JP6385673B2 - 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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Description
本出願は、2010年11月9日に出願された米国仮特許出願第61/411,775号、および2010年6月21日に出願された米国仮特許出願第61/357,039号の利益を主張するものであり、これらの全体の開示を参照によりここに組み込む。
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
いくつかの乾燥粉末吸入器の設計において、吸入器の流路の幾何学的形状または構成により部分的に決定される重要な特徴である、その流動抵抗を測定する試験を行った。高抵抗を示す吸入器は、より低い抵抗の吸入器と同様の流量を得るためには、より大きい圧力降下を必要とする。簡単に言うと、それぞれの吸入器およびカートリッジシステムの抵抗性を測定するために、様々な流量を吸入器に適用し、そこでの吸入器を通して得られた圧力を測定する。これらの測定は、圧力降下を供給するために、吸入器のマウスピースに取り付けられる真空ポンプと、流れを変化させその結果得られた圧力を記録するための流れ制御器および圧力計とを利用することにより、達成することができる。ベルヌーイの法則によると、圧力降下の平方根を流量に対してプロットした場合、吸入器の抵抗性は、曲線の線形の部分の勾配である。これらの実施例において、ここに記載されているような乾燥粉末吸入器およびカートリッジを備える吸入システムの抵抗性は、抵抗性測定デバイスを使用し、投薬形態において測定された。投薬形態では、吸入器空気導管を通り、吸入器内のカートリッジを通る空気路が形成されている。
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
アダプタ(MannKind Corp.、米国特許出願第12/727,179号、この開示にて関連する対象の手段の教示を参照によりここに組み込む)を備えたレーザー回折装置(Helos Laser Diffraction system, Sympatec Inc.)による粒度分布の測定は、ここに記載されているカートリッジ−吸入器システム(図22から30において示されるカートリッジ170を用いる図1から9の吸入器)で提供される、インシュリンおよびフマリルジケトピペラジン粒子のミリグラム(mg)における様々な量の製剤で行った。デバイスは、配管の一端に取り付けられ、それが流量計(TSI, Inc. Model 4043)およびバルブに適合され、圧縮された空気源からの圧力または流れを制御する。レーザーシステムが作動し、レーザー光がプルームを測定する準備がなされると、空気バルブが作動して、吸入器から粉末を放出させる。レーザーシステムは、所定の測定条件に基づいて、自動的に吸入デバイスから出ていくプルームを測定する。レーザー回折システムは、装置に組み込まれたソフトウェアにより操作され、コンピュータプログラムによって制御される。異なる量の粉末および異なる粉末ロットを含有するサンプルにおいて、測定を行った。測定条件は、次の通りである。
・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
当該実験は、図22から30において示されているカートリッジ170のプロトタイプを備えた、図1から9において示されている多数の吸入器プロトタイプを使用する、吸入システムを利用し実施された。多数のカートリッジはそれぞれの吸入器と使用された。それぞれのカートリッジを充填の前に電子天秤で計量した。カートリッジに所定の質量の粉末を充填し、再度計量し、それぞれの充填済カートリッジを吸入器に配置し、粉末製剤、すなわちTECHNOSPHERE(登録商標)インシュリン(インシュリン−FDKP、典型的には3Uから4Uインシュリン/mg粉末、およそ10%から15%インシュリンw/w)粉末バッチを空にする効率に関して試験を行った。多数の圧力降下を利用して、性能の一貫性を特徴付けた。テーブル3は、吸入器あたり35のカートリッジ放出測定値を使用した、この試験の結果を示す。テーブル3のデータにおいて、全ての試験は、同様の臨床級インシュリン−FDKP粉末のバッチを使用して実施した。当該結果は、2から5kPaまでの範囲での、適切な使用者の圧力降下は、カートリッジから粉末を非常に効率的に空にすることを実証している。
アンダーセンカスケード衝突による予測的堆積の測定
当該実験では、28.3LPMの流量を使用して、シミュレートされた用量の送達の間のステージプレート粉末堆積物を収集するため、アンダーセンカスケード衝突装置を使用して行われた。この流量は、結果として、吸入システム(DPIおよびカートリッジ)全体におよそ6kPaの圧力降下をもたらした。そして、プレートステージ上の堆積を、フィルタおよび電子天秤を使用して、重量測定により分析した。10mg、6.6mgおよび3.1mgの充填質量における凝集性粉末の充填質量を、吸入システム性能に関して評価した。それぞれの衝突試験は、5個のカートリッジにおいて実施した。ステージ2−Fにおいて収集された累積粉末質量を、5.8μmより小さい空気力学的粒度に従って測定した。収集された粉末質量とカートリッジ充填含有との比を決定し、充填質量での呼吸可能画分(RF)パーセントとして提供する。当該データを、テーブル4において示す。
TECHNOSPHERE(登録商標)インシュリン(TI)の褶曲度
褶曲度は、粒子の実際の比表面積と、同等な球の比表面積との比である。球の比表面積は、以下の通りである。
体積メジアン幾何学直径(VMGD)の特徴による放出された製剤の幾何学的粒度分析
乾燥粉末吸入器から放出された乾燥粉末製剤のレーザー回折は、粉末に対して行われる解凝集レベルを特徴付けるために用いられる一般的な方法である。この方法は、工業規格衝突方法で行われるような空気力学的サイズではなく、幾何学的サイズの測定を示す。典型的には、放出された粉末の幾何学的サイズは、平均粒度により特徴付けられる体積分布、VMGDを含む。重要なことは、放出された粒子の幾何学的サイズは、衝突方法により提供される空気力学的サイズと比較し、高い分解能で認められることである。より小さいサイズが好ましく、個々の粒子が肺管に送達されるより高い可能性が得られる。このように、吸入器の解凝集および最終的な性能の差異は、回折による解決を、より容易にすることができる。これらの実験において、実施例3にて記述した吸入器および既存の吸入器を、レーザー回折により、実際の患者の吸気能力に類似した圧力において試験を行い、粉末製剤を解凝集する吸入システムの有効性を決定する。具体的には、製剤は、凝集性ジケトピペラジンの粉末を、活性インシュリンが導入された成分とこれを有さないものと共に、含ませて実験を行った。これらの粉末製剤について、特徴的な表面積、異性体比、およびCarr指数を得た。テーブル5において、VMGDと、試験の間における容器の排出効率が記載されている。FDKP粉末はおよそ50のCarr指数を有し、TI粉末はおよそ40のCarr指数を有する。
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
TECHNOSPHERE(登録商標)製剤は、MEDTONE(登録商標)送達システム(MTDS、MannKind Corporation, Valencia, CA)を利用して患者へと首尾よく送達されていた。このシステムは、単回使用カートリッジ内に予め計量され高い抵抗性の呼吸を動力として動かすことができる再使用可能なMEDTONE(登録商標)吸入器に挿入された、乾燥粉末製剤を含む。改良された送達システム(実施例1において記載されたDPI2)は、MTDSの代替のものとして開発された。これらのシステムにおけるIn vitroでの粉末性能を、吸入器の性能の様々なパラメーターに関して比較した。MEDTONE(登録商標)システムにおけるカートリッジ毎での2回の放出に対し、DPI2ではカートリッジ毎での単回放出を使用した。
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
上記実施例1において記載したDPI1により送達された様々な充填質量のTECHNOSPHERE(登録商標)吸入粉末(FDKP−吸入粉末)の安全性および耐容性を評価するために、吸入システム、すなわち吸入器および様々な充填質量の乾燥吸入粉末を含有しているカートリッジ、修正されたCQLQ、VAS、ならびに吸入システムのピークの流れを使用し、測定を行った。MEDTONE(登録商標)吸入器システムを比較のため使用した。実験は、DPI1吸入器を通りFDKP−吸入粉末として吸入されるFDKPの薬物動態(PK)に基づいて変化する、吸入の労力および吸入の時間での効果を評価するため、使用中のシステムからデータを収集することも実施した。
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
この試験は、インシュリンおよびFDKPの薬物動態(PK)により決定される、肺吸入送達システム(DPI2)により送達された、様々な充填重量のTECHNOSPHERE(登録商標)インシュリン吸入粉末(FDKP−インシュリン)の相対的なバイオアベイラビリティを、MEDTONE(登録商標)吸入器と比較し、評価するよう実験された。
C−ペプチド結合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
実施例9において記載したような試験にて、段階1、非盲検、ランダム化されたクロスオーバーの試験プロトコールを使用し、46名の健康な通常のボランティアにおいて試験を行った。当該試験では、用量を送達するのにカートリッジ毎に2回の吸入を必要とするMEDTONE(登録商標)と比較した場合、カートリッジ内に含まれている用量を送達するのに単回吸入を必要とするDPI2吸入器を使用し投与されるFDKP−インシュリン製剤の生物学的同等性を評価するように行った。さらに、当該実験では、対象へと送達されるインシュリン濃度の10Uの用量を含む2つのカートリッジのFDKP−インシュリン吸入粉末の用量は、DPI2吸入器を使用し口腔吸入によりFDKP−インシュリン製剤が投与されるインシュリンの20Uの用量を含む1つのカートリッジに対し、生物学的同等性を有するものか否かについても評価を行った。対象には、DPI2またはMEDTONE(登録商標)を使用して口腔吸入によりFDKP−インシュリンが投与された。当該対象は、DPI2吸入器を使用する、20Uインシュリン単回用量、10Uインシュリンの2回用量、またはMEDTONE(登録商標)吸入器を使用する30Uインシュリンを受けた。2時間にわたり、様々な時間において、それぞれ治療された個々から血液サンプルを採取した。サンプルはインシュリン濃度を測定し分析された。当該試験のための薬物動態パラメーターは、C−ペプチド結合インシュリン濃度値に基づくものである。当該試験から得られた結果を以下のテーブル10に示す。
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
吸入器システムは、本明細書に記載されている、カートリッジを備える乾燥粉末吸入器(DPI2)から構成される。吸入動作の間および後の時間の期間において、DPI2を、吸入器にて生じた圧力差を測定する、米国特許出願第12/488,469号明細書(米国特許出願公開第2009/0314292号明細書、当該文献に教示されている吸入動作および労作ならびにその測定に関する全てについてを参照によりここに組み込む)において開示されている、BLUHALE(登録商標)装置と適合する。図41は、吸入器を通る圧力降下が単回吸入の間および後の5秒の期間において測定された、DPI2の例示的なグラフ式のプロファイルである。2秒でのピーク吸気圧力またはPIP(2)は、吸入開始後の最初の2秒の間に得られる曲線上における最も高い場所または最も高い圧力を示している。図41は、DPI2でのPIP(2)が約5kPaであり、1秒内での曲線下面積またはAUC(1)が3.7kPa・秒であることを示している。
粒子直径試験に基づく吸入器性能閾値実験
これらの実施例では、DPI2型の吸入器が使用された。個々の吸入器には、デバイスの性能を試験できるよう、インシュリンおよびFDKPを含む微小粒子を含有する乾燥粉末製剤を有するカートリッジが装填されている。吸入器は、上述の実施例11において例示したように、プロファイルを収集するため前もって使用しておいた。BLUHALE(登録商標)での吸入プロファイルを収集した後、吸入器を、使用者により例示的な吸入を再現できるよう、国際特許出願番号PCT/US2010/055323において記載されているような吸入シミュレーターに適合した。なお、PCT/US2010/055323に教示されている吸入動作および労作ならびにその測定に関する全てについて、参照によりここに組み込む。シミュレーターを使用した吸入プロファイルは、その後、上述の実施例2において記載したよう粒径分布を測定するよう、2つの吸入器からレーザー回折装置の中へ粉末を放出して適用させる。レーザー回折装置は、体積メジアン幾何学直径(VMGD)を測定する。放出された粒子の50%が直径において4.88μmより小さければ、値は許容範囲であると考えられ、DPI2での最適な使用では、粒径平均において33%増加に基づいて選択される。粉末用量を有する2つの吸入器はレーザー回折装置内に装填され、様々な吸入プロファイル、すなわち様々なPIP(2)およびAUC(1)の値での粉末の放出または放射が得られた。当該試験は、それぞれの吸入器にて5回繰り返した計10測定であり、データを分析しプロットした。図42は、2つの吸入器でのPIP(2)およびAUC(1)のグラフとしての実施例の結果を示し、グラフ上におけるそれぞれの点は10放出の平均を表している。空となっているカートリッジ(または放出された乾燥粉末)は全ての放出での87%よりも大きくなっていた。グラフの三角形の吸入境界領域は、AUC(1)の値を与えられたデバイスを得るために、PIP(2)の値が物理的に不可能であるグラフ上における領域を表している。上述した明細書に基づいた基準に準じていると思われ、図42における基準線を通っているGen2の上であり右である吸入動作が、許容される性能である。図42のデータは、本発明のデバイスの許容される性能における低限が、約2kPaのPIP(2)であり、少なくとも約1.2kPa・秒のAUC(1)であることを示している。しかし、他の実施例において、許容される性能は、少なくとも約1.0または少なくとも約1.1kPa・秒であったことも証明された。
(付記)
(付記1)
a)マウスピースと、
b)容器ハウジングと、
c)少なくとも1つの剛性の空気導管とを備え、
約75%より多い量の乾燥粉末が、単回吸入における粉末粒子として前記容器ハウジング内に適合された容器から放出されるよう構成されており、前記マウスピースを通る単回吸入が、2秒以内において約2kPaのピーク吸気圧力を生じさせる場合、放出された粉末粒子は、約5ミクロンより小さい体積メジアン幾何学直径を有する、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)
前記乾燥粉末は肺送達のための製剤であり、約1mgから約30mgの量の乾燥粉末を備えている、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1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1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、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、血管拡張物質、血管収縮神経物質、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)
前記単回吸入は、1秒以内における圧力対時間曲線から、少なくとも約1.0、1.1または1.2kPa・秒の曲線下面積(AUC)を生じさせる、付記1に記載の乾燥粉末吸入器。
(付記13)
前記容器は、前記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14)
吸入器は、容器を含んでいない、付記1に記載の乾燥粉末吸入器。
(付記15)
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16)
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乾燥粉末吸入器を提供し、乾燥粉末の用量を含ませる工程と、
2秒以内において少なくとも2kPaのピーク吸気圧力に達する十分な力を適用する工程と、
吸気圧力対時間曲線の最初の1秒(AUC 0−1秒 )において、少なくとも約1.0、1.1または1.2kPa・秒における曲線下面積を生じさせる工程であって、前記乾燥粉末の用量の75%より大きい量が粉末粒子として前記吸入器から放射または放出される工程と、
を備える、高抵抗性乾燥粉末吸入器を使用する、乾燥粉末の送達方法。
(付記17)
前記乾燥粉末は、肺送達のための製剤であり、約1gから約30gの前記乾燥粉末の量を含んでいる、付記16に記載の方法。
(付記18)
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17に記載の方法。
(付記19)
前記ジケトピペラジンは、式3,6−ビス(N−X−4−アミノブチル)−2,5−ジケトピペラジンで示され、Xはフマリル、スクシニル、マレイルおよびグルタリルからなる群から選択される、付記18に記載の方法。
(付記20)
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19に記載の方法。
(付記21)
乾燥粉末製剤は、薬物、または、有機小分子、ペプチド、ポリペプチド、タンパク質もしくは核酸分子からなる群から選択される活性剤を含む、付記16に記載の方法。
(付記22)
前記有機小分子は、血管作用剤、神経伝達アゴニスト、神経伝達アンタゴニストまたはステロイド分子である、付記21に記載の方法。
(付記23)
前記乾燥粉末製剤はフマリルジケトピペラジン微小粒子を含み、当該フマリルジケトピペラジン微小粒子は、前記乾燥粉末吸入器から放出された際に、約2μmから8μmの範囲の体積メジアン幾何学直径(VMGD)、および、4μmよりも小さい幾何標準偏差を有していることが測定される、付記20に記載の方法。
Claims (13)
- a)マウスピースと、
b)乾燥粉末を保持するように構成されており、チャンバーを備える容器ハウジングと、
c)少なくとも1つの空気導管とを備え、
吸入器の一部分には、前記吸入器を通る空気の体積の20%から70%のための第1の流路が定められていて、前記第1の流路は前記容器ハウジングおよび前記チャンバーを通る入口部から前記マウスピースへと延びており、
前記吸入器の一部分には、前記吸入器を通る空気の体積の30%から80%のための第2の流路が定められていて、前記第2の流路は前記チャンバーへの前記入口部を迂回して前記チャンバーを去る前記第1の流路と合流しており、
前記第1の流路は、前記第2の流路と合流する場所で方向を変えて、前記チャンバーを出る流動化された粒子が前記第2の流路の流れと衝突して剪断され、
前記吸入器は、2秒以内において少なくとも2kPaのピーク吸気圧力を達成可能とするように動作可能に構成されており、
前記吸入器は、吸気圧力対時間曲線の最初の1秒(AUC0−1秒)において少なくとも約1.0kPa・秒の曲線下面積を生じさせるように、且つ5μmより小さい体積メジアン幾何学直径(VMGD)を有する粉末粒子として前記乾燥粉末の75%より多い量が放射または放出されるように動作可能に構成されている、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。
- 前記乾燥粉末は肺送達のための製剤であり、前記吸入器は約1mgから約30mgの量の乾燥粉末を備える、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、請求項5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1に記載の乾燥粉末吸入器。
- 前記活性剤は、内分泌ホルモンである、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、ポリペプチドまたはこれらの断片を含む、請求項1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、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。
- 単回吸入において、1秒以内における圧力対時間曲線から、少なくとも約1.1kPa・秒の曲線下面積(AUC)を生じさせる、請求項1に記載の乾燥粉末吸入器。
- 容器は、前記吸入器に一体化しており、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。
- 容器は、前記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、請求項1に記載の乾燥粉末吸入器。
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RU2571331C1 (ru) | 2015-12-20 |
US9358352B2 (en) | 2016-06-07 |
WO2011163272A1 (en) | 2011-12-29 |
EP2582421A1 (en) | 2013-04-24 |
MX2012015093A (es) | 2013-05-28 |
RU2013102529A (ru) | 2014-07-27 |
CA2801936C (en) | 2021-06-01 |
CA2801936A1 (en) | 2011-12-29 |
JP2013530756A (ja) | 2013-08-01 |
AU2011271097A1 (en) | 2013-01-10 |
MX359281B (es) | 2018-09-21 |
KR20130117755A (ko) | 2013-10-28 |
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