JP6669334B2 - 掻痒治療用の組成物とキット及びそれらの使用方法 - Google Patents
掻痒治療用の組成物とキット及びそれらの使用方法 Download PDFInfo
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- JP6669334B2 JP6669334B2 JP2017518220A JP2017518220A JP6669334B2 JP 6669334 B2 JP6669334 B2 JP 6669334B2 JP 2017518220 A JP2017518220 A JP 2017518220A JP 2017518220 A JP2017518220 A JP 2017518220A JP 6669334 B2 JP6669334 B2 JP 6669334B2
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Description
α−アミラーゼ#1、ブタ膵臓、30U/mg、シグマ・アルドリッチ(Sigma Aldrich)、A3176-500KU、ロットSLBF3831V。
AC、抗菌組成物、水、95.5重量%、PHMB 0.1重量%、EDTA 0.065重量%、P407 2重量%、HPMC、2重量%、SC50 0.3重量%、SC10、0.1重量%、pH5.5。
プロテアーゼは、皮膚疾患の治療に関与している。α−アミラーゼがコラーゲンゲル(すなわち、タンパク質ベースのゲル)を切断することができるプロテアーゼを含有するかどうかを決定するために、可能性のある消化酵素としてα−アミラーゼ及びコラゲナーゼを用いて、種々の周波数条件下におけるレオロジーによって、コラーゲンゲル消化を研究した。α−アミラーゼがコラーゲンゲルの消化力を有していない場合、その抗掻痒活性は、コラゲナーゼなどによるようなコラーゲンポリマー鎖のペプチド結合の加水分解によるのではなく、プロテアーゼによるいかなる汚染にも基づくものではない。
2mg(250U)のコラゲナーゼ
8mg(250U)のα−アミラーゼ#1
例1 白人70歳代男性は、かゆみによって損傷を受けた皮膚に細菌性α−アミラーゼ#6溶液を塗布したが、それは引っ掻きにより赤く腫れた炎症を起こしていた。α−アミラーゼ溶液は、NaOHによりpH7に調節され、水/アミラーゼの重量比が99.66/0.34であって、α−アミラーゼ活性は1g/25,000Uであった。酵素製剤で処理した不織布を用いて、炎症を起こした赤い腫れを含む掻痒皮膚に溶液を塗布した。溶液は、観察可能な不快感を伴わうことなく皮膚上に10分間放置され、濡れた布で数回拭いて除去された。掻痒は最初の塗布から約15分後に減少し、皮膚は少なくとも12時間炎症の少ない状態のままであった。このプロセスを12時間ごとに2日間繰り返して、掻痒をなくし、赤い腫れを著しく減少させてなくした。
例5 表1において、アミラーゼ製剤は、動物、ヒト及び細菌源由来のα−アミラーゼ、大麦(穀類)由来のβ−アミラーゼ、及び真菌由来のγ−アミラーゼ、及びそれらの組み合わせに基づいて、水中で調製された。
Claims (24)
- 非タンパク質分解酵素成分を含む掻痒を局所的に治療するための酵素掻痒組成物であって、前記非タンパク質分解酵素成分が少なくとも80重量%のアミラーゼを含み、前記酵素掻痒組成物中の非タンパク質分解酵素のタンパク質分解酵素に対する重量比が少なくとも4:1である組成物。
- 前記アミラーゼがヒト、動物、細菌、植物、真菌から単離されたアミラーゼ、及び遺伝子組換えにより単離されたアミラーゼからなる群から選択された請求項1記載の組成物。
- 前記非タンパク質分解酵素成分が少なくとも10重量%のα−アミラーゼを含む請求項1記載の組成物。
- 前記非タンパク質分解酵素成分がβ−アミラーゼ、γ−アミラーゼ、又はその両方を含む請求項3記載の組成物。
- さらに、薬学的に許容される担体又は賦形剤を含む請求項1記載の組成物。
- 前記非タンパク質分解酵素成分は、コンドロイチナーゼ、ヒアルロニダーゼ、リパーゼ、グリコシダーゼ、ヘパラナーゼ、デルマタナーゼ、プルラナーゼ、N−アセチルグルコサミニダーゼ、ラクターゼ、ホスホリパーゼ、トランスグリコシラーゼ、エステラーゼ、チオエステル加水分解酵素、スルファターゼ、エスカラーゼ、ヌクレアーゼ、ホスファターゼ、ホスホジエステラーゼ、マンナナーゼ、マンノシダーゼ、イソアミラーゼ、リアーゼ、イヌリナーゼ、タンナーゼ、ペントサナーゼ、グルカナーゼ、アラビノシダーゼ、ペクチナーゼ、セルラーゼ、キチナーゼ、キシラナーゼ、クチナーゼ、ペクチン酸リアーゼ、ヘミセルラーゼ、及びそれらの混合物からなる群から選択される他の加水分解酵素を20重量%まで含む請求項1記載の組成物。
- 前記アミラーゼがヒト膵臓、動物の膵臓、及び細菌からなる群から選択された少なくとも1つの供給源から得られたα−アミラーゼを含む請求項1記載の組成物。
- 前記非タンパク質分解酵素成分がオキシダーゼ、ペルオキシダーゼ、グルコースオキシダーゼ、カタラーゼ、オキシドレダクターゼ、フェノールオキシダーゼ、ラッカーゼ、リポキシゲナーゼ、イソメラーゼ、及びリグニナーゼから選択された酵素を20重量%まで含む請求項1記載の組成物。
- さらに、アミラーゼとビグアニドの合計重量に基づいて少なくとも0.01重量パーセント(100ppm)から1.0重量パーセント(10,000ppm)の量の、少なくとも1種のポリマー性ビグアニドを含む請求項1記載の組成物。
- 前記ポリマー性ビグアニドがポリ(ヘキサメチレンビグアニド)又は1種のその塩を含む請求項9記載の組成物。
- さらに、前記組成物の0.01重量%から50重量%の濃度の水溶性ポリマーを含み、前記水溶性ポリマーがメチルセルロース、ヒドロキシエチルセルロース、ヒドロキシプロピルセルロース、ヒドロキシプロピルメチルセルロース、カルボキシメチルセルロース、グアーガム、ヒドロキシエチルグアー、ヒドロキシプロピルグアー、ヒドロキシプロピルメチルグアー、カルボキシメチルグアー、カルボキシメチルキトサン、ローカストビーンガム、カラギーナン、キサンタンガム、ジェランガム、アロエベラゲル、スクレログルカン、シゾフィラン、アラビアガム、タマリンドガム、ポリ(ビニルアルコール)、ポリ(エ
チレンオキシド)、ポリ(エチレングリコール)、ポリ(メチルビニルエーテル)、カルボマー及びその塩、ポリ(アクリル酸)及びその塩、ポリ(メタクリル酸)及びその塩、ポリ(2−アクリルアミド−2−メチルプロパンスルホン酸)ナトリウム、ポリアクリルアミド、ポリ(N,N−ジメチルアクリルアミド)、ポリ(N−ビニルアセトアミド)、ポリ(N−ビニルホルムアミド)、ポリ(2−ヒドロキシエチルメタクリレート)、ポリ(メタクリル酸グリセリル)、ポリ(N−ビニルピロリドン)、ポリ(N−イソプロピルアクリルアミド)及びポリ(N−ビニルカプロラクタム)、並びにそれらの組み合わせからなる群から選択された請求項1記載の組成物。 - さらに、前記組成物の総重量に基づいて0.01重量%から1重量%の濃度のキレート剤を含み、前記キレート剤がエチレンジアミン四酢酸(EDTA)、ニトリロ三酢酸、ニトリロトリプロピオン酸、ジエチレントリアミン五酢酸、2−ヒドロキシエチルエチレンジアミン三酢酸、1,6−ジアミノヘキサメチレン四酢酸、1,2−ジアミノシクロヘキサン四酢酸、O,O’−ビス(2−アミノエチル)エチレングリコール四酢酸、1,3−ジアミノプロパン四酢酸、N,N’−ビス(2−ヒドロキシベンジル)エチレンジアミン−N,N’−二酢酸、エチレンジアミン−N,N’−二酢酸、エチレンジアミン−N,N’−ジプロピオン酸、トリエチレンテトラアミン六酢酸、エチレンジアミン−N,N’−ビス(メチレンホスホン酸)、イミノ二酢酸、一ナトリウム−N−ラウリル−β−イミノジプロピオン酸(ラウリミノ二プロピオン酸ナトリウム、デリファット(登録商標)160C)、N,N−ビス(2−ヒドロキシエチル)グリシン、1,3−ジアミノ−2−ヒドロキシプロパン四酢酸、1,2−ジアミノプロパン四酢酸、エチレンジアミンテトラキス(メチレンホスホン酸)、N−(2−ヒドロキシエチル)イミノ二酢酸、ビホスホネート、エディトロン酸塩、それらの塩、及びそれらの組み合わせからなる群から選択された請求項1記載の組成物。
- さらに、1,2−プロパンジオール(プロピレングリコール)、1,2−ブタンジオール、1,2−ペンタンジオール、1,2−ヘキサンジオール、1,2−ヘプタンジオール、1,2−オクタンジオール(カプリリルグリコール)、1,2−ノナンジオール、1,2−デカンジオール、1,2−ウンデカンジオール、1,2−ドデカンジオール、1,2−トリデカンジオール、1,2−テトラデカンジオール、1,2−ペンタデカンジオール、1,2−ヘキサデカンジオール、1,2−ヘプタデカンジオール、1,2−オクタデカンジオール、2−メチル−2,4−ペンタンジオール、1,3−ブタンジオール、ジエチレングリコール、トリエチレングリコール、グリコールビス(ヒドロキシエチル)エーテル、及びそれらの組み合わせからなる群から選択されたモノアルキルグリコールを含む請求項1記載の組成物。
- さらに、1−O−ヘプチルグリセロール、1−O−オクチルグリセロール、1−O−ノニルグリセロール、1−O−デシルグリセロール、1−O−ウンデシルグリセロール、1−O−ドデシルグリセロール、1−O−トリデシルグリセロール、1−O−テトラデシルグリセロール、1−O−ペンタデシルグリセロール、1−O−ヘキサデシルグリセロール(キミルアルコール)、1−O−ヘプタデシルグリセロール、1−O−オクタデシルグリセロール(バチルアルコール)、1−O−オクタデカ−9−エニルグリセロール、セラチルアルコール、グリセロール1−(2−エチルヘキシル)エーテル、オクトキシグリセリン、2−エチルヘキシルグリセリン、3−(2−エチルヘキシルオキシ)プロパン−1,2−ジオール、グリセロール1−ヘプチルエーテル、グリセロール1−オクチルエーテル、グリセロール1−デシルエーテル、グリセロール1−ドデシルエーテル、グリセロール1−トリデシルエーテル、グリセロール1−テトラデシルエーテル、グリセロール1−ペンタデシルエーテル、グリセロール1−ヘキサデシルエーテル、グリセロール1−オクタデシルエーテル、及びそれらの組み合わせからなる群から選択されたグリセロールアルキルエーテルを含む請求項1記載の組成物。
- さらに、少なくとも0.05重量%の量の少なくとも1種のポリマー性ビグアニド、0.01重量%から1重量%の濃度のキレート剤、及び、モノアルキルグリコール、モノアルキルグリセロール、及びそれらの組み合わせからなる群から選択されたビシナルジオールを含む0.05重量%から4重量%の濃度のビシナルジオール成分を含み、ポリマー性ビグアニド、キレート剤、及びビシナルジオールの百分率は前記組成物の総重量に基づく請求項1記載の組成物。
- さらに、少なくとも、鎮痛薬、麻酔薬、神経因性疼痛薬、及びそれらの混合物からなる群から選択された医薬を含む請求項1記載の組成物。
- 少なくとも1つの前記医薬は、リドカイン、カプサイシン、カラミンローション、ベンゾカイン、テトラカイン、プリロカイン、ブピバカイン、レボブピバカイン、プロカイン、カルボカイン、エチドカイン、メピバカイン、ノルトリプチリン、アミトリプチリン、プレガバリン、ジクロフェナク、フェンタニル、ガバペンチン、ケトコナゾール、オピオイド、非ステロイド系抗炎症薬、サリチレート、及びそれらの混合物からなる群から選択された請求項16記載の組成物。
- 前記組成物は、粉末、水溶液、有機液体溶液、シリコーン流体、ゲル、ヒドロゲル、クリーム、フィルム、ラテックス、エアロゾル、スラリー、ペースト、バーム、軟膏、及び発泡体からなる群から選択された形態である請求項1記載の組成物。
- さらに包帯を含み、前記非タンパク質分解酵素成分は、天然又は合成繊維、メッシュ、ガーゼ、布、親水コロイド、アルギン酸塩、ヒドロゲル、半透性フィルム、透過性フィルム、又は天然又は合成ポリマーに吸着された請求項1記載の組成物。
- さらに緩衝剤を含む請求項1記載の組成物。
- 前記非タンパク質分解酵素成分は、少なくとも20重量%のα−アミラーゼ及び20重量%以下の他の非タンパク質分解性の非アミラーゼ酵素を含む請求項1記載の組成物。
- 前記非タンパク質分解酵素成分は、前記組成物の総重量に基づき少なくとも0.001重量%の量で存在する請求項1記載の組成物。
- 非刺激性で揮発性の疎水性溶媒中に疎水性逆エマルション界面活性剤によって可溶化されたα−アミラーゼを含む逆マイクロエマルジョンを含み、前記非刺激性で揮発性の疎水性溶媒は、揮発性直鎖及び環状シロキサン、揮発性アルカン、揮発性フルオロカーボン及びクロロフルオロカーボン、加圧下の液体二酸化炭素、及びそれらの組み合わせからなる群から選択された請求項1記載の組成物。
- 非タンパク質分解酵素成分を含む酵素掻痒組成物であって、前記非タンパク質分解酵素成分が少なくとも80重量%のアミラーゼを含み、前記酵素掻痒組成物中の非タンパク質分解酵素のタンパク質分解酵素に対する比が少なくとも4:1である組成物と、前記酵素掻痒組成物をかゆみ組織に塗布するための使用説明書を含むかゆみ組織に塗布するためのキット。
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US14/511,988 | 2014-10-10 | ||
US14/511,988 US20160101166A1 (en) | 2014-10-10 | 2014-10-10 | Compositions and kits for treating pruritus and methods of using the same |
PCT/US2015/054683 WO2016057789A1 (en) | 2014-10-10 | 2015-10-08 | Compositions and kits for treating pruritus and methods of using the same |
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US (2) | US20160101166A1 (ja) |
EP (1) | EP3204038B1 (ja) |
JP (1) | JP6669334B2 (ja) |
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BR (1) | BR112017006925B1 (ja) |
CA (1) | CA2963812A1 (ja) |
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MX (1) | MX2017004198A (ja) |
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US11439659B2 (en) * | 2018-12-03 | 2022-09-13 | The Regents Of The University Of California | Methods and compositions to prevent and treat inflammation and allergic reactions |
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2014
- 2014-10-10 US US14/511,988 patent/US20160101166A1/en not_active Abandoned
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2015
- 2015-10-08 AU AU2015330889A patent/AU2015330889B2/en active Active
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EP3204038A1 (en) | 2017-08-16 |
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AU2015330889A1 (en) | 2017-04-27 |
AU2015330889B2 (en) | 2021-01-07 |
BR112017006925A2 (pt) | 2017-12-12 |
DK3204038T3 (da) | 2022-06-13 |
ES2914615T3 (es) | 2022-06-14 |
EP3204038A4 (en) | 2018-06-13 |
NZ730769A (en) | 2024-02-23 |
PT3204038T (pt) | 2022-06-06 |
JP2017530164A (ja) | 2017-10-12 |
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