |
KR20170097689A (ko) * | 2014-12-22 | 2017-08-28 | 히사미쓰 세이야꾸 가부시키가이샤 | 파프제 |
KR102094586B1 (ko) | 2014-12-22 | 2020-03-27 | 히사미쓰 세이야꾸 가부시키가이샤 | 파프제 |
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