JP6272366B2 - 細菌バイオフィルムの処置および他の使用をはじめとする、生体医学的使用のための消毒薬としてのビスマス−チオール - Google Patents
細菌バイオフィルムの処置および他の使用をはじめとする、生体医学的使用のための消毒薬としてのビスマス−チオール Download PDFInfo
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- JP6272366B2 JP6272366B2 JP2016003005A JP2016003005A JP6272366B2 JP 6272366 B2 JP6272366 B2 JP 6272366B2 JP 2016003005 A JP2016003005 A JP 2016003005A JP 2016003005 A JP2016003005 A JP 2016003005A JP 6272366 B2 JP6272366 B2 JP 6272366B2
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Description
本願は、2010年2月3日出願のPCT出願第PCT/US2010/023108号、および2010年8月12日出願の米国特許仮出願第61/373,188号の利益を主張するものであり、それらは、それぞれ参照により全体が本明細書に組み込まれる。
技術分野
ここに開示された発明の実施形態は、微生物感染の処置のための組成物および方法に関する。詳細には、本発明の実施形態は、細菌バイオフィルムおよび他の状態の処置をはじめとし、慢性創傷および急性創傷などの創傷において、そして臨床でのパーソナルヘルスケアおよび他の局面で、上皮組織における細菌感染を管理する改善された処置に関する。
皮膚の創傷治癒と微生物感染への応答および抵抗、ならびに/または身体組織の治癒もしくは保持に寄与する複雑な一連の協調的分子内および分子間相互作用は一般に、例えば日和見感染および院内感染(例えば、感染のリスクを高めうる臨床レジメン)、抗生物質の局所もしくは全身投与(細胞の発育、遊走または他の機能に影響を及ぼす場合があり、抗生物質耐性微生物に向けて選択することもできる)、頻繁な創傷ドレッシング材交換、治癒を早めるための創傷の外気暴露、一時的な人工の構造支持マトリックスもしくは足場材料の使用、壊死組織除去および/もしくは反復手術により感染もしくは壊死組織を切除することの潜在的必要性、ならびに/または他の要因など、様々な外的要因により有害な影響を受ける場合がある。
組織内の細胞間の連続性、または組織間の連続性が、例えば物理的、機械的、生物学的、病理学的および/または化学的力(例えば、熱傷、真皮感染、刺し傷、拳銃または榴散弾による創傷、皮膚潰瘍、放射能中毒、悪性腫瘍、壊疽、自己免疫疾患、免疫欠損性疾患、吸入または感染などによる呼吸器傷害、危険物の摂取または感染などによる胃腸傷害、凝固不能などの循環および造血障害)、または他の外傷性損傷などにより崩壊された時に、創傷が生じる。
無傷で機能を果たしている皮膚および他の上皮組織(例えば、生物体とその外部環境の間にバリアを形成する一般には無血管の上皮表面、例えば皮膚内に見出され、呼吸器および胃腸管、腺組織などの内層にも見出されるもの)の維持は、ヒトおよび他の動物の健康および生存に重大である。皮膚は、ヒトおよび他の高等な脊椎動物(例えば、ホ乳類)の最大身体器官であり、バリア機能、機械的強度および水への不浸透性を通して環境傷害から防御する。重大な環境的境界面として、皮膚は、防御的身体被覆を提供して生理学的平衡の維持を可能にする。
抗微生物性、詳細には抗菌性を有する複数の天然産物(例えば、抗生物質)および合成化学薬品は、当該技術分野で公知であり、化学構造と、抗微生物効果、例えば微生物を殺傷する能力(殺菌性などの「殺傷」効果)、微生物の発育を停止もしくは損傷する能力(静菌性などの「静止」効果)、あるいは微生物機能、例えば部位でのコロニー形成もしくは感染、細菌によるエキソポリサッカライド分泌、ならびに/またはプランクトン性集団からバイオフィルム集団への変換もしくはバイオフィルム形成の拡大などを妨害する能力と、により少なくとも一部が特徴づけられている。例えば殺菌または静菌能力、効果的濃度、および宿主組織への毒性のリスクなど、そのような組成物の選択および使用に影響を及ぼす因子を含む抗生物質、殺菌剤、消毒薬など(ビスマス−チオールまたはBT化合物を含む)は、例えば、U.S.6,582,719号で議論されている。
初めて本明細書に開示されており、理論に束縛されるのを望むものではないが、本明細書に記載された特定の実施形態によれば、ビスマス−チオール(BT)化合物は、非常に様々な臨床的感染疾患および状態の処置、ならびにパーソナルヘルスケアに用いられる消毒薬として用いることができ、BTにより少なくとも一部は仲介される予防または防護により実行される節減など、そのような感染の処置にかかるコストも低下させる。
別の実施形態において、微粒子BT化合物を含む組成物が、経口使用のために配合され、口内の微生物発育を予防または低減するため、そして口腔の微生物感染および炎症を予防および/または処置するための方法において用いてもよい。それゆえこれらの組成物は、歯垢、口臭、歯周病、歯肉炎、および口の他の感染を予防または処置するのに(即ち、それらの発症を低下もしくは阻害する、また発生もしくは再発の尤度を低下させるのに)有用である。微粒子BT化合物を含む経口組成物は、バイオフィルムの発生を予防および/もしくは制御する(即ち、緩徐にする、遅延する、阻害する)、バイオフィルムを崩壊させる、または口内表面、詳細には歯もしくは歯茎上に存在するバイオフィルムの量を減少させるのにも有用となりうる。
抗微生物剤:例えば、クロルヘキシジン:サンギナリンエキス、メトロニダゾール、第四級アンモニウム化合物(例えば、セチルピリジニウムクロリド);ビスグアニド(例えば、クロルヘキシジンジグルコナート、ヘキセチジン、オクテニジン、アレキシジン);ハロゲン化ビスフェノール系化合物(例えば、2,2’−メチレンビス−(4−クロロ−6−ブロモフェノール)または他のフェノール系抗菌化合物;アルキルヒドロキシベンゾアート;カチオン性抗微生物ペプチド;アミノグリコシド;キノロン;リンコサミド;ペニシリン:セファロスポリン;マクロリド;テトラサイクリン;当該技術分野で公知の他の抗生物質;コレウス・フォルスコリのエッセンシャルオイル;銀または銀コロイド抗微生物剤;スズまたは銅を基剤とする抗微生物剤;マヌカオイル;オレガノ;タイム;ローズマリー;または他のハーブエキス;およびグレープフルーツシードエキス。
抗炎症剤または抗酸化剤:例えば、イブプロフェン、フルルビプロフェン、アスピリン、インドメタシン、アロエベラ、ターメリック、オリーブリーフエキス、クローブ、パンテノール、レチノール、ω−3脂肪酸、γ−リノレン酸(GLA)、緑茶、生姜、グレープシードなど。虫歯予防剤:例えば、フッ化ナトリウムおよびフッ化第一スズ、フッ化アミン、モノフルオロリン酸ナトリウム、トリメタリン酸ナトリウム、クエン酸亜鉛または他の亜鉛剤、およびカゼイン。プラーク緩衝液:例えば、尿素、乳酸カルシウム、グリセロリン酸カルシウム、およびポリアクリル酸ストロンチウム。ビタミン:例えば、ビタミンA、CおよびE。植物エキス。脱感作剤:例えば、クエン酸カリウム、塩化カリウム、酒石酸カリウム、重炭酸カリウム、シュウ酸カリウム、硝酸カリウム、およびストロンチウム塩。歯石防止剤:例えば、アルカリ金属ピロリン酸塩、次亜リン酸塩含有ポリマー、有機ホスホン酸塩およびホスホクエン酸塩など。生体分子:例えば、バクテリオシン、バクテリオファージ、抗体、酵素など。着香剤:例えば、ペパーミントおよびスペアミントオイル、ウイキョウ、シナモンなど。タンパク質性材料:例えば、コラーゲン。防腐剤。不透明化剤。着色剤。pH調整剤。甘味剤。薬学的に許容しうる担体:例えば、デンプン、スクロース、水または水/アルコール系など。界面活性剤:例えば、陰イオン性、非イオン性、陽イオン性および双性イオン性または両性界面活性剤、植物材料由来のサポニン(例えば、米国特許第6,485,711号参照)。粒子研磨剤:例えば、シリカ、アルミナ、炭酸カルシウム、リン酸二カルシウム、ピロリン酸カルシウム、ヒドロキシアパタイト、トリメタリン酸塩、不溶性ヘキサメタリン酸塩、凝集粒子研磨剤、チョーク、微粉砕性天然チョークなど。吸湿剤:例えば、グリセロール、ソルビトール、プロピレングリコール、キシリトール、ラクチトールなど。結合剤および増粘剤:例えば、カルボキシメチルセルロースナトリウム、ヒドロキシエチルセルロース(Natrosol(登録商標))、キサンタンガム、アラビアガム、合成ポリマー(例えば、ポリアクリラートおよびカルボキシビニルポリマー、例えばCarbopol(登録商標))。抗微生物剤などの有効成分の送達を向上させるポリマー化合物。オーラルケア組成物のpHおよびイオン強度を緩衝する緩衝剤および塩。漂白剤:例えば、ペルオキシ化合物(例えば、ペルオキシ二リン酸カリウム)。発砲系:例えば、重炭酸ナトリウム/クエン酸系。変色系。特定の実施形態において、研磨剤は、シリカまたは微粉砕天然チョークである。
特定の実施形態において、整形外科的手順(例えば、整形外科手術、整形外科治療、関節形成術(二段階関節形成術を含む)、歯科矯正治療)により生じた微生物感染および炎症を予防および/または処置するための微粒子BT化合物を含む組成物を使用する方法が、提供される。本明細書に記載された微粒子BT化合物を含む組成物は、それゆえ、骨格および支持構造(即ち、骨、関節、筋肉、靭帯、腱)の微生物感染、例えば骨髄炎を予防および/または処置する(即ち、その発症を低下または阻害する、その発生または再発の尤度を低下させる)のに有用である。微粒子BT化合物を含む本明細書に記載された組成物は、バイオフィルムの発生を予防および/もしくは制御する(即ち、緩徐化、遅延、阻害する)、バイオフィルムを崩壊させる、あるいは関節内、または骨、靭帯、腱もしくは歯の表面に存在するバイオフィルムの量を減少させるのにも有用となりうる。
他の特定の実施形態は、単独でのBT、またはビスマス部分が異なるV族金属、例えばアンチモン(Sb)もしくはヒ素(As)で置換されたBT、および/あるいは本明細書に記載された通り、BTが経口摂取される栄養配合剤中で相乗的もしくは増強的抗微生物活性を示す、1種以上の抗生物質と組み合わせられたそのようなBTのいずれである、本明細書に記載された微粒子BTの使用を企図する。
特定の実施形態は、本明細書に開示された微粒子BT化合物を含有する医薬組成物にも関し、特定のそのような実施形態において、医薬組成物は、BT化合物が本明細書に記載された相乗的または増強的効果を示す抗生物質など、1種以上の抗生物質を更に含んでいてもよい。一実施形態において、動物、好ましくはホ乳類、最も好ましくはヒト患者に投与される場合に、1種以上のそのような微粒子BT化合物を、本明細書に開示された薬学的に許容しうる担体、賦形剤または希釈剤中で、薬学的量で含有する組成物が提供される。
実施例1
BT化合物の調製
以下のBT化合物を、Domenico他(U.S RE37,793号、U.S.6,248,371号、同6,086,921号、同6,380,248号)の方法により、またはBisEDTに関して以下に記載された合成プロトコルによる微粒子として、調製した。示されているのは、硫黄含有化合物と三価錯体を形成するのに用いられた反応体の理論比およびビスマスの公知の性向に基づく、比較としての、単一ビスマス原子に対する原子比である。カッコ内の数値は、1種の(または数種の)チオール剤に対するビスマスの比である(例えば、Bi:チオール1/チオール2;表1も参照)。
1)CPD 1B−1 Bis−EDT(1:1) BiC2H4S2
2)CPD 1B−2 Bis−EDT(1:1.5) BiC3H6S3
3)CPD 1B−3 Bis−EDT(1:1.5) BiC3H6S3
4)CPD 1C Bis−EDT(可溶性Bi調製物)(1:1.5) BiC3H6S3
5)CPD 2A Bis−Bal(1:1) BiC3H6S2O
6)CPD 2B Bis−Bal(1:1.5) BiC4.5H9O1.5S3
7)CPD 3A Bis−Pyr(1:1.5) BiC7.5H6N1.5O1.5S1.5
8)CPD 3B Bis−Pyr(1:3) BiC15H12N3O3S3
9)CPD 4 Bis−Ery(1:1.5) BiC6H12O3S3
10)CPD 5 Bis−Tol(1:1.5) BiC10.5H9S3
11)CPD 6 Bis−BDT(1:1.5) BiC6H12S3
12)CPD 7 Bis−PDT(1:1.5) BiC4.5H9S3
13)CPD 8−1 Bis−Pyr/BDT(1:1/1)
14)CPD 8−2 Bis−Pyr/BDT(1:1/0.5)
15)CPD 9 Bis−2ヒドロキシ,プロパンチオール(1:3)
16)CPD 10 Bis−Pyr/Bal(1:1/0.5)
17)CPD 11 Bis−Pyr/EDT(1:1/0.5)
18)CPD 12 Bis−Pyr/Tol(1:1/0.5)
19)CPD 13 Bis−Pyr/PDT(1:1/0.5)
20)CPD 14 Bis−Pyr/Ery(1:1/0.5)
21)CPD 15 Bis−EDT/2ヒドロキシ,プロパンチオール(1:1/1)
慢性創傷感染のコロニーバイオフィルムモデル:BT化合物による阻害
慢性創傷内に存在する細菌は、バイオフィルムのライフスタイルを採り入れるため、本質的には記載された方法に従って(Anderl et al., 2003 Antimicrob Agents Chemother 47:1251−56; Walters et al., 2003 Antimicrob Agents Chemother 47:317; Wentland et al., 1996 Biotchnol. Prog. 12:316; Zheng et al., 2002 Antimicrob Agents Chemother 46:900)、調製されたバイオフィルムを用いて、細菌細胞生存に対する効果について、BTをバイオフィルムに対して検査した。
慢性創傷感染のドリップフローバイオフィルムモデル
BT化合物による阻害
ドリップフローバイオフィルムは、細菌バイオフィルムを形成させて、それに対して候補となる抗菌化合物の効果を検査するための公認の信頼性のあるモデルである。ドリップフローバイオフィルムは、ドリップフローリアクターの溝に入れたクーポン(基質)上に生成する。すりガラス顕微鏡スライドなど、多くの異なるタイプの材料を、細菌バイオフィルム形成用の基板として用いることができる。栄養性液体培地をドリップフローバイオリアクターの細胞チャンバーに上部付近で滴加することにより、培地をチャンバーに入れ、その後、クーポンの長さに10℃の傾斜で流す。
創傷バイオフィルムによる、角化細胞の掻き傷修復の阻害:BT化合物によるバイオフィルム抑制
この実施例は、創傷治癒の確立されたインビトロ角化細胞掻き傷モデルを改変して、バイオフィルム関連の創傷病理および創傷治癒への関連性、詳細には急性もしくは慢性創傷または本明細書に記載された創傷含有バイオフィルムへの関連性を有するモデルへ到達することを記載している。慢性創傷バイオフィルムの効果についての角化細胞掻き傷モデルにより、ホ乳類(例えばヒト)角化細胞および細菌バイオフィルム集団の培養を、互いに流動接触している別個のチャンバー内で進行させて、バイオフィルムにより同化された可溶性成分の、角化細胞創傷治癒事象に対する効果に影響を及ぼす条件の効果の評価を可能にする。
創傷バイオフィルムによる、角化細胞の掻き傷修復の阻害
単離されたヒト角化細胞を、ガラスカバースリップ上で培養して、先の実施例4に記載された方法論に従って掻き傷を作製した。創傷された培養物を、角化細胞培養物と流体連通している膜支持体上で、培養条件下、単独で、または共培養されたバイオフィルムの存在下で保持した。その後、角化細胞の細胞発育および/または遊走が掻き傷のゾーン全体で角化細胞単層を再度定着させる間の掻き傷閉鎖の時間間隔を、測定した。図3は、バイオフィルムの流体連通による(しかし直接接触していない)存在が引っ掻かれた角化細胞単層の治癒時間に与えた効果を示している。
相乗的なビスマス−チオール(BT)抗生物質の組み合わせ
この実施例は、1種以上のビスマス−チオール化合物と、複数の抗生物質耐性菌など様々な菌種および菌株に対する1種以上の抗生物質との組み合わせによる、実証された相乗的効果の例を示す。
抗生物質耐性菌株を含むグラム陽性およびグラム陰性菌に対するビスマス−チオール(BT)および抗生物質の効果の比較
この実施例において、BisEDTおよび比較剤のインビトロ活性を、皮膚および軟部組織感染を担うグラム陽性および陰性菌の複数の臨床単離物に対して評価した。
微粒子BT−抗生物質の増強および相乗活性
この実施例は、微粒子ビスマス−チオール(BT)が、増強的および/または相乗的相互作用を通して抗生物質活性を促進することを示している。
b ダクロン移植片に0.1mg/lのBT、10mg/lのRIP、10mg/lのリファンピンを含浸させた。
c 対照群のMSおよびMRと比較した場合に統計学的に有意
d MS3群と比較した場合に統計学的に有意
e MR1群、MR2群およびMR3群と比較した場合に統計学的に有意
0.5以下のFIC指数は、相乗性を示し、0.5を超え1.0未満のFICは、増強性を示す。
Domenico P, R O’Leary, BA Cunha. 1992. Differential effect of bismuth and salicylate compounds on antibiotic sensitivity of Pseudomanas aeruginosa. Eur J Clin Microbiol Infec Dis 11:170−175; Domenico P, D Parikh, BA Cunha. 1994. Bismuth modulation of antibiotic activity against gastrointestinal bacterial pathogens. Med Microbiol Lett 3:114−119; Domenico P, Kazzaz JA, Davis JM, Niederman MS.2002. Subinhibitory bismuth ethanedithiol(BisEDT)sensitizes resistant Staphylococcus aureus to nafcillin or gentamicin. Annual Meeting, ASM, Salt Lake City, UT; Domenico P, Kazzaz JA, Davis JM. 2003. Combating antibiotic resistance with bismuth−thiol. Research Advances in Antimicrob Agents Chemother 3:79−85; Domenico P, E Gurzenda, A Giacometti, O Cirioni, R Ghiselli, F Orland, M Korem, V Saba, G Scalise, N Balaban. 2004. BisEDT and RIP act in synergy to prevent graft infections by resistant staphylococci. Peptides 25:2047−2053; Halwani M, Blomme S, Suntres ZE, Alipour M, Azghani AO, Kumar A, Omri A. 2008. Liposomal bismuth−ethanedithiol formulation enhances antimicrobial activity of tobramycin. Intl J Pharmaceut 358:278−84;Halwani M, Hebert S, Suntres ZE, Lafrenie RM, Azghani AO, Omri A. 2009. Bismuth−thiol incorporation enhances biological activities of liposomal tobramycin against bacterial biofilm and quorum sensing molecules production by Pseudomonas aeruginosa. Int J Pharmaceut 373:141−6; Veloira WG, Gurzenda EM, Domenico P, Davis JM, Kazzaz JA. 2003. Synergy of tobramycin and bismuth thiols against Burkholderia cepacia. J Antimicrob Chemother 52:915−919.
微粒子BT−抗生物質の増強および相乗活性
この実施例は、微粒子ビスマスチオールであるBisEDTが、特異的な微生物標的生物体に対する特異的抗生物質との増強的および/または相乗的相互作用を通して抗生物質活性を促進することを示す。表26に示された各組み合わせの一点データは、本質的には実施例8で用いられた方法に従って作成した。
微粒子BT−抗生物質の増強および相乗活性
先に記載された通り調製された微粒子BisEDTおよび4種のBisEDT類似体と他の薬剤との組み合わせの、複数のグラム陰性病原菌の代表的菌株に対する効果を検査した。一般的検査法の変法を利用して、用いられた部分阻止濃度(FIC)およびFIC指数(FICI)の相乗性(FICI≦0.5)、増強性(0.5<FICI≦1.0)、拮抗性(FICI>4.0)および重要性なし(1.0<FICI≦4.0)を決定した(V Lorian. Williams and Wikins, Baltimore, MDにより編集されたAntibiotics in Laboratory Medicine, Third Edition, pp.432−492内のElipoulos G and R Moellering. 1991. Antimicrobial combinations.; Odds, 2003 J. Antimicrob. Chemother. 52(1):1)。チェッカーボード技術を用いて、FIC指数を決定し、この試験に用いた。
2FICI、部分阻止濃度指数
2FICI、部分阻止濃度指数
2FICI、部分阻止濃度指数
2FICI、部分阻止濃度指数
2FICI、部分阻止濃度指数
2FICI、部分阻止濃度指数
2FICI、部分阻止濃度指数
2FICI、部分阻止濃度指数
2FICI、部分阻止濃度指数
2FICI、部分阻止濃度指数
2FICI、部分阻止濃度指数
2FICI、部分阻止濃度指数
2FICI、部分阻止濃度指数
2FICI、部分阻止濃度指数
2FICI、部分阻止濃度指数
2FICI、部分阻止濃度指数
2FICI、部分阻止濃度指数
2FICI、部分阻止濃度指数
2FICI、部分阻止濃度指数
2FICI、部分阻止濃度指数
ドブネズミの大腿骨臨界欠損における感染へのビスマス−チオールの効果
開放骨折のための現行のケア標準法は、イリゲーション、壊死組織除去および抗生物質であり、これは、創傷における細菌量を感染が生じない程度に減少させることを意図するものである。これらの処置にもかかわらず、感染は、戦争による重度の脛骨開放骨折の最大75%を複雑化させる。興味深いことに、初期感染が、多くの場合グラム陰性菌により起こるとしても、治癒問題および切断に関与する後期感染は、グラム陽性菌感染、多くはスタフィロコッカス種によるものである(Johnson 2007)。
S.アウレウスの接種後6時間目に、創傷の壊死組織を除去して、生理食塩水でイリゲーションし、BTゲル 1mlを欠損内に挿入した。
S.アウレウスの接種後6時間目に、創傷の壊死組織除を除去して、生理食塩水でイリゲーションし、添加されたBTゲル 1mlを欠損内に挿入した。用いられた抗生物質は、損傷後合計3日間に1日2回の皮下注射により送達された5mgkg−1と等しい用量のセファゾリンであった。最初の用量は、壊死組織除去の直前に投与した。過去のデータから、この用量が細菌レベルを約106から約104へ低減し、それゆえ異なるBTの相対的効果を測定する可能性が示唆された。
S.アウレウスの接種後6時間目に、創傷の壊死組織を除去して、生理食塩水でイリゲーションした。対照動物は、先に記載されたレジメンによりセファゾリンでも処置した。
インビボラット損傷モデルの手順を、Chen他により記載された通り実施した(2002 J. Orthop. Res.20:142;2005 J. Orthop. Res. 23:816;2006 J. Bone Joint Surg. Am. 88:1510; 2007 J. Orthop. Trauma 21:693)。ラットに麻酔をかけて、手術の準備をした。大腿骨骨幹部の前外側面を、3cm切開して暴露させた。骨膜および付着した筋肉を、骨から剥離させた。ポリアセチルプレート(27×4×4mm)を大腿骨の前外側表面に配置した。プレートをプレドリルして、0.9mm径のねじれたキルシュナーワイヤを通した。これらのプレートの基板は、大腿骨骨幹部の輪郭に適合するようにかたどった。プレートを鋳型として用いて両方の大腿皮質骨を通して、パイロットホールを削り、プレートおよび大腿骨を通してねじれたキルシュナーワイヤを挿入した。プレート上の6mm間隔に存在するくぼみが、骨の除去のためのガイドになった。熱による損傷を予防する試みとして、組織を継続的なイリゲーションにより冷却しながら、小型の振動鋸を用いて欠損を作製した。
Costerton JW, Cheng KJ, Geesey GG, et al. Bacerial Biofilms in Nature and Disease. Ann Rev Microbiol. 1987;41:435−64
Domenico P, Baldassarri L, Schoch PE, Kaehler K, Sasatsu M, Cunha BA. Activities of Bismuth Thiols against Staphylococci and Staphyloccocal Biofilms. Antimicrob Agents and Chemother. 2001;45(5):1417−21
Halwani M, Blomme S, Suntres ZE, et al. Liposomal bismuth−ethanedithol formulation enhances antimicrobial activity of tobramycin. Int J Pharm. 2008;358:278−84
Johnson EN, Burns TC, Hayda RA, Hospenthal DR, Murray CK. Infection complications of open type III tibial fractures among combat casualties. Clin Infect Dis. 2007; 45(4):409−415
Domenico et al., Canadian J. Microbiol. 31:472−78(1985); Domenico et al., Reduction of capsular polysaccharides and potentiation of aminoglycoside inhibition in gram−negative bacteria with bismuth subsalicylate. J Antimicrob Chemo 1991;28:801−810; Domenico et al., Infection 20:66−72(1992); Domenico et al., Infect. Immun. 62:4495−99(1994); Domenico et al., J. Antimicrol. Chemother. 38:1031−40(1996); Domenico et al., Enhancement of bismuth antibacterial activity with lipophilic thiol chelators. Antimicrob Agents Chemother 1997;41:1697−703; Domenico et al., Surface antigen exposure by bismuth−dimercaprol suppression of Klebsiella pneumoniae capsular polysaccharide. Infect Immun 67:664−669(1999); Domenico et al., 2000. The potential of bismuth−thiols for treatment and prevention of infection. Infect Med 17:123−127; Domenico et al., Activities of bismuth thiols against staphylococci and staphylococcal biofilms. Antimicrob Agents Chemother 2001; 45:1417−21; Domenico et al., Combating antibiotic resistance with bismuth−thiols. Resaerch Advances in Antimicrob Agents Chemother 2003; 3:79−85; Domenico et al., Reduction of capsular polysaccharides and potentiation of aminoglycoside inhibition in gram−negative bacteria with bismuth subsalicylate. J Antimicrob Chemo 1991;28:801−810; Domenico et al., BisEDT and RIP act in synergy to prevent graft infections by resistant staphylococci. Peptides 2004.;25:2047−53; Domenico et al., 2005. Pyrithion enhanced antimicrobial activity of bismuth. Antibiotics for Clinicians 9:291−297;米国特許第6,582,719号;米国特許RE37,793号、米国特許第6,248,371号、同6,086,921号、同6,380,248号;同第6,582,719号、同第6,380,248号、同第6,875,453号。
Claims (19)
- ビスマス−チオール(BT)化合物を含む複数の微粒子を含むビスマス−チオール組成物であって、前記微粒子の実質的に全てが、0.4μm〜5μmの体積平均径を有し、前記BT化合物が、ビスマスまたはビスマス塩およびチオール含有化合物を含み、
前記BT化合物がチオール含有化合物と会合したビスマスを含み、
前記チオール含有化合物が、1,2−エタンジチオール、2,3−ジメルカプトプロパノール、ピリチオン、ジチオエリトリトール、3,4−ジメルカプトトルエン、2,3−ブタンジチオール、1,3−プロパンジチオール、2−ヒドロキシプロパンチオールおよび1−メルカプト−2−プロパノールからなる群から選択される1種以上の薬剤を含む、
前記組成物。 - ビスマス−チオール(BT)化合物を含む複数の微粒子を含むビスマス−チオール組成物を調製する方法であって、前記微粒子の実質的に全てが、0.4μm〜5μmの体積平均径を有し、
前記方法が、以下の(a)および(b)のステップ:
(a)固体沈殿物を実質的に含まない溶液を得るのに十分となる条件および時間で、(i)少なくとも50mMの濃度のビスマスを含むビスマス塩を含み、親水性、極性または有機性可溶化剤を含まない酸性水溶液を、(ii)25容量%のエタノールを含む混和物を得るのに十分な量のエタノールと混和するステップ;ならびに
(b)前記BT化合物を含む微粒子を含む沈殿物の形成に十分となる条件および時間で、ビスマスに対して1:3〜3:1のモル比で反応溶液中に存在するチオール含有化合物を含むエタノール性溶液を(a)の混和物に添加して、反応溶液を得るステップであって、前記チオール含有化合物が、1,2−エタンジチオール、2,3−ジメルカプトプロパノール、ピリチオン、ジチオエリトリトール、3,4−ジメルカプトトルエン、2,3−ブタンジチオール、1,3−プロパンジチオール、2−ヒドロキシプロパンチオールおよび1−メルカプト−2−プロパノールからなる群から選択される薬剤を1つ以上含むステップ、
を含み、
前記酸性水溶液が、少なくとも5重量%のビスマスを含む、
前記方法。 - 細菌病原、真菌病原およびウイルス病原のうちの1種以上に対して天然表面を防御するための薬物の製造のための、ビスマス‐チオール(BT)化合物の使用であって、前記防御が、
(i)細菌、真菌またはウイルス病原による天然表面の感染の予防、
(ii)細菌、真菌またはウイルス病原の実質的に全てのプランクトン性細胞の細胞生存性または細胞発育の阻害、
(iii)細菌、真菌またはウイルス病原によるバイオフィルム形成の阻害、および
(iv)細菌、真菌またはウイルス病原の実質的に全てのバイオフィルム型細胞のバイオフィルム生存性またはバイオフィルム発育の阻害、
のうちの1つ以上に十分となる条件および時間で、天然表面を有効量のBT組成物と接触させることを含み、
前記BT化合物がチオール含有化合物と会合したビスマスを含み、
前記BT組成物が、ビスマスまたはビスマス塩およびチオール含有化合物を含むビスマス−チオール(BT)化合物を含む複数の微粒子を含み、前記微粒子の実質的に全てが、0.4μm〜5μmの体積平均径を有し、前記チオール含有化合物が、1,2−エタンジチオール、2,3−ジメルカプトプロパノール、ピリチオン、ジチオエリトリトール、3,4−ジメルカプトトルエン、2,3−ブタンジチオール、1,3−プロパンジチオール、2−ヒドロキシプロパンチオールおよび1−メルカプト−2−プロパノールから選択される1種以上の薬剤を含む、
前記使用。 - 前記細菌病原が、
(i)1種以上のグラム陰性菌;
(ii)1種以上のグラム陽性菌;
(iii)1種以上の抗生物質感受性菌;
(iv)1種以上の抗生物質耐性菌;および
(v)スタフィロコッカス・アウレウス(S.アウレウス)、MRSA(メチシリン耐性S.アウレウス)、スタフィロコッカス・エピデルミディス、MRSE(メチシリン耐性S.エピデルミディス)、マイコバクテリウム・ツベルクローシス、マイコバクテリウム・アビウム、シュードモナス・エルギノーサ、薬物耐性P.エルギノーサ、エシェリヒア・コリ、腸管毒素原性E.コリ、腸管出血性E.コリ、クレブシエラ・ニューモニエ、クロストリジウム・ディフィシル、ヘリコバクター・ピロリ、レジオネラ・ニューモフィラ、エンテロコッカス・フェカーリス、メチシリン感受性エンテロコッカス・フェカーリス、エンテロバクター・クロアカエ、サルモネラ・ティフィムリウム、プロテウス・ブルガリス、エルシニア・エンテロコリチカ、ビブリオ・コレラ、シゲラ・フレクスネリ、バンコマイシン耐性エンテロコッカス(VRE)、バークホルデリア・セパシア菌群、フランシセラ・ツラレンシス、バチルス・アントラシス、エルシニア・ペスチス、シュードモナス・エルギノーサ、ストレプトコッカス・ニューモニエ、ペニシリン耐性ストレプトコッカス・ニューモニエ、エシェリヒア・コリ、バークホルデリア・セパシア、バークホルデリア・マルチボランス、マイコバクテリウム・スメグマチスおよびアシネトバクター・バウマニーからなる群より選択される細菌病原、
のうちの少なくとも1つを含む、請求項3に記載の使用。 - (a)前記細菌病原が、メチシリン、バンコマイシン、ナフシリン、ゲンタマイシン、アンピシリン、クロラムフェニコール、ドキシサイクリンおよびトブラマイシンからなる群より選択される抗生物質に対して耐性を示すこと、
(b)前記表面が、表皮、真皮、呼吸器管、胃腸管および腺の内層からなる群より選択される上皮組織表面を含むこと、
(c)前記接触のステップが、1回または複数回実施されること、
(d)少なくとも1回の接触ステップが、前記表面をスプレーすること、イリゲーションすること、浸漬および塗布することのうちの1つを含むこと、
(e)少なくとも1回の接触ステップが、吸入、摂取および経口イリゲーションのうちの1つを含むこと、
(f)少なくとも1回の接触ステップが、局所、腹腔内、経口、非経口、静脈内、動脈内、経皮、舌下、皮下、筋肉内、口腔内、鼻腔内、吸入、眼内、耳内、心室内、脂肪内、関節内および髄腔内から選択される経路による対象への投与を含むこと、および
(g)前記BT組成物が、BisBAL、BisEDT、Bis−ジメルカプロール、Bis−DTT、Bis−2−メルカプトエタノール、Bis−DTE、Bis−Pyr、Bis−Ery、Bis−Tol、Bis−BDT、Bis−PDT、Bis−Pyr/Bal、Bis−Pyr/BDT、Bis−Pyr/EDT、Bis−Pyr/PDT、Bis−Pyr/Tol、Bis−Pyr/Ery、ビスマス−1−メルカプト−2−プロパノール、およびBis−EDT/2−ヒドロキシ−1−プロパンチオールからなる群より選択されるBT化合物を1種以上含むこと
の内の少なくとも1つが該当する、請求項3に記載の使用。 - 前記防御が、前記表面をBT組成物と接触させるステップに関して、同時に、または連続して、前記表面を(i)相乗効果をもたらす抗生物質および(ii)c、のうちの少なくとも一方と接触させることを更に含み、
BT化合物がBisEDTであるとき、前記相乗効果をもたらす抗生物質、または協同抗微生物効果促進抗生物質が、トブラマイシン、ナフシリン、ゲンタマイシン、クリンダマイシン、ガチフロキサシン、ミノサイクリン、バンコマイシンおよびセファゾリンのいずれでもない、
請求項5に記載の使用。 - 抗生物質耐性菌病原が存在する天然表面で抗生物質耐性を克服するための薬物の製造のための、ビスマス‐チオール(BT)組成物の使用であって、前記克服が、
(i)上皮組織表面の、細菌病原による感染の予防、
(ii)細菌病原の実質的に全てのプランクトン性細胞の細胞生存性または細胞発育の阻害、
(iii)細菌病原によるバイオフィルム形成の阻害、および
(iv)細菌病原の実質的に全てのバイオフィルム型細胞のバイオフィルム生存性またはバイオフィルム発育の阻害、
のうちの1つ以上に十分となる条件および時間で、前記天然表面を、有効量の(1)少なくとも1種のビスマス−チオール(BT)組成物および(2)少なくとも1種のBT組成物の効果を促進するもしくは少なくとも1種のBT組成物と相乗的に作用することが可能である少なくとも1種の抗生物質と同時に、または連続して接触させることを含み、
前記BT組成物が、ビスマスまたはビスマス塩およびチオール含有化合物を含むビスマス−チオール(BT)化合物を含む複数の微粒子を含み、前記微粒子の実質的に全てが、0.4μm〜5μmの体積平均径を有し、それにより上皮組織表面での抗生物質耐性を克服し、
前記BT化合物がチオール含有化合物と会合したビスマスを含み、
前記チオール含有化合物が、1,2−エタンジチオール、2,3−ジメルカプトプロパノール、ピリチオン、ジチオエリトリトール、3,4−ジメルカプトトルエン、2,3−ブタンジチオール、1,3−プロパンジチオール、2−ヒドロキシプロパンチオールおよび1−メルカプト−2−プロパノールからなる群から選択される、少なくとも1種の薬剤を含む、
使用。 - (a)細菌病原が、メチシリン、バンコマイシン、ナフシリン、ゲンタマイシン、アンピシリン、クロラムフェニコール、ドキシサイクリン、トブラマイシン、クリンダマイシンおよびガチフロキサシンからなる群より選択される抗生物質に対して耐性を示し、
(b)前記表面が、表皮、真皮、呼吸器管、胃腸管および腺の内層からなる群より選択される組織の上皮表面を含むこと、
(c)前記接触のステップが、1回または複数回実施されること、
(d)少なくとも1回の接触ステップが、前記表面をスプレーすること、イリゲーションすること、浸漬コーティングすること、および塗布することのうちの1つを含むこと、
(e)少なくとも1回の接触ステップが、吸入、摂取および経口イリゲーションのうちの1つを含むこと、
(f)少なくとも1回の接触ステップが、局所、腹腔内、経口、非経口、静脈内、動脈内、経皮、舌下、皮下、筋肉内、口腔内、鼻腔内、吸入、眼内、耳内、心室内、脂肪内、関節内および髄腔内から選択される経路による対象への投与を含むこと、
(g)前記BT組成物が、BisBAL、BisEDT、Bis−ジメルカプロール、Bis−DTT、Bis−2−メルカプトエタノール、Bis−DTE、Bis−Pyr、Bis−Ery、Bis−Tol、Bis−BDT、Bis−PDT、Bis−Pyr/Bal、Bis−Pyr/BDT、Bis−Pyr/EDT、Bis−Pyr/PDT、Bis−Pyr/Tol、Bis−Pyr/Ery、ビスマス−1−メルカプト−2−プロパノール、およびBis−EDT/2−ヒドロキシ−1−プロパンチオールからなる群より選択されるBT化合物を1種以上含むこと、
(h)前記相乗性または増強性抗生物質が、クリンダマイシン、ガチフロキサシン、アミノグリコシド系抗生物質、カルバペネム系抗生物質、セファロスポリン系抗生物質、フルオロキノロン系抗生物質、ペニシリナーゼ耐性ペニシリン系抗生物質、およびアミノペニシリン系抗生物質からなる群より選択される抗生物質を含むこと、および
(i)前記相乗性または増強性抗生物質が、アミカシン、アルベカシン、ゲンタマイシン、カナマイシン、ネオマイシン、ネチルマイシン、パロモマイシン、ロドストレプトマイシン、ストレプトマイシン、トブラマイシンおよびアプラマイシンからなる群より選択されるアミノグリコシド系抗生物質であること
の内の少なくとも1つが該当し、
BT化合物がBisEDTであるとき、前記相乗性または増強性抗生物質が、トブラマイシン、ナフシリン、ゲンタマイシン、クリンダマイシン、ガチフロキサシン、ミノサイクリン、バンコマイシンおよびセファゾリンのいずれでもない、
請求項7に記載の使用。 - (a)ビスマス−チオール(BT)化合物を含む複数の微粒子を含み、前記微粒子の実質的に全てが0.4μm〜5μmの体積平均径を有する少なくとも1種のBT組成物と、
(b)前記BT化合物と相乗的に作用すること、またはそれを増強することが可能である少なくとも1種の抗生物質化合物と
を含む細菌バイオフィルムを含有する天然表面を処置するための消毒性組成物であって、
前記BT化合物が、ビスマスまたはビスマス塩およびチオール含有化合物を含み、
前記BT化合物がチオール含有化合物と会合したビスマスを含み、
前記チオール含有化合物が、1,2−エタンジチオール、2,3−ジメルカプトプロパノール、ピリチオン、ジチオエリトリトール、3,4−ジメルカプトトルエン、2,3−ブタンジチオール、1,3−プロパンジチオール、2−ヒドロキシプロパンチオールおよび1−メルカプト−2−プロパノールからなる群から選択される1種以上の薬剤を含み、
BT化合物がBisEDTであるとき、前記相乗的に作用すること、またはそれを増強することが可能である少なくとも1種の抗生物質化合物が、トブラマイシン、ナフシリン、ゲンタマイシン、クリンダマイシン、ガチフロキサシン、ミノサイクリン、バンコマイシンおよびセファゾリンのいずれでもない、
組成物。 - 前記抗生物質化合物が、メチシリン、バンコマイシン、ナフシリン、ゲンタマイシン、アンピシリン、クロラムフェニコール、ドキシサイクリン、トブラマイシン、クリンダマイシン、ガチフロキサシン、セファゾリンおよびアミノグリコシド系抗生物質から選択される抗生物質を含む、請求項9に記載の組成物。
- 細菌バイオフィルムを含有する天然表面を処置するための薬物の製造のための、ビスマス−チオール(BT)化合物の使用であって、前記処置が、
(a)前記天然表面上または表面内の細菌感染部が、(i)グラム陽性菌、(ii)グラム陰性菌、ならびに(iii)(i)および(ii)の両方、のいずれかを含むと特定すること、および
(b)1種以上のBT化合物を含むBT組成物を含む製剤を前記表面へ投与すること、
を含み、ここで
(i)前記細菌感染部が、グラム陽性菌を含む場合、前記製剤が、有効量の少なくとも1種のBT化合物および少なくとも1種のリファマイシン系抗生物質を含み、
(ii)前記細菌感染部が、グラム陰性菌を含む場合、前記製剤が、有効量の少なくとも1種のBT化合物およびアミカシンを含み、
(iii)前記細菌感染部が、グラム陽性菌およびグラム陰性菌の両方を含む場合、前記製剤は有効量のBT化合物、リファマイシンおよびアミカシンのうちの1種または複数を含み、
前記BT化合物が、ビスマスまたはビスマス塩、およびチオール含有化合物を含み、
前記BT化合物がチオール含有化合物と会合したビスマスを含み、
前記チオール含有化合物が、1,2−エタンジチオール、2,3−ジメルカプトプロパノール、ピリチオン、ジチオエリトリトール、3,4−ジメルカプトトルエン、2,3−ブタンジチオール、1,3−プロパンジチオール、2−ヒドロキシプロパンチオールおよび1−メルカプト−2−プロパノールからなる群から選択される1種以上の薬剤を含む、
前記使用。 - (a)細菌感染部が、1種または複数の抗生物質耐性菌を含み、
(b)処置することが、(i)細菌バイオフィルムを根絶すること、(ii)細菌バイオフィルムを低減すること、および(iii)細菌バイオフィルムの発育を抑制すること、のうちの少なくとも1つを含み、および
(c)前記BT組成物が、ビスマス−チオール(BT)化合物を含む複数の微粒子を含み、前記微粒子の実質的に全てが、0.4μm〜5μmの体積平均径を有する、
請求項11に記載の使用。 - 前記ビスマス塩が、Bi(NO3)3であることを特徴とする、請求項1に記載の組成物。
- (a)前記ビスマス塩が、Bi(NO3)3であること、および、
(b)前記酸性水溶液が、少なくとも0.5重量%の硝酸を含むこと、
の少なくとも1つが該当する、請求項2に記載の方法。 - 不純物を除去するために、前記沈殿物を回収することをさらに含む、請求項2に記載の方法。
- 前記相乗効果をもたらす抗生物質または前記協同 抗微生物効果促進抗生物質が、アミノグリコシド系抗生物質、カルバペネム系抗生物質、セファロスポリン系抗生物質、フルオロキノロン系抗生物質、グリコペプチド系抗生物質、リンコサミド系抗生物質、ペニシリナーゼ耐性ペニシリン系抗生物質、およびアミノペニシリン系抗生物質からなる群より選択される、請求項6に記載の使用。
- 前記アミノグリコシド系抗生物質が、アミカシン、アルベカシン、ゲンタマイシン、カナマイシン、ネオマイシン、ネチルマイシン、パロモマイシン、ロドストレプトマイシン、ストレプトマイシン、トブラマイシンおよびアプラマイシンからなる群より選択される、請求項16に記載の使用。
- 前記アミノグリコシド系抗生物質が、アミカシン、アルベカシン、ゲンタマイシン、カナマイシン、ネオマイシン、ネチルマイシン、パロモマイシン、ロドストレプトマイシン、ストレプトマイシン、トブラマイシンおよびアプラマイシンからなる群より選択される、請求項10に記載の組成物。
- 前記細菌病原が、スタフィロコッカス・アウレウス(S.アウレウス)、MRSA(メチシリン耐性S.アウレウス)、スタフィロコッカス・エピデルミディス、MRSE(メチシリン耐性S.エピデルミディス)、マイコバクテリウム・ツベルクローシス、マイコバクテリウム・アビウム、シュードモナス・エルギノーサ、薬物耐性P.エルギノーサ、エシェリヒア・コリ、腸管毒素原性E.コリ、腸管出血性E.コリ、クレブシエラ・ニューモニエ、クロストリジウム・ディフィシル、ヘリコバクター・ピロリ、レジオネラ・ニューモフィラ、エンテロコッカス・フェカーリス、メチシリン感受性エンテロコッカス・フェカーリス、エンテロバクター・クロアカエ、サルモネラ・ティフィムリウム、プロテウス・ブルガリス、エルシニア・エンテロコリチカ、ビブリオ・コレレ、シゲラ・フレクスネリ、バンコマイシン耐性エンテロコッカス(VRE)、バークホルデリア・セパシア菌群、フランシセラ・ツラレンシス、バチルス・アントラシス、エルシニア・ペスチス、シュードモナス・エルギノーサ、ストレプトコッカス・ニューモニエ、ペニシリン耐性ストレプトコッカス・ニューモニエ、エシェリヒア・コリ、バークホルデリア・セパシア、バークホルデリア・マルチボランス、マイコバクテリウム・スメグマチスおよびアシネトバクター・バウマニーからなる群より選択される、請求項7に記載の使用。
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JP2020055839A (ja) * | 2010-08-12 | 2020-04-09 | マイクロビオン コーポレーション | 農業用、工業用およびその他の使用のための消毒薬としてのビスマス−チオール |
JP7097344B2 (ja) | 2010-08-12 | 2022-07-07 | マイクロビオン コーポレーション | 農業用、工業用およびその他の使用のための消毒薬としてのビスマス-チオール |
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