JP6312262B2 - 乾燥粉末薬物送達システム - Google Patents
乾燥粉末薬物送達システム Download PDFInfo
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- JP6312262B2 JP6312262B2 JP2015521869A JP2015521869A JP6312262B2 JP 6312262 B2 JP6312262 B2 JP 6312262B2 JP 2015521869 A JP2015521869 A JP 2015521869A JP 2015521869 A JP2015521869 A JP 2015521869A JP 6312262 B2 JP6312262 B2 JP 6312262B2
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Description
乾燥粉末吸入器−カートリッジシステムの抵抗および流動分布の測定
インシュリン製剤を有する吸入器システムを使用した粒度分布の測定
・レーザー測定開始トリガー条件:≧0.6%のレーザー強度が特定の検出チャネルで検出された場合、
・レーザー測定終了トリガー条件:≦0.4%のレーザー強度が特定の検出チャネルで検出された場合、
・真空源と吸入器チャンバとの間の距離は、およそ9.525cmである。
吸入システム性能の尺度としてのカートリッジからの粉末放出の測定
アンダーセンカスケード衝突による予測的堆積の測定
TECHNOSPHERE(登録商標)インシュリン(TI)の褶曲度
体積メジアン幾何学的直径(VMGD)の特徴による放出された製剤の幾何学的粒度分析
次世代乾燥粉末送達システムにおいて実現されたIn vitroでの性能改良
吸入システムの例示的な実施の形態でのFDKPのバイオアベイラビリティにおける改良
例示的な吸入システムでのFDKPおよびインシュリンのバイオアベイラビリティにおける改良
C−ペプチド補正インシュリン濃度および幾何平均に基づく薬物動態パラメーター
測定基準に基づいたin vitroでの吸入器性能の使用における吸入プロファイルの特徴
粒度試験に基づく吸入器性能閾値実験
図7(デバイス2)において例示される吸入器システムであり、O字形状(図49および50)経路を生ずる粉末容器またはリザーバを通る空気導管を含有するカートリッジを備えているものについて、従来の吸入器(デバイス1、Diskus、GSK)と比較してその性能を評価するために、薬学的な担体または賦形剤、ラクトースおよび2つの活性剤を含む製剤を用いて試験を行った。サンプルは、活性成分として微小化フルチカゾン250μgおよび微小化サルメテロール50μgを含む活性剤と混ぜたラクトースの製剤で構成した。ラクトースは、薬学的に許容可能な担体として使用した。吸入性能を、国際特許出願第PCT/US2010/055323号(WO/2011/056889)において記載されているような吸入シミュレーション装置を使用して、同量の粉末(11.5mg)を含有する2つの異なる吸入器で測定した。同第PCT/US2010/055323号の文献は、その関連する主たる教示において、参照によりここに組み込まれる。吸入器を、2kPaおよび4kPaの圧力差において試験した。この圧力差は、デバイス1のような従来の吸入器を用いて人が一般的に生じさせることができる圧力降下である。単回吸入において吸入器から放出または排出される合計粉末を、2および4kPaの圧力において測定した。これらの圧力は、テーブル11において報告されるように、シミュレーションの間にピークの流れを生じさせる。これらの実験からの代表的なデータも、テーブル12において示されている。
この実施例は、放出される用量の割合を改善するか、または、使用する粉末の特定の種類での許容範囲に対してデバイス排出を増やすために採用された、様々な吸入器設計について試験を行った。例えば、非晶質粉末は標準的な吸入器からはうまく放出されにくく、製品における活性剤の損失で患者に費用がかかってしまうということが分かった。この実施例では、従って、乾燥粉末吸入器の2つの種類を設計し、組み立てた。O−シリーズ(図49および50)の乾燥粉末吸入器は、空気の流れが容器から出る前に、吸入の間にO字形状内で、粉末容器を通る空気の流れの転動・再循環作用を生じさせる剛性の導管を備える。第2の吸入器またはU−シリーズも設計され、対照のために組み立てた。この乾燥粉末吸入器は、実質上U字形状の容器を通る剛性の空気導管を備え、デフレクタを有するように構成されている。それによって、使用の際に、容器に入る空気の流れは、容器を出る前に、U字形状/半月型の経路内または下方に向かって容器空隙または空間内で空気の流れを向け直す。試験する粉末は、結晶または非晶質のいずれかとした。
(付記)
(付記1)
a)マウスピースを備える第1の要素と、
b)容器を備える第2の要素と、
c)少なくとも2つの剛性の空気導管と、を備え、
前記少なくとも2つの剛性の空気導管の1つは、使用時に、粉末容器内の乾燥粉末の動きを方向付けるデフレクタまたは幹状部を有するように構成されている、乾燥粉末吸入器。
(付記2)
毎分約0.065(√kPa)/リットルから毎分約0.200(√kPa)/リットルの範囲の空気流動抵抗値を有する、付記1に記載の乾燥粉末吸入器。
(付記3)
前記乾燥粉末は、経口吸入のための製剤であり、約1mgから約50mgの量の乾燥粉末を含む、付記1に記載の乾燥粉末吸入器。
(付記4)
前記乾燥粉末は、ジケトピペラジンまたはその薬学的に許容可能な塩を含む、付記1に記載の乾燥粉末吸入器。
(付記5)
前記ジケトピペラジンは、式2,5−ジケト−3,6−ビス(N−X−4−アミノブチル)ピペラジンで示され、Xは、フマリル、スクシニル、マレイル、マロニル、オキサリルおよびグルタリルからなる群から選択される、付記4に記載の乾燥粉末吸入器。
(付記6)
前記ジケトピペラジンは、ビス−3,6−(N−フマリル−4−アミノブチル)−2,5−ジケト−ジケトピペラジンである、付記5に記載の乾燥粉末吸入器。
(付記7)
前記乾燥粉末は、薬物または活性剤を含む、付記3に記載の乾燥粉末吸入器。
(付記8)
前記活性剤は、内分泌ホルモン、ワクチン、または、抗喘息剤(anti−asmatics)、血管拡張剤、血管収縮剤、筋弛緩剤、神経伝達物質アゴニストもしくはアンタゴニストを含む小分子、または、その類似体である、付記7に記載の乾燥粉末吸入器。
(付記9)
前記乾燥粉末は、ペプチド、ポリペプチド、もしくはこれらの断片、有機小分子、または、核酸分子を含む、付記3に記載の乾燥粉末吸入器。
(付記10)
前記ペプチドは、インシュリン、グルカゴン、グルカゴン様ペプチド−1、副甲状腺ホルモン、デオキシリボヌクレアーゼ、オキシトシン、オキシントモジュリン、ペプチドYY、エキセンジン、これらの類似体、または、これらの断片である、付記9に記載の乾燥粉末吸入器。
(付記11)
前記有機小分子は、血管拡張剤、血管収縮神経剤、神経伝達物質アゴニストまたは神経伝達物質アンタゴニストである、付記9に記載の乾燥粉末吸入器。
(付記12)
前記容器は、容器ハウジング内部に一体化しており、乾燥粉末が充填されている、付記1に記載の乾燥粉末吸入器。
(付記13)
前記吸入器には、容器が含まれていない、付記1に記載の乾燥粉末吸入器。
(付記14)
前記容器は、吸入器から分離して提供され、乾燥粉末が充填されている、付記1に記載の乾燥粉末吸入器。
(付記15)
前記粉末は、非晶質粉末である、付記1に記載の乾燥粉末吸入器。
(付記16)
前記有機小分子は、トリプタンまたはオピエートである、付記11に記載の乾燥粉末吸入器。
(付記17)
前記トリプタンは、スマトリプタンまたはリザトリプタンである、付記16に記載の乾燥粉末吸入器。
(付記18)
付記1に記載の乾燥粉末吸入器を使用して、非晶質粉末薬剤の有効量を対象へ投与することを含む、対象へ乾燥粉末を送達する方法。
Claims (17)
- a)マウスピースを備える第1の要素と、
b)実質上文字Uの形状であり、カートリッジ内に配置された乾燥粉末容器を備える、第2の要素と、
c)前記マウスピースへ導かれ、周囲の空気と連通するよう構成されている、少なくとも2つの剛性の空気導管と、を備え、
前記カートリッジは、投薬形態において、前記乾燥粉末容器の内部空間を横断するU字形状の軌道における、前記少なくとも2つの剛性の空気導管の1つからの空気の流れを方向付けるデフレクタまたは幹状部を有しており、
前記空気の流れは、前記マウスピースに対して平行の方向から実質上、下向きに前記乾燥粉末容器に入り、前記マウスピースに対して実質上平行の方向で前記乾燥粉末容器内の乾燥粉末を通過し、前記マウスピースに対して実質上垂直な方向で前記乾燥粉末容器を出るようになっており、
収容形態において、前記乾燥粉末は、前記少なくとも2つの剛性の空気導管および前記デフレクタまたは幹状部から封鎖されている、
乾燥粉末吸入器。 - 毎分約0.065(√kPa)/リットルから毎分約0.200(√kPa)/リットルの範囲の空気流動抵抗値を有する、請求項1に記載の乾燥粉末吸入器。
- 前記乾燥粉末は、経口吸入のための製剤であり、約1mgから約50mgの量の乾燥粉末を含む、請求項1に記載の乾燥粉末吸入器。
- 前記乾燥粉末は、ジケトピペラジンまたはその薬学的に許容可能な塩を含む、請求項1に記載の乾燥粉末吸入器。
- 前記ジケトピペラジンは、式2,5−ジケト−3,6−ビス(N−X−4−アミノブチル)ピペラジンで示され、Xは、フマリル、スクシニル、マレイル、マロニル、オキサリルおよびグルタリルからなる群から選択される、請求項4に記載の乾燥粉末吸入器。
- 前記乾燥粉末は、薬物または活性剤を含む、請求項3に記載の乾燥粉末吸入器。
- 前記活性剤は、内分泌ホルモン、ワクチン、または、抗喘息剤(anti−asmatics)、血管拡張剤、血管収縮剤、筋弛緩剤、神経伝達物質アゴニストもしくはアンタゴニストを含む小分子である、請求項7に記載の乾燥粉末吸入器。
- 前記乾燥粉末は、ペプチド、ポリペプチド、もしくはこれらの断片、有機小分子、または、核酸分子を含む、請求項3に記載の乾燥粉末吸入器。
- 前記ペプチドは、インシュリン、グルカゴン、グルカゴン様ペプチド−1、副甲状腺ホルモン、デオキシリボヌクレアーゼ、オキシトシン、オキシントモジュリン、ペプチドYY、エキセンジン、これらの類似体、または、これらの断片である、請求項9に記載の乾燥粉末吸入器。
- 前記乾燥粉末が有機小分子を含む場合、前記有機小分子は、血管拡張剤、血管収縮神経剤、神経伝達物質アゴニストまたは神経伝達物質アンタゴニストである、請求項9に記載の乾燥粉末吸入器。
- 前記乾燥粉末容器は、前記カートリッジ内部に一体化しており、乾燥粉末が充填されている、請求項1に記載の乾燥粉末吸入器。
- 前記吸入器には、容器が含まれていない、請求項1に記載の乾燥粉末吸入器。
- 前記乾燥粉末容器は、吸入器から分離可能であり、乾燥粉末が充填されている、請求項1に記載の乾燥粉末吸入器。
- 前記乾燥粉末は、非晶質粉末である、請求項1に記載の乾燥粉末吸入器。
- 前記有機小分子は、トリプタンまたはオピエートである、請求項11に記載の乾燥粉末吸入器。
- 前記トリプタンは、スマトリプタンまたはリザトリプタンである、請求項16に記載の乾燥粉末吸入器。
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