JP5324223B2 - 肺感染症を治療する抗感染薬の脂質ベースの組成物及びその使用法 - Google Patents
肺感染症を治療する抗感染薬の脂質ベースの組成物及びその使用法 Download PDFInfo
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- JP5324223B2 JP5324223B2 JP2008544430A JP2008544430A JP5324223B2 JP 5324223 B2 JP5324223 B2 JP 5324223B2 JP 2008544430 A JP2008544430 A JP 2008544430A JP 2008544430 A JP2008544430 A JP 2008544430A JP 5324223 B2 JP5324223 B2 JP 5324223B2
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- mycobacterium
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- amikacin
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Description
世界保健機構によると、呼吸器疾患は世界中で死亡原因の第一位であり、世界の人口の少なくとも20%が罹患しているという。また2500万を越えるアメリカ人が慢性肺疾患を有しており、アメリカ人就労者を就労不能にする要因の第一位(>500億ドル/年間)であり、第三位の死因でもある。
本発明の目的の一つは、肺経路を通じて個体に投与される抗感染薬の治療効果を向上させるために脂質ベースの組成物被包を用いることである。
1:100 w:w 乃至約 100:1 w:wの間であると考えられ、感染性物質の最小阻止濃度や、当該調合物の持続放出特性により、決定されよう。また、特定の感染性物質及び薬物処方に応じて、遊離型、対、被包された型の薬物の比を、細菌致死及び耐性防止に関して公知の薬力学的ターゲットに基づいて最適化することができる。 Schentag, J. J. J. Chemother.
1999, 11, 426-439。
更なる実施態様では、前記抗感染薬はアミカシンであり、前記リポソームはDPPC及びコレステロールを含み、そして前記リポソームは単層ベシクル及び多層ベシクルの混合物を含む。
更なる実施態様では、前記抗感染薬はアミノグリコシドである。更なる実施態様では、前記抗感染薬はアミカシン、ゲンタマイシン、又はトブラマイシンである。
加えて、当該技術は、結核菌や生物テロの吸入性物質(例えば炭そ菌及びツラレミア)) を含む細胞内感染の治療に有用である。また当該技術を、免疫無防備状態の患者(例えば臓器移植又はAIDS患者)における日和見性真菌感染(例えばアスペルギルス症)を処置するための予防薬として用いてもよい。
定義
便宜上、本発明の更なる説明をする前に、本明細書、実施例及び付属の請求項で用いられたいくつかの用語をここに集める。これらの定義は、本開示の他の部分を参照しつつ読まれ、当業者と同じ通りに理解されねばならない。そうでないと定義しない限り、ここで用いられた全ての技術及び科学用語は、当業者が通常理解するものと同じ意味を有する。
to”)」は交換可能に用いられている。
本発明の医薬調合物中に用いられる脂質は、合成であっても、半合成であっても、又は、天然で生じる脂質でもよく、その中にはホスホリピド、トコフェロール、ステロール、脂肪酸、アルブミンなどの糖タンパク質、負に帯電した脂質及び陽イオン性脂質がある。ホスホリピドの場合、これらには、卵ホスファチジルコリン(EPC)、卵ホスファチジルグリセロール(EPG)、卵ホスファチジルイノシトール(EPI)、卵ホスファチジルセリン(EPS)、ホスファチジルエタノールアミン(EPE)、及びホスファチジン酸(EPA)などの脂質;大豆ホスファチジルコリン(SPC);SPG、SPS、SPI、SPE、及びSPAなどの大豆相当物; 水素化卵及び大豆相当物(例えばHEPC、HSPC)、12乃至26個の炭素原子の鎖を含有するグリセロール位置の2及び3の脂肪酸のエステル結合と、グリセロールの1位にコリン、グリセロール、イノシトール、セリン、エタノールアミンを含む異なる先頭基とからなる他のホスホリピドや、対応するホスファチジン酸が含まれよう。これらの脂肪酸上の鎖は飽和していても、又は不飽和でもよく、そして当該ホスホリピドは、様々な鎖長及び様々な不飽和度の脂肪酸から成っていてもよい。具体的には、本調合物の組成物には、ジパルミトイルホスファチジルコリン(DPPC)、天然で生じる肺サーファクタントの主要な成分を含めることができる。他の例には、ジミリストイルホスファチジルコリン(DMPC)及びジミリストイルホスファチジルグリセロール(DMPG)ジパルミトイルホスファチジルコリン(DPPQ及びジパルミトイルホスファチジルグリセロール(DPPG)ジステアロイルホスファチジルコリン(DSPQ及びジステアロイルホスファチジルグリセロール(DSPG)、ジオレイルホスファチジル−エタノールアルニン(原語:ethanolarnine )(DOPE)及び混合型ホスホリピド、例えばパルミトイルステアロイルホスファチジルコリン(PSPC)及びパルミトイルステアロールホスファチジルグリセロール(PSPG)、及び単一アシル化ホスホリピド、例えばモノ−オレオイル−ホスファチジルエタノールアルニン(原語:ethanolarnine )(MOPE)がある。
及びホスファチジルセリン(PS)がある。例には、DMPG、DPPG、DSPG、DMPA、DPPA、DSPA、DMPI、DPPI、DSPI、DMPS、DPPS 及び DSPSがある。
リポソームは、捕捉された水性容積を内包する、完全に密封された脂質二重層の膜である。リポソームは(単一膜の二重層を持つ)単層のベシクルであったり、又は、(それぞれが隣から水性の層により分離された複数の膜の二重層を特徴とするタマネギ様の構造)多層のベシクルであったりする。二重層は、疎水性の「尾」の領域と、親水性の「頭」の領域とを有する二つの脂質単層から成る。この膜二重層の構造は、脂質単層の疎水性の(非極性の)「尾」が二重層に中心に向かっており、他方、親水性の「頭」が水相を向いているような構造である。
5,030,453 号、及び第5,169,637号)、ファウンテンら(米国特許第 4,588,578号)及びカリスら(米国特許第4,975,282号)らは、それらの水性区画のそれぞれに実質的に等しい層間溶質分布を有する多層リポソームを作製する方法を開示している。パファドジョポラスらは米国特許第4,235,871号で逆相蒸発によるオリゴ層リポソームの調製を開示している。
Deamer and Uster (1983); and Chapman et al. (1968)を参照されたい)。
の最初のリポソーム調製は、有機溶媒にホスホリピドを懸濁させた後、乾燥するまで蒸発させて反応容器上にホスホリピドのフィルムを残させるステップを含む。次に、適量の水相を加え、60混合物を「膨潤」させて、多層ベシクル(MLV)から成る出来たリポソームを機械的手段により分散させる。この調製法はパパハジョポラスら(Biochim. Biophys, Acta., 1967,
135:624-638)が解説した小型の音波破砕された単層ベシクル及び大型の単層ベシクルの開発の基盤となる。
Dekker, Inc., New York, 1983, Chapter 1に見られる。また引用をもってその関連部分をここに援用することとするSzoka, Jr. et al., (1980, Ann. Rev. Biophys.
Bioeng., 9:467)も参照されたい。
乃至1.0 ミクロンの範囲の粒子からなる。リポソーム製品の持続的な放出特性は、脂質メンブレンの性質や、組成中への他の医薬品添加物(例えばステロール)の含有により、調節することができる。
本発明の範囲に含まれる感染性物質は細菌である場合もある。当該細菌は:シュードモナス-アエルギノーサ(原語:Pseudomonas aeruginosa)、バシラス-アンスラシス(原語:Bacillus anthracis)、リステリア-モノサイトゲネス(原語:Listeria
monocytogenes)、スタフィロコッカス-アウレウス(原語:Staphylococcus aureus)、 サルメネローシス(原語:Salmenellosis)、イェルシニア-ペスティス(原語:Yersina pestis)、マイコバクテリウム-レプレー(原語:Mycobacterium leprae)、M.アフリカヌム(原語:M. africanum)、M.アジアチクム(原語:M. asiaticum)、M.アヴィウム-イントゥラセルライレ(原語:M. avium-intracellulaire)、M.ケロネイ-アブセッサス(原語:M. chelonei
abscessus)、M.ファラックス(原語:M. fallax)、M.フォーテュイタム(原語:M. fortuitum)、M.カンサシー(原語:M. kansasii)、M.レプレー(原語:M. leprae)、M.マルモエンセ(原語:M. malmoense)、M.シモイデイ(原語:M. shimoidei)、M.シミエー(原語: M. simiae)、M.スズルガイ(原語:M. szulgai)、M.キセノピー(原語:M. xenopi)、M.ツベルキュローシス(原語:M. tuberculosis)、ブルセラ-メリテンシス(原語:Brucella melitensis)、ブルセラ-スイス(原語:Brucella suis)、ブルセラ-アボルツス(原語:Brucella abortus)、ブルセラ-カニス(原語:Brucella canis)、レジオネラ-ニューモノフィリア(原語:Legionella pneumonophilia)、フランシセラ-ツラレンシス(原語:Francisella
tularensis)、ニューモシスティス-カリニー(原語:Pneumocystis carinii)、マイコプラズマ、及びブルクホルデリア-カパシア(原語:Burkholderia cepacia)から選択することができる。
抗感染薬という用語は、本明細書全体を通じ、限定はしないが細菌、酵母及び真菌、ウィルス、原虫又は寄生生物を含め、特定の他の有害な病原性生物を致死又はその成長を阻害することができると共に、生きた生物、特に哺乳動物、特にヒト、などの動物に投与することのできる生物学的に活性な物質を述べるために用いられている。
セファロスポリンは世代によって更に分類される。世代によるセファロスポリンの非限定的な例には以下のものがある。第一世代のセファロスポリンの例には、セファドロキシル、セファゾリン、セファレキシン、セファロチン、セファピリン、及びセファラジン(原語:Cephradine)がある。第二世代セファロスポリンの例には、セファクロール、セファマンドール、セフォニシド、セフォテタン、セフォキシチン、セフプロジル、セフトメタゾール(原語:Ceftmetazole)、セフロキシム、セフロキシム-アキセチル、及びロラカルベフがある。第三世代セファロスポリンの例には、セフジニル、セフチブテン、セフジトレン、セフェタメット、セフポドキシム、セフプロジル、セフロキシム(アセキチル)、セフロキシム(ナトリウム)、セフォペラゾン、セフィキシム、セフォタキシム、セフポドキシム-プロキセチル、セフタジジム、セフチゾキシム、及びセフトリアキソンがある。第四世代セファロスポリンの例にはセフェピムがある。
キノロン及びフルオロキノロンの非限定的な例には、シノキサシン、シプロフロキサシン、エノキサシン、ガチフロキサシン、グレパフロキサシン、レボフロキサシン、ロメフロキサシン、モキシフロキサシン、ナリジクス酸、ノルフロキサシン、オフロキサシン、スパルフロキサシン、トロヴァフロキサシン、オキソリン酸、ゲミフロキサシン、及びペルフロキサシン(原語:Perfloxacin)がある。
ペニシリンの非限定的な例には、アモキシシリン、アンピシリン、バカンピシリン、カルベニシリン-インダニル、メズロシリン、ピペラシリン、及びチカルシリンがある。
ペニシリン及びベータ-ラクタマーゼ阻害剤の非限定的な例には、アモキシシリン-クラブラン酸、アンピシリン-スルバクタム、スルファクタム、タゾバクタム(原語:Tazobactam)、ベンジルペニシリン、クロキサシリン、ジクロキサシリン、メチシリン、オキサシリン、ペニシリンG(ベンザチン、カリウム、プロカイン)、ペニシリンV、ペニシリナーゼ耐性ペニシリン、イソキサゾイルペニシリン、アミノペニシリン、ウレイドペニシリン、ピペラシリン+タゾバクタム、チカルシリン+クラブラン酸、及びナフシリン、がある。
カルベペネムの非限定的な例には、イミペネム-シラスタチン(原語:Imipenem-Cilastatin)及びメロペネムがある。
モノバクタムの非限定的な例にはアズトレオナムがある。
マクロライド及びリンコサミンの非限定的な例にはアジスロマイシン、クラリスロマイシン、クリンダマイシン、ジリスロマイシン、エリスロマイシン、リンコマイシン、及びトロレアンドマイシンがある。
グリコペプチドンの非限定的な例には、テイコプラニン及びヴァンコマイシンがある。
リファンピンの非限定的な例には、リファブチン、リファンピン、及びリファペンチンがある。
オキサゾリドノンの非限定的な例にはリネゾリドがある。
テトラサイクリンの非限定的な例にはデメクロサイクリン、ドキシサイクリン、メタサイクリン、ミノサイクリン、オキシテトラサイクリン、テトラサイクリン、及びクロルテトラサイクリンがある。
アミノグリコシドの非限定的な例にはアミカシン、ゲンタマイシン、カナマイシン、ネオマイシン、ネチルミシン、ストレプトマイシン、トブラマイシン、及びパロモマイシンがある。
ストレプトグラミンの非限定的な例にはキノプリスチン+ダルフォプリスチン(原語:Quinopristin+Dalfopristin)がある。
スルホンアミドの非限定的な例にはマフェニド、スルファジアジン銀、スルフアセトアミド、スルファジアジン、スルファメトキサゾール、スルファサラジン、スルフィソキサゾール、トリメトプリム−スルファメトキサゾール、及びスルファメチゾールがある。
その他の抗生剤の非限定的な例にはバシトラシン、クロラムフェニコール、コリステメテート(原語:Colistemetate)、フォスフォマイシン、イソニアジド、メテナミン、メトロニダゾール、ムピロシン、ニトロフラントイン、ニトロフラゾン、ノヴォビオシン、ポリミキシンB、スペクチノマイシン、トリメトプリン、トリメトプリン/スルファメトキサゾール、陽イオン性ペプチド、コリスチン、イセガナン、シクロセリン、カプレオマイシン、ピラジンアミド、パラ-アミノサリチル酸、及びエリスロマイシンエチルスクシネート+スルフィソキサゾールがある。
本発明のいずれかの組成物の投薬量は、患者の症状、年齢及び体重、治療もしくは防止しようとする障害の性質及び重篤度、投与経路、及び当該組成物の形に応じて様々であろう。当該の調合物のいずれも、一回分の用量として投与しても、あるいは、分割した用量にして投与してもよい。本発明の組成物の投薬量は、当業者で公知の技術により、又は、ここで教示するように、容易に決定できよう。
抗感染薬の医薬調合物は、リポソーム及び遊離抗感染薬の水性懸濁液から成っても、あるいは、リポソーム及び遊離抗感染薬を含有する無水粉末から成っていてもよい。当該の調合物は、リポソームを形成するための脂質医薬品添加物、そして適当な浸透圧及びpHを提供するための塩/緩衝剤を含有していてもよい。乾燥粉末調合物は、乾燥中や、吸入用に適した粒子サイズ(即ち1-5μm)を作るために必要かも知れない微粉砕ステップ中に、被包された型の抗感染薬が漏出することを防ぐための付加的な医薬品添加物を含有するであろう。このような医薬品添加物は、当該の抗感染薬調合物のガラス転移温度を高めるようにデザインされる。当該の医薬品添加物は、いずれか当該の組成物又はその成分を身体の一つの器官又は部分から身体の別の器官又は部分に運ぶ又は輸送することに関与する、液体又は固体の充填剤、希釈剤、溶媒又は封入材料であってもよい。各医薬品添加物は、当該の組成物やその成分に対して適合性があり、かつ、患者にとって有害でないという意味において「許容可能」でなくてはならない。適した医薬品添加物にはトレハロース、ラフィノース、マンニトール、スクロース、ロイシン、トリロイシン、及び塩化カルシウムがある。他の適した医薬品添加物の例には(1)ラクトース及びグルコースなどの糖類;(2)コーンスターチ及びいもでんぷんなどのでんぷん;(3)カルボキシメチルセルロースナトリウム、エチルセルロース及び酢酸セルロースなどのセルロース及びその誘導体;(4)粉末トラガカント;(5)麦芽;(6)ゼラチン;(7)タルク;(8)ココアバター及びザ薬用ろうなどの医薬品添加物;(9)ピーナッツ油、綿実油、ベニバナ油、ごま油、オリーブ油、コーン油及び大豆油などの油類;(10)プロピレングリコールなどのグリコール;(11)グリセリン、ソルビトール、及びポリエチレングリコールなどのポリオール;(12)オレイン酸エチル及びラウリン酸エチルなどのエステル;(13)寒天;(14)水酸化マグネシウム及び水酸化アルミニウムなどの緩衝剤;(15)アルギン酸;(16)発熱性物質なしの水;(17)等張生理食塩水;(18)リンガー液;(19)エチルアルコール;(20)リン酸緩衝液;及び(21)医薬調合に用いられる、その他の非毒性適合性物質、がある。
本発明の医薬調合物を、鼻腔内投与に適合させたいずれかの投薬量調剤器具に入れて用いてもよい。当該の器具は、計量精度が最適であり、容器、バルブ及びアクチュエータなど、その構成要素の鼻腔用調合物との適合性が最適であるように構築されねばならず、また、例えば計量ネブライザ、乾燥粉末吸入器、ソフトミスト吸入器、又はネブライザのそれなど、機械的なポンプ・システムに基づくであろう。投与される用量が大きいため、好適な器具には、ジェット・ネブライザ(例えばAKITA社製 PARI LC Star)、ソフトミスと吸入器(例えば PARI e-Flow)、及びカプセル・ベースの乾燥粉末吸入器(例えばPH&TTurbospin)がある。適した推進剤はフルオロカーボン、ハイドロカーボン、窒素及び酸化二窒素、又はこれらの混合物などの気体から選択されよう。
実施例1
健康なボランティアにおいて遊離型と被包された型の両方のアミカシンとして送達される場合のアミカシンの薬物動態。 噴霧化させたリポソーム型アミカシンは被包された型の(ほぼ60%)及び遊離型(ほぼ40%)のアミカシンの混合物を含有する。健康なボランティアでの吸入後、補正された公称用量はガンマ・シンチグラフィーで判定したときに100mgだった。図1は、経時的な血清中濃度の薬物動態学的モデリングに基づく、アミカシン及びTOBI(R)(100%遊離型で投与)の肺内濃度を示す。両方の曲線とも、200mlの肺内のアミノグリコシドの分布体積を表したものである。興味深いことに、肺内の抗感染薬のピーク・レベルは、100 mg の用量のリポソーム型アミカシンと、300 mg の用量のTOBI(R)でほぼ等しい。これは、全身循環に吸収されることで、約1.5時間の半減期で肺から遊離型トブラマイシンが急速に除去された結果である。これらの結果は、リポソームへの被包によりもたらされる、肺ターゲティングの向上の実証として役立つ。当該のアミカシン調合物中の遊離型及び被包された型の抗感染薬の存在が、観察された2つの成分薬物動態プロファイルにより実証されている。遊離型アミカシンは全身循環に急速に吸収される(半減期はTOBIと同様)が、被包された型のこの薬物は、約45時間の肺内半減期を有する。遊離型アミカシンは殺菌活性を提供するのに利用されるが、被包された型のこの薬物は持続的な肺内薬物レベルを提供するため、耐性細菌株の致死の向上を可能にする。リポソーム区画の測定された肺内濃度は、シュードモナス-アエルギノーサの1240種の臨床分離株のMIC50の有意に上であり、耐性の発生を抑えると考えられる。
噴霧化後の、リポソーム内に被包されたアミカシンのパーセンテージに対する遊離型アミカシンの影響。 アミカシンのリポソーム型製剤は、被包された型の薬物の著しい漏出を噴霧化中に示すと考えられる。下の表1に示すように、溶液中の遊離型アミカシンの存在により、抗感染薬のリポソームからの漏出が約4分の1、減少することが示された。いずれの特定の理論に縛られることも望む訳ではないが、噴霧化中にリポソームが弾け、再形成すると、その過程で被包された型の抗感染薬が失われると考えられる。あるいは、被包された型の抗感染薬は、リポソーム膜が漏出性となって噴霧化中に失われる。過剰な遊離型抗感染薬が溶液中に存在すると、リポソームの近傍ではこの遊離型抗感染薬が容易に利用可能になって、再形成中のリポソームに取り込まれる。
ここで引用した全ての特許及び公開文献は、引用をもってここに援用されたものである。
当業者であれば、ごく慣例的な実験を行なうのみで、ここに解説された本発明の特定の実施態様の均等物を数多く、認識され、又は確認できることであろう。このような均等物は以下の請求の範囲の包含するところと意図されている。
Claims (14)
- 肺感染症を治療する又は予防を提供するシステムであって:
a)リポソーム中に被包されたアミカシンを含む医薬調合物であって、前記調合物の脂質成分がホスファチジルコリン及びステロールから成り、前記調合物が溶液又は懸濁液である、医薬調合物と、;
b)エーロゾルを生じることのできる吸入送達器具であって、前記エーロゾルが、即時の殺菌活性を提供するのに有効な量の遊離アミカシンと、持続的な殺菌活性を提供するのに有効な量の被包されたアミカシンとを含む、吸入送達器具と、
を含む、システム。 - 前記リポソームが単層ベシクル及び多層ベシクルの混合物を含む、請求項1に記載のシステム。
- 前記リポソームがホスホリピド及びステロールを含む、請求項1に記載のシステム。
- 前記リポソームがホスファチジルコリン及びステロールを含む、請求項1に記載のシステム。
- 前記リポソームがジパルミトイルホスファチジルコリン(DPPC)及びステロールを含む、請求項1に記載のシステム。
- 前記リポソームがジパルミトイルホスファチジルコリン(DPPC)及びコレステロールを含む、請求項1に記載のシステム。
- 前記リポソームがDPPC及びコレステロールを含み、そして前記リポソームが単層ベシクル及び多層ベシクルの混合物を含む、請求項1に記載のシステム。
- 遊離アミカシン、対、リポソーム中に被包された型のアミカシンの重量比が1:100乃至100:1の間である、請求項1に記載のシステム。
- 遊離アミカシン、対、リポソーム中に被包された型のアミカシンの重量比が1:10乃至10:1の間である、請求項1に記載のシステム。
- 遊離アミカシン、対、リポソーム中に被包された型のアミカシンの重量比が1:2乃至2:1の間である、請求項1に記載のシステム。
- 前記肺感染症が、慢性閉塞性肺疾患(COPD)、気管支拡張症、アクテリアル(原語:acterial)肺炎、及び、慢性気管支炎の急性気管支増悪(ABECB)、結核菌、マイコバクテリウム・リプリー(原語:Mycobacterium leprae)、マイコバクテリウム・アフリカヌム(原語:Mycobacterium africanum)、マイコバクテリウム・アジアティカム(原語: Mycobacterium asiaticum)、マイコバクテリウム・アヴィウム-イントラセルラエー(原語: Mycobacterium avium-intracellulaire)、マイコバクテリウム・コロネイ-アブセッサス(原語: Mycobacterium chelonei abscessus)、マイコバクテリウム・ファラックス(原語:Mycobacterium fallax)、マイコバクテリウム・フォルトゥイタム(原語:Mycobacterium
fortuitum)、マイコバクテリウム・カンサシー(原語:Mycobacterium kansasii)、マイコバクテリウム・マルモエンス(原語:Mycobacterium malmoense)、マイコバクテリウム・シモイデイ(原語:Mycobacterium
shimoidei)、マイコバクテリウム・シミアエ(原語: Mycobacterium simiae)、マイコバクテリウム・ズルガイ(原語:Mycobacterium szulgai)、マイコバクテリウム・キセノピ(原語:Mycobacterium
xenopi)、
生物テロの吸入性物質により引き起こされる感染症、及び日和見性真菌感染から成る群より選択される、請求項1に記載のシステム。 - 前記リポソームが単層ベシクルを含む、請求項1に記載のシステム。
- 前記リポソームが多層ベシクルを含む、請求項1に記載のシステム。
- 前記リポソームが単層ベシクル及び多層ベシクルの混合物を含む、請求項1に記載のシステム。
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