JP4744138B2 - 経皮吸収型製剤 - Google Patents
経皮吸収型製剤 Download PDFInfo
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- JP4744138B2 JP4744138B2 JP2004374433A JP2004374433A JP4744138B2 JP 4744138 B2 JP4744138 B2 JP 4744138B2 JP 2004374433 A JP2004374433 A JP 2004374433A JP 2004374433 A JP2004374433 A JP 2004374433A JP 4744138 B2 JP4744138 B2 JP 4744138B2
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- Prior art keywords
- film
- acid
- sensitive adhesive
- preparation
- polyester
- 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.)
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- 125000000951 phenoxy group Chemical group [H]C1=C([H])C([H])=C(O*)C([H])=C1[H] 0.000 description 1
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- 239000011574 phosphorus Substances 0.000 description 1
- 150000003018 phosphorus compounds Chemical class 0.000 description 1
- XNGIFLGASWRNHJ-UHFFFAOYSA-L phthalate(2-) Chemical compound [O-]C(=O)C1=CC=CC=C1C([O-])=O XNGIFLGASWRNHJ-UHFFFAOYSA-L 0.000 description 1
- LGRFSURHDFAFJT-UHFFFAOYSA-N phthalic anhydride Chemical compound C1=CC=C2C(=O)OC(=O)C2=C1 LGRFSURHDFAFJT-UHFFFAOYSA-N 0.000 description 1
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Description
上記経皮吸収型製剤用基材シートのプライマー層上に形成された粘着剤層とを有し、
上記粘着剤層は、(メタ)アクリル酸2−エチルヘキシルエステルを重合性単量体とする単独重合体又は共重合体を含むアクリル系粘着剤及び脂肪酸エステルを含有する
ことを特徴とする経皮吸収型製剤である。
以下、本発明を詳細に説明する。
上記ポリエステルポリオールは、多塩基酸と多価アルコールとを反応して得られるものである。
上記多塩基酸無水物としては、例えば、フタル酸無水物、コハク酸無水物、ヘット酸無水物、ハイミック酸無水物、マレイン酸無水物、テトラヒドロフタル酸無水物、ヘキサヒドラフタル酸無水物、テトラプロムフタル酸無水物、テトラクロルフタル酸無水物、トリメリット酸無水物、ピロメリット酸無水物、ベンゾフェノテトラカルボン酸無水物、2,3,6,7ーナフタリンテトラカルボン酸2無水物、5−(2,5−オキソテトラヒドロフリル)−3−メチル−3−シクロヘキセン−1,2−ジカルボン酸無水物等を挙げることができる。これらは、単独で用いてもよく、2種以上を併用してもよい。
上記接着促進剤としては、例えば、シランカップリング剤、チタネートカップリング剤、リン類及びリン酸の誘導体化合物等を挙げることができる。これらは、単独で用いてもよく、2種以上を併用してもよい。
上記他のフィルムとしては、例えば、ポリオレフィンフィルム、軟質塩化ビニル樹脂フィルム、織布、編布、不織布等を挙げることができる。
上記経皮吸収型製剤用基材シートが、上記積層フィルム及び上記プライマー層からなるものである場合、上記プライマー層は、上記積層フィルムのポリエステルフィルムの表面に形成されることになる。
上記ポリエチレンテレフタレートフィルムとポリオレフィンフィルムからなる積層シートが、柔軟な風合いをだすためには、50%モジュラスは、45N/cm以下であることが好ましい。50%モジュラスの測定は、サンプルサイズ:19mm巾短冊、チャック間:100mm、標線間:50m、引張速度:50mm/minの条件で測定する。
上記アクリル系重合体としては、例えば、(メタ)アクリル酸アルキルエステルの単独重合体又はこれらの共重合体等を挙げることができる。
上記脂肪酸類としては、例えば、モノカプリン酸、オレイン酸、カプリル酸、ラウリン酸、ウンデシレン酸、イソステアリン酸、リノール酸等の炭素数が6〜20のものを挙げることができる。
2軸延伸ポリエチレンテレフタレートフィルム(帝人デュポン社製「NCS6」)6μmにポリエステル系ポリウレタン樹脂(大日本インキ化学社製、「T−5265」)をグラビアロールにてコーティング(乾燥目付0.5g/m2)し、支持体(経皮吸収型製剤用基材シート)とした。
得られた支持体に、不活性ガス中にて、アクリル系粘着剤としてアクリル酸2−エチルヘキシルエステル50部及びアクリル酸2−メトキシエチルエステル25部、酢酸ビニル25部、脂肪酸エステルを膏体層(粘着剤層)中の配合量が10%、β−エストラジオールを膏体層中の配合量が10%となるように添加、混合し、乾燥後の粘着剤層の厚さが60μmとなるように調整、塗工、乾燥し、膏体層を作成し、経皮吸収製剤を得た。
2軸延伸ポリエチレンテレフタレートフィルム(帝人デュポン社製「NCS25」)25μmにポリエステル系ポリウレタン樹脂(大日本インキ化学社製、「T−5265」)をグラビアロールにてコーティング(乾燥目付0.5g/m2)し、支持体(経皮吸収型製剤用基材シート)とした。
得られた支持体に、実施例1と同様にして膏体層を作成し、経皮吸収製剤を得た。
(積層基材シートの作成)
トクヤマ社製リアクターTPO樹脂「PER210E」40質量部、日本ポリケム社製ポリエチレン樹脂「カーネルKF281」50質量部、日本ポリオレフィン社製ポリプロピレン「ジェイアロマーPM620」10質量部、日本油脂社製酸化防止剤「アンチオクス10」0.1質量部をバンバリーミキサーで溶融混練後、カレンダー本体の各ロールを通し、エンボス加工後の厚みが0.10mmのフィルムを作成した。このポリオレフィンフィルムと2軸延伸ポリエチレンテレフタレートフィルム(帝人デュボン製、厚さ4.5μm)を、ウレタン樹脂2液接着剤(セイコー化学社社製「UD417」)にて接着し、この2軸延伸ポリエチレンテレフタレートフィルム面に、ポリエステル系ポリウレタン樹脂(大日本インキ化学社製、「T−5265」)をグラビアロールにてコーティング(乾燥目付0.5g/m2)し、支持体(経皮吸収型製剤用基材シート)とした。
(経皮吸収製剤の作成)
得られた支持体に、実施例1と同様にして膏体層を作成し、経皮吸収製剤を得た。
(積層基材シートの作成)
2軸延伸ポリエチレンテレフタレートフィルム(帝人デュボン製、厚さ4.5μm)の代わりに、2軸延伸ポリエチレンテレフタレートフィルム(帝人デュポン社製、厚さ9μm)を用いた以外は、実施例3と同様にして支持体を作成した。
(経皮吸収製剤の作成)
得られた支持体に、実施例1と同様にして膏体層を作成し、経皮吸収製剤を得た。
2軸延伸ポリエチレンテレフタレートフィルム(帝人デュポン社製「NCS6」)6μmを支持体とした。
この支持体に、実施例1と同様にして膏体層を作成し、経皮吸収製剤を得た。
(積層基材シートの作成)
トクヤマ社製リアクターTPO樹脂「PER210E」40質量部、日本ポリケム社製ポリエチレン樹脂「カーネルKF281」50質量部、日本ポリオレフィン社製ポリプロピレン「ジェイアロマーPM620」10質量部、日本油脂社製酸化防止剤「アンチオクス10」0.1質量部をバンバリーミキサーで溶融混錬後、カレンダー本体の各ロールを通し、エンボス加工後の厚みが0.10mmのフィルムを作成した。このポリオレフィンフィルムと2軸延伸ポリエチレンテレフタレートフィルム(帝人デュポン製、厚さ9μm)を、ウレタン樹脂2液接着剤(セイコー化学社社製「UD417」)にて接着し、支持体(経皮吸収型製剤用基材シート)とした。
(経皮吸収製剤の作成)
得られた支持体に、実施例1と同様にして膏体層を作成し、経皮吸収製剤を得た。
得られた経皮吸収型製剤(粘着シート)について、次の試験を行い、結果を表1に示した。
〔(1)アクリル系粘着剤と支持体の密着性(40℃×1ヶ月)〕
経皮吸収型製剤(粘着シート)を離型紙に貼った状態で10cm角にし、アルミ/ポリエチレンフィルムパックに入れ、熱ラミネートし、40℃のオーブンで1ヶ月後放置した。経皮吸収製剤を人の皮膚に貼り付け24時間後に剥がしたときの糊残りがなく、支持体と粘着剤の密着性が充分なときを○とし、糊残りがあるときには×とした。
上記(1)の評価後のフィルムを目視にて、表面に脂肪酸エステル、薬物等が透過・ブリードしているものを×、変化の無いものを○と判断した。
経皮吸収型製剤(粘着シート)を手の甲上に置き、その追従性、密着性、なじみ性、折れ曲がり性を目視及び手触りにて総合的に判断し、評価した。手の甲に沿って充分に追従し、密着性、なじみ性、皮膚への適合性に優れ、風合いが良いものを○、やや硬い感触があるが実用上は問題ないものを△、硬く、実用性が無いものを×とした。
2 プライマー層
3 粘着剤層
4 離型剤層
Claims (4)
- ポリエステルフィルムからなる単層フィルム又はポリエステルフィルムと他のフィルムとの積層フィルムのポリエステルフィルム側に、ポリエステル系ポリウレタン樹脂を含んでなるプライマー層を有する経皮吸収型製剤用基材シートと、
前記経皮吸収型製剤用基材シートのプライマー層上に形成された粘着剤層とを有し、
前記粘着剤層は、(メタ)アクリル酸2−エチルヘキシルエステルを重合性単量体とする単独重合体又は共重合体を含むアクリル系粘着剤及び脂肪酸エステルを含有する
ことを特徴とする経皮吸収型製剤。 - ポリエステルフィルムからなる単層フィルムは、厚さが2〜25μmである請求項1記載の経皮吸収型製剤。
- 積層フィルムは、ポリエステルフィルムと、ポリオレフィンフィルム、軟質塩化ビニル樹脂フィルム、織布、編布及び不織布からなる群より選択される少なくとも1種との積層フィルムである請求項1記載の経皮吸収型製剤。
- 粘着剤層は、薬物を含有するものである請求項1、2又は3記載の経皮吸収型製剤。
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KR101852972B1 (ko) * | 2016-12-19 | 2018-04-30 | 주식회사 인터코스 | 마스크팩 |
KR101868113B1 (ko) * | 2016-12-19 | 2018-06-18 | 주식회사 인터코스 | 마스크팩의 제조방법 |
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JP5043396B2 (ja) * | 2006-10-13 | 2012-10-10 | 日本電子精機株式会社 | 貼付剤 |
JP5196828B2 (ja) * | 2007-04-03 | 2013-05-15 | バンドー化学株式会社 | 皮膚貼付薬シート |
JP5163868B2 (ja) * | 2007-12-28 | 2013-03-13 | ライオン株式会社 | 貼付剤 |
WO2010125691A1 (ja) * | 2009-05-01 | 2010-11-04 | ライオン株式会社 | 貼付剤 |
EP3674378A1 (en) * | 2011-06-27 | 2020-07-01 | Nitto Denko Corporation | Gasket |
CN104093760B (zh) * | 2012-04-19 | 2016-01-20 | Dic株式会社 | 树脂组合物、双组分型层压粘接剂、层压薄膜以及太阳能电池的背板 |
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JPH0584260A (ja) * | 1991-03-07 | 1993-04-06 | Bando Chem Ind Ltd | 皮膚貼付薬シート |
JPH06287134A (ja) * | 1992-04-16 | 1994-10-11 | Bando Chem Ind Ltd | 皮膚貼付薬シートの製造方法 |
JP2003012507A (ja) * | 2001-07-02 | 2003-01-15 | Teisan Seiyaku Kk | 外用剤適用貼付剤 |
JP2003286158A (ja) * | 2002-03-26 | 2003-10-07 | Tokuhon Corp | 貼付剤及びその製造方法 |
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JPH0584260A (ja) * | 1991-03-07 | 1993-04-06 | Bando Chem Ind Ltd | 皮膚貼付薬シート |
JPH06287134A (ja) * | 1992-04-16 | 1994-10-11 | Bando Chem Ind Ltd | 皮膚貼付薬シートの製造方法 |
JP2003012507A (ja) * | 2001-07-02 | 2003-01-15 | Teisan Seiyaku Kk | 外用剤適用貼付剤 |
JP2003286158A (ja) * | 2002-03-26 | 2003-10-07 | Tokuhon Corp | 貼付剤及びその製造方法 |
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KR101852972B1 (ko) * | 2016-12-19 | 2018-04-30 | 주식회사 인터코스 | 마스크팩 |
KR101868113B1 (ko) * | 2016-12-19 | 2018-06-18 | 주식회사 인터코스 | 마스크팩의 제조방법 |
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