JP5667041B2 - 乾燥粉末吸入システム - Google Patents
乾燥粉末吸入システム Download PDFInfo
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- JP5667041B2 JP5667041B2 JP2011502116A JP2011502116A JP5667041B2 JP 5667041 B2 JP5667041 B2 JP 5667041B2 JP 2011502116 A JP2011502116 A JP 2011502116A JP 2011502116 A JP2011502116 A JP 2011502116A JP 5667041 B2 JP5667041 B2 JP 5667041B2
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- cartridge
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- air
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Description
(実施例)
[00070]以下の例は、本発明のいくつかの実施形態を実証するために含まれる。これらの例において開示される技術は、本発明の実施において十分に機能する代表的な技術を明らかにするものであることを、当業者は理解されたい。しかし、本発明の趣旨および範囲から逸脱することなく、開示される特定の実施形態において多数の変更を成すことが可能であり、それらの変更により同様のまたは類似の結果を依然として得ることが可能であることを、本開示に鑑みて当業者は理解されたい。
[00071]1型糖尿病を有する被験者において調査を行った。この調査は、製剤中にインスリンおよびジケトピペラジンを含む肺送達用の製剤が、1)様々な投与強度を用いてむらなく送達され得るか否かを、および2)投与強度の互換性が患者の安全にとって重要になり得る場合に、投薬の直線性が、比例的な用量により実現され得るか否かを決定するために、実施した。先行技術の市販の吸入されるインスリンでは、これは実現されず、用量組合せは、非等価性となり、不正確な投薬の危険性の可能性をもたらした。したがって、インスリンおよびFDKP(インスリン−FDKP)を含む製剤による肺送達システムの開発における重要な目的は、治療的用量範囲にわたって用量直線性を実現することであった。
[00076]合計の吸入器およびカートリッジ抵抗は、カートリッジの入口ポートおよび出口ポートが一連の抵抗器としての役割を果たすことにより、測定可能である。第1に、入口ポートによる抵抗が、カートリッジリグにおいて測定される。カートリッジリグについての回路図形態の代表的なものが、図20Aおよび図20Bに示され、カートリッジは、開構成においてはホルダ内に位置し、回路は、R3が、カートリッジ内への空気流に対する抵抗を表し、R4が、カートリッジを出る空気流に対する抵抗を表し、Paが、カートリッジ間の差圧であり、Pが、入口ポートおよび出口ポート間で測定された圧力を表すように、規定される。第2に、吸入器およびカートリッジを備える吸入器システムによる抵抗が、図21Aおよび図21Bに示されるように決定され、R1は、フロートまたは弁による抵抗を表し、R2は、カートリッジの周囲の空気流に対する抵抗を表し、R3は、カートリッジを通る空気流に対する抵抗を表し、R4は、カートリッジを出る空気流に対する抵抗を表し、Pは、測定された圧力を表し、Paは、システム間の圧力を表し、Fは、合計流れ測定値を表す。抵抗器に関して値が決定され、圧力降下測定値が得られると、カートリッジを通るおよびカートリッジの周囲の流れバランス分布が決定され得る。
Claims (12)
- ハウジング及びマウスピースアセンブリを含む乾燥粉末吸入器、並びに、前記乾燥粉末吸入器に適合化されている吸入用乾燥粉末薬剤の収容用カートリッジを備える吸入システムであって、
前記ハウジングは、固定機構を持つマウスピース係合セクションを含み、
前記マウスピースアセンブリは、前記カートリッジを収容するように構成され、且つ、ギャップセクションを有するフランジを持つマウスピースチャンバを含み、
前記マウスピース係合セクション及び前記マウスピースチャンバは、互いに係合し、係合した状態で、移動可能に構成されており、
前記マウスピースアセンブリは、前記カートリッジを前記ハウジングに装填する又は前記ハウジングから取り外す際に、前記ハウジングに対して、カートリッジ装填/取出し位置を取り、
前記カートリッジ装填/取出し位置で前記固定機構と前記ギャップセクションとが対合するような位置に、前記フランジは前記ギャップセクションを有し、
前記固定機構は前記ギャップセクションを着脱可能に固定する、
前記吸入システムは、複数の空気導管を含み、
前記空気導管は、空気と前記吸入用乾燥粉末薬剤とを混合して患者の肺系統に送達するための粉末煙を形成するように作動的に構成されている前記カートリッジの周囲及び前記カートリッジを通る所定の空気流を提供するように構成されており、
前記空気導管の一つは、前記カートリッジ内を通過するカートリッジ通過空気導管であり、
前記カートリッジは、前記カートリッジが開構成を取るときに前記カートリッジ通過空気導管を形成する孔を含み、
前記孔から進入し前記カートリッジ通過空気導管を通る前記所定の空気流は、吸入の際に前記乾燥粉末吸入器に流入する総空気流体積の約10から30%の範囲であることを特徴とする吸入システム。 - 前記カートリッジの周囲の前記所定の空気流は、総空気流体積の約70から90%の範囲である、請求項1に記載の吸入システム。
- 前記吸入用乾燥粉末薬剤は、ペプチド、タンパク質、ホルモン、それらの類似体、又はそれらの組合せから選択される薬学的活性成分、及びジケトピペラジンを含む、請求項1又は2に記載の吸入システム。
- 前記空気導管は、0.08から0.15kPa1/2/(リットル/分)の範囲の空気流抵抗を提供するように調節された断面積を有する、請求項1から3のいずれか1項に記載の吸入システム。
- 前記ハウジングは、上壁部と、下壁部と、第1の側壁部と、第2の側壁部と、マウスピース保管セクションと、周囲空気の取入れを可能にするための第1の開口及び前記マウスピース係合セクションを通る空気流を可能にするための前記マウスピース係合セクションに連通する第2の開口を有する導管を有する空気取入セクションとをさらに備え、
前記マウスピースアセンブリは、前記マウスピースチャンバから延在し前記マウスピースチャンバに連絡する空気入口及び周囲空気に連通する空気出口を有する***配置セクションをさらに備える、請求項1から4のいずれか1項に記載の吸入システム。 - 前記ハウジングの前記マウスピース係合セクションは、前記ハウジングの前記第1の側壁部、前記第2の側壁部、及び前記下壁部のそれぞれと連続する外方壁部、内方壁部、及び下壁部を有する、請求項5に記載の吸入システム。
- 前記マウスピース係合セクションは、前記カートリッジを受容及び保持するように構成された、前記ハウジングの前記下壁部からの突起部をさらに備える、請求項5又は6に記載の吸入システム。
- 前記マウスピースアセンブリは、保管位置から、カートリッジ装填位置へ、及び吸入位置へ移動可能であり、
前記マウスピースアセンブリは、前記カートリッジを保持するように及び前記吸入位置において前記空気取入セクションの前記第2の開口に位置合わせされている開口を有するように構成されている混合チャンバを備える、請求項5から7のいずれか1項に記載の吸入システム。 - 前記マウスピースチャンバは、空気入口を備え、前記カートリッジを固定するように構成され、前記乾燥粉末吸入器内における適切なカートリッジ配置を可能にするためのインジケータを有する、請求項5から8のいずれか1項に記載の吸入システム。
- 前記マウスピースアセンブリは、前記マウスピースチャンバを覆うキャップを備え、
前記キャップは、閉位置から開位置に移動可能であり、前記閉位置において前記カートリッジに係合するアンビルを有する、請求項5から9のいずれか1項に記載の吸入システム。 - 前記ハウジングは、逆止弁を備える空気流制御機構をさらに備える、請求項5から10のいずれか1項に記載の吸入システム。
- 前記カートリッジを通る前記所定の空気流は、前記混合チャンバに進入する空気流体積の約10%から約30%の範囲であり、前記マウスピースチャンバに進入する前記空気流体積の約70%から約90%の範囲である、請求項8に記載の吸入システム。
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US9006175B2 (en) | 1999-06-29 | 2015-04-14 | Mannkind Corporation | Potentiation of glucose elimination |
US7305986B1 (en) | 1999-07-23 | 2007-12-11 | Mannkind Corporation | Unit dose capsules for use in a dry powder inhaler |
US7464706B2 (en) | 1999-07-23 | 2008-12-16 | Mannkind Corporation | Unit dose cartridge and dry powder inhaler |
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2009
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