JP4912566B2 - 吸入療法に使用するためのエアロゾル形成装置 - Google Patents
吸入療法に使用するためのエアロゾル形成装置 Download PDFInfo
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Description
一般的には、組成物中の薬物は本発明の装置に関して上記で説明した薬物または薬物クラスの1つである。
任意の粒子の「空気力学的径」は、任意の粒子と同一沈降速度を有する1g/mLの密度(水の密度)を備える球状液滴の径を意味する。
[エアロゾル化装置]
[一般的考察]
1.前記化合物は非極性である(または弱い極性を有する)。
2.前記化合物は乾燥している混合ガスとともに疎水性である、または親水性である。
3.結果として生じるエアロゾルは標準またはそれに近い温度および圧力である。
4.凝固係数は粒径範囲にわたって一定であるので、このため粒径の安定性を予測する個数濃度は一定である。
1.気化した化合物の量(g)。
2.気化した化合物がその中に混合されるガスの容積(cc)。
3.粒子/ccの数で表した「安定性」の個数濃度。
4.エアロゾルの幾何標準偏差(GSD)。
M=(ρNπ/6)(MMD)3exp[−9/2(1nσg)2]
式中:ρ=密度(gm/cc)
N=個数濃度(粒子/cc)
MMD=質量中央径(cm)
σg=GSD
M=エアロゾルの単位容積当たり質量(gms/cc)。
ρNπ/6(MMD1)3exp[−9/2(1nσg)2]=ρNπ/6(MMD2)3exp[−9/2(1nσg)2]
これを簡略化すると、
(MMD1)3exp[−9/2(1nσg)2]=(MMD2)3exp[−9/2(1nσg2)2]
または
(MMD1)3/(MMD2)3=exp[−9/2(1nσg2)2]/exp[−9/2(1nσg1)2]
である。ケース1のGSDを1.0へ設定すると、
exp[−9/2(1nσg1)2=1
そこでこのため、
(MMD1/MMD2)3=exp[−9/2(1nσg2)2]
または
MMD1/MMD2=exp[−3/2(1nσg2)2]
となる。
MMD2= MMD1/exp[−3/2(1nσg2)2] (σg1=1に対して)
となる。
MMD1=(6C/ρNV)1/3である。
式中:C=化合物の質量(gm)
ρ=密度(gm/cc)(上記と同様)
N=個数濃度(粒子/cc)(上記と同様)
V=混合ガスの容積(cc)
MMD1を上記の方程式に挿入すると下記が得られる。すなわち、cmで測定されたものとして、
MMD2=(6C/ρNVπ)1/3/[exp[−3/2(1nσg2)2]
(1)前記化合物は、超微細範囲内の粒子を作製するためにおよそ1〜2秒間で気化されなければならない。
(2)前記化合物は可能な限り高速で気化温度へ上昇させられなければならない。
(3)前記化合物は、いったん気化したらできる限り迅速に冷却させられなければならない。
(4)前記化合物は、分解を最小限に抑えるために最小時間で最高温度へ上昇させられなければならない。
(5)空気または他のガスは、最高気化速度を達成するために前記化合物の表面を迅速に越えて移動させられなければならない。
(6)空気またはその他のガスの加熱は、低く、すなわち周囲温度の約15℃以上を超えない温度上昇で維持されなければならない。
(7)前記化合物は、再現性の一貫した粒径を有するために一貫した速度で空気またはその他のガス内へ混合されなければならない。
(8)ガスの速度は気化中の化合物を超えると増加するので、装置を通過する断面積は減少するはずである。さらに、前記化合物の表面積が増加するにつれて、ガスの加熱が増加する。
[実施例1] 実施例1を使用したIn Vivo試験の結果
1.ランの開始時に、オペレータは吸入コントローラ30を始動させて圧トランスデューサ240および吸気流量計4からのデータ監視を開始した。
2.コントローラ30は、コントローラ20へ信号を送信して実施例1を始動させ、さらに2個の温度センサおよび流量計4からのデータ収集を開始した。
3.事前プログラミングされた遅延時間後、実施例1はエアロゾルの発生を開始した。(注:コントローラ30の始動とエアロゾルの発生の開始との間には約0.4秒間の遅延時間があった。)
4.独立して事前プログラミングされた遅延時間(最初のトリガー信号から)後、コントローラ30は吸気弁58を開放して実験下のイヌの強制吸入を始動させた。
5.実施例1は吸入中のエアロゾル発生を完了した。
6.コントローラ30は、吸入時間を通して流量計4および圧トランスデューサ240を監視し、規定の容積または圧力が満たされると吸気弁58での流れを遮断した。(注:事前に規定された圧力は、被験動物への傷害を防止するための安全機能である。事前に規定された容積での呼吸の終了は、本実験の所望の発生である。)
7.息こらえ遅延時間(5秒間)後に、排気弁40が開かれ、イヌは息を吐き出すことができた。
8.排気されたエアロゾルは、後に解析するために排気フィルタ40上に捕捉された。コントローラ30は以下についての数値を記録した。すなわち、投薬された容積、終圧、エアパルス時間、および平均流量である。コントローラ20は、ミリ秒分解能で吸気流量、排気流量、箔温度、マウスピース温度、スライド位置、加熱装置オン/オフ時間、およびその他の内部診断電気パラメータを持続的に記録した。
F= (DIV/DINHAL)*(AUCINHAL/AUCIV)
式中、Dは用量、AUCは測定可能な最終時点に決定したAUCであった。
[実施例2] 実施例1を使用したIn Vitro試験の結果
[実施例4] 実施例700を使用したIn Vitro試験の結果
[実施例5] 実施例800を使用したIn Vitro試験の結果
[実施例6] 実施例900を使用したIn Vitro試験の結果
[実施例7] エアロゾル化の好ましさを決定するための薬物スクリーニングについての一般的方法
Claims (21)
- 吸入療法のための薬物含有エアロゾルを送出する装置であって、
ハウジングと、
金属製基質を有するサブアッセンブリと、ガス/蒸気混合領域とを含む、前記ハウジング内の空気通路と、
前記金属製基質上に薄層フィルムとして被覆された薬物含有組成物を加熱して蒸気を形成する加熱システムとを含み、
前記ガス/蒸気混合領域において、前記蒸気はガスと混合して、エアロゾルを形成する装置。 - 前記空気通路内に、ガス流を制御するためのバルブを備える、請求項1記載の装置。
- 前記ハウジングには一対の開口が設けられ、一方が前記空気通路の入口として機能し、他方が前記空気通路の出口として機能する、請求項1又は2記載の装置。
- 前記入口から前記薬物含有組成物の表面を越えて前記出口へとガスを流すように前記空気通路が配置されている、請求項3記載の装置。
- 前記加熱システムが抵抗加熱システムである、請求項1〜4のいずれか一項に記載の装置。
- 前記加熱システムが誘導加熱システムである、請求項1〜4のいずれか一項に記載の装置。
- 前記空気通路が、断面積が限定された部分を含む、請求項1〜6のいずれか一項に記載の装置。
- 前記空気通路が、空気が前記空気通路を通過するときに渦を引き起こすための手段を含む、請求項7記載の装置。
- 前記金属製基質がステンレススチールを含む、請求項1〜8のいずれか一項に記載の装置。
- 前記金属製基質が少なくとも1000℃/秒の割合で加熱される、請求項1〜9のいずれか一項に記載の装置。
- 前記金属製基質上に被覆された前記薬物含有組成物が10nm〜10μmの間の厚みを有する、請求項1〜10のいずれか一項に記載の装置。
- 吸入療法に使用するための薬物含有エアロゾルを作り出す装置の作動方法であって、
前記装置は、
ハウジングと、
エアロゾル形成のためのガス/蒸気混合領域を含むと共に、金属製基質を有するサブアッセンブリを含む、前記ハウジング内の空気通路と、
前記金属製基質上に薄層フィルムとして被覆された薬物含有組成物を加熱して蒸気を形成する加熱システムとを含んでおり、
(a)前記薬物含有組成物で被覆された前記金属製基質を前記加熱システムによって加熱し、前記薬物含有組成物を気化させて、蒸気を形成する第1ステップと、
(b)粒子を有するエアロゾルが形成されるように、前記蒸気をある量の空気と混合する第2ステップであって、前記粒子のMMAD(空気力学的質量中央径)が少なくとも1秒間は安定性であるステップとを含む作動方法。 - 前記第1ステップでは、前記金属製基質が、該金属製基質を加熱帯に通して移動させることによって加熱される、請求項12記載の作動方法。
- 前記第2ステップで形成される前記エアロゾルは約109粒子/ccを有する、請求項12記載の作動方法。
- 前記加熱帯が主として交流磁場によって誘導された渦電流によって作り出される、請求項13記載の作動方法。
- 前記薬物含有組成物における前記薬物が抗パーキンソン薬である、請求項15記載の作動方法。
- 前記薬物含有組成物における前記薬物がオピオイドである、請求項15記載の作動方法。
- 前記薬物含有組成物における前記薬物が抗不安薬である、請求項15記載の作動方法。
- 前記薬物は0.15未満の分解指数を有する、請求項12〜18のいずれか一項に記載の作動方法。
- 前記薬物は0.05未満の分解指数を有する、請求項19に記載の作動方法。
- 前記第2ステップでは、薬物を含有する前記エアロゾルが前記空気通路に含まれている、請求項12〜20のいずれか一項に記載の作動方法。
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