JP2011162514A - 経皮吸収製剤並びにその製造方法 - Google Patents
経皮吸収製剤並びにその製造方法 Download PDFInfo
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Abstract
【解決手段】 支持体と前記支持体の表面上に配置された粘着剤層とを備えた経皮吸収製剤であって、前記支持体がカレンダー加工を施した織布又は編布からなるものであり、前記粘着剤層の厚さが20〜200μmであり、前記支持体に面した前記粘着剤層の表面の凹凸の高低差が10〜100μmであり、且つ、前記凹凸の高低差と前記粘着剤層の厚さとの比率(前記凹凸の高低差/前記粘着剤層の厚さ)が0.01〜0.5であることを特徴とする経皮吸収製剤。
【選択図】 なし
Description
前記支持体がカレンダー加工を施した織布又は編布からなるものであり、前記粘着剤層の厚さが20〜200μmであり、前記支持体に面した前記粘着剤層の表面の凹凸の高低差が10〜100μmであり、且つ、前記凹凸の高低差と前記粘着剤層の厚さとの比率(前記凹凸の高低差/前記粘着剤層の厚さ)が0.01〜0.5であることを特徴とするものである。
織布又は編布にカレンダー加工を施して支持体を得る工程と、
前記支持体の表面上に粘着剤層を配置し、前記粘着剤層の厚さが20〜200μmであり、前記支持体に面した前記粘着剤層の表面の凹凸の高低差が10〜100μmであり、且つ、前記凹凸の高低差と前記粘着剤層の厚さとの比率(前記凹凸の高低差/前記粘着剤層の厚さ)が0.01〜0.5である粘着剤層を得る工程と、
を含むことを特徴とする方法である。
例えば、溶剤法、ホットメルト法が挙げられる。
先ず、経皮吸収製剤の粘着剤層を作製した。すなわち、薬物としてリスペリドン40gと、感圧性粘着剤としてスチレン−イソプレン−スチレンブロック共重合体60gと、ポリアクリル酸エステル粘着剤(アクリル酸2−エチルヘキシル共重合体)25gと、粘着付与樹脂として脂環族飽和炭化水素樹脂(荒川化学工業社製、製品名「アルコンP−100」)225gと、可塑剤として流動パラフィン47gと、経皮吸収促進剤(有機酸およびその塩、脂肪酸プロピレングリコールエステル)103gと、有機溶媒としてトルエン500gとを混合し、均一に溶解させ、粘着剤層を構成する組成物(塗布液)を得た。得られた塗布液を剥離ライナー(離型処理としてシリコーン処理が施されたポリエチレンテレフタレートフィルム)上に展延し、温風(110℃)を0.2時間あててトルエンを乾燥除去し、厚さ約140μmの粘着剤層を得た。
カレンダー加工を施したポリエステル製メリヤス編布の代わりにポリエステルフィルム(スリーエム社製、製品名「Scotchpak#9732」、ポリエステル/ポリ酢酸ビニル積層フィルム、厚さ50.8μm、水蒸気透過率16g/m2/24hr)を用いた以外は実施例1と同様にして経皮吸収製剤を作製した。
ポリエステル製メリヤス編布にカレンダー加工を施さなかった以外は実施例1と同様にして経皮吸収製剤を作製した。
経皮吸収製剤の断面を走査型電子顕微鏡(SEM、フィリップス社製)で観察し撮影した。得られた結果を実施例1については図2に、比較例1については図3に、比較例2については図4に示す。
経皮吸収製剤の剥離ライナーを除去した状態で透湿度を測定した。測定はJIS Z0208に記載の方法(防湿包装材料透湿度試験方法(カップ法))に準じて行った。得られた結果を表1に示す。
経皮吸収製剤を約3cm2の大きさに裁断し、ダーマトームを用いて約500μmの厚さにしたヒト死体摘出皮膚の角質側に貼付した。一方、ヒト死体摘出皮膚の真皮側をレセプター層側にして、32℃の温水を外周部に循環させたフロースルーセルに装着した。レセプター層に生理食塩水を用い、約2mL/hrの流速で4時間毎にサンプリングを行った。貼付してから24時間後に経皮吸収製剤を剥離し、その後72時間までサンプリングを行った。得られたレセプター溶液を20ml測り取り、高速液体クロマトグラフィーを用いて、経皮吸収製剤から皮膚に吸収されたリスぺリドンの濃度を測定し、1時間あたりの皮膚透過速度を算出した。得られた結果を実施例1及び比較例1については図5に、比較例1及び比較例2については図6に示す。
Claims (12)
- 支持体と前記支持体の表面上に配置された粘着剤層とを備えた経皮吸収製剤であって、
前記支持体がカレンダー加工を施した織布又は編布からなるものであり、前記粘着剤層の厚さが20〜200μmであり、前記支持体に面した前記粘着剤層の表面の凹凸の高低差が10〜100μmであり、且つ、前記凹凸の高低差と前記粘着剤層の厚さとの比率(前記凹凸の高低差/前記粘着剤層の厚さ)が0.01〜0.5であることを特徴とする経皮吸収製剤。 - 前記凹凸の平均ピッチが50〜600μmであることを特徴とする請求項1に記載の経皮吸収製剤。
- 前記粘着剤層の粘度が3000〜9000Pa・sであることを特徴とする請求項1又は2に記載の経皮吸収製剤。
- 前記支持体の厚さが0.05〜0.5mmであり、且つ前記支持体の目付が30〜180g/m2であることを特徴とする請求項1〜3のうちのいずれか一項に記載の経皮吸収製剤。
- 前記支持体の通気度が30〜130cm3/cm2/sであることを特徴とする請求項1〜4のうちのいずれか一項に記載の経皮吸収製剤。
- 前記支持体の50%モジュラスが1〜20N/50mmであることを特徴とする請求項1〜5のうちのいずれか一項に記載の経皮吸収製剤。
- 支持体と前記支持体の表面上に配置された粘着剤層とを備えた経皮吸収製剤の製造方法であって、
織布又は編布にカレンダー加工を施して支持体を得る工程と、
前記支持体の表面上に粘着剤層を配置し、前記粘着剤層の厚さが20〜200μmであり、前記支持体に面した前記粘着剤層の表面の凹凸の高低差が10〜100μmであり、且つ、前記凹凸の高低差と前記粘着剤層の厚さとの比率(前記凹凸の高低差/前記粘着剤層の厚さ)が0.01〜0.5である粘着剤層を得る工程と、
を含むことを特徴とする経皮吸収製剤の製造方法。 - 前記凹凸の平均ピッチが50〜600μmであることを特徴とする請求項7に記載の経皮吸収製剤の製造方法。
- 前記粘着剤層の粘度が3000〜9000Pa・sであることを特徴とする請求項7又は8に記載の経皮吸収製剤の製造方法。
- 前記支持体の厚さが0.05〜0.5mmであり、且つ前記支持体の目付が30〜180g/m2であることを特徴とする請求項7〜9のうちのいずれか一項に記載の経皮吸収製剤の製造方法。
- 前記支持体の通気度が30〜130cm3/cm2/sであることを特徴とする請求項7〜10のうちのいずれか一項に記載の経皮吸収製剤の製造方法。
- 前記支持体の50%モジュラスが1〜20N/50mmであることを特徴とする請求項7〜11のうちのいずれか一項に記載の経皮吸収製剤の製造方法。
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Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPWO2015129808A1 (ja) * | 2014-02-27 | 2017-03-30 | 久光製薬株式会社 | ケトプロフェン含有パップ剤 |
JPWO2018124089A1 (ja) * | 2016-12-28 | 2019-10-31 | 久光製薬株式会社 | 貼付剤 |
US11872320B2 (en) | 2021-02-25 | 2024-01-16 | Hisamitsu Pharmaceutical Co., Inc. | Method for treating osteoarthritis |
Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2005170828A (ja) * | 2003-12-10 | 2005-06-30 | Toray Ind Inc | 貼付剤用布帛および貼付剤 |
JP2006075588A (ja) * | 2004-08-12 | 2006-03-23 | Nitto Denko Corp | 貼付材及び貼付製剤 |
JP2007151916A (ja) * | 2005-12-07 | 2007-06-21 | Hisamitsu Pharmaceut Co Inc | 貼付剤 |
WO2008016077A1 (en) * | 2006-08-04 | 2008-02-07 | Hisamitsu Pharmaceutical Co., Inc. | Adhesive preparation |
-
2010
- 2010-02-12 JP JP2010029535A patent/JP5860201B2/ja active Active
Patent Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2005170828A (ja) * | 2003-12-10 | 2005-06-30 | Toray Ind Inc | 貼付剤用布帛および貼付剤 |
JP2006075588A (ja) * | 2004-08-12 | 2006-03-23 | Nitto Denko Corp | 貼付材及び貼付製剤 |
JP2007151916A (ja) * | 2005-12-07 | 2007-06-21 | Hisamitsu Pharmaceut Co Inc | 貼付剤 |
WO2008016077A1 (en) * | 2006-08-04 | 2008-02-07 | Hisamitsu Pharmaceutical Co., Inc. | Adhesive preparation |
Cited By (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPWO2015129808A1 (ja) * | 2014-02-27 | 2017-03-30 | 久光製薬株式会社 | ケトプロフェン含有パップ剤 |
US9707194B2 (en) | 2014-02-27 | 2017-07-18 | Hisamitsu Pharmaceutical Co., Inc. | Ketoprofen-containing poultice |
JPWO2018124089A1 (ja) * | 2016-12-28 | 2019-10-31 | 久光製薬株式会社 | 貼付剤 |
US11020356B2 (en) | 2016-12-28 | 2021-06-01 | Hisamitsu Pharmaceutical Co., Inc. | Drug-containing patch |
JP7069042B2 (ja) | 2016-12-28 | 2022-05-17 | 久光製薬株式会社 | 貼付剤 |
US11872320B2 (en) | 2021-02-25 | 2024-01-16 | Hisamitsu Pharmaceutical Co., Inc. | Method for treating osteoarthritis |
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