JP5662038B2 - 貼付剤および貼付製剤 - Google Patents
貼付剤および貼付製剤 Download PDFInfo
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- JP5662038B2 JP5662038B2 JP2010047178A JP2010047178A JP5662038B2 JP 5662038 B2 JP5662038 B2 JP 5662038B2 JP 2010047178 A JP2010047178 A JP 2010047178A JP 2010047178 A JP2010047178 A JP 2010047178A JP 5662038 B2 JP5662038 B2 JP 5662038B2
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Description
(i)粘着剤層成分の貼付剤等の端部からの滲み出しまたははみ出しが抑制され、包装体内で保存中、貼付剤等の包装体内面への付着が抑制されて、包装体内からの取り出しが容易であり;
(ii)皮膚に貼付した際に、端部が衣服等とこすれる機会が低減され、端部がめくれにくく、十分な皮膚接着力を有し、皮膚面からきわめて脱落しにくく;
(iii)使用に際し、剥離ライナーの粘着剤層からの剥離も容易である貼付剤および貼付製剤を提供することである。
[1]支持体の少なくとも一方の面に粘着剤層を有し、かつ粘着剤層の支持体とは反対側の面に剥離ライナーを有する貼付剤であって、
(a)粘着剤層の側面端部が露出しており、
(b)少なくとも一つの側面端部において、粘着剤層の側面端部が、支持体の側面端部より貼付剤の中央部側に位置し、かつ
(c)剥離ライナーを下にして貼付剤を水平面上に置いた場合に、貼付剤の該側面端部における支持体上端と剥離ライナー下端の間隔Aが、貼付剤中央部の厚さBより大きいものである、貼付剤。
[2]少なくとも一つの側面端部において、粘着剤層の側面端部が、支持体の側面端部より1μm〜1000μm貼付剤の中央部側に位置する、上記[1]に記載の貼付剤。
[3]少なくとも一つの側面端部において、貼付剤の該側面端部における支持体上端と剥離ライナー下端の間隔Aが、粘着剤層の該側面端部における貼付剤の厚さCよりも大きいものである、上記[1]に記載の貼付剤。
[4]少なくとも一つの側面端部において、粘着剤層の該側面端部における貼付剤の厚さCが、貼付剤中央部の厚さBと等しいものである、上記[1]に記載の貼付剤。
[5]少なくとも一つの側面端部において、粘着剤層端部が凹面状である、上記[1]に記載の貼付剤。
[6]粘着剤層がゴム系粘着剤を含有する、上記[1]〜[5]のいずれかに記載の貼付剤。
[7]粘着剤層が架橋されていない、上記[1]〜[6]のいずれかに記載の貼付剤。
[8]粘着剤層が有機液状成分を含有する、上記[1]〜[7]のいずれかに記載の貼付剤。
[9]上記[1]〜[8]のいずれかの貼付剤において、粘着剤層に薬物を含有させてなる、貼付製剤。
J0=ηsp/c(1+Aηsp) (1)
上式中、ηsp=t/t0−1
t;溶液のフロータイム(Hagenbach−couette補正式による)
t0;溶媒のフロータイム(Hagenbach−couette補正式による)
c;溶液の濃度(g/cm3)
A;高分子溶液に特有の定数
J0=kMvα (2)
Mv;粘度平均分子量
k、α;高分子に特有の定数
(1)粘着シートの調製
<粘着剤層形成用組成物の調製>
高分子量ポリイソブチレン(粘度平均分子量;4,000,000) 0.620kg、脂環族飽和炭化水素樹脂(環球法による軟化点;120℃〜160℃) 1.127kg、トルエン 4.456kg、およびn−ヘキサン 4.726kgを秤量し、調合タンクにて24時間以上攪拌した。次いで、中分子量ポリイソブチレン(粘度平均分子量;55,000) 1.071kgを秤量し、調合タンクに投入し24時間以上攪拌した。その後、ミリスチン酸イソプロピル 1.232kgおよびトルエン 0.270kgを秤量し、調合タンクに投入し4時間以上攪拌して粘着剤層形成用組成物を得た。
<打ち抜き用原反の調製>
上記組成物を、バックロールとコンマロールからなるコーターを用いて、厚さ75μmのポリエチレンテレフタレート(以下「PET」)製剥離ライナーの易剥離処理面に、乾燥後の粘着剤層の厚さが160μmとなるように塗布し、乾燥した。得られた粘着剤層の粘着面を、厚さ3.5μmのPETフィルムと目付け量:10g/m2〜20g/m2のPET製不織布の積層体よりなる支持体のPET不織布面に圧着させ、貼付剤打ち抜き用原反を得た。
上記の貼付剤打ち抜き用原反を、型押し部(熱プレス+型押し金型)およびダイセット金型(オス型、メス型)を備える打抜包装機を用いて打ち抜き、貼付剤を成形した。型押し部の押し幅、加熱温度、および型押し時の圧力を表1に示すように調整することにより、実施例1、2及び比較例1〜3の貼付剤を得た。
実施例および比較例の各貼付剤をルテニウム酸水溶液で染色した後、凍結ミクロトーム(大和光機工業株式会社製、LR−85)により切断し、切断面をFE−SEM(株式会社日立製作所製、S−4800)にて、50倍〜1000倍の倍率で撮影した。各貼付剤の電子顕微鏡写真において、周辺部および中央部について、ゲージ目盛りを読むことにより、PET製フィルムおよびPET製不織布の厚さ、ならびに貼付剤本体の厚さ(粘着剤層の厚さと支持体の厚さの和)を測定した。その際、PET製不織布の表面には凹凸が存在するが、断面写真においてその凸部10箇所を無作為に選択し、当該凸部におけるPET製不織布の厚さを算術平均して、PET製不織布の厚さとした。次いで貼付剤本体の厚さからPET製フィルムの厚さおよび前記PET製不織布の厚さを差し引き、周辺部および中央部について、粘着剤層の厚さを求めた。また、貼付剤の側面端部における支持体上端と剥離ライナー下端との間隔A、および粘着剤層の側面端部が支持体の側面端部よりどれだけ貼付剤の中央部側に位置するかを測定した。なお、実施例および比較例の各貼付剤について、それらの端部の断面の写真を図6〜図10に示した。
図11に示すように、貼付剤包装体の2辺をハサミで、またはVノッチに従い開封した。開封部より、貼付剤の角をつかんで取り出し、以下の評価基準に従い、包装体からの貼付剤の取り出し性を三段階で評価した。
<評価基準>
○;粘着剤層成分の滲み出しまたははみ出しがなく、容易に取り出すことができる
△;貼付剤の一部で粘着剤層成分の滲み出しまたははみ出しがあるが、取り出しは可能である
×;粘着剤層成分の滲み出しまたははみ出しが顕著であり、取り出しが困難である
専門の評価者が貼付剤を包装体から取り出し、朝から24時間胸部に貼付し、貼付状態について、以下の評価基準に従い、三段階で評価した。貼付剤を貼付している間の評価者の行動は通常通りとした。また評価者が朝に入浴する場合は、入浴直後(30分以内)を避けて貼付することとした。実施例および比較例の各貼付剤について、同一の評価者(1名)が1回ずつ評価した。
<評価基準>
○;貼付剤は24時間脱落せず、端部のメクレも発生しなかった
△;貼付剤は24時間脱落しなかったが、端部のメクレが発生した
×;貼付剤が24時間以内に脱落した
50歳以上の男性パネラー5名に、貼付剤から剥離ライナーを剥離させ、その剥離性について官能評価させた。評価結果を以下の基準で要約した。
<評価の要約基準>
○;全員が容易に剥離できると感じた
△;一部のパネラーが容易に剥離できないと感じた
×;全員が容易に剥離できないと感じた
上記粘着剤層形成用組成物において、トルエン以外の全配合成分100重量部に対し、インドメタシン(消炎鎮痛剤)を1重量部加えて、経皮吸収性製剤用の粘着剤層形成用組成物を調製した。前記組成物を用いて、上記実施例1、2と同様の方法により貼付製剤を得た。実施例3および4の貼付製剤は、包装体からの取り出し性、皮膚貼付性および剥離ライナーの剥離性において、上記実施例1および2の貼付剤と同様の効果を奏するものである。
2 粘着剤層
3 剥離ライナー
4 中央部
5 周辺部
a 貼付剤側面端部における支持体の上端
b 貼付剤側面端部における剥離ライナーの下端
b’貼付剤側面端部における支持体の上端aから剥離ライナー下端に引いた垂線と剥離ライナー下端との交点
c 粘着剤層側面端部における支持体の上端
d 粘着剤層側面端部における剥離ライナーの下端
d’粘着剤層側面端部における支持体の上端cから剥離ライナー下端に引いた垂線と剥離ライナー下端との交点
e 貼付剤中心部における支持体の上端
f 貼付剤中心部における支持体上端eから剥離ライナー下端に引いた垂線と剥離ライナー下端との交点
A 貼付剤側面端部における支持体上端と剥離ライナーの下端の間隔
B 貼付剤中央部の厚さ
C 粘着剤層側面端部における貼付剤の厚さ
Claims (9)
- 支持体の少なくとも一方の面に粘着剤層を有し、かつ粘着剤層の支持体とは反対側の面に剥離ライナーを有する貼付剤であって、
(a)粘着剤層の側面端部が露出しており、
(b)少なくとも一つの側面端部において、粘着剤層の側面端部が、支持体の側面端部よりも、貼付剤の中央部側に位置し、かつ
(c)剥離ライナーを下にして貼付剤を水平面上に置いた場合に、貼付剤の該側面端部における支持体上端と剥離ライナー下端の間隔Aが、貼付剤中央部の厚さBよりも大きいものである、貼付剤。 - 少なくとも一つの側面端部において、粘着剤層の側面端部が、支持体の側面端部より1μm〜1000μm貼付剤の中央部側に位置する、請求項1に記載の貼付剤。
- 少なくとも一つの側面端部において、貼付剤の該側面端部における支持体上端と剥離ライナー下端の間隔Aが、粘着剤層の該側面端部における貼付剤の厚さCよりも大きいものである、請求項1に記載の貼付剤。
- 少なくとも一つの側面端部において、粘着剤層の該側面端部における貼付剤の厚さCが、貼付剤中央部の厚さBと等しいものである、請求項1に記載の貼付剤。
- 少なくとも一つの側面端部において、粘着剤層端部が凹面状である、請求項1に記載の貼付剤。
- 粘着剤層がゴム系粘着剤を含有する、請求項1に記載の貼付剤。
- 粘着剤層が架橋されていない、請求項1に記載の貼付剤。
- 粘着剤層が有機液状成分を含有する、請求項1に記載の貼付剤。
- 請求項1〜8のいずれか1項に記載の貼付剤において、粘着剤層に薬物を含有させてなる、貼付製剤。
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