JPWO2008016077A1 - 貼付剤 - Google Patents
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- JPWO2008016077A1 JPWO2008016077A1 JP2008527771A JP2008527771A JPWO2008016077A1 JP WO2008016077 A1 JPWO2008016077 A1 JP WO2008016077A1 JP 2008527771 A JP2008527771 A JP 2008527771A JP 2008527771 A JP2008527771 A JP 2008527771A JP WO2008016077 A1 JPWO2008016077 A1 JP WO2008016077A1
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- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
- A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
- A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
- A61K9/7046—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds
- A61K9/7053—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds obtained by reactions only involving carbon to carbon unsaturated bonds, e.g. polyvinyl, polyisobutylene, polystyrene
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- A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
- A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
- A61L15/42—Use of materials characterised by their function or physical properties
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- A61K31/618—Salicylic acid; Derivatives thereof having the carboxyl group in position 1 esterified, e.g. salsalate
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- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
- A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
- A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
- A61K9/7076—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising ingredients of undetermined constitution or reaction products thereof, e.g. rosin or other plant resins
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- A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
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- A61L15/22—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
- A61L15/24—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds; Derivatives thereof
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- A—HUMAN NECESSITIES
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- A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
- A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
- A61L15/42—Use of materials characterised by their function or physical properties
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- A—HUMAN NECESSITIES
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- A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F13/00—Bandages or dressings; Absorbent pads
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F15/00—Auxiliary appliances for wound dressings; Dispensing containers for dressings or bandages
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- A—HUMAN NECESSITIES
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- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
- A61L2300/216—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials with other specific functional groups, e.g. aldehydes, ketones, phenols, quaternary phosphonium groups
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- B32B7/00—Layered products characterised by the relation between layers; Layered products characterised by the relative orientation of features between layers, or by the relative values of a measurable parameter between layers, i.e. products comprising layers having different physical, chemical or physicochemical properties; Layered products characterised by the interconnection of layers
- B32B7/04—Interconnection of layers
- B32B7/12—Interconnection of layers using interposed adhesives or interposed materials with bonding properties
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T428/00—Stock material or miscellaneous articles
- Y10T428/28—Web or sheet containing structurally defined element or component and having an adhesive outermost layer
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T428/00—Stock material or miscellaneous articles
- Y10T428/28—Web or sheet containing structurally defined element or component and having an adhesive outermost layer
- Y10T428/2852—Adhesive compositions
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
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- Y10T442/00—Fabric [woven, knitted, or nonwoven textile or cloth, etc.]
- Y10T442/20—Coated or impregnated woven, knit, or nonwoven fabric which is not [a] associated with another preformed layer or fiber layer or, [b] with respect to woven and knit, characterized, respectively, by a particular or differential weave or knit, wherein the coating or impregnation is neither a foamed material nor a free metal or alloy layer
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
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Abstract
Description
Journal of Clin Pharmacol 2004;44:1151−1157 Journal of chromatography.B,Biomedical sciences and applications、1999年6月11日;729(1−2):163−71
実施例1〜3で使用される支持体、ポリエチレンテレフタレートの両面メリヤス編み織布であり、また、それぞれの粘着剤層の成分及び配合割合は下記表1に示している。
上記実施例1及び3の貼付剤の透湿度は、カップ法(JIS Z0208)に従い、温度40℃、相対湿度90%で測定した。
実施例1の貼付剤280cm2(サリチル酸メチル:336mg;l−メントール:100mg)を健常成人7名に8時間貼付し、経時的に採血を実施した。採血は貼付開始時から、0、0.5、1、2、3、4、6、8、10、12、18、及び24時間にそれぞれ行われ、1回の採血量は7mLであった。なお、サリチル酸メチル及びl−メントールは日用品に多く含まれているため、貼付前及び貼付中の使用を避けた。
サリチル酸メチル、サリチル酸メチルの代謝物であるサリチル酸、及びl−メントールの血漿中濃度をそれぞれ測定した。測定は、サリチル酸について液体クロマトグラムマススペクトル法にて、サリチル酸メチル及びl−メントールについてガスクロマトグラムマススペクトル法にて行われた。それぞれの測定法は事前にバリデートし、測定の信頼性を確認した。なお、貼付中の血漿中濃度としては、実際の測定値から貼付前の内因性の濃度(0時間の測定値)を差し引いた値を使用した。Cmax及びAUC0−24は定法に従って算出した。
実施例5と同様の実験を健常成人101名に対し行った結果、サリチル酸メチルのAUC0−24は、最大値139.0ng・hr/mL、最小値3.7ng・hr/mL、平均値30.1ng・hr/mLであり、Cmaxは、最大値109.4ng/mL、最小値2.5ng/mL、平均値21.1ng/mLであった(ただし、サリチル酸メチルのAUC0−24については上記101名のうち48名についての測定結果である)。 また、サリチル酸のAUC0−24は、最大値24731ng・hr/mL、最小値3464ng・hr/mL、平均値8848ng・hr/mLであり、Cmaxは、最大値4100ng/mL、最小値531ng/mL、平均値1291ng/mLであった。 そして、l−メントールのAUC0−24は、最大値273.0ng・hr/mL、最小値11.1ng・hr/mL、平均値80.6ng・hr/mLであり、Cmaxは、最大値51.0ng/mL、最小値2.6ng/mL、平均値12.4ng/mLであった。それぞれの薬物動態パラメータを表3に示す。なお、この血漿中濃度の測定は、FDA(米国食品医薬品局)のガイドライン(Guidance for Industry=Bioanalytical Method Validation)に準拠して行った。
Claims (10)
- 伸縮性を有する支持体と、該支持体の少なくとも片面に積層された粘着剤層とを備える貼付剤であって、
前記伸縮性を有する支持体は、捲縮加工が施された両面メリヤス編みの織布からなり、
前記粘着剤層は、該層の全質量基準で10質量%以上のサリチル酸メチルを含有しており、
前記貼付剤全体として、温度40℃、相対湿度90%で測定した透湿度が1〜350g/m2・24hrであり、
前記粘着剤層の塗布量を50〜300g/m2とし、接触面積が280cm2となるようにヒトの皮膚に前記貼付剤を8時間貼付したときに、前記サリチル酸メチルの血漿中のAUC0−24の平均値±標準偏差の範囲が3.0〜60.0ng・hr/mLであり、前記サリチル酸メチルの代謝物であるサリチル酸の血漿中のAUC0−24の平均値±標準偏差の範囲が5000〜13000ng・hr/mLである、貼付剤。 - 前記粘着剤層の塗布量を50〜300g/m2とし、接触面積が280cm2となるようにヒトの皮膚に前記貼付剤を8時間貼付したときに、
前記サリチル酸メチルの血漿中のCmaxの平均値±標準偏差の範囲が2.0〜40.0ng/mLであり、前記サリチル酸の血漿中のCmaxの平均値±標準偏差の範囲が700〜2000ng/mLである、請求項1に記載の貼付剤。 - 前記粘着剤層は、該層の全質量基準でl−メントールを1質量%以上含有する、請求項1又は2に記載の貼付剤。
- 前記粘着剤層の塗布量を50〜300g/m2とし、接触面積が280cm2となるようにヒトの皮膚に前記貼付剤を8時間貼付したときに、
前記l−メントールの血漿中のAUC0−24の平均値±標準偏差の範囲が30.0〜130.0ng・hr/mLであり、血漿中のCmaxの平均値±標準偏差の範囲が5.0〜20.0ng/mLである、請求項3に記載の貼付剤。 - 前記織布は、80〜150g/m2の目付けを有する、請求項1〜4のいずれか一項に記載の貼付剤。
- 前記粘着剤層は、熱可塑性エラストマーを含有する、請求項1〜5のいずれか一項に記載の貼付剤。
- 前記熱可塑性エラストマーが、スチレン−イソプレン−スチレンブロック共重合体、スチレン−ブタジエン−スチレンブロック共重合体、スチレン−イソプレンゴム、スチレン−ブタジエンゴム、ポリイソプレン、ポリブタジエン、及びポリイソブチレンからなる群より選択される1種又は2種以上である、請求項6記載の貼付剤。
- 前記熱可塑性エラストマーの含有量は、前記粘着剤層の全質量基準で25質量%〜50質量%である、請求項6又は7に記載の貼付剤。
- 前記粘着剤層は、粘着付与剤としてロジン系樹脂及び/又は石油系樹脂を含有する、請求項1〜8のいずれか一項に記載の貼付剤。
- 前記粘着付与剤の含有量は、前記粘着剤層の全質量基準で10質量%〜30質量%である、請求項9記載の貼付剤。
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JP2008527771A JP5230423B2 (ja) | 2006-08-04 | 2007-08-01 | 貼付剤 |
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PCT/JP2007/065067 WO2008016077A1 (en) | 2006-08-04 | 2007-08-01 | Adhesive preparation |
JP2008527771A JP5230423B2 (ja) | 2006-08-04 | 2007-08-01 | 貼付剤 |
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JP5230423B2 JP5230423B2 (ja) | 2013-07-10 |
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US (3) | US8455376B2 (ja) |
EP (1) | EP2047845B1 (ja) |
JP (1) | JP5230423B2 (ja) |
KR (1) | KR101420450B1 (ja) |
CN (1) | CN101442993B (ja) |
AU (1) | AU2007279643B2 (ja) |
BR (1) | BRPI0712396B8 (ja) |
CA (1) | CA2652220C (ja) |
ES (1) | ES2755027T3 (ja) |
HU (1) | HUE047985T2 (ja) |
MX (1) | MX2008014574A (ja) |
MY (1) | MY149142A (ja) |
NZ (1) | NZ572705A (ja) |
RU (1) | RU2441649C2 (ja) |
SG (1) | SG174034A1 (ja) |
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JP5230423B2 (ja) * | 2006-08-04 | 2013-07-10 | 久光製薬株式会社 | 貼付剤 |
DE102009006591A1 (de) * | 2009-01-29 | 2010-08-05 | Tesa Se | Haftklebemasse |
JP5860201B2 (ja) * | 2010-02-12 | 2016-02-16 | 久光製薬株式会社 | 経皮吸収製剤並びにその製造方法 |
EP2614819A4 (en) * | 2010-09-03 | 2014-04-23 | Km Transderm | PERCUTANEOUS ABSORBENT AND ADHESIVE SHEET FOR TRANSDERMAL STAMP |
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CA2652220A1 (en) | 2008-02-07 |
HUE047985T2 (hu) | 2020-05-28 |
KR20090035474A (ko) | 2009-04-09 |
RU2008144958A (ru) | 2010-05-20 |
BRPI0712396A2 (pt) | 2012-10-16 |
TWI414299B (zh) | 2013-11-11 |
ES2755027T3 (es) | 2020-04-21 |
SG174034A1 (en) | 2011-09-29 |
KR101420450B1 (ko) | 2014-07-16 |
MX2008014574A (es) | 2009-02-06 |
US20100047328A1 (en) | 2010-02-25 |
US8455376B2 (en) | 2013-06-04 |
AU2007279643A1 (en) | 2008-02-07 |
EP2047845B1 (en) | 2019-10-09 |
US9233184B2 (en) | 2016-01-12 |
CA2652220C (en) | 2014-07-08 |
EP2047845A4 (en) | 2013-10-30 |
US20090149794A1 (en) | 2009-06-11 |
BRPI0712396A8 (pt) | 2020-03-24 |
WO2008016077A1 (en) | 2008-02-07 |
CN101442993B (zh) | 2011-10-05 |
US20140371693A1 (en) | 2014-12-18 |
NZ572705A (en) | 2011-12-22 |
BRPI0712396B8 (pt) | 2021-05-25 |
MY149142A (en) | 2013-07-15 |
BRPI0712396B1 (pt) | 2020-04-22 |
AU2007279643B2 (en) | 2012-09-13 |
JP5230423B2 (ja) | 2013-07-10 |
EP2047845A1 (en) | 2009-04-15 |
CN101442993A (zh) | 2009-05-27 |
TW200817013A (en) | 2008-04-16 |
US8809615B2 (en) | 2014-08-19 |
RU2441649C2 (ru) | 2012-02-10 |
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