JP2016504381A - 微生物により引き起こされる若しくは悪化する疾患の治療方法、又はその症状の緩和方法 - Google Patents
微生物により引き起こされる若しくは悪化する疾患の治療方法、又はその症状の緩和方法 Download PDFInfo
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- VBEQCZHXXJYVRD-GACYYNSASA-N uroanthelone Chemical compound C([C@@H](C(=O)N[C@H](C(=O)N[C@@H](CS)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CS)C(=O)N[C@H](C(=O)N[C@@H]([C@@H](C)CC)C(=O)NCC(=O)N[C@@H](CC=1C=CC(O)=CC=1)C(=O)N[C@@H](CO)C(=O)NCC(=O)N[C@@H](CC(O)=O)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CS)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CC(O)=O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CC=1C2=CC=CC=C2NC=1)C(=O)N[C@@H](CC=1C2=CC=CC=C2NC=1)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCNC(N)=N)C(O)=O)C(C)C)[C@@H](C)O)NC(=O)[C@H](CO)NC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CO)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@@H](NC(=O)[C@H](CC=1NC=NC=1)NC(=O)[C@H](CCSC)NC(=O)[C@H](CS)NC(=O)[C@@H](NC(=O)CNC(=O)CNC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CS)NC(=O)[C@H](CC=1C=CC(O)=CC=1)NC(=O)CNC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CC=1C=CC(O)=CC=1)NC(=O)[C@H](CO)NC(=O)[C@H](CO)NC(=O)[C@H]1N(CCC1)C(=O)[C@H](CS)NC(=O)CNC(=O)[C@H]1N(CCC1)C(=O)[C@H](CC=1C=CC(O)=CC=1)NC(=O)[C@H](CO)NC(=O)[C@@H](N)CC(N)=O)C(C)C)[C@@H](C)CC)C1=CC=C(O)C=C1 VBEQCZHXXJYVRD-GACYYNSASA-N 0.000 description 1
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- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4425—Pyridinium derivatives, e.g. pralidoxime, pyridostigmine
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- 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
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
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- A61P11/04—Drugs for disorders of the respiratory system for throat disorders
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- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
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Abstract
Description
本願は、2013年5月31日に出願した米国仮出願第61/829,608号(「Method for Reducing Microbial Load for Treatment of Disease Caused or Aggravated by Microorganisms or Relieving Symptoms Thereof.」)の優先権の利益を主張する。本願はまた、2013年7月30日に出願した米国仮出願第61/859,960号(「Method for Reducing Duration and Severity of Symptoms of Communicable Disease.」)の優先権の利益を主張する。本願はまた、2013年1月4日に出願した米国仮出願第61/749,195号(「Barrier-Forming Composition with Active Agents and Method.」)の優先権の利益を主張する。当該仮出願の内容全体を参照により本明細書に援用するものとする。
約0.0001%≦C≦約0.4%;
約0.07%≦H≦約70%;かつ
0.0005%<A
又は
約0%≦C≦約0.4%;
約55%≦H≦約70%;かつ
0.0005%<Aであり、
ここで、全てのパーセンテージは全組成物の重量によるものであり;
Cは炭水化物ガム;Hは湿潤剤;及びAは抗菌剤である。該組成物は、感染症の症状を軽減する作用のある第二活性物質も含む。
約0.0001%≦C≦約0.4%;
約0.07%≦H≦約70%;かつ
0.0005%<A
又は
約0%≦C≦約0.4%;
約55%≦H≦約70%;かつ
0.0005%<Aであり、
ここで、全てのパーセンテージは全組成物の重量によるものである。本実施形態の範囲は、下記表VのMIC試験で報告された、超低希釈時におけるバリア形成組成物の、多くの微生物に対する殺菌力の実証効果を反映している。効果的に塗布された後、バリア層は殺菌作用又は静菌作用を示す。
約0.01%≦C≦約0.4%;
約4.5%≦H≦約65%;かつ
0.0005%<A
又は
約0%≦C≦約0.4%;
約55%≦H≦約65%;かつ
0.0005%<A。
これらのパーセンテージは全て組成物全体における重量%を指す。
(実験例1)
<ヒト歯肉上皮細胞及び線維芽細胞の培養物>
(実験例2)
<操作ヒト口腔粘膜(EHOM)組織>
(実験例3〜9)
(実験例10〜26)
(実験例27及び28)
<バリア形成組成物が、粘膜組織を通過する微生物に対するEHOMの機械的バリア機能に影響を及ぼすか否かの判定>
(実験例29及び30)
(実験例31及び32)
<バリア形成組成物が微生物侵入に対抗するEHOMの機械的バリア機能に影響を与えるか否かの判定>
(実験例33〜40)
(実験例41〜47)
<検査製剤は毒性がなく細胞/組織を損傷させない>
(実験例48〜61)
(実験例62)
(実験例63〜69)
<in vitroにおけるバリア形成組成物の抗菌活性持続時間:ポスト抗菌効果(PAE)判定>
(実験例70)
(実験例71〜76)
(実験例77〜79)
(実験例80及び81)
(実験例80及び81)
<バリア形成組成物による成熟バイオフィルムの処理能力>
(実験例85〜86)
<バリア形成組成物はウイルスに対しても活性がある>
(実験例87及び88)
<定量PCRを使用したウイルス負荷に対するバリア形成組成物の活性>
<バリア形成組成物は、インフルエンザウイルスに対する直接的な抗ウイルス効果を有する>
(実験例92及び93)
(実験例94及び96)
<バリア形成組成物はHIVに対して活性を示す>
(実験例97)
(実験例98〜100)
<抗菌バリア対市販洗口製品の持続時間>
(実験例104〜153)
(実験例154〜160)
(実験例161)
<グリセリン‐キサンタンガム製剤がヒト口腔粘膜上に被膜を形成する>
(実験例162及び163)
<バリア形成組成物への微生物の曝露が細胞増殖を阻害する経時的顕微鏡検査法>
(実験例164〜166)
<in vivo試験:バリア形成組成物(実験例7)はヒトにおける口腔微生物負荷量を低減する:短期活性及び長期活性>
<短期活性>
(実験例167〜169)
(実験例170〜198)
(実験例199〜205)
<微生物侵入を防止するためのバリアを形成する追加的な保湿剤の識別>
(実験例206〜213)
<キサンタンガムの溶解限度の判定>
(実験例214)
<バリア形成組成物中のカチオン性CPCとバリア形成組成物中の中性抗菌剤との比較>
(実験例215)
<疎水性の物理化学的試験及び比較>
式I:
RF=スポットの移動距離/溶媒前面の距離
(実験例216)
(実験例219〜224)
(実験例255)
<塩化セチルピリジニウム組成物は無生物表面で抗菌活性を示す>
(実験例256)
(結果)
<1.慢性URIsの頻度>
<2.治療後往診でのURIsの頻度>
<4.URI関連症状の期間>
0.05)。
<7.口腔微生物負荷への効果>
<8.ワクチン接種状況の影響>
(結果の概要)
<予防(1)慢性URIsの頻度及び治療後往診、並びに(2)日記内容に基づく>
(症状の期間及び重症度)
(安全性/副作用)
(治験ガイドラインの遵守)
(医療訪問及び長期欠勤への影響)
(微生物負荷量の減少)
(インフルエンザワクチンは治験に対し影響しない)
Claims (30)
- 微生物により引き起こされる若しくは悪化する疾患の治療方法、若しくは該疾患の症状の治療方法、又は両方の組み合わせのための方法であって、
治療有効量のバリア形成組成物を表面に投与することによって、該疾患を治療すること、該疾患の症状を治療すること、若しくは罹患期間を短縮すること、又は両方を行うこと、
ここで該表面は哺乳動物の粘膜を含み、該哺乳動物は、該微生物により引き起こされる若しくは悪化する該疾患に罹患しているか又は該疾患の症状を発現しており、
該バリア形成組成物は抗菌剤を含む;と
バリア被膜に接触した微生物を殺滅又は中和する効果があるバリア被膜を該表面上に形成することと
を含む、方法。 - 前記表面の前記微生物の負荷量を効果的に低減させることを更に含む、請求項1に記載の方法。
- 前記疾患又は該疾患の1つ若しくは複数の症状の期間、頻度、又は重症度を減少させることを更に含む、請求項1に記載の方法。
- 咳、咽頭痛、及び発熱のうちの1つ又は複数の期間、頻度、又は重症度を減少させることを更に含む、請求項1に記載の方法。
- 前記疾患が、インフルエンザ、ライノウイルス、細菌性上気道又は下気道感染症、ウイルス性上気道又は下気道感染症、連鎖球菌感染症、ブドウ球菌感染症、及び人工呼吸器関連肺炎からなる群より選択される1つ又は複数の疾患である、請求項1に記載の方法。
- 前記疾患が上気道感染症である、請求項1に記載の方法。
- 1つ又は複数の前記症状が、以下のうちの少なくとも1つを含む、請求項3に記載の方法:
鼻水、吐き気、咳、頭痛、くしゃみ、副鼻腔の圧迫感、うずきと痛み、涙目、咽頭痛、鼻づまり、悪寒、嘔吐、倦怠感、疲労感、鼻漏、及び発熱。 - 上気道感染症の複数の症状が、前記組成物を投与することにより治療される、請求項1に記載の方法。
- 治療有効量の前記バリア形成組成物を、1回又は2回以上、少なくとも2回の連続する24時間の期間にわたって前記表面に投与することを更に含む、請求項1に記載の方法。
- 治療有効量の前記バリア形成組成物を、24時間以内に3回又は4回以上で、少なくとも2回の連続する24時間の期間にわたって前記表面に投与することを更に含む、請求項1に記載の方法。
- 前記投与ステップ後約1〜約6時間で、前記微生物の負荷量が約25%〜約99%減少する、請求項1に記載の方法。
- 前記粘膜が、口腔粘膜、鼻粘膜及び咽頭粘膜のうちの1つ又は複数である、請求項1に記載の方法。
- 前記バリア層が、約6〜約24時間の持続時間にわたる殺菌作用又は静菌作用を有する、請求項1に記載の方法。
- 前記バリア形成組成物がスプレーにより施される、請求項1に記載の方法。
- 前記抗菌剤が広域スペクトル抗菌剤である、請求項1に記載の方法。
- 前記微生物が、カンジダ、ニューモニア、メチシリン耐性黄色ブドウ球菌、レンサ球菌、ポルフィロモナス・ジンジバリス、化膿レンサ球菌、肺炎レンサ球菌、ストレプトコッカス・ミュータンス、黄色ブドウ球菌、エルシニア・エンテロコリチカ、アシネトバクター・バウマニ、サングイスレンサ球菌、ストレプトコッカス・オラリス、ストレプトコッカス・ミティス、ストレプトコッカス・サリバリウス、ストレプトコッカス・ゴルドニ、アグリゲイティバクター・アクチノミセテムコミタンス、フソバクテリウム・ヌクレアタム、カンジダ・アルビカンス、カンジダ・クルセイ、カンジダ・トロピカリス、カンジダ・グラブラータ、上気道感染症を引き起こす微生物、下気道感染症を引き起こす微生物、HIV、ライノウイルス、EBV、及びインフルエンザウイルスからなる群より選択される、請求項1に記載の方法。
- 前記微生物が、カンジダ、ニューモニア、メチシリン耐性黄色ブドウ球菌、レンサ球菌、ポルフィロモナス・ジンジバリス、化膿レンサ球菌、肺炎レンサ球菌、ストレプトコッカス・ミュータンス、黄色ブドウ球菌、エルシニア・エンテロコリチカ、アシネトバクター・バウマニ、サングイスレンサ球菌、ストレプトコッカス・オラリス、ストレプトコッカス・ミティス、ストレプトコッカス・サリバリウス、ストレプトコッカス・ゴルドニ、アグリゲイティバクター・アクチノミセテムコミタンス、フソバクテリウム・ヌクレアタム、カンジダ・アルビカンス、カンジダ・クルセイ、カンジダ・トロピカリス、カンジダ・グラブラータ、HIV、EBV、インフルエンザウイルス、上気道感染症を引き起こす微生物、下気道感染症を引き起こす微生物、センティペーダ・ペリオドンティイ、アイケネラコローデンス、腸内細菌、フソバクテリウム・ヌクレアタム亜種ヌクレアタム、フソバクテリウム・ヌクレアタム亜種ポリモルフム、フソバクテリウム・ヌクレアタム亜種ビンセンティ、フゾバクテリウム・ペリオドンティカム、ポルフィロモナス・エンドドンタリス、プレボテラ(バクテロイデス)・メラニノジェニカ、プレボテラ・インテルメディア、バクテロイデス(バクテロイデス)・レーシェイ、ソロバクテリウム・ムーレイ、タンネレラ・フォーサイシア(バクテロイデス・フォーサイシア)、トレポネーマ・デンティコラ、クロストリジウム・ディフィシレ、百日咳菌、バークホルデリア、アスペルギルス・フミガーツス、ペニシリウム属、クラドスポリウム、HPV、感冒ウイルス、肺炎桿菌、豚コレラ菌、大腸菌(O157:H7)、毛瘡白癬菌、ライノウイルス、RSウイルス、ポリオウイルス1型、ロタウイルスWa株、A型インフルエンザウイルス、単純ヘルペスウイルス1型及び2型、並びにA型肝炎ウイルスからなる群より選択される、請求項1に記載の方法。
- 前記抗菌剤がモノ第4級アンモニウム化合物である、請求項1に記載の方法。
- 前記バリア被膜が、少なくとも約1時間の持続時間にわたって、該バリア被膜に接触した微生物を捕捉して殺滅する又は中和する効果がある、請求項1に記載の方法。
- 前記バリア形成組成物が、湿潤剤と、抗菌剤と、任意にガムとを含み、該ガムが存在する場合、該ガムが該バリア形成組成物全体の約0.01重量%〜約0.4重量%の量で存在する、請求項1に記載の方法。
- 前記バリア形成組成物が、以下の要件を満足する、請求項1に記載の方法:
約0.0001%≦C≦約0.4%;
約0.07%≦H≦約70%;かつ
0.0005%<A
又は
約0%≦C≦約0.4%;
約55%≦H≦約70%;かつ
0.0005%<Aであり、
ここで、全てのパーセンテージは全組成物の重量によるものであり;
Cは炭水化物ガム;Hは湿潤剤;そしてAは抗菌剤である。 - 前記バリア形成組成物が溶液である、請求項1に記載の方法。
- 前記バリア形成組成物を投与する前記ステップが、以下に対応して発生する、請求項1に記載の方法:
a.前記哺乳動物が存在する又は存在することになる汚染環境を特定すること(ここで、該汚染環境は、有害なウイルス、真菌、若しくは細菌で汚染されていると知られている、若しくは予想されるものである);又は
b.環境内で汚染事象が観察されること(ここで、前記哺乳動物は、高いリスク状態で、該環境に存在する又は該環境に存在することになる)。 - 前記バリア形成組成物が500cps未満の粘度を有する、請求項1に記載の方法。
- 前記バリア形成組成物が、約6〜約24時間の持続時間にわたる殺菌作用又は静菌作用を有する、請求項1に記載の方法。
- 前記組成物が、ナノエマルジョン活性を介して微生物を殺滅すること又は抗接着メカニズムにより微生物を寄せ付けないことによって機能することに有効ではない、請求項1に記載の方法。
- 水溶液を含み、以下の要件を満足する、組成物:
約0.0001%≦C≦約0.4%;
約0.07%≦H≦約70%;かつ
0.0005%<A
又は
約0%≦C≦約0.4%;
約55%≦H≦約70%;かつ
0.0005%<A、
(ここで、全てのパーセンテージは全該組成物の重量によるものであり;
Cは炭水化物ガム;Hは湿潤剤;そしてAは抗菌剤である);及び
感染症の症状を軽減する作用のある第二活性物質。 - 以下の要件が満たされている、請求項27に記載の組成物:
約5%≦H≦約45%;かつ
0.05%<A≦5%。 - 前記第二活性物質が、炭酸カルシウム及びマグネシウム、水酸化マグネシウム及びアルミニウム、炭酸ナトリウム、重炭酸ナトリウム、及びC7H5BiO4、レスベラトロール、フラボノイド、アントシアニン、オオバコ種子殻、スルフォラファン、クサソテツ、イソフラボノイド、アルファリノレン酸、オメガ3脂肪酸、チョウセンニンジン、ニンニク油、チオール、カロチン、ユビキノール、アスコルビン酸、ポリフェノール、非特異的免疫刺激剤、内因性免疫刺激剤、デオキシコール酸、マクロファージ刺激物質、合成免疫刺激剤、マクロカイン、イミキモド、レシキモド、顆粒球マクロファージコロニー刺激因子、ジサリチル酸ビスマス、メチルセルロース、植物繊維、グアーガム、ふすま、ステルクリア、イサゴール、メチルセルロースなどの吸収剤、オピオイド、ロペラミド塩酸塩、オランザピン、5-HT3受容体アンタゴニスト、ドーパミンアンタゴニスト、ドラセトロン、NK1受容体アンタゴニスト、アプレピタント、ヒスタミンH1受容体アンタゴニスト、シクリジン、ジフェンヒドラミン、カンナビノイド、大麻、ドロナビノール、ベンゾジアゼピン、ミダゾラム、ロラゼパム、抗コリン薬、ヒヨスチン、ステロイド、デキサメタゾン、プロピオン酸誘導体、ナプロキセン、イブプロフェン、酢酸誘導体、インドメタシン、エトドラク、エノール酸誘導体、フェナム酸誘導体、COX-2誘導体、アセトアミノフェン、スルホンアニリド、ジクロフェナク、カプサイシン、NSAIDs、イブプロフェン、トロラミンサリチル酸若しくはサリチル酸メチル、メンサシン、ゾストライクス、プソイドエフェドリン、フェニレフリン、エフェドリン、レボメタンフェタミン、ナファゾリン、オキシメタゾリン、フェニルプロパノールアミン、プロピルヘキセドリン、シネフリン、テトラヒドロゾリン、鎮咳薬、デキストロメトルファン、コデイン、ノスカピン、ブロムヘキシン、アセチルシステイン、去痰剤、粘液溶解薬、蜂蜜、アセチルシステイン、アンブロキソール、グイネフェシン、並びに上気道感染症若しくは上気道感染症の症状を治療する作用のある薬剤のうちの1つ又は複数から選択される、請求項27に記載の組成物。
- 微生物により引き起こされる若しくは悪化する疾患の治療方法、若しくは該疾患の症状の治療方法、又は両方の組み合わせのための方法であって、
治療有効量のバリア形成組成物を表面に投与することによって、該疾患を治療すること、該疾患の症状を治療すること、又は両方の組み合わせを行うこと、
ここで該表面は哺乳動物の粘膜を含み、該哺乳動物は、該微生物により引き起こされる又は悪化する該疾患に罹患しており、
該バリア形成組成物は、該微生物の細胞膜に結合して該細胞膜を破壊することにより細胞死を引き起こして作用する抗菌剤を含む;と
該疾患の期間、頻度、若しくは重症度を効果的に減少させること、又は該疾患の1つ又は複数の症状の期間、頻度、若しくは重症度を効果的に減少させることとを含み、
安全であって有害な副作用がない、方法。
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JP2008535918A (ja) * | 2005-04-11 | 2008-09-04 | ナノバイオ コーポレーション | 感染性の症状を処置するための四級アンモニウムハライド |
WO2012145307A1 (en) * | 2011-04-19 | 2012-10-26 | Brian Sokol | Method of inhibiting harmful microorganisms and barrier-forming composition therefor |
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JP2007515204A (ja) * | 2003-11-07 | 2007-06-14 | ヴァイラトックス, エルエルシー | 塩化セチルピリジニウムの殺ウイルス活性 |
JP2008507583A (ja) * | 2004-07-23 | 2008-03-13 | シノフレッシュ ヘルスケアー,インク. | ウイルスを阻害、破壊及び/又は不活性化するための方法及び組成物 |
JP2008535918A (ja) * | 2005-04-11 | 2008-09-04 | ナノバイオ コーポレーション | 感染性の症状を処置するための四級アンモニウムハライド |
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Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US10398645B2 (en) | 2011-04-19 | 2019-09-03 | Arms Pharmaceutical, Llc | Method of inhibiting harmful microorganisms and barrier-forming composition therefor |
US10426761B2 (en) | 2011-04-19 | 2019-10-01 | Arms Pharmaceutical, Llc | Method for treatment of disease caused or aggravated by microorganisms or relieving symptoms thereof |
Also Published As
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EP2941255A1 (en) | 2015-11-11 |
JP6901824B2 (ja) | 2021-07-14 |
WO2014107221A1 (en) | 2014-07-10 |
EP2941255A4 (en) | 2016-07-06 |
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