JP5635829B2 - 皮膚用薬の対象への投与方法 - Google Patents
皮膚用薬の対象への投与方法 Download PDFInfo
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- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/02—Cosmetics or similar toiletry preparations characterised by special physical form
- A61K8/0208—Tissues; Wipes; Patches
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- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/02—Cosmetics or similar toiletry preparations characterised by special physical form
- A61K8/04—Dispersions; Emulsions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0014—Skin, i.e. galenical aspects of topical compositions
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- 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
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
- A61P17/04—Antipruritics
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
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- A—HUMAN NECESSITIES
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
- A61P17/08—Antiseborrheics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
- A61P17/14—Drugs for dermatological disorders for baldness or alopecia
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/10—Antimycotics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P33/00—Antiparasitic agents
- A61P33/14—Ectoparasiticides, e.g. scabicides
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/08—Antiallergic agents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
- A61Q19/00—Preparations for care of the skin
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Description
ここで議論する刊行物は、本出願の出願日前のものを開示するためにのみ提供する。先行発明の理由により、本発明がそれら刊行物に先行する資格がないことを認めると解釈すべきでない。更には提供した刊行日は実際の刊行日と異なるかも知れないので、独立して確認する必要があり得る。
ここで示された図は必ずしも縮図ではなく、明確化のためある要素および特徴を強調したものもある。
上記要約のとおり、本発明は皮膚用薬を宿主に投与する方法および組成物を提供する。主題の発明のさらなる記述においては、その方法と組成物を更に詳しく説明し、続いて当該方法と組成物を使用する代表的な適用例を概説する。
主題の発明に従うと、皮膚用薬の局所製剤がその対象に投与されヒドロゲルパッチがその皮膚用薬を遮蔽するために使用される。主題のヒドロゲルパッチ組成物の特徴は薬学的に活性な成分を含まないことであり、以下に詳細に説明するように「ブランク」のヒドロゲルパッチである。主題の発明を実施するには、皮膚用薬の局所製剤を対象の適用部位に局所的に投与する。局所的に投与するとすぐに、ブランクのヒドロゲルパッチ組成物を用いて皮膚用薬の局所製剤を遮蔽する。遮蔽された局所製剤は、その有効量の皮膚用薬を対象に投与するため十分な時間そこで維持される。
主題の方法で使用される主題のヒドロゲルパッチ組成物の特徴は、上記のとおり、主題のヒドロゲルパッチ組成物が薬学的に活性な薬物を含まず、またはむしろそれを欠くということである。こうして、主題の発明のヒドロゲルパッチ組成物はブランクのヒドロゲルパッチ組成物として正しく特徴付けされる。この点において、主題の方法で使用される薬学的に活性な任意の薬物は主題のヒドロゲルパッチ組成物から分離された成分である。
ヒドロゲルパッチ組成物のpHは一般に生理的に許容可能な範囲であり、通常3.0〜8.0、特に4.0〜7.0の範囲である。
上記の通り、少なくとも一つ以上のヒドロゲルパッチ組成物と皮膚用薬の局所製剤を含むキットがまた提供される。主題のキットに含まれるヒドロゲルパッチ組成物は支持体または裏当て材、例えば、上記のような非多孔性支持体の上にあってもよい。主題のキットのある態様では一つより多い主題のヒドロゲルパッチ組成物が提供される。そのような一つより多いヒドロゲルパッチ組成物がある態様では、多くのヒドロゲルパッチ組成物が一つの包装で一緒に封をされていてもよい。しかしながら、一般にはキット中の各ヒドロゲルパッチ組成物は個々に包装されていて、ひとつのヒドロゲルパッチ組成物がその包装から取り出されて使用されてもその他のヒドロゲルパッチ組成物はいずれも無傷で破られない。
主題の方法は、対象への皮膚用薬の局所投与が望まれる任意の適用で用途が見出せる。一般にはそのような対象は「哺乳類」であり、この語は哺乳類に属する有機体を記述する場合に広く使用されて、肉食動物目(例えば、イヌ、ネコ)、げっ歯目(例えば、マウス、モルモット、ラット)、霊長類(例えば、ヒト、チンパンジー、モンキー)が含まれる。多くの態様では対象はヒトである。
それぞれの例において、紅斑、硬結、および落屑を0−4のスケールで等級化した。各例で報告されたスコアは以下の基準に従ったスコアの総計(全スコア)である(例えば、紅斑3+硬結2+落屑4=全スコア9)。
乾癬治療のためのトリアムシノロン0.1%の投与(ヒドロゲルパッチ組成物による遮蔽ありまたはなし)
手順
ヒト宿主の対称的な二つの乾癬部位に、一日二回、二週間の期間、トリアムシノロン0.1%軟膏を局所投与した。主題のヒドロゲルパッチ組成物(ブランク)を用いて一方の部位に投与されたトリアムシノロン0.1%軟膏を遮蔽し、もう一方のトリアムシノロン0.1%軟膏は遮蔽しなかった。ヒドロゲルパッチはトリアムシノロン0.1%軟膏を投与するごとに交換した。治療を二週間継続し、四週間後に最終評価を行った。
乾癬治療のためのクロベタゾール0.05%の投与(ヒドロゲルパッチ組成物による遮蔽ありまたはなし)
手順
ヒト宿主の対称的な二つの乾癬部位に、一日二回、二週間の期間、クロベスタゾール0.05%軟膏を局所投与した。主題のヒドロゲルパッチ組成物(ブランク)を用いて一方の部位に投与されたクロベスタゾール0.05%軟膏を遮蔽し、もう一方のクロベスタゾール0.05%軟膏は遮蔽しなかった。ヒドロゲルパッチはクロベスタゾール0.05%を投与するごとに交換した。治療を二週間継続し、四週間後に最終評価を行った。
ヒドロゲルパッチ組成物による乾癬の治療(皮膚用薬の局所製剤の局所投与なし)
手順
ヒト宿主の乾癬部位に、一日二回、二週間の期間、主題のヒドロゲルパッチ組成物(ブランク)を局所適用した。宿主の対称的な感染部位には適用せず対照とした。治療を二週間継続し、四週間後に最終評価を行った。
Claims (5)
- 局所投与用の皮膚用薬を使用することなく、宿主の皮膚症状を治療するためのヒドロゲルパッチ組成物であって;
(i)水溶性高分子ゲル
(ii)20%(w/w)から80%(w/w)の水
(iii)水保持剤;および
(iv)架橋剤を含み、
該ヒドロゲルパッチ組成物は支持体上に存在して、薬学的に活性な薬物を含まず、かつ、
上記宿主の皮膚症状が乾癬であるヒドロゲルパッチ組成物。 - 該水溶性高分子ゲルが、ゼラチン、デンプン、寒天、マンナン、アルギン酸、ポリアクリル酸、ポリアクリル酸エステル、デキストリン、メチルセルロース、メチルセルロースナトリウム、ヒドロキシプロピルセルロース、カルボキシメチルセルロースナトリウム、セルロースガム、カルボキシビニルポリマー、ポリビニルアルコール、ポリビニルピロリドン、アラビアゴム、アカシア、トラガカントガム、カラヤガム、デンプンアクリル酸エステルコポリマー、デンプンアクリル酸ナトリウムグラフトコポリマーおよびこれらの組み合わせの少なくとも一つを含む、請求項1のヒドロゲルパッチ組成物。
- 該架橋剤が、乾燥水酸化アルミニウムゲル、酢酸ジヒドロキシアルミニウム、メタケイ酸アルミン酸マグネシウム(マグネシウムアルミノメタシリケート)、水酸化アルミニウム、メタケイ酸アルミン酸マグネシウム(マグネシウムメタシリケートアルミネート)、合成ケイ酸アルミニウム、水酸化カルシウム、硫酸アルミニウムアンモニウム、塩化カルシウムおよびこれらの組み合わせからなる群より選択される、請求項1のヒドロゲルパッチ組成物。
- 該水保持剤が、グリセリン、ソルビトール、プロピレングリコール、ジエチレングリコール、1,3−ブチレングリコール、エチレングリコールおよびこれらの組み合わせからなる群より選択される、請求項1のヒドロゲルパッチ組成物。
- 30%(w/w)から50%(w/w)の水を含む、請求項1のヒドロゲルパッチ組成物。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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US44557203P | 2003-02-07 | 2003-02-07 | |
US60/445,572 | 2003-02-07 |
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JP2006502835A Division JP5232385B2 (ja) | 2003-02-07 | 2004-01-14 | 皮膚用薬の対象への投与方法 |
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JP2014169845A Division JP2014237712A (ja) | 2003-02-07 | 2014-08-22 | 皮膚用薬の対象への投与方法 |
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JP2010280696A JP2010280696A (ja) | 2010-12-16 |
JP5635829B2 true JP5635829B2 (ja) | 2014-12-03 |
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JP2006502835A Expired - Fee Related JP5232385B2 (ja) | 2003-02-07 | 2004-01-14 | 皮膚用薬の対象への投与方法 |
JP2010176053A Expired - Fee Related JP5635829B2 (ja) | 2003-02-07 | 2010-08-05 | 皮膚用薬の対象への投与方法 |
JP2014169845A Ceased JP2014237712A (ja) | 2003-02-07 | 2014-08-22 | 皮膚用薬の対象への投与方法 |
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US (3) | US7887842B2 (ja) |
EP (1) | EP1589917B1 (ja) |
JP (3) | JP5232385B2 (ja) |
KR (2) | KR100853436B1 (ja) |
CN (1) | CN100502821C (ja) |
AR (1) | AR042986A1 (ja) |
ES (1) | ES2387804T3 (ja) |
TW (2) | TW201043270A (ja) |
WO (1) | WO2004071469A2 (ja) |
Families Citing this family (65)
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JP5254616B2 (ja) | 2004-09-13 | 2013-08-07 | クロノ セラピューティクス、インコーポレイテッド | 生物学的同調性(biosynchronous)経皮的薬物送達 |
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- 2004-01-14 KR KR20057014391A patent/KR100853436B1/ko not_active IP Right Cessation
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- 2004-01-14 EP EP04702188A patent/EP1589917B1/en not_active Expired - Lifetime
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- 2004-01-30 AR ARP040100291 patent/AR042986A1/es not_active Application Discontinuation
- 2004-02-06 TW TW99117183A patent/TW201043270A/zh unknown
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JP2010280696A (ja) | 2010-12-16 |
US7887842B2 (en) | 2011-02-15 |
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KR100853436B1 (ko) | 2008-08-21 |
JP5232385B2 (ja) | 2013-07-10 |
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JP2006517224A (ja) | 2006-07-20 |
US20040202706A1 (en) | 2004-10-14 |
TW201043270A (en) | 2010-12-16 |
US20100203107A1 (en) | 2010-08-12 |
CN1747703A (zh) | 2006-03-15 |
KR20080035024A (ko) | 2008-04-22 |
TW200505508A (en) | 2005-02-16 |
WO2004071469A2 (en) | 2004-08-26 |
AR042986A1 (es) | 2005-07-13 |
WO2004071469A3 (en) | 2004-12-29 |
US20130115268A1 (en) | 2013-05-09 |
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