JP7280870B2 - 皮膚障害の処置 - Google Patents
皮膚障害の処置 Download PDFInfo
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- JP7280870B2 JP7280870B2 JP2020517761A JP2020517761A JP7280870B2 JP 7280870 B2 JP7280870 B2 JP 7280870B2 JP 2020517761 A JP2020517761 A JP 2020517761A JP 2020517761 A JP2020517761 A JP 2020517761A JP 7280870 B2 JP7280870 B2 JP 7280870B2
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- cantharidin
- skin
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- A61K31/34—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide
- A61K31/343—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide condensed with a carbocyclic ring, e.g. coumaran, bufuralol, befunolol, clobenfurol, amiodarone
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/12—Ketones
- A61K31/121—Ketones acyclic
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
- A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
- A61K31/235—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids having an aromatic ring attached to a carboxyl group
- A61K31/24—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids having an aromatic ring attached to a carboxyl group having an amino or nitro group
- A61K31/245—Amino benzoic acid types, e.g. procaine, novocaine
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- A61K9/00—Medicinal preparations characterised by special physical form
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- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
- A61P31/20—Antivirals for DNA viruses
- A61P31/22—Antivirals for DNA viruses for herpes viruses
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Description
本出願は、35 U.S.C.§119(e)のもと、2017年6月6日に出願され、「Treatment of Cutaneous Disorders」と題された米国仮出願第62/516,061号の優先権を主張し、これはあらゆる目的についてその全体において参照により本明細書に組み込まれる。
背景
多くの皮膚障害は、皮膚上に病変を生成する。これらの病変のうちいくつかは、皮膚上の表皮増殖の形態である。実例として、いぼは、ウイルス感染によって引き起こされる小さな表皮の皮膚増殖であり、しばしば手または足に見受けられる。いぼの最も一般的な種類は、尋常性疣贅と呼ばれるものであり、それはヒトパピローマウイルス(HPV)の複数の異なる株によって引き起こされ得る。体のほとんどの部分で、これらのいぼは、一般的ないぼと呼ばれるだろう;しかしながら、足にある場合には足底疣贅、または生殖器にある場合には性器疣贅もしくはコンジローマ(condoloma)と呼ばれるだろう。伝染性軟属腫などの他の表皮のウイルス性疾患(viral condition)は、いぼと似ているが、別個のウイルスによって引き起こされるものである。これらのウイルス媒介の皮膚の増殖は、見苦しいものであり、がんへの変形についておよび蔓延について有意なリスクを有するであって、それらの除去を望ましいものとするであろう。他の表面の過剰増殖性障害は、いぼと似ているが、非ウイルス性メカニズムによって引き起こされており、脂漏性角化症、光線性角化症および汗孔角化症を含む。
カンタリジンを使用する皮膚病変(例として、伝染性軟属腫、脂漏性角化症、光線性角化症、稗粒腫、加齢によるシミ、汗孔角化症、または皮膚がん)を処置する方法、ならびに関連する組成物およびデバイスが提供される。いくつかのケースにおいて、本発明の主題は、相互に関係のある産物、特定の問題への代替の溶液、および/または1以上のシステムおよび/または物品の複数の種々の使用を伴う。
カンタリジンを使用する1以上の皮膚病変を処置する方法ならびに関連する組成物、処置計画、キット、デバイス、およびシステムが提供される。いくつかの態様において、1以上の皮膚病変を有する対象を処置する方法は、皮膚にカンタリジンを含む組成物を投与することを伴うだろう。実例として、組成物は、皮膚上の1以上の皮膚病変(例として、伝染性軟属腫(molluscum cantagiosum)の感染に由来する)に投与されるだろう。方法は、最小限の有害な副作用を伴うかまたは全く有害な副作用(例として、ひどく有害な副作用、恒久的な皮膚組織の損傷、瘢痕化、病変を取り囲む皮膚で過度に水疱を起こさせること、高められた血漿カンタリジン濃度、全身のカンタリジンへの暴露)を伴わずに、皮膚病変(単数または複数)の効果的な処置(例として、除去)を可能にするだろう。処置の有効性および/または安全性は、組成物のある特色および/または皮膚病変(単数または複数)のカンタリジンへの長期の暴露に起因されるだろう。実例として、比較的高いパーセンテージの皮膚病変(単数または複数)へ投与されたカンタリジンは、比較的長い期間(例として、6時間超)皮膚病変上に保持されるだろう。いくつかの態様において、皮膚に投与されたカンタリジンを含む組成物は、組成物およびしたがって皮膚病変(単数または複数)へのカンタリジンの限局性の送達(例として、周囲の皮膚の組成物またはカンタリジンへの暴露を防ぐためにおよび/または全身の組成物またはカンタリジンへの暴露を防ぐために)、皮膚病変(単数または複数)への比較的良好な付着、皮膚病変(単数または複数)内へのカンタリジンの経時的な比較的高い浸透、および/または比較的低い濃度(例として、約1.2%w/v以下)および/または薬物動力学のカンタリジンの使用について可能にするだろう。本明細書に記載の方法は、皮膚の表皮に主に影響を与える皮膚障害を含む、多種多様の皮膚障害について使用されてもよい。例えば、方法は、処置する伝染性軟属腫(molluscum cantagiosum)の感染、脂漏性角化症、光線性角化症、稗粒腫、皮膚がん、加齢によるシミ、およびヒトパピローマウイルスによって引き起こされない他の障害に使用されてもよい。
表1:例のカンタリジン製剤
表5:接着が優先される場合に有用であり得る、容易に視覚化される濃カンタリジン製剤の例
表6:ケミカルピーリングとして有用であり得る速乾性カンタリジン製剤の例
表7:いぼおよび軟属腫の処置のためのカンタリジン製剤の例
表8:カンタリジン製剤の例
表10:対象の個体群統計および薬物動態データ
Claims (30)
- 対象における皮膚病変を処置するための組成物であって、
カンタリジン、ここで、組成物は、約0.88のカンタリジンの重量パーセント当たりの重量を含む;
アセトン、ここで、組成物は、約60のアセトンの重量パーセント当たりの重量を含む;
エタノール、ここで、組成物は、約31.5のエタノールの重量パーセント当たりの重量を含む;
ヒマシ油、ここで、組成物は、約1.4のヒマシ油の重量パーセント当たりの重量を含む;
ニトロセルロース、ここで、組成物は、約4.5のニトロセルロースの重量パーセント当たりの重量を含む;
ヒドロキシプロピルセルロース、ここで、組成物は、約0.88のヒドロキシプロピルセルロースの重量パーセント当たりの重量を含む;および
ショウノウ、ここで、組成物は、約0.92のショウノウの重量パーセント当たりの重量を含む、
を含む、前記組成物。 - 安息香酸デナトニウム、ここで、組成物は、約0.006の安息香酸デナトニウムの重量パーセント当たりの重量を含む;および
ゲンチアナバイオレット、ここで、組成物は、約0.0005のゲンチアナバイオレットの重量パーセント当たりの重量を含む、
をさらに含む、請求項1に記載の組成物。 - 約0.88重量パーセントのカンタリジン;
約60重量パーセントのアセトン;
約31.5重量パーセントのエタノール;
約1.4重量パーセントのヒマシ油;
約4.5重量パーセントのニトロセルロース;
約0.88重量パーセントのヒドロキシプロピルセルロース;
約0.92重量パーセントのショウノウ;
約0.006重量パーセントの安息香酸デナトニウム;および
約0.0005重量パーセントのゲンチアナバイオレット
から実質的になる、請求項1に記載の組成物。 - 皮膚病変が、ヒトパピローマウイルスによって引き起こされない、請求項1~3のいずれか一項に記載の組成物。
- 皮膚病変が、ヒトパピローマウイルスによって引き起こされる、請求項1~3のいずれか一項に記載の組成物。
- 皮膚病変が、伝染性軟属腫、脂漏性角化症、光線性角化症、稗粒腫、加齢によるシミ、汗孔角化症、または皮膚がんである、請求項1~3のいずれか一項に記載の組成物。
- 皮膚病変が、伝染性軟属腫である、請求項6に記載の組成物。
- 皮膚病変が、主に皮膚の表皮に影響を与える皮膚障害からのものである、請求項1~7のいずれか一項に記載の組成物。
- 皮膚病変が、いぼである、請求項1~5のいずれか一項に記載の組成物。
- いぼが、尋常性疣贅、性器疣贅または足底疣贅である、請求項9に記載の組成物。
- 皮膚病変が、対象の生殖器の領域にある、請求項1~10のいずれか一項に記載の組成物。
- 使い捨てのアプリケーターデバイスをさらに含む、請求項1~11のいずれか一項に記載の組成物。
- 対象が、約15歳以下であり、体重のポンド(lb)当たり約0.1個以上の皮膚病変を有しており、および/または対象の重量が、約100lb以下である、請求項1~12のいずれか一項に記載の組成物。
- 皮膚病変当たり約3mg以上の量で組成物が投与される、請求項1~13のいずれか一項に記載の組成物。
- 投与される組成物の少なくとも一部が皮膚病変に約12時間超残存する、請求項1~14のいずれか一項に記載の組成物。
- 投与される組成物の少なくとも一部が皮膚病変に約18時間以上残存する、請求項1~15のいずれか一項に記載の組成物。
- 投与される組成物の少なくとも一部が皮膚病変に約24時間以上残存する、請求項1~15のいずれか一項に記載の組成物。
- 投与される組成物の少なくとも一部が皮膚病変に約24時間残存する、請求項1~15のいずれか一項に記載の組成物。
- 投与される組成物の少なくとも一部が皮膚病変に約12時間以上および約72時間以下残存する、請求項1~15のいずれか一項に記載の組成物。
- 投与される組成物の少なくとも一部が皮膚病変に約12時間以上および約48時間以下残存する、請求項1~15のいずれか一項に記載の組成物。
- 投与される組成物の少なくとも一部が皮膚病変に約18時間以上および約24時間以下残存する、請求項1~15のいずれか一項に記載の組成物。
- 皮膚病変の表皮組織の少なくとも一部を、皮膚病変の皮膚組織の少なくとも一部から分離させ、および/または皮膚組織が実質的に除去および/または損傷しない、請求項1~21のいずれか一項に記載の組成物。
- 投与された組成物の少なくとも一部が皮膚病変に残存し、およびここで、組成物の投与の間に投与されたカンタリジンの約10%以上が、皮膚病変中に浸透する、請求項1~22のいずれか一項に記載の組成物。
- 組成物の投与の間に投与されたカンタリジンの約90%以上が、皮膚病変中に浸透する、請求項23に記載の組成物。
- 投与された組成物の少なくとも一部が皮膚病変に残存し、およびここで、組成物は、組成物の投与後少なくとも12時間以内に、皮膚病変を取り囲む皮膚の少なくとも一部に水疱を誘発しない、請求項1~24のいずれか一項に記載の組成物。
- 投与された組成物の少なくとも一部が皮膚病変に残存し、およびここで、組成物は、組成物の投与後少なくとも12時間以内に、皮膚病変および任意に皮膚病変の端の約2mm以内の皮膚に水疱を誘発するのみである、請求項1~25のいずれか一項に記載の組成物。
- 組成物が数多の皮膚病変を約50%以上低減する、請求項1~26のいずれか一項に記載の組成物。
- 組成物が、皮膚病変を欠く皮膚との24時間の連続的な接触後に瘢痕をもたらさないか、または約10μL以下の組成物が皮膚上の直径5mmのエリアにわたって投与されるとき、または組成物の5mmの液滴が皮膚に投与されるとき、皮膚との24時間の連続的な接触後、約20mm超の直径を有する水疱を生成しない、請求項1~27のいずれか一項に記載の組成物。
- 投与された対象におけるカンタリジンの血漿濃度が、組成物の投与後、少なくとも2時間後、約3.3ng/ml以下である、投与された対象におけるカンタリジンの血漿濃度が、組成物の投与後、少なくとも6時間後、約3.3ng/ml以下である、および/または投与された対象におけるカンタリジンの血漿濃度が、組成物の投与後、少なくとも24時間後、約3.3ng/ml以下である、請求項1~28のいずれか一項に記載の組成物。
- 組成物の少なくとも一部が、投与された対象による12時間の通常の活動の後、皮膚病変の少なくとも一部に堅固に付着したままである、請求項1~29のいずれか一項に記載の組成物。
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