JP2016510807A - 局所組成物および局所障害の処置方法 - Google Patents
局所組成物および局所障害の処置方法 Download PDFInfo
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- 229940035049 sorbitan monooleate Drugs 0.000 description 1
- 235000011071 sorbitan monopalmitate Nutrition 0.000 description 1
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- SEEPANYCNGTZFQ-UHFFFAOYSA-N sulfadiazine Chemical compound C1=CC(N)=CC=C1S(=O)(=O)NC1=NC=CC=N1 SEEPANYCNGTZFQ-UHFFFAOYSA-N 0.000 description 1
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- AODPIQQILQLWGS-GXBDJPPSSA-N tetrahydrocortisol Chemical compound C1[C@H](O)CC[C@]2(C)[C@H]3[C@@H](O)C[C@](C)([C@@](CC4)(O)C(=O)CO)[C@@H]4[C@@H]3CC[C@@H]21 AODPIQQILQLWGS-GXBDJPPSSA-N 0.000 description 1
- 210000003813 thumb Anatomy 0.000 description 1
- 229960004089 tigecycline Drugs 0.000 description 1
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- XFYDIVBRZNQMJC-UHFFFAOYSA-N tizanidine Chemical compound ClC=1C=CC2=NSN=C2C=1NC1=NCCN1 XFYDIVBRZNQMJC-UHFFFAOYSA-N 0.000 description 1
- 239000003860 topical agent Substances 0.000 description 1
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- GFNANZIMVAIWHM-OBYCQNJPSA-N triamcinolone Chemical compound O=C1C=C[C@]2(C)[C@@]3(F)[C@@H](O)C[C@](C)([C@@]([C@H](O)C4)(O)C(=O)CO)[C@@H]4[C@@H]3CCC2=C1 GFNANZIMVAIWHM-OBYCQNJPSA-N 0.000 description 1
- 229960002117 triamcinolone acetonide Drugs 0.000 description 1
- YNDXUCZADRHECN-JNQJZLCISA-N triamcinolone acetonide Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@]2(F)[C@@H]1[C@@H]1C[C@H]3OC(C)(C)O[C@@]3(C(=O)CO)[C@@]1(C)C[C@@H]2O YNDXUCZADRHECN-JNQJZLCISA-N 0.000 description 1
- 229960003500 triclosan Drugs 0.000 description 1
- SCRSFLUHMDMRFP-UHFFFAOYSA-N trimethyl-(methyl-octyl-trimethylsilyloxysilyl)oxysilane Chemical compound CCCCCCCC[Si](C)(O[Si](C)(C)C)O[Si](C)(C)C SCRSFLUHMDMRFP-UHFFFAOYSA-N 0.000 description 1
- LINXHFKHZLOLEI-UHFFFAOYSA-N trimethyl-[phenyl-bis(trimethylsilyloxy)silyl]oxysilane Chemical compound C[Si](C)(C)O[Si](O[Si](C)(C)C)(O[Si](C)(C)C)C1=CC=CC=C1 LINXHFKHZLOLEI-UHFFFAOYSA-N 0.000 description 1
- HRXKRNGNAMMEHJ-UHFFFAOYSA-K trisodium citrate Chemical compound [Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O HRXKRNGNAMMEHJ-UHFFFAOYSA-K 0.000 description 1
- 231100000397 ulcer Toxicity 0.000 description 1
- 229960003165 vancomycin Drugs 0.000 description 1
- MYPYJXKWCTUITO-UHFFFAOYSA-N vancomycin Natural products O1C(C(=C2)Cl)=CC=C2C(O)C(C(NC(C2=CC(O)=CC(O)=C2C=2C(O)=CC=C3C=2)C(O)=O)=O)NC(=O)C3NC(=O)C2NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(CC(C)C)NC)C(O)C(C=C3Cl)=CC=C3OC3=CC2=CC1=C3OC1OC(CO)C(O)C(O)C1OC1CC(C)(N)C(O)C(C)O1 MYPYJXKWCTUITO-UHFFFAOYSA-N 0.000 description 1
- MYPYJXKWCTUITO-LYRMYLQWSA-O vancomycin(1+) Chemical compound O([C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@H]1OC1=C2C=C3C=C1OC1=CC=C(C=C1Cl)[C@@H](O)[C@H](C(N[C@@H](CC(N)=O)C(=O)N[C@H]3C(=O)N[C@H]1C(=O)N[C@H](C(N[C@@H](C3=CC(O)=CC(O)=C3C=3C(O)=CC=C1C=3)C([O-])=O)=O)[C@H](O)C1=CC=C(C(=C1)Cl)O2)=O)NC(=O)[C@@H](CC(C)C)[NH2+]C)[C@H]1C[C@](C)([NH3+])[C@H](O)[C@H](C)O1 MYPYJXKWCTUITO-LYRMYLQWSA-O 0.000 description 1
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- CPYIZQLXMGRKSW-UHFFFAOYSA-N zinc;iron(3+);oxygen(2-) Chemical compound [O-2].[O-2].[O-2].[O-2].[Fe+3].[Fe+3].[Zn+2] CPYIZQLXMGRKSW-UHFFFAOYSA-N 0.000 description 1
- 239000002132 β-lactam antibiotic Substances 0.000 description 1
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Abstract
Description
本出願は、2013年3月10日出願の米国仮出願番号61/775,598の利益および優先権を主張し、これは引用によりその全体を本明細書に包含させる。
局所障害は広汎であり、皮膚、爪および粘膜のような体表面の多数の種々の状態を含む。局所障害は多様な皮膚炎、アクネ、酒さ、爪真菌症、粃糠疹、光線性角化症、湿疹、紅斑、蕁麻疹、痔、裂肛、肛門掻痒症、尋常性疣贅、性器疣贅、肛門疣贅および疱疹を含む。現在、軟膏剤、クリーム剤、ゲル剤、ローション剤、ゼリー剤および糊状剤、フォーム剤、スプレー剤および薬用パッドを含む、局所状態の処置のための多数の局所適用製剤がある。
局所組成物および局所障害の処置方法をここに開示する。
疱疹は、通常性的接触を介して伝染するウイルス性障害である。
ここに開示する態様を、さらに添付する図面を引用して説明する。図面は必ずしも一定の尺度では示しておらず、むしろ、一般にここに開示する態様の原理を説明するために、強調がされている。
本発明は、活性薬物を含む局所組成物、痔、裂肛、肛門亀裂、痔瘻、肛門膿瘍、肛門掻痒症およびその他の局所の肛門直腸損傷、皮膚炎、アクネ、酒さ、爪真菌症、粃糠疹、光線性角化症、湿疹、紅斑、蕁麻疹、尋常性疣贅、性器疣贅、肛門疣贅および疱疹を含むが、これらに限定されない局所障害の処置のためのその使用を提供する。
約10.0%(w/w)〜約30.0%(w/w)のシリコーンフィルム形成成分;
約1.0%(w/w)〜約5.0%(w/w)のラウリル硫酸ナトリウム、アルキル−およびアルコキシ−ジメチコンコポリオール、ポリソルベートおよびこれらの組み合わせからなる群から選択される少なくとも1種の界面活性剤;
約30.0%(w/w)〜約75.0%(w/w)の非極性揮発性シロキサン溶媒;および
約0.005%(w/w)〜約25.0%(w/w)のプラモキシン、フェニレフリン、ヒドロコルチゾン、サリチル酸、ニトログリセリン、シルデナフィル、プロカイン、リドカイン、テトラカイン、ジブカイン、プリロカイン、フェナカイン、ベンジルアルコール、ベンゾカイン、ジペロドン、ジクロニン、ジメチソキン、エピネフリン、塩酸テトラヒドロゾリン、アンフェタミン類、抗ヒスタミン類、メチルフェニデート、メフェドロン、オキシメタゾリン、シュードエフェドリン、シロシビン、硫酸エフェドリン、イミキモド、ポドフィリン、ポドフィロトキシン、フルオロウラシル、シネカテキンス、植物抽出物、アダパレン、過酸化ベンゾイル、タザロテン、アゼライン酸、クリンダマイシン、アシクロビル、ペンシクロビル、ファムシクロビル、ドコサノールまたはそれらの塩およびそれらの組み合わせからなる群から選択される薬物
を含む局所組成物を提供し、ここで、該組成物は皮膚表面または粘膜表面への適用後60秒以内に乾燥し、乾燥組成物を形成するように適切に設計されており、ここで、該乾燥組成物は、
(i)体表面の不規則性および体表面の動作に密接に順応する軟性フィルムであり、
(ii)12時間を超えてひび割れまたは剥離を起こさず、不変であり、長期間に亘り薬物を放出する耐久性フィルムを形成する。
ある態様において、局所障害は性器疣贅または肛門疣贅および疱疹である。
ある態様において、局所障害はアクネまたは酒さである。
それゆえに、例えば、フェニレフリンHCl 0.25%およびプラモキシンHCl 1%を含むプレパレーションH(登録商標)マキシマム・ストレングスは、“1日4回まで、特に夜、朝および各排便後”に適用される。
(i)少なくとも1種の軟性フィルム形成成分;
(ii)少なくとも1種の界面活性剤;
(iii)少なくとも1種の非極性揮発性溶媒;
(iv)少なくとも15%w/wの水;および
(v)治療に有効な濃度の少なくとも1種の薬物
を含む、1日1回肛門直腸局所組成物が提供され、ここで、該組成物は肛門直腸領域の粘膜表面への適用後60秒以内に乾燥し、乾燥組成物を形成するように適切に設計されており、ここで、該乾燥組成物は、(i)粘膜表面の不規則性および粘膜表面の動作に密接に順応する軟性フィルムであり、(ii)12時間を超えてひび割れまたは剥離を起こさず、不変であり、長期間に亘り薬物を放出する耐久性フィルムを形成する。乾燥フィルムは非汚染性である。上記組成物は、2日に1回または週に2回のように、1日1回より少なく、局所投与し得る。
(i)少なくとも1種の軟性フィルム形成成分;
(ii)少なくとも1種の界面活性剤;
(iii)少なくとも1種の非極性揮発性溶媒;
(iv)少なくとも15%w/wの水;
(v)少なくとも1種の粘度調整剤;および
(vi)治療に有効な濃度の少なくとも1種の薬物
を含む、1日1回肛門直腸局所用組成物が提供され、ここで、該組成物は肛門直腸領域の粘膜表面への適用後60秒以内に乾燥し、乾燥組成物を形成するように適切に設計されており、ここで、該乾燥組成物は、(i)粘膜表面の不規則性および粘膜表面の動作に密接に順応する軟性フィルムであり、(ii)12時間を超えてひび割れまたは剥離を起こさず、不変のままであり、長期間に亘り薬物を放出する耐久性フィルムを形成する。乾燥フィルムは非汚染性である。
[(CH3)3−Si−O]x−(SiO4/2)y
〔式中、xおよびyは、例えば、50〜80の範囲であり得る。〕
で表され得る。このようなシロキシケイ酸類は、Resin MQ(登録商標)の商品名でGeneral ElectricおよびDow Corningから市販されている。シルセスキオキサンの一つの非限定的例はポリメチルシルセスキオキサンである。トリメチルシロキシケイ酸およびポリメチルシルセスキオキサンは、例えば、米国特許番号7,879,316および7,879,346および米国特許出願公開番号2005/0201961に記載されているように、フィルム形成特性により化粧品業界で広く使用されている。本発明は、トリメチルシロキシケイ酸の治療適用、とりわけ肛門直腸障害の処置のための使用を開示した最初のものである。トリメチルシロキシケイ酸は、本発明の局所組成物の揮発性溶媒に可溶性である。組成物中のシリコーン樹脂フィルム形成剤の量は、標的表面への乾燥フィルムの所望の接着特性に基づき決定する。量は、とりわけ、標的表面、処置する状態および組成物成分の量による。シリコーン樹脂フィルム形成剤の量は、さらに、局所組成物の粘性を規定する。組成物中のシリコーン樹脂フィルム形成剤の量は、典型的に約10%(w/w)〜40%(w/w)の範囲である。ここで使用する用語“約”は、記載する値の±10%を意味する。
一つの態様において、本発明の組成物は本質的に非刺痛性である。
本発明の組成物は、さらに、麻酔剤、血管収縮剤、鎮痒剤、抗炎症剤、筋弛緩剤、収斂剤、角質溶解剤、免疫調節剤、細胞毒、抗生物質、防腐剤、抗アクネ剤またはこれらの組み合わせのような少なくとも1種の薬学的活性剤を含む。各々の可能性は、本発明の別の態様である。さらなる医薬活性剤は、例えば、鎮痛剤、抗菌剤および植物性または抽出物を含む。本発明の組成物はさらに抗酸化剤を含み得る。組成物は、さらに1種以上の保護剤活性成分、添加物および担体を含み得る。特に組成物の安定性および無菌性の維持のために、および組成物を適用する体表面への活性剤の送達、放出および/または適用を促進するために、当分野で知られるような薬学的におよび皮膚科学的に許容される添加物および担体を組成物に包含してよい。
一つの態様において、本発明の局所組成物は、(i)トリメチルシロキシケイ酸;(ii)ラウリル硫酸ナトリウム、アルキル−およびアルコキシ−ジメチコンコポリオール、ポリソルベートおよびこれらの組み合わせからなる群から選択される少なくとも1種の界面活性剤;(iii)非極性揮発性シロキサン溶媒および(iv)プラモキシン、フェニレフリン、ヒドロコルチゾン、サリチル酸、ニトログリセリン、シルデナフィルまたはそれらの塩およびそれらの組み合わせからなる群から選択される薬物を含む。一つの態様において、組成物は、さらに約15%(w/w)〜約40%(w/w)の水を含む。一つの態様において、組成物は、さらに、組成物のpHを約4.2〜4.4のpHに調節するための緩衝液を含む。一つの態様において、組成物はさらに粘度調整剤を含む。
本発明において使用するための組成物は、一般に肛門および直腸への一用量適用(例えば、使い捨て容器中のワイプまたはスワブ)において使用するためのまたは反復適用において使用するための容器−アプリケーターデバイスに保存する。一用量アプリケーターは、大気水分を含む湿気に製剤が接触することを阻止する、破壊可能または除去可能シールを有するものを含む。
肛門直腸領域の障害は、一般的集団が普通に遭遇するが、多くの患者が羞恥心により受診が遅れ、または受診しないため、しばしば適切に対処されていない。さらに、このような状態のための多くの薬物療法が、適切な軽減および治癒の提供に至っていない。さらに、痔および肛門疣贅のような状態の処置が意図される多くの薬物療法は、自己適用が困難である可能性があり、適用後の不快感のために満足されていない。
表1は、痔の処置に使用するために製剤した、水中油型エマルジョン液体の形態の本発明の局所組成物の種々の態様を要約する。
実施例1のプレパレーションHを次のとおり製造した。
トリメチルシロキシケイ酸粉末を、室温でメチルシロキサンに溶解した。セチルPEG/PPG−10/1ジメチコンを、トリメチルシロキシケイ酸の溶液に添加した。プラモキシンおよびフェニレフリンを水に溶解した。水溶液のpHを酢酸緩衝液により4.2〜4.4に調節した。Tween 80を水溶液に添加した。トリメチルシロキシケイ酸溶液を水溶液と合わせ、ホモゲナイザーの手段により室温で混合した。
得られた局所液体溶液をワイプ基材に適用し、密閉して、局所液体組成物が含浸された使い捨てワイプを提供した。本組成物を、使い捨てワイプを使用して、外部痔に罹患している成人の肛門領域を拭いて適用した。
表2は、痔の処置のためのゲルの形態の本発明の局所組成物の種々の態様を要約する。
組成物Lを次のとおり製剤した。
トリメチルシロキシケイ酸粉末を、RTでメチルシロキサンに溶解した。ケイ素界面活性剤セチルPEG/PPG−10/1ジメチコンをトリメチルシロキシケイ酸の溶液に添加した。プラモキシンおよびフェニレフリンを水に溶解した。水溶液のpHを酢酸緩衝液で4.2〜4.4に調節した。Tween 80を水溶液に、泡立ちを避けるためゆっくり混合しながら添加した。ヒドロキシエチルセルロース(Natrosol HHX)を、激しい混合下、70℃まで加熱して水相に分散させた。混合物形成後、混合を室温に冷却されるまで続けた。トリメチルシロキシケイ酸溶液を水溶液と合わせ、ホモゲナイザーで室温で混合した。ヒドロキシプロピルメチルセルロースの水相への溶解により、粘性ゲルが形成された。
得られた粘性局所ゲル組成物は、25000〜45000cPの範囲の粘性を有した。
42歳の女性患者に、実施例3の表2のゲル組成物Lを、肘、首および腕の内側に適用した。その直後(約20秒)、組成物は乾燥し、皮膚上に薄フィルムが残った。
フィルムを、12時間、18時間および24時間後に耐久性および柔軟性について試験した。この間、患者は、通常の日常活動を行い、1回シャワーを浴びた。
フィルムは12時間、18時間および24時間後に変化していないことを確認した。フィルムは体表面から落ちず、ひび割れまたは剥離はなかった。フィルムは、12時間、18時間および24時間後に柔軟のままであることが判明した。フィルムは、通常の活動中の1日をとおして、患者の皮膚の不規則さならびに皮膚の動作に密接して順応した。フィルム下の皮膚はわずかに青白く、24時間後でも血管収縮剤フェニレフリンがなお活性であることを示した。24時間後、フィルムを皮膚から剥がし、高速液体クロマトグラフィー(HPLC)により試験し、長期間であったにも関わらず、フィルム中に相当量の2活性剤(プラモキシンおよびフェニレフリン)が見出された。
本開示の乾燥フィルムの耐久性を評価するために試験を行った。モデルは、有効なフィルムは皮膚と外部環境の間に物的障壁を提供するとの原則に基づく。それゆえに、フィルムはまた、無害な不活性マーカー物質の洗い落ちおよびこすり落ちも阻止するはずである。活性炭粉末(ACP)は一つのこのようなマーカーである。
フィルム性能を、本開示のフィルムを、健常成人対象の背中に均一に作ったACP調製部位上に無作為に適用し、装着期間(例えば、1日間、2日間、3日間またはそれ以上)にわたり、これらの部位上に残るACPの量を測定することにより評価する。対象は、通常の日常活動を行い、1日1回シャワーを浴び、過度の身体活動または長期の水への暴露を避けるよう要求する。日々、試験部位の標準デジタル写真を撮り、コンピューター支援画像解析を使用して、残存ACP量をモニターする。着用1日、2日および3日後に残存するマーカー染み(ACP)を、フィルム有効性の指標として使用する。染みが残っていれば残っているほど、フィルムは試験部位の保護に対して有効である。結果を、0日目の元々のACPマーカーのパーセンテージとして表す平均±SEM耐久性のチャートとして示すことができる。
本開示の乾燥フィルムの柔軟性を評価するために試験を行った。フィルムを合成皮膚上に調製し、ASTM方法D4338−97に基づき、3つのサイズの心棒屈曲棒(1/2インチ、1/4インチ、1/8インチ)上で屈曲させる。各フィルムで複数データ点を回収する。フィルムが屈曲過程中に裂けるか否かを記録する。
刺青練習用皮膚(合成皮膚)を本開示のフィルムで被覆した。皮膚を、フィルムの上部表面との密接な接触を維持しながら、心棒上で逆U字の角度を形成するように巻きつける。各試験で新鮮な切片を使用して、試験を、心棒の直径を徐々に小さくしながら反復する。
方法:
1) フィルムを、2×4インチ寸法の刺青練習用皮膚に適用する。
2) 試験フィルムおよび試験装置を、試験条件で24時間保管する。
3) 試験を、試験フィルムおよび試験装置を条件付けするために使用したのと同一環境で行う。
4) 最大直径心棒を、試験フレーム内の水平操作位置に置く。
5) 試験フィルムを、片手の親指と人差指で、指の間が最長寸法となるように、握る。低温試験では、温かい指から試験フィルムを隔離するために軍手を使用してよい。
6) 試験フィルムの平鋼(または他の支持構造)を、試験心棒の縦軸に対して直角で接線方向に横たえる。
7) 試験フィルムを、下部表面を、心棒との密接な接触を維持しながら、心棒に対して反対に巻きつけ、心棒上で逆U字型を形成させる。
8) 裸眼で観察されたフィルムの割れ目、ひび割れまたは亀裂を記録する。
9) 新鮮なフィルムを、次の小さい直径の心棒に巻きつける。
10) 試験を、新鮮なフィルムを使用して、異なる直径の3種の心棒上で、数回反復する。
11) フィルムの柔軟性を、曲げられたときにフィルムがひび割れない能力により決定する。
背景:無作為臨床試験で、患者を3群に分け、PP−110ゲル(表2の組成物L)、PP−110ワイプ(表1における製剤H1)またはコンパレーターとしてプレパレーションH(登録商標)クリームを与えた。PP−110は1日1回適用し、プレパレーションHは表示どおり1日4回適応した。
全患者に、割り当てられた処置を使用しながら、14日間にわたる疼痛、出血、掻痒感、腫脹、不快感および粘液分泌のようなパラメータを記録するよう依頼した。ほとんどのパラメータについて、患者は毎日0=なし、l=軽度、2=中度および3=顕著を選択するよう依頼した。唯一の例外は疼痛であり、l=なし〜10=最大の間の疼痛レベルを選択するよう依頼した。
疼痛:PP−110(ゲルまたはワイプ)での処置の14日間をとおして報告された疼痛は、PP−110を1日1回使用し、プレパレーションHを1日4回使用したにも関わらず、プレパレーションHアームにおいて報告された疼痛と比較して減少した。図1は、プレパレーションHと比較して、ゲルおよびワイプとしての本発明の組成物での処置後の痔核疼痛レベルを示す。示すデータは、測定した各パラメータについて前日からの変化を意味するデルタである。
実施例1における表1のプレパレーションH2を、プレパレーションHに準じて、ペムレンTR−1を添加して製造した。
トリメチルシロキシケイ酸粉末を、メチルシロキサンに室温で溶解した。セチルPEG/PPG−10/1ジメチコンをトリメチルシロキシケイ酸の溶液に添加した。プラモキシンおよびフェニレフリンを水に溶解した。水溶液のpHを酢酸緩衝液により4.2〜4.4に調節した。Tween 80を水溶液に添加した。トリメチルシロキシケイ酸溶液を水溶液と合わせ、ホモゲナイザーの手段により室温で混合した。
局所液体組成物が得られ、その粘性は、水の粘性に近い1〜1.2cPであった。
得られた局所液体組成物をワイプ基材に適用し、密閉して、局所液体組成物が含浸された使い捨てワイプを提供した。組成物を、使い捨てワイプを使用して、外部痔に罹患している成人の肛門領域を拭いて適用した。
Claims (34)
- 少なくとも1種の軟性フィルム形成成分;
少なくとも1種の界面活性剤;
少なくとも15%(w/w)の水;
少なくとも1種の非極性揮発性シロキサン溶媒;および
プラモキシン、フェニレフリン、ヒドロコルチゾン、サリチル酸、ニトログリセリン、シルデナフィル、ニフェジピン、ベラパミル、ジルチアゼム、プロカイン、リドカイン、テトラカイン、ジブカイン、プリロカイン、フェナカイン、ベンジルアルコール、ベンゾカイン、ジペロドン、ジクロニン、ジメチソキン、エピネフリン、塩酸テトラヒドロゾリン、アンフェタミン類、抗ヒスタミン類、メチルフェニデート、メフェドロン、オキシメタゾリン、シュードエフェドリン、シロシビン、硫酸エフェドリン、イミキモド、ポドフィリン、ポドフィロトキシン、フルオロウラシル、シネカテキンス、植物抽出物、アダパレン、過酸化ベンゾイル、タザロテン、アゼライン酸、クリンダマイシン、アシクロビル、ペンシクロビル、ファムシクロビル、ドコサノールまたはそれらの塩およびそれらの組み合わせからなる群から選択される治療に有効な濃度の少なくとも1種の薬物を含む局所組成物であって、ここで、該組成物は体表面への適用後60秒以内に乾燥し、乾燥組成物を形成するように適切に設計されており、該乾燥組成物が
(i)体表面の不規則性および体表面の動作に密接に順応する軟性フィルムであり、
(ii)12時間を超えてひび割れまたは剥離を起こさず、不変のままであり、長期間に亘り薬物を放出する耐久性フィルムを形成する、
局所組成物。 - 実質的に非刺痛性である、請求項1に記載の組成物。
- 少なくとも1種のフィルム形成成分がシロキシケイ酸、シルセスキオキサンおよびこれらの組み合わせからなる群から選択されるシリコーン樹脂である、請求項1に記載の組成物。
- ゲルの形態である、請求項1に記載の組成物。
- 水中油型エマルジョンの形態である、請求項1に記載の組成物。
- 少なくとも1種の界面活性剤がポリソルベートである、請求項1に記載の組成物。
- ポリソルベートがポリオキシエチレンソルビタンモノオレアートである、請求項6に記載の組成物。
- さらにジメチコン/ビニルジメチコンクロスポリマー、シリコーンガムブレンドからなる群から選択される添加剤を含む、ゲル化剤およびこれらの組み合わせ、請求項1に記載の組成物。
- 約15%(w/w)〜約40%(w/w)の水を含む、請求項1に記載の組成物。
- さらに組成物のpHを約4.2〜4.4のpHに調節するための緩衝液を含む、請求項1に記載の組成物。
- さらに有機ケイ素界面活性剤を含む、請求項1に記載の組成物。
- 有機ケイ素界面活性剤がセチルジメチコンコポリオールである、請求項11に記載の組成物。
- さらに粘度調整剤を含む、請求項1に記載の組成物。
- 約15.0%(w/w)〜約25.0%(w/w)のトリメチルシロキシケイ酸;
約1.0%(w/w)〜約5.0%(w/w)のポリオキシエチレンソルビタンモノオレアート;および
約30.0%(w/w)〜約50.0%(w/w)の非極性揮発性シロキサン溶媒を含む、
請求項1に記載の組成物。 - 処置を必要とする対象の体表面に治療有効量の請求項1に記載の組成物を1日1回局所適用することを含む、局所障害の処置方法。
- 該組成物の局所適用後一定時間後、1日数回適用する同一成分を同一濃度で含む市販の組成物で観察されるものと同等またはそれより良好な治療効果が観察可能である、請求項15に記載の方法。
- 局所障害が痔、裂肛、肛門亀裂、痔瘻、肛門膿瘍および肛門掻痒症からなる群から選択される、請求項15に記載の方法。
- 局所障害が性器疣贅または肛門疣贅である、請求項15に記載の方法。
- 局所障害が疱疹である、請求項15に記載の方法。
- 局所障害がアクネまたは酒さである、請求項15に記載の方法。
- 処置を必要とする対象の体表面に治療有効濃度の請求項1に記載の組成物を2日に1回局所適用することを含む、局所障害の処置方法。
- 該組成物の局所適用後一定時間後、1日数回適用する同一成分を同一濃度で含む市販の組成物で観察されるのと同等またはそれより良好な治療効果が観察可能である、請求項21に記載の方法。
- 局所障害が痔、裂肛、肛門亀裂、痔瘻、肛門膿瘍および肛門掻痒症からなる群から選択される、請求項21に記載の方法。
- 局所障害が性器疣贅または肛門疣贅である、請求項21に記載の方法。
- 局所障害がアクネまたは酒さである、請求項21に記載の方法。
- 局所障害が疱疹である、請求項21に記載の方法。
- 処置を必要とする対象の体表面に治療有効濃度の請求項1に記載の組成物を週に2回局所適用することを含む、局所障害の処置方法。
- 該組成物の局所適用後一定時間後、1日数回適用する同一成分を同一濃度で含む市販の組成物で観察されるのと同等またはそれより良好な治療効果が観察可能である、請求項27に記載の方法。
- 局所障害が痔、裂肛、肛門亀裂、痔瘻、肛門膿瘍および肛門掻痒症からなる群から選択される、請求項27に記載の方法。
- 局所障害が性器疣贅または肛門疣贅である、請求項27に記載の方法。
- 局所障害が疱疹である、請求項27に記載の方法。
- 局所障害がアクネまたは酒さである、請求項27に記載の方法。
- 請求項1に記載の組成物および保存および組成物の体表面への適用に適する容器−アプリケーターデバイスを含む、キット。
- 容器−アプリケーターデバイスが使い捨てワイプ、シリンジ、ドロッパー、スプレーディスペンサー、圧縮性ボトルまたはチューブ、スパーテル、坐薬挿入チューブ、突出チューブおよび可膨張性メンバーからなる群から選択される、請求項33に記載のキット。
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US201361775598P | 2013-03-10 | 2013-03-10 | |
US61/775,598 | 2013-03-10 | ||
PCT/IB2014/001233 WO2014140925A2 (en) | 2013-03-10 | 2014-03-10 | Topical compositions and methods of treatment of topical disorders |
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JP2016510807A true JP2016510807A (ja) | 2016-04-11 |
JP2016510807A5 JP2016510807A5 (ja) | 2016-12-08 |
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US (5) | US10085994B2 (ja) |
EP (1) | EP2968133A4 (ja) |
JP (1) | JP2016510807A (ja) |
KR (1) | KR20150136077A (ja) |
CN (1) | CN105142611B (ja) |
AU (1) | AU2014229497A1 (ja) |
BR (1) | BR112015022223B1 (ja) |
CA (1) | CA2904507C (ja) |
IL (1) | IL241191B (ja) |
MX (1) | MX2015012302A (ja) |
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WO (1) | WO2014140925A2 (ja) |
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Also Published As
Publication number | Publication date |
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RU2670750C2 (ru) | 2018-10-25 |
CA2904507A1 (en) | 2014-09-18 |
US20140255521A1 (en) | 2014-09-11 |
RU2670750C9 (ru) | 2018-12-13 |
US10085995B2 (en) | 2018-10-02 |
KR20150136077A (ko) | 2015-12-04 |
US10085994B2 (en) | 2018-10-02 |
WO2014140925A3 (en) | 2015-07-30 |
IL241191B (en) | 2020-02-27 |
BR112015022223B1 (pt) | 2022-06-28 |
US20140255522A1 (en) | 2014-09-11 |
EP2968133A4 (en) | 2016-03-09 |
RU2015143158A (ru) | 2017-04-18 |
WO2014140925A2 (en) | 2014-09-18 |
CA2904507C (en) | 2021-05-04 |
EP2968133A2 (en) | 2016-01-20 |
CN105142611A (zh) | 2015-12-09 |
BR112015022223A2 (pt) | 2017-07-18 |
MX2015012302A (es) | 2016-06-21 |
CN105142611B (zh) | 2019-06-04 |
US20150272957A1 (en) | 2015-10-01 |
US9072747B2 (en) | 2015-07-07 |
IL241191A0 (en) | 2015-11-30 |
US20140256688A1 (en) | 2014-09-11 |
US20180344743A1 (en) | 2018-12-06 |
RU2015143158A3 (ja) | 2018-03-20 |
AU2014229497A1 (en) | 2015-09-24 |
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