JP2017190353A - 吸入用の一価金属カチオン乾燥粉末 - Google Patents
吸入用の一価金属カチオン乾燥粉末 Download PDFInfo
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Abstract
Description
本願は、2010年9月29日出願の米国特許仮出願第61/387,883号の利益、および2011年5月3日出願の米国特許仮出願第61/481,879号の利益を主張するものであり、これらの出願の全体的教示は、参照により本明細書に組み入れられる。
治療薬の肺送達は、他の送達様式を超える複数の利点を提供する可能性がある。これらの利点には、薬物作用の急速な開始、患者の自己投与の簡便さ、薬物副作用軽減の可能性、送達の容易さ、針の排除などがある。これらの利点を用いれば、吸入治療により、入院患者または外来患者のセッティングへの使用が容易な薬物送達システムを提供することが可能である。
〔1〕呼吸可能乾燥粒子を含む呼吸可能乾燥粉末であって、前記呼吸可能乾燥粒子は、
a)1種以上の一価金属カチオン塩、ここで、前記1種以上の一価金属カチオン塩が、前記乾燥粒子の少なくとも約3重量%の量で存在する、および
b)薬学的活性剤、ここで、前記薬学的活性剤は、喘息を治療するために使用される、
を含み、前記呼吸可能乾燥粒子が、レーザ回折(RODOS/HELOSシステム)により測定されると約5ミクロン以下の体積中位幾何学径(VMGD)および約1.5未満の分散可能性比(1バール/4バール)を有し、前記呼吸可能乾燥粒子は、0.45g/cc〜1.2g/ccのタップ密度を有し、但し、前記呼吸可能乾燥粒子が二価金属カチオンを前記乾燥粒子の3重量%以上の量で含まない、呼吸可能乾燥粉末、
〔2〕喘息の治療のための医薬の製造における〔1〕記載の呼吸可能乾燥粉末の使用、
〔3〕喘息の急性増悪の治療のための医薬の製造における〔1〕記載の呼吸可能乾燥粉末の使用、
〔4〕前記増悪が、ウイルス感染、細菌感染、真菌感染、寄生虫感染または環境アレルゲンにより誘発される、〔3〕記載の使用、
〔5〕前記増悪が、真菌感染により誘発される、〔3〕記載の使用、
〔6〕中度〜重度の喘息に関連する炎症の治療のための医薬の製造における〔1〕記載の呼吸可能乾燥粉末の使用、
〔7〕呼吸可能乾燥粒子を含む呼吸可能乾燥粉末であって、前記呼吸可能乾燥粒子は、
a)1種以上の一価金属カチオン塩、ここで、前記1種以上の一価金属カチオン塩が、前記乾燥粒子の少なくとも約3重量%の量で存在する、および
b)薬学的活性剤、ここで、前記薬学的活性剤は、慢性閉塞性肺疾患を治療するために使用される、
を含み、前記呼吸可能乾燥粒子が、レーザ回折(RODOS/HELOSシステム)により測定されると約5ミクロン以下の体積中位幾何学径(VMGD)および約1.5未満の分散可能性比(1バール/4バール)を有し、前記呼吸可能乾燥粒子は、0.45g/cc〜1.2g/ccのタップ密度を有し、但し、前記呼吸可能乾燥粒子が二価金属カチオンを前記乾燥粒子の3重量%以上の量で含まない、呼吸可能乾燥粉末、
〔8〕慢性閉塞性肺疾患の治療のための医薬の製造における〔7〕記載の呼吸可能乾燥粉末の使用、
〔9〕慢性閉塞性肺疾患の急性増悪の治療のための医薬の製造における〔7〕記載の呼吸可能乾燥粉末の使用、
〔10〕呼吸可能乾燥粒子を含む呼吸可能乾燥粉末であって、前記呼吸可能乾燥粒子は、
a)1種以上の一価金属カチオン塩、ここで、前記1種以上の一価金属カチオン塩が、前記乾燥粒子の少なくとも約3重量%の量で存在する、および
b)薬学的活性剤、ここで、前記薬学的活性剤は、真菌感染を治療するために使用される、
を含み、前記呼吸可能乾燥粒子が、レーザ回折(RODOS/HELOSシステム)により測定されると約5ミクロン以下の体積中位幾何学径(VMGD)および約1.5未満の分散可能性比(1バール/4バール)を有し、前記呼吸可能乾燥粒子は、0.45g/cc〜1.2g/ccのタップ密度を有し、但し、前記呼吸可能乾燥粒子が二価金属カチオンを前記乾燥粒子の3重量%以上の量で含まない、呼吸可能乾燥粉末、
〔11〕真菌感染の治療のための医薬の製造における〔10〕記載の呼吸可能乾燥粉末の使用、
〔12〕真菌感染により誘発される急性増悪の治療のための医薬の製造における〔10〕記載の呼吸可能乾燥粉末の使用、
〔13〕呼吸可能乾燥粒子を含む呼吸可能乾燥粉末であって、前記呼吸可能乾燥粒子は、
a)1種以上の一価金属カチオン塩、ここで、前記1種以上の一価金属カチオン塩が、前記乾燥粒子の少なくとも約3重量%の量で存在する、および
b)薬学的活性剤、ここで、前記薬学的活性剤は、気管支拡張症を治療するために使用される、
を含み、前記呼吸可能乾燥粒子が、レーザ回折(RODOS/HELOSシステム)により測定されると約5ミクロン以下の体積中位幾何学径(VMGD)および約1.5未満の分散可能性比(1バール/4バール)を有し、前記呼吸可能乾燥粒子は、0.45g/cc〜1.2g/ccのタップ密度を有し、但し、前記呼吸可能乾燥粒子が二価金属カチオンを前記乾燥粒子の3重量%以上の量で含まない、呼吸可能乾燥粉末、
〔14〕気管支拡張症の治療のための医薬の製造における〔13〕記載の呼吸可能乾燥粉末の使用、
〔15〕気管支拡張症の急性増悪の治療のための医薬の製造における〔13〕記載の呼吸可能乾燥粉末の使用
に関する。
本明細書において用いられる用語「乾燥粉末」は、吸入デバイス中で分散され得て、続いて対象により吸入され得る、細密に分散された呼吸可能乾燥粒子を含有する組成物を指す。そのような乾燥粉末は、最大約25%、最大約20%、または最大約15%の水もしくは他の溶媒を含有してもよく、または水もしくは他の溶媒を実質的に含まなくてもよく、または無水であってもよい。
本発明の態様は、1種以上の一価金属カチオン塩、好ましくは1種以上のナトリウム塩および/またはカリウム塩を含有する呼吸可能乾燥粉末および乾燥粒子に関する。
一態様において、本発明の呼吸可能乾燥粒子は、1種以上の一価金属カチオン塩、例えばナトリウム塩、カリウム塩および/またはリチウム塩を含有するが、薬学的活性剤は含有しない。これらのタイプの呼吸可能乾燥粒子は、薬学的活性剤を局所もしくは全身送達のために呼吸管(例えば、肺)に送達する担体粒子として用いることができる。例えば、このタイプの呼吸可能乾燥粒子は、例えば微粒子化粉末の形態で、薬学的活性剤とブレンドされて、本発明の乾燥粉末を製造することができる。
が挙げられる。
本発明の乾燥粒子は、好ましくは小さく、分散可能であり、ナトリウムカチオン(Na+)および/またはカリウムカチオン(K+)が高密にすることができる。一般に本発明の乾燥粒子は、1.0バールであるHELOS/RODOSで測定すると、約10μm以下(例えば、約0.1μm〜約10μm)のVMGDを有する。好ましくは本発明の乾燥粒子は、1.0バールのHELOS/RODOSで測定すると、約9μm以下(例えば、約0.1μm〜約9μm)、約8μm以下(例えば、約0.1μm〜約8μm)、約7μm以下(例えば、約0.1μm〜約7μm)、約6μm以下(例えば、約0.1μm〜約6μm)、約5μm以下(例えば、5μm未満、約0.1μm〜約5μm)、約4μm以下(例えば、約0.1μm〜約4μm)、約3μm以下(例えば、約0.1μm〜約3μm)、約2μm以下(例えば、約0.1μm〜約2μm)、約1μm以下(例えば、約0.1μm〜約1μm)、約1μm〜約6μm、約1μm〜約5μm、約1μm〜約4μm、約1μm〜約3μm、または約1μm〜約2μmのVMGDを有する。
1.HELOS/RODOSシステムを用いて測定すると1バールで、0.5ミクロン〜10ミクロンの間、好ましくは1ミクロン〜7ミクロンの間、1ミクロン〜5ミクロンの間、または1ミクロン〜3ミクロンの間のVMGD;
2.1.6以下、好ましくは1.5未満、1.4未満、1.3未満、1.2未満または1.1未満の1バール/4バール;ならびに
3.約0.4g/cm3〜約1.2g/cm3、約0.5g/cm3〜約1.0g/cm3、好ましくは約0.6g/cm3〜約0.9g/cm3の間のタップ密度、
を特徴とする呼吸可能乾燥粒子を含む。
1.HELOS/RODOSシステムを用いて測定すると1バールで、0.5ミクロン〜10ミクロンの間、好ましくは1ミクロン〜7ミクロンの間、1ミクロン〜5ミクロンの間、または1ミクロン〜3ミクロンの間のVMGD;
2.1.6以下、好ましくは1.5未満、1.4未満、1.3未満、1.2未満または1.1未満の1バール/4バール;ならびに
3.0.5〜6.0の間、1.0〜5.0の間、または1.0〜3.0の間のMMAD、
を特徴とする呼吸可能乾燥粒子を含む。
1.HELOS/RODOSシステムを用いて測定すると1バールで、0.5ミクロン〜10ミクロンの間、好ましくは1ミクロン〜7ミクロンの間、1ミクロン〜5ミクロンの間、または1ミクロン〜3ミクロンの間のVMGD;
2.1.6以下、好ましくは1.5未満、1.4未満、1.3未満、1.2未満または1.1未満の1バール/4バール;ならびに
3.少なくとも30%、少なくとも40%、少なくとも50%、または少なくとも60%のFPF_TD<5.0μm、
を特徴とする呼吸可能乾燥粒子を含む。
1.HELOS/RODOSシステムを用いて測定すると1バールで、10ミクロン未満、0.5ミクロン〜10ミクロンの間、1ミクロン〜7ミクロンの間、好ましくは1ミクロン〜5ミクロンの間、または1ミクロン〜3ミクロンの間のVMGD;
2.1.6以下、好ましくは1.5未満、1.4未満、1.3未満、1.2未満または1.1未満の1バール/4バール;ならびに
3.1.5を超える、1.8を超える、または2.1を超えるハウスナー比、
を特徴とする呼吸可能乾燥粒子を含む。
1.約0.4g/cm3〜約1.2g/cm3、約0.5g/cm3〜約1.0g/cm3、好ましくは約0.6g/cm3〜約0.9g/cm3のタップ密度;
2.少なくとも30%、少なくとも40%、少なくとも50%、または少なくとも60%のFPF_TD<5.0μm;
3.1.5を超える、1.8を超える、または2.1を超えるハウスナー比、
を特徴とする呼吸可能乾燥粒子を含む。
(a)活性剤、例えばLABA(例えば、ホルモテロール、サルメテロール)、短時間作用性βアゴニスト(例えば、アルブテロール)、コルチコステロイド(例えば、フルチカゾン)、LAMA(例えば、チオトロピウム)、抗生物質(例えば、レボフロキサシン、トブラマイシン)、抗体(例えば、治療抗体)、ホルモン(例えば、インスリン)、サイトカイン、増殖因子、およびそれらの組み合わせを更に含有してもよい。乾燥粉末が、CFの処置を意図する場合、好ましい追加的活性剤は、約0.01%〜約10%の間、約10%〜約50%の間、または約50%〜約99.9%の間の量の短期間作用性βアゴニスト(例えば、アルブテロール)、抗生物質(例えば、レボフロキサシン)、組換えヒトデオキシリボヌクレアーゼI(例えば、ドルナーゼα、DNアーゼとしても既知)、ナトリウムチャネルブロッカー(例えば、アミロライド)、およびそれらの組み合わせであり、そして
(b)乾燥粒子の約80重量%以下、または約50重量%以下、または約20重量%以下の量で存在し得る賦形剤、例えばロイシン、マルトデキストリン、マンニトールまたはそれらの任意の組み合わせなどを更に含有していてもよい。
呼吸可能乾燥粒子および乾燥粉末は、任意の適切な方法を用いて調製することができる。呼吸可能乾燥粉末および粒子を調製する多くの適切な方法は、当該技術分野で従来通りであり、シングルおよびダブルエマルジョン溶媒留去、噴霧乾燥、噴霧凍結乾燥、ミリング(例えば、ジェットミリング)、ブレンディング、溶媒抽出、溶媒留去、相分離、単純および複合コアセルベーション、界面重合、超臨界二酸化炭素(CO2)の使用を含む適切な方法、音波結晶化(sonocrystallization)、ナノ粒子凝集形成および他の適切な方法、ならびにそれらの組み合わせが挙げられる。呼吸可能乾燥粒子は、当該技術分野で公知のミクロスフェアまたはマイクロカプセルを生成する方法を用いて生成することができる。これらの方法は、所望の空気力学特性(例えば、空気力学径および幾何学径)を有する呼吸可能乾燥粒子の形成をもたらす条件を用いることができる。所望なら、所望の特性、例えばサイズおよび密度を有する呼吸可能乾燥粒子は、適切な方法、例えばふるいを利用して選択することができる。
本発明の呼吸可能乾燥粉末および呼吸可能乾燥粒子は、呼吸管に投与されるためのものである。呼吸管への投与は、送達される薬学的活性剤の局所活性、または全身活性のためのものであってもよい。例えば呼吸可能乾燥粉末は、鼻腔または上気道に投与されて、鼻腔または上気道に、例えば抗炎症活性、抗ウイルス活性、または抗菌活性を提供することができる。呼吸可能乾燥粉末は、肺深部に投与して、肺への局所活性または全身循環への吸収を提供することができる。肺を通した特定の薬学的活性剤の全身送達は、経口投与後に実質的な初回通過代謝(例えば、肝臓内)を受ける薬剤には特に有利である。
方法:
幾何学または体積径 体積中位幾何学径(VMGD)およびDv(50)と呼ばれる場合もある体積中位径(VMD)(×50)を、レーザ回折技術を用いて測定した。この設備は、HELOS回折装置およびRODOS乾燥粉末分散装置(Sympatec, Inc., Princeton, NJ)からなる。RODOS分散装置は、入ってくる圧縮乾燥空気のレギュレータ圧力(典型的には最大オリフィスリング圧で1.0バールに設定)により制御されるせん断力を、粒子試料に加える。圧力設定を変動させて、粉末を分散するのに用いられるエネルギー量を変動させてもよい。例えばレギュレータ圧力は、0.2バール〜4.0バールで変動してもよい。粉末試料を、マイクロスパチュラからRODOS漏斗に分配させる。分散された粒子は、レーザビームにより移動して、その結果生成した回折光パターンを、典型的にはR1レンズを用いて、一連の検出器により採取する。その後、小さな粒子ほど大きな角度で光を回折するという原理に基づいて、その全体的回折パターンを、Fraunhofer回折モデルを用いて体積に基づく粒径分布に変換する。この方法を利用して、体積中位幾何学径の幾何標準偏差(GSD)も決定した。
この実施例では、一定範囲の吸入流速および体積で乾燥粉末吸入器から送達された場合の乾燥粉末配合剤の分散可能性が実証される。
この実施例では、乾燥粉末吸入器から送達されると、一価カチオン性塩を一部として含む乾燥粉末配合剤の空気力学径分布が、呼吸管内での付着に適した範囲内になることを実証する。
硫酸ナトリウムおよびマンニトールまたはマルトデキストリンで構成された複数種の一価カチオン粉末を、均質な粒子の噴霧乾燥により製造した。製造された粉末を、以下の表9に示す。
A.粉末の調製
ナトリウム塩、場合により非塩性賦形剤、および少なくとも1種の薬学的活性剤を含有する乾燥粒子で構成された乾燥粉末を製造するために、供給原料溶液を調製した。表13に、乾燥粒子で構成された乾燥粉末の調製に用いられる供給原料配合剤の成分を列挙している。重量%は、乾量基準で示している。
粉末の物理特性およびエアロゾル特性を、以下の表16〜20に要約する。±の付いた値は、報告された値の標準偏差を示す。2ステージACI−2の結果を、FPFTD<3.4μmおよびFPFTD<5.6μmに関して表16に報告する。配合剤は全て、20%を超えるFPFTD<3.4μmを有したが、配合剤XXV、XXXおよびXXXIの全てが、30%を超えるFPFTD<3.4μmを有した。配合剤XVIII、XIX、XX、XXI、XXIV、XXVIIIおよびXXXIIはそれぞれ、45%を超えるFPFTD<3.4μmを有した。配合剤は全て、40%を超えるFPFTD<5.6μmを有した。配合剤XVIII〜XXIV、XXVII、XXVIII、XXXII、およびXXXIIIはそれぞれ、60%を超えるFPFTD<5.6μmを有した。
ロイシン、塩化ナトリウム、プロピオン酸フルチカゾン(FP)およびキシナホ酸サルメテロール(SX)で構成された乾燥粉末配合剤を、アレルギー性喘息のマウスモデルにおける活性について検査した。アレルギー性喘息のマウスモデルを、オボアルブミン(OVA)を用いて確立させた。概略図1に示す通り、このモデルにおいて、マウスを2週間にわたりOVAに感作し、続いてOVAを含むエアロゾルでチャレンジした。このチャレンジは、気道炎症を誘発し、肺機能の変化を引き起こす。炎症における主たる変化は、肺の好酸球数の増加である。肺の炎症および肺機能における類似の変化が、喘息のヒトにおいて観察される。
A.炎症
配合剤X(乾量基準で30重量%ロイシン、65.4重量%NaCl、4.0重量%プロピオン酸フルチカゾン、および0.58重量%キシナホ酸サルメテロール)を、アレルゲンとしてオボアルブミン(OVA)を用いて、アレルギー性喘息のマウスモデルにおいて評価した。モデルは、実施例6および7に概略的に記載および図示されている。
OVAによるマウスの感作と、続くOVAによるマウスのチャレンジを、実施例6および7に概略的に記載および図示される通り実行した。OVAで感作およびチャレンジされたマウスは、炎症の変化に加えて、実施例7に述べられた通り気道過敏性の上昇を示し、それは気管支誘発に続く気道抵抗の変化として測定することができる。肺機能検査は、30日目に処置の1時間後に実施した。これは、マウスにおける特異的気道抵抗(sRaw)を測定することを含むものであった。sRawは、肺機能を評価する手段であった。ベースラインsRaw測定を、5分間実施した。続いてマウスは、メタコリン(MCh)0mg/ml、50mg/mlまたは100mg/ml用量を用いて、ヘッドチャンバー内で噴霧により送達された上昇濃度のMChで肺機能を評価するMChチャレンジを受けた。
実施例6〜8で用いられたものと類似の、アレルギー性喘息のオボアルブミンマウスモデル。OVAでの感作と続くチャレンジの実施例6および7のプロトコルに従った。肺機能検査を、実施例8に従って実施した。
ロイシン、塩化ナトリウム、プロピオン酸フルチカゾン(FP)およびキシナホ酸サルメテロール(SX)で構成された乾燥粉末(DP)配合剤を、アレルギー性喘息のマウス・イエチリダニ(HDM)モデルにおいて、炎症および気道過敏性を低下させる能力に関して更に検査した。以下の概略図3に示す通り、2週間の期間の0、7および14日目に、凍結乾燥デルマトファゴイデス・プテロニッシナスHDM 25μgの鼻内投与により、アレルギー性喘息のマウスモデルを確立させた。マウスへのHDMの暴露は、肺における総炎症細胞、主として好酸球の増加を誘発し、慢性暴露では気道過敏性を誘発することが示された。肺の炎症および肺機能におけるこれらの類似の変化が、ヒト喘息において観察されている。
この試験において、急性肺傷害のマウスモデルを用いて、ナトリウム塩を共配合したFP/SXの肺炎症に対する影響を試験した。マウスを、シュードモナス・アエルギノサから単離されたエアロゾル化リポ多糖(LPS)に暴露した。このチャレンジにより、肺炎症が誘発され、肺機能の変化が引き起こされた。炎症における主たる変化は、肺の好中球数の増加であった。肺炎症および肺機能の類似の変化が、急性肺傷害に見舞われたヒトにおいて観察されている。
シュードモナス・アエルギノサの好中球減少性マウスモデルを用いて、配合剤IV(乾量基準で10.0重量%マンニトール、40重量%塩化ナトリウム、50重量%塩酸シプロフロキサシン)の有効性を評価した。マウス(C57BL6;〜20g)に、感染日(0日目)に対して4日前(200mg/kg)および1日前(100mg/kg)に注射用滅菌水に溶解させたシクロホスファミド一水和物(Sigma Aldrich; St Louis, MO)2用量を与えた。シクロホスファミドを腹腔内注射により与えたが、それは好中球を枯渇させる作用がある。
細菌感染のマウスモデルを用いて、配合剤XXIの有効性をインビボで評価した。好中球減少を、4日前および1日前のシクロホスファミドの注射により誘導した。細菌(シュードモナス・アエルギノサ)を、ルリア・ベルターニ(LB)ブロス2.0mL中で37℃で一晩発育させて、PBS 50μl中での鼻内投与により、マウスあたりおよそ5×103CFUを送達させた。感染の4時間後に、全身暴露チャンバーおよびカプセルに基づく乾燥粉末吸入器システムを用いて、動物を配合剤XXI(乾量基準で27重量%ロイシン、53重量%NaClおよび20重量%レボフロキサシン)およびプラセボ−B乾燥粉末(98%ロイシン、2%NaCl)で処置した。翌日、動物を安楽死させ、肺および脾臓を採取してホモジナイズし、肺細菌量および全身細菌量をそれぞれ決定した。ホモジネートをトリプシン大豆寒天プレート上で系列希釈して、37℃で一晩インキュベートした。翌日、コロニー形成単位(CFU)を計数して、肺および脾臓それぞれのCFU/mlを計算した。
この試験において、組換えヒトインスリン(Sigma−Aldrich, St. Louis, MO, およそ27.5U/mg乾燥粉末)を含有する配合剤XXIVおよびXXVIII(表25)を用いて、一価カチオン系乾燥粉末配合剤が肺へのタンパク質送達に使用され得るか、そしてこの乾燥粉末がタンパク質を全身送達するのに用いられ得るか、を決定した。
この試験において、配合剤XXV(乾量基準で、50重量%硫酸ナトリウム、47.5重量%マンニトール、2.5重量%ウシ免疫グロブリンG(IgG))を用いて、一価カチオン塩系乾燥粉末配合剤が、タンパク質を、肺へ、そして/または肺により全身へ送達し得るかを決定した。
2種のナトリウム塩系プロピオン酸フルチカゾン/キシナホ酸サルメテロール(FP/SX)配合剤である配合剤IおよびXXXIIIを加工した(表26参照)。配合剤I乾燥粉末を、Buchi B−290 Mini Spray Dryer (BUCHI Labortechnik AG, Flawil, Switzerland)での噴霧乾燥により製造し、高性能サイクロンから60mLガラス容器に粉末を採取した。そのシステムは、Buchi B−296除湿機および外部LG除湿機(モデル49007903, LG Electronics, Englewood Cliffs, NJ)を常時運転した。液体供給物の霧化では、1.5mm径のBuchi二液ノズルを用いた。二液霧化気体を40mmに設定し、アスピレータ率を90%(35m3/h)に設定した。室内空気を、乾燥気体として用いた。そのプロセスガスの入口温度は180℃、出口温度は86〜87℃であり、液体供給物の流速は8mL/分〜9mL/分であった。固体濃度は、60%エタノールおよび40%水中に10g/Lであった。
ライノウイルスマイナー1B株でのライノウイルス感染のマウスモデルを、用いた(REF)。雌近交系Balb/cマウス(使用初日の体重:16.8〜24.3g)を、Charles River Laboratoriesから得た。マウス(n=4)を、ライノウイルス−1Bの5×106 TCID50で鼻内感染させた。ウイルス感染の18時間後に、カスタム仕様の全身暴露システムを用いて、マウスを乾燥粉末配合剤XXXIIに暴露した。乾燥粉末処置のおよそ1時間後に、肺機能検査を実施した。ベースライン特異的気道抵抗(sRaw)測定を処置5分前に実施し、続いてマウスは、ヘッドチャンバーへの噴霧により送達される上昇濃度のメタコリン(MCh)(0〜100mg/ml)で、MChチャレンジを受けた。表28のデータは、MCh投与5分間の平均sRawとして表している。
[1]1種以上の一価金属カチオン塩を含む呼吸可能乾燥粒子を含む呼吸可能乾燥粉末であって、前記呼吸可能乾燥粒子が、10%ロイシンおよび90%NaCl、または60%ロイシンおよび40%NaClからならないことを前提とし、前記呼吸可能乾燥粒子が二価金属カチオンを前記乾燥粒子の3重量%以上の量で含有しないことを更なる前提とする、前記1種以上の一価金属カチオン塩が、前記乾燥粒子の少なくとも約3重量%の量で存在し、前記呼吸可能粒子が、レーザ回折(RODOS/HELOSシステム)により測定されると約10ミクロン以下の体積中位幾何学径(VMGD)および約2未満の分散可能性比(1バール/4バール)を有する、呼吸可能乾燥粉末。
[2]呼吸可能乾燥粒子が、二価金属カチオン塩を前記乾燥粒子の5重量%以上の量で含有しないことを更なる前提とする、[1]に記載の呼吸可能乾燥粉末。
[3]前記呼吸可能乾燥粒子が、約5.0ミクロン以下の体積中位幾何学径(VMGD)を有する、[1]または[2]に記載の呼吸可能乾燥粉末。
[4]HELOS/RODOSレーザ回折システムで1バールおよび4バール分散設定で測定されると、約1.5未満の分散可能性比(1/4バール)を有する、前記のいずれか1項に記載の呼吸可能乾燥粉末。
[5]少なくとも45%の、5.6ミクロン未満の細粒分(FPF)を有する、前記のいずれか1項に記載の呼吸可能乾燥粉末。
[6]少なくとも30%の、3.4ミクロン未満の細粒分(FPF)を有する、[1]〜[4]のいずれか1項に記載の呼吸可能乾燥粉末。
[7]少なくとも45%の、5.0ミクロン未満の細粒分(FPF)を有する、[1]〜[4]のいずれか1項に記載の呼吸可能乾燥粉末。
[8]約5ミクロン以下の質量中位空気力学径(MMAD)を有する、前記のいずれか1項に記載の呼吸可能乾燥粉末。
[9]前記一価金属カチオン塩が、25℃、1バールの水中に0.5g/L以上の溶解度を有する、前記のいずれか1項に記載の呼吸可能乾燥粉末。
[10]前記一価金属カチオン塩が、25℃、1バールの水中に400g/L以上の溶解度を有する、前記のいずれか1項に記載の呼吸可能乾燥粉末。
[11]少なくとも1種の薬学的に許容し得る賦形剤を更に含む、前記のいずれか1項に記載の呼吸可能乾燥粉末。
[12]少なくとも1種の賦形剤が、前記乾燥粒子の約50重量%以下の量で存在する、[11]に記載の呼吸可能乾燥粉末。
[13]少なくとも1種の賦形剤が、前記乾燥粒子の約50重量%以上の量で存在する、[11]に記載の呼吸可能乾燥粉末。
[14]少なくとも1種の賦形剤が、ロイシン、マルトデキストリン、マンニトールおよびそれらの組み合わせからなる群より選択される、[11]〜[13]のいずれか1項に記載の呼吸可能乾燥粉末。
[15]前記一価金属カチオン塩が、ナトリウム塩、カリウム塩、リチウム塩、およびそれらの組み合わせからなる群より選択される、前記のいずれか1項に記載の呼吸可能乾燥粉末。
[16]前記一価金属カチオン塩が、ナトリウム塩である、[1]〜[14]に記載の呼吸可能乾燥粉末。
[17]前記ナトリウム塩が、塩化ナトリウム、乳酸ナトリウム、クエン酸ナトリウム、硫酸ナトリウムまたはそれらの組み合わせである、[16]に記載の呼吸可能乾燥粉末。
[18]前記一価金属カチオン塩が、カリウム塩である、[1]〜[14]に記載の呼吸可能乾燥粉末。
[19]前記カリウム塩が、塩化カリウムまたはクエン酸カリウムである、[18]に記載の呼吸可能乾燥粉末。
[20]前記粉末のタップ密度が、0.4g/ccを超える、前記のいずれか1項に記載の呼吸可能乾燥粉末。
[21]前記粉末のタップ密度が、0.45g/ccを超える、[1]〜[19]のいずれか1項に記載の呼吸可能乾燥粉末。
[22]前記粉末のタップ密度が、0.55g/ccを超える、[1]〜[19]のいずれか1項に記載の呼吸可能乾燥粉末。
[23]薬学的活性剤を更に含む、前記のいずれか1項に記載の呼吸可能乾燥粉末。
[24]呼吸可能乾燥粒子が、前記薬学的活性剤を含有する、[23]に記載の呼吸可能乾燥粉末。
[25]薬学的活性剤が、抗生物質、LABA、LAMA、コルチコステロイド、またはそれらの任意の組み合わせである、[23]または[24]に記載の呼吸可能乾燥粉末。
[26]薬学的活性剤が、高分子である、[23]または[24]に記載の呼吸可能乾燥粉末。
[27]薬学的活性剤が、抗体、ホルモン、および増殖因子からなる群より選択される、[23]または[24]に記載の呼吸可能乾燥粉末。
[28]薬学的活性剤が、モノクローナル抗体、単鎖抗体、キメラ抗体、二官能性/二特異性抗体、ヒト化抗体、またはそれらの組み合わせである、[23]または[24]に記載の呼吸可能乾燥粉末。
[29]a)一価金属カチオン塩を含む第一の呼吸可能乾燥粒子であって、前記呼吸可能乾燥粒子が、10%ロイシンおよび90%NaCl、または60%ロイシンおよび40%NaClからならないことを前提とし、前記呼吸可能乾燥粒子が二価金属カチオンを前記乾燥粒子の3重量%以上の量で含有しないことを更なる前提とする、前記一価金属カチオン塩が、前記乾燥粒子の少なくとも約3重量%の量で存在し、前記呼吸可能粒子が、RODOS/HELOSレーザ回折システムにより1バールおよび4バールの分散設定で測定されると約10ミクロン以下の体積中位幾何学径(VMGD)および約2未満の分散可能性比(1/4バール)を有する、第一の呼吸可能乾燥粒子と;
b)薬学的活性剤を含む第二の呼吸可能乾燥粒子と、
を含む呼吸可能乾燥粉末。
[30]前記呼吸可能乾燥粒子が、二価金属カチオン塩を前記乾燥粒子の5重量%以上の量で含有しないことを更なる前提とする、[29]に記載の呼吸可能乾燥粉末。
[31]前記薬学的活性剤が、抗生物質、LABA、LAMA、コルチコステロイド、またはそれらの任意の組み合わせである、[29]または[30]に記載の呼吸可能乾燥粉末。
[32]前記薬学的活性剤が、高分子である、[29]または[30]に記載の呼吸可能乾燥粉末。
[33]前記薬学的活性剤が、抗体、ホルモン、および増殖因子からなる群より選択される、[29]または[30]に記載の呼吸可能乾燥粉末。
[34]前記薬学的活性剤が、モノクローナル抗体、単鎖抗体、キメラ抗体、二官能性/二特異性抗体、ヒト化抗体、またはそれらの組み合わせである、[29]または[30]に記載の呼吸可能乾燥粉末。
[35]前記第二の呼吸可能乾燥粒子が、微粒子化された粒子である、[29]〜[34]のいずれか1項に記載の呼吸可能乾燥粉末。
[36]前記第一の呼吸可能乾燥粒子が、約5.0ミクロン以下の体積中位幾何学径(VMGD)を有する、[29]〜[35]のいずれか1項に記載の呼吸可能乾燥粉末。
[37]HELOS/RODOSレーザ回折システムで1バールおよび4バールの分散設定で測定されると、約1.5未満の分散可能性比(1/4バール)を有する、[29]〜[36]のいずれか1項に記載の呼吸可能乾燥粉末。
[38]少なくとも45%の、5.6ミクロン未満の細粒分(FPF)を有する、[29]〜[37]のいずれか1項に記載の呼吸可能乾燥粉末。
[39]少なくとも30%の、3.4ミクロン未満の細粒分(FPF)を有する、[29]〜[38]のいずれか1項に記載の呼吸可能乾燥粉末。
[40]少なくとも45%の、5.0ミクロン未満の細粒分(FPF)を有する、[29]〜[39]のいずれか1項に記載の呼吸可能乾燥粉末。
[41]約5ミクロン以下の質量中位空気力学径(MMAD)を有する、[29]〜[40]のいずれか1項に記載の呼吸可能乾燥粉末。
[42]前記一価金属カチオン塩が、25℃、1バールの水中に0.5g/L以上の溶解度を有する、[29]〜[41]のいずれか1項に記載の呼吸可能乾燥粉末。
[43]前記一価金属カチオン塩が、25℃、1バールの水中に400g/L以上の溶解度を有する、[29]〜[41]のいずれか1項に記載の呼吸可能乾燥粉末。
[44]前記第一の呼吸可能乾燥粒子が、少なくとも1種の薬学的に許容し得る賦形剤を更に含む、[29]〜[43]のいずれか1項に記載の呼吸可能乾燥粉末。
[45]少なくとも1種の賦形剤が、前記乾燥粒子の約50重量%以下の量で存在する、[44]に記載の呼吸可能乾燥粉末。
[46]少なくとも1種の賦形剤が、前記乾燥粒子の約50重量%以上の量で存在する、[44]に記載の呼吸可能乾燥粉末。
[47]少なくとも1種の賦形剤が、ロイシン、マルトデキストリン、マンニトールおよびそれらの組み合わせからなる群より選択される、[44]〜[46]のいずれか1項に記載の呼吸可能乾燥粉末。
[48]前記一価金属塩が、ナトリウム塩、カリウム塩、リチウム塩、およびそれらの組み合わせからなる群より選択される、[29]〜[47]のいずれか1項に記載の呼吸可能乾燥粉末。
[49]前記一価金属カチオン塩が、ナトリウム塩である、[29]〜[47]のいずれか1項に記載の呼吸可能乾燥粉末。
[50]前記ナトリウム塩が、塩化ナトリウム、乳酸ナトリウム、クエン酸ナトリウム、硫酸ナトリウムまたはそれらの組み合わせである、[49]に記載の呼吸可能乾燥粉末。
[51]前記一価金属カチオン塩が、カリウム塩である、[29]〜[47]のいずれか1項に記載の呼吸可能乾燥粉末。
[52]前記カリウム塩が、塩化カリウムまたはクエン酸カリウムである、[51]に記載の呼吸可能乾燥粉末。
[53]前記第一の乾燥粒子のタップ密度が、0.4g/ccを超える、[29]〜[52]のいずれか1項に記載の呼吸可能乾燥粉末。
[54]前記第一の乾燥粒子のタップ密度が、0.45g/ccを超える、[29]〜[52]のいずれか1項に記載の呼吸可能乾燥粉末。
[55]前記第一の乾燥粒子のタップ密度が、0.55g/ccを超える、[29]〜[52]のいずれか1項に記載の呼吸可能乾燥粉末。
[56]少なくとも1.5、好ましくは少なくとも1.7のハウスナー比を有する、いずれかの前記に記載の呼吸可能乾燥粉末。
[57][1]〜[56]のいずれか1項に記載の呼吸可能乾燥粉末の有効量を、それを必要とする患者の呼吸管に投与することを含む、呼吸器疾患を処置する方法。
[58][1]〜[56]のいずれか1項に記載の呼吸可能乾燥粉末の有効量を、それを必要とする患者の呼吸管に投与することを含む、呼吸器疾患の急性増悪を処置または予防する方法。
[59][1]〜[56]のいずれか1項に記載の呼吸可能乾燥粉末の有効量を、それを必要とする患者の呼吸管に投与することを含む、呼吸管の感染性疾患を処置または予防する方法。
[60]呼吸可能乾燥粉末の有効量を個体の呼吸管に投与して、呼吸器疾患が処置されることを含む、個体の呼吸器疾患の処置における使用のための、[1]〜[56]のいずれか1項に記載の呼吸可能乾燥粉末。
[61]呼吸可能乾燥粉末の有効量を個体の呼吸管に投与して、呼吸器疾患の急性増悪が処置または予防されることを含む、個体の呼吸器疾患の急性増悪の処置または予防における使用のための、[1]〜[56]のいずれか1項に記載の呼吸可能乾燥粉末。
[62]呼吸可能乾燥粉末の有効量を個体の呼吸管に投与して、感染性疾患が処置または予防されることを含む、個体の呼吸管の感染性疾患の処置または予防における使用のための、[1]〜[56]のいずれか1項に記載の呼吸可能乾燥粉末。
[63]前記呼吸器疾患が、嚢胞性線維症、喘息またはCOPDである、[57]〜[62]のいずれか1項に記載の呼吸可能乾燥粉末の方法。
Claims (15)
- 呼吸可能乾燥粒子を含む呼吸可能乾燥粉末であって、前記呼吸可能乾燥粒子は、
a)1種以上の一価金属カチオン塩、ここで、前記1種以上の一価金属カチオン塩が、前記乾燥粒子の少なくとも約3重量%の量で存在する、および
b)薬学的活性剤、ここで、前記薬学的活性剤は、喘息を治療するために使用される、
を含み、前記呼吸可能乾燥粒子が、レーザ回折(RODOS/HELOSシステム)により測定されると約5ミクロン以下の体積中位幾何学径(VMGD)および約1.5未満の分散可能性比(1バール/4バール)を有し、前記呼吸可能乾燥粒子は、0.45g/cc〜1.2g/ccのタップ密度を有し、但し、前記呼吸可能乾燥粒子が二価金属カチオンを前記乾燥粒子の3重量%以上の量で含まない、呼吸可能乾燥粉末。 - 喘息の治療のための医薬の製造における請求項1記載の呼吸可能乾燥粉末の使用。
- 喘息の急性増悪の治療のための医薬の製造における請求項1記載の呼吸可能乾燥粉末の使用。
- 前記増悪が、ウイルス感染、細菌感染、真菌感染、寄生虫感染または環境アレルゲンにより誘発される、請求項3記載の使用。
- 前記増悪が、真菌感染により誘発される、請求項3記載の使用。
- 中度〜重度の喘息に関連する炎症の治療のための医薬の製造における請求項1記載の呼吸可能乾燥粉末の使用。
- 呼吸可能乾燥粒子を含む呼吸可能乾燥粉末であって、前記呼吸可能乾燥粒子は、
a)1種以上の一価金属カチオン塩、ここで、前記1種以上の一価金属カチオン塩が、前記乾燥粒子の少なくとも約3重量%の量で存在する、および
b)薬学的活性剤、ここで、前記薬学的活性剤は、慢性閉塞性肺疾患を治療するために使用される、
を含み、前記呼吸可能乾燥粒子が、レーザ回折(RODOS/HELOSシステム)により測定されると約5ミクロン以下の体積中位幾何学径(VMGD)および約1.5未満の分散可能性比(1バール/4バール)を有し、前記呼吸可能乾燥粒子は、0.45g/cc〜1.2g/ccのタップ密度を有し、但し、前記呼吸可能乾燥粒子が二価金属カチオンを前記乾燥粒子の3重量%以上の量で含まない、呼吸可能乾燥粉末。 - 慢性閉塞性肺疾患の治療のための医薬の製造における請求項7記載の呼吸可能乾燥粉末の使用。
- 慢性閉塞性肺疾患の急性増悪の治療のための医薬の製造における請求項7記載の呼吸可能乾燥粉末の使用。
- 呼吸可能乾燥粒子を含む呼吸可能乾燥粉末であって、前記呼吸可能乾燥粒子は、
a)1種以上の一価金属カチオン塩、ここで、前記1種以上の一価金属カチオン塩が、前記乾燥粒子の少なくとも約3重量%の量で存在する、および
b)薬学的活性剤、ここで、前記薬学的活性剤は、真菌感染を治療するために使用される、
を含み、前記呼吸可能乾燥粒子が、レーザ回折(RODOS/HELOSシステム)により測定されると約5ミクロン以下の体積中位幾何学径(VMGD)および約1.5未満の分散可能性比(1バール/4バール)を有し、前記呼吸可能乾燥粒子は、0.45g/cc〜1.2g/ccのタップ密度を有し、但し、前記呼吸可能乾燥粒子が二価金属カチオンを前記乾燥粒子の3重量%以上の量で含まない、呼吸可能乾燥粉末。 - 真菌感染の治療のための医薬の製造における請求項10記載の呼吸可能乾燥粉末の使用。
- 真菌感染により誘発される急性増悪の治療のための医薬の製造における請求項10記載の呼吸可能乾燥粉末の使用。
- 呼吸可能乾燥粒子を含む呼吸可能乾燥粉末であって、前記呼吸可能乾燥粒子は、
a)1種以上の一価金属カチオン塩、ここで、前記1種以上の一価金属カチオン塩が、前記乾燥粒子の少なくとも約3重量%の量で存在する、および
b)薬学的活性剤、ここで、前記薬学的活性剤は、気管支拡張症を治療するために使用される、
を含み、前記呼吸可能乾燥粒子が、レーザ回折(RODOS/HELOSシステム)により測定されると約5ミクロン以下の体積中位幾何学径(VMGD)および約1.5未満の分散可能性比(1バール/4バール)を有し、前記呼吸可能乾燥粒子は、0.45g/cc〜1.2g/ccのタップ密度を有し、但し、前記呼吸可能乾燥粒子が二価金属カチオンを前記乾燥粒子の3重量%以上の量で含まない、呼吸可能乾燥粉末。 - 気管支拡張症の治療のための医薬の製造における請求項13記載の呼吸可能乾燥粉末の使用。
- 気管支拡張症の急性増悪の治療のための医薬の製造における請求項13記載の呼吸可能乾燥粉末の使用。
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