JP4922934B2 - 衝撃作動ヒートパッケージを組み込んだエアロゾル薬剤送達デバイス - Google Patents
衝撃作動ヒートパッケージを組み込んだエアロゾル薬剤送達デバイス Download PDFInfo
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- JP4922934B2 JP4922934B2 JP2007525587A JP2007525587A JP4922934B2 JP 4922934 B2 JP4922934 B2 JP 4922934B2 JP 2007525587 A JP2007525587 A JP 2007525587A JP 2007525587 A JP2007525587 A JP 2007525587A JP 4922934 B2 JP4922934 B2 JP 4922934B2
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Description
少なくとも1つの空気吸入口と少なくとも1つの排気口を有するマウスピースを備える空気経路を画成するハウジングと、空気路内に配置された少なくとも2つ以上の衝撃作動ヒートパッケージと、衝撃作動ヒートパッケージ上に配置された少なくとも1つの薬剤と、衝撃作動ヒートパッケージに衝撃を与えるよう構成された機構とを有する、薬剤送達デバイスを設けるステップと、
マウスピースから吸入するステップと、
衝撃が与えられるよう構成された機構を作動するステップと、
を含んだ、薬剤を患者に供給する方法を提供するものであり、
衝撃作動ヒートパッケージは少なくとも1つの薬剤を気化して、患者が吸入する空気路内に薬剤を含んだエアロゾルを生成する。
ニコチン金属配位錯体の固体薄膜の調製
[0108]1Lのアセトンに20gのシュウ酸を溶解することによって、2%のシュウ酸溶液が調製された。ガラス繊維フィルタ(ワットマン紙)が、約10秒間、2%のシュウ酸溶液にフィルタを浸漬することによってシュウ酸で被膜された。シュウ酸で被膜されたフィルタが空気乾燥された。
ニコチンZnBr2錯体からのニコチン気化によるニコチンアエロゾルの粒径の決定
[0112]1Lのアセトン(JTBaker)に20gのシュウ酸(Aldrich)を溶解して、2%のシュウ酸溶液が調製された。GF50、O81mmのガラス繊維フィルタ(Schleicher&Schull)が、約10秒間2%のシュウ酸溶液にフィルタを浸漬することによって、シュウ酸で被膜された。シュウ酸で被膜されたフィルタは、一晩空気乾燥された。
衝撃ヒートパッケージに対する開始剤組成物の調製
[0116]粒径が20μm未満のチタン620重量部と、100重量部の塩素酸カリウムと、180重量部の赤リンと、100重量部の塩素酸ナトリウムと、620重量部の水とを、2%のポリビニルアルコール結合剤と合わせることによって、開始剤組成物が形成された。
衝撃点火ヒートパッケージ
[0117]1/4インチ断面の薄いステンレス鋼ワイヤアンビルを備える点火アセンブリが開始剤組成物で浸漬被膜され、約1時間およそ40〜50℃で乾燥された。乾燥した被膜ワイヤアンビルは、厚さが0.003インチ、または厚さが0.005インチで、長さが約1.65インチ、外径が0.058インチの、壁部が軟らかいアルミニウム管に挿入された。管はワイヤアンビルを所定位置で保持するよう圧着され、エポキシで封止された。
衝撃点火ヒートパッケージからの気化を用いたアルプラゾラムエアロゾルの生成
[0127]組み立てられたヒートパッケージ上に、注射器を用いて、ジクロロメタン中のアルプラゾラム溶液を手で被膜して、燃料を含むヒートパッケージの端部に塗布溶液を塗布した(ヒートパッケージの全長は1.18インチ、ヒートパッケージの薬剤塗布長さは約0.39インチであった)。アルプラゾラムを含む2〜3マイクロリットルの溶液が、膜厚が1.58μmで0.125mgのアルプラゾラムを被膜するために塗布された。被膜されたヒートパッケージは、ヒュームフード内で少なくとも30分間乾燥された。最後の微量の溶媒が、蒸発実験の前に、30分間真空内で除去された。
衝撃点火ヒートパッケージからの蒸発を用いたプラミペキソールエアロゾルの生成
[0129]組み立てられたヒートパッケージ上に、注射器を用いて、メタノール中のプラミペキソール溶液を手で被膜して、燃料を含むヒートパッケージの端部に塗布溶液を塗布した(ヒートパッケージの全長は1.18インチ、ヒートパッケージの薬剤塗布長さは約0.39インチであった)。プラミペキソールを含む2〜3マイクロリットルの溶液が、膜厚が6.33μmで0.500mgのプラミペキソールを被膜するために塗布された。被膜されたヒートパッケージは、ヒュームフード内で少なくとも30分間乾燥された。最後の微量の溶媒が、蒸発実験の前に、30分間真空内で除去された。
衝撃点火ヒートパッケージからの蒸発を用いたシクレソニドエアロゾルの生成
[0131]組み立てられたヒートパッケージ上に、注射器を用いて、クロロホルム中のシクレソニド溶液を手で被膜して、燃料を含むヒートパッケージの端部に塗布溶液を塗布した(ヒートパッケージの全長は1.18インチ、ヒートパッケージの薬剤塗布長さは約0.39インチであった)。シクレソニドを含む2〜3マイクロリットルの溶液が、膜厚が2.53μmで0.200mgのシクレソニドを被膜するために塗布された。被膜されたヒートパッケージは、ヒュームフード内で少なくとも30分間乾燥された。最後の微量の溶媒が、蒸発実験の前に、30分間真空内で除去された。
衝撃点火を用いる燃料としてのPyrofuzeの発火
[0133]ヒートパッケージに燃料を詰め込む以外に、燃料としてワイヤを使用可能であることが決定された。
Claims (16)
- 少なくとも1つの衝撃作動ヒートパッケージを含む薬剤送達デバイスであって、
前記衝撃作動ヒートパッケージが、
機械的衝撃によって変形可能な領域を含むエンクロージャと、
前記エンクロージャの変形可能な領域内に配置されたアンビルと、
前記エンクロージャの変形可能な領域内に配置された衝撃開始剤組成物であって、エンクロージャの前記変形可能な領域が変形すると火花を生成し、それによって、変形可能な領域とアンビルとの間の前記開始剤組成物を圧縮するように構成された衝撃開始剤組成物と、
前記エンクロージャ内に配置されており、前記開始剤組成物から生成される火花によって衝突されて点火されるように構成された燃料と、
を含む、薬剤送達デバイス。 - 少なくとも1つの空気吸入口と、少なくとも1つの排気口を有するマウスピースとを含む空気路を画成するハウジングと、
前記空気路内に配置された少なくとも1つの衝撃作動ヒートパッケージであって、前記衝撃作動ヒートパッケージが、
機械的衝撃によって変形可能な領域を含むエンクロージャと、
前記エンクロージャの変形可能な領域内に配置されたアンビルと、
前記エンクロージャの変形可能な領域内に配置された衝撃開始剤組成物であって、エンクロージャの前記変形可能な領域が変形すると火花を生成し、それによって、変形可能な領域とアンビルとの間の前記開始剤組成物を圧縮するように構成された衝撃開始剤組成物と、
前記エンクロージャ内に配置されており、前記開始剤組成物から生成される火花によって衝突されて点火されるように構成された燃料と、
を含み、
前記少なくとも1つの衝撃作動ヒートパッケージ上に配置された少なくとも1つの薬剤と、
前記少なくとも1つの衝撃作動ヒートパッケージに衝撃を与えるように構成された機構と、
を含む薬剤送達デバイス。 - 前記薬剤が薄膜として前記ヒートパッケージの表面上に配置されており、前記薄膜の厚さが、任意に、0.01μm〜20μmの範囲、または0.5μm〜10μmの範囲にある、請求項2に記載の薬剤送達デバイス。
- 前記薬剤が、少なくとも250℃の温度に加熱されると気化する、請求項2に記載の薬剤送達デバイス。
- 前記薬剤が、アルブテロール、アルプラゾラム、アポモルヒネHCl、アリピプラゾール、アトロピン、アザタジン、ベンズトロピン、ブロマゼパム、ブロムフェニラミン、ブデソニド、ブメタニド、ブプレノルフィン、ブトルファノール、カルビノキサミン、クロルジアゼポキシド、クロルフェニラミン、シクレソニド、クレマスチン、クロニジン、コルヒチン、シプロヘプタジン、ジアゼパム、ドネペジル、エレトリプタン、エスタゾラム、エストラジオール、フェンタニル、フルマゼニル、フルニソリド、フルニトラゼパム、フルフェナジン、プロピオン酸フルチカゾン、フロバトリプタン、ガランタミン、グラニセトロン、ヒドロモルフォン、ヒオスシアミン、イブチリド、ケトチフェン、ロペラミド、メラトニン、メタプロテレノール、メタドン、ミダゾラム、ナラトリプタン、ニコチン、オキシブチニン、オキシコドン、オキシモルホン、ペルゴリド、パーフェナジン、ピンドロール、プラミペキソール、プロクロルペラジン、リザトリプタン、ロピニロール、スコポラミン、セレギリン、タダラフィル、テルブタリン、テストステロン、テトラハイドロカナビノール、トルテロジン、トリアムシノロンアセトニド、トリアゾラム、トリフルオペラジン、トロピセトロン、ザレプロン、ゾルミトリプタン、ゾルピデムのうちの少なくとも1つから選択されている、請求項2に記載の薬剤送達デバイス。
- 衝撃を与えるように構成された前記機構が、機械的に、電気的に、または吸入によって作動される、請求項2に記載の薬剤送達デバイス。
- 衝撃を与える前記電気的機構が、
前記空気路に結合された空気流感知アクチュエータと、
前記ヒートパッケージを作動するように構成された、前記空気流感知アクチュエータに結合された機構と、
を含み、
前記ヒートパッケージが、マウスピースによる吸入によって発生する前記空気路内の空気流によって作動される、請求項6に記載の薬剤送達デバイス。 - 衝撃を与えるように構成された吸入機構が、
前記空気路に結合された圧力感知ダイヤフラムと、
前記ハウジング内に配置されており、解放されると前記衝撃作動ヒートパッケージに衝撃を与えるように構成された、予め付勢されたばねと、
前記ダイヤフラムおよびハウジングに回転可能に結合されたレバーであって、回転すると前記ばねを解放して前記衝撃作動ヒートパッケージに衝撃を与える、レバーと、
を含み、
前記ヒートパッケージが、前記マウスピースによる吸入によって発生する前記空気路内の空気流によって作動される、請求項6に記載の薬剤送達デバイス。 - 衝撃を与えるように構成された機械的作動機構が、
(i)手動操作スイッチと、
前記衝撃作動ヒートパッケージに衝撃を与えるように構成された予め付勢されたばねと、
前記スイッチに結合されたレバーであって、作動すると前記ばねを解放して前記衝撃作動ヒートパッケージに衝撃を与える、レバーと、を含むか、または、
(ii)手動操作スイッチと、
前記衝撃作動ヒートパッケージに衝撃を与えるように構成された形状体と、
前記形状体を推進させるように構成された予め付勢されたばねと、
前記スイッチに結合されたレバーであって、作動すると前記ばねを解放して、前記形状体を推進させて前記衝撃作動ヒートパッケージに衝撃を与える、レバーと、を含むか、または
(iii)前記衝撃作動ヒートパッケージに衝撃を与えるように構成された形状体を含むか、または
(iv)回転可能なスリーブを含み、このスリーブが回転するときにばねに応力を与えてばねを解放する、請求項6に記載の薬剤送達デバイス。 - 前記薄膜が薬剤の金属配位錯体を含み、前記金属配位錯体が任意に少なくとも1つの金属塩と少なくとも1つの薬剤とを含み、
前記少なくとも1つの金属塩が任意にZn、Cu、Fe、Co、Ni、Alの塩、およびそれらの混合物から選択されており、
前記金属配位錯体が任意に少なくとも1つの有機溶剤に溶解可能であり、任意に、前記薬剤を含む前記金属配位錯体が100℃〜500℃の範囲の温度に加熱されたときに前記薬剤が前記金属配位錯体から選択的に気化される、請求項3に記載の薬剤送達デバイス。 - 前記ヒートパッケージが作動されると、前記薬剤を含むエアロゾルが空気路に生成され、任意に、該エアロゾルを形成する前記薬剤の前記蒸気純度が少なくとも95%である、請求項2に記載の薬剤送達デバイス。
- 前記空気路内を通る空気流が10L/分〜200L/分の範囲である、請求項2に記載の薬剤送達デバイス。
- 前記デバイスが複数の衝撃作動ヒートパッケージを含み、前記複数の衝撃作動ヒートパッケージのそれぞれが任意に凹部内に配置されている、請求項2に記載の薬剤送達デバイス。
- 前記デバイスがさらに、非作動ヒートパッケージに対する作動を進行するように構成された機構を含む、請求項13に記載の薬剤送達デバイス。
- 薬剤送達デバイス中の薬剤を気化する方法であって、
前記デバイスは、
少なくとも1つの空気吸入口と、少なくとも1つの排気口を有するマウスピースとを含む空気路を画成するハウジングと、
前記空気路内に配置された少なくとも1つの衝撃作動ヒートパッケージであって、
機械的衝撃によって変形可能な領域を含むエンクロージャと、
前記エンクロージャの変形可能な領域内に配置されたアンビルと、
前記エンクロージャの変形可能な領域内に配置されており、エンクロージャの前記変形可能な領域が変形すると火花を生成して、それによって、変形可能な領域とアンビルとの間の前記開始剤組成物を圧縮するように構成された衝撃開始剤組成物と、
前記エンクロージャ内に配置されており、前記開始剤組成物から生成される火花によって衝突されて点火されるように構成された燃料と、
を含む前記衝撃作動ヒートパッケージと、
前記少なくとも1つの衝撃作動ヒートパッケージ上に配置された少なくとも1つの薬剤と、
前記少なくとも1つの衝撃作動ヒートパッケージに衝撃を与えるように構成された機構と
を含み、
該方法は、前記少なくとも1つの衝撃作動ヒートパッケージに衝撃を与えるように構成された機構を作動させることを含み、それによって、前記開始剤組成物が前記燃料を点火し、前記ヒートパッケージに移動した熱エネルギーが前記薬剤を気化させる方法。 - 吸入療法におけるエアロゾルの形成方法であって、
薬剤送達デバイスを設ける工程を含み、
前記薬剤送達デバイスが、
少なくとも1つの空気吸入口と、少なくとも1つの排気口を有するマウスピースとを含む空気路を画成するハウジングと、
前記空気路内に配置された少なくとも2つ以上の衝撃作動ヒートパッケージであって、
機械的衝撃によって変形可能な領域を含むエンクロージャと、
前記エンクロージャの変形可能な領域内に配置されたアンビルと、
前記エンクロージャの変形可能な領域内に配置されており、エンクロージャの前記変形可能な領域が変形すると火花を生成して、それによって、変形可能な領域とアンビルとの間の前記開始剤組成物を圧縮するように構成された衝撃開始剤組成物と、
前記エンクロージャ内に配置されており、前記開始剤組成物から生成される火花によって衝突されて点火されるように構成された燃料と、
を含む、前記衝撃作動ヒートパッケージと、
前記少なくとも2つ以上の衝撃作動ヒートパッケージ上に配置された少なくとも1つの薬剤と、
前記衝撃作動ヒートパッケージに衝撃を与えるように構成された機構と、
を含み、
前記衝撃を与えるように構成された機構を作動する工程とを含み、
前記衝撃作動ヒートパッケージが少なくとも1つの薬剤を気化して、空気路内に薬剤を含んだエアロゾルを生成する方法。
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