JP6715305B2 - 経肺投与によって心疾患を治療するための単位用量、エアロゾル、キット、および方法 - Google Patents
経肺投与によって心疾患を治療するための単位用量、エアロゾル、キット、および方法 Download PDFInfo
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- JP6715305B2 JP6715305B2 JP2018204914A JP2018204914A JP6715305B2 JP 6715305 B2 JP6715305 B2 JP 6715305B2 JP 2018204914 A JP2018204914 A JP 2018204914A JP 2018204914 A JP2018204914 A JP 2018204914A JP 6715305 B2 JP6715305 B2 JP 6715305B2
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Description
本発明は、例えば以下の項目を提供する。
(項目1)
心房性不整脈を治療する方法であって、
有効量の少なくとも1つの薬学的抗不整脈薬を、それを必要とする患者に投与することを含み、前記少なくとも1つの薬学的抗不整脈薬が、最初に肺静脈を通って心臓に侵入し、左心房に到達するようにする、方法。
(項目2)
前記少なくとも1つの薬学的抗不整脈薬の量は、前記投与の開始から10秒〜30分の時点で、心臓の冠状静脈洞内でピークに達する、項目1に記載の方法。
(項目3)
心臓の冠状静脈洞内の前記少なくとも1つの薬学的抗不整脈薬の前記量は、前記投与の開始から2分〜8分の時点でピークに達する、項目2に記載の方法。
(項目4)
心臓の冠状静脈洞内の前記少なくとも1つの薬学的抗不整脈薬の前記量は、投与の開始後2.5分で、0.1mg/L〜60mg/Lの範囲である、項目2または3に記載の方法。
(項目5)
心臓の冠状静脈洞内の前記少なくとも1つの薬学的抗不整脈薬の前記量は、投与の開始後30分で、0.1mg/L未満である、項目2〜4のうちのいずれかに記載の方法。
(項目6)
前記有効量は、心臓の1回のみの通過に対する有効量である、項目1〜5のうちのいずれかに記載の方法。
(項目7)
前記投与された少なくとも1つの薬学的抗不整脈薬の名目投与量の10%〜60%が、冠状静脈洞に到達する、項目1〜6のうちのいずれかに記載の方法。
(項目8)
投与された薬学的抗不整脈薬が前記患者の体内に侵入する量は、0.1mg〜200mgの範囲である、項目1〜7のうちのいずれかに記載の方法。
(項目9)
吸入を介して投与された前記少なくとも1つの薬学的抗不整脈薬の名目量は、腕に静脈内投与された同一の薬学的抗不整脈薬の量以下であり、冠状静脈洞内で同一量を達成する、項目1〜8のうちのいずれかに記載の方法。
(項目10)
前記投与は、1〜6回の吸入を含む、項目1〜9のうちのいずれかに記載の方法。
(項目11)
前記少なくとも1つの薬学的抗不整脈薬は、クラスIa、クラスIb、クラスIc、クラスII、クラスIII、クラスIV、およびクラスV抗不整脈薬から選択される少なくとも1つのメンバーを含む、項目1〜10のうちのいずれかに記載の方法。
(項目12)
前記少なくとも1つの薬学的抗不整脈薬は、少なくとも1つのクラスIa抗不整脈薬を含む、項目1〜11のうちのいずれかに記載の方法。
(項目13)
前記少なくとも1つの薬学的抗不整脈薬は、キニジン、プロカインアミド、およびジソピラミドから選択される、少なくとも1つのクラスIa抗不整脈薬を含む、項目1〜12のうちのいずれかに記載の方法。
(項目14)
前記少なくとも1つの薬学的抗不整脈薬は、少なくとも1つのクラスIb抗不整脈薬を含む、項目1〜13のうちのいずれかに記載の方法。
(項目15)
前記少なくとも1つの薬学的抗不整脈薬は、リドカイン、トカイニド、フェニトイン、モリシジン、およびメキシレチンから選択される、少なくとも1つのクラスIb抗不整脈薬を含む、項目1〜14のうちのいずれかに記載の方法。
(項目16)
前記少なくとも1つの薬学的抗不整脈薬は、少なくとも1つのクラスIc抗不整脈薬を含む、項目1〜15のうちのいずれかに記載の方法。
(項目17)
前記少なくとも1つの薬学的抗不整脈薬は、フレカイニド、プロパフェノン、およびモリシジンから選択される、少なくとも1つのクラスIc抗不整脈薬を含む、項目1〜16のうちのいずれかに記載の方法。
(項目18)
前記少なくとも1つの薬学的抗不整脈薬は、少なくとも1つのクラスII抗不整脈薬を含む、項目1〜17のうちのいずれかに記載の方法。
(項目19)
前記少なくとも1つの薬学的抗不整脈薬は、プロパノロール、アセブトロール、ソルタロール、エスモロール、チモロール、メトプロロール、およびアテノロールから選択される、少なくとも1つのクラスII抗不整脈薬を含む、項目1〜18のうちのいずれかに記載の方法。
(項目20)
前記少なくとも1つの薬学的抗不整脈薬は、少なくとも1つのクラスIII抗不整脈薬を含む、項目1〜19のうちのいずれかに記載の方法。
(項目21)
前記少なくとも1つの薬学的抗不整脈薬は、アミオダロン、ソタロール、ブレチリウム、イブチジド、メタンスルホンアミド、ベルナカラント、およびドフェチリドから選択される、少なくとも1つのクラスIII抗不整脈薬を含む、1〜20項目のうちのいずれかに記載の方法。
(項目22)
前記少なくとも1つの薬学的抗不整脈薬は、少なくとも1つのクラスIV抗不整脈薬を含む、項目1〜21のうちのいずれかに記載の方法。
(項目23)
前記少なくとも1つの薬学的抗不整脈薬は、ベプリジル、ニトレンジピン、アムロジピン、イスラジピン、ニフェジピン、ニカルジピン、ベラパミル、およびジルチアゼムから選択される、少なくとも1つのクラスIV抗不整脈薬を含む、項目1〜22のうちのいずれかに記載の方法。
(項目24)
前記少なくとも1つの薬学的抗不整脈薬は、少なくとも1つのクラスV抗不整脈薬を含む、項目1〜23のうちのいずれかに記載の方法。
(項目25)
前記少なくとも1つの薬学的抗不整脈薬は、ジゴキシンおよびアデノシンから選択される、少なくとも1つのクラスV抗不整脈薬を含む、項目1〜24のうちのいずれかに記載の方法。
(項目26)
前記心房性不整脈は、頻拍を含む、項目1〜25のうちのいずれかに記載の方法。
(項目27)
前記心房性不整脈は、上室性頻拍症を含む、項目1〜25のうちのいずれかに記載の方法。
(項目28)
前記心房性不整脈は、発作性上室性頻拍を含む、項目1〜25のうちのいずれかに記載の方法。
(項目29)
前記心房性不整脈は、心房細動を含む、項目1〜25のうちのいずれかに記載の方法。
(項目30)
前記心房性不整脈は、発作性心房細動を含む、項目1〜25のうちのいずれかに記載の方法。
(項目31)
前記心房性不整脈は、持続性および永久的な心房細動における急性発作を含む、項目1〜25のうちのいずれかに記載の方法。
(項目32)
前記心房性不整脈は、心房粗動を含む、項目1〜25のうちのいずれかに記載の方法。
(項目33)
前記心房性不整脈は、発作性心房粗動を含む、項目1〜25のうちのいずれかに記載の方法。
(項目34)
前記心房性不整脈は、孤立性心房細動を含む、項目1〜25のうちのいずれかに記載の方法。
(項目35)
前記投与は、前記少なくとも1つの薬学的抗不整脈薬を含む液体を投与することを含む、項目1〜34のうちのいずれかに記載の方法。
(項目36)
前記投与は、前記少なくとも1つの薬学的抗不整脈薬を含む粉末を投与することを含む、項目1〜34のうちのいずれかに記載の方法。
(項目37)
前記投与は、前記少なくとも1つの薬学的抗不整脈薬を含む凝縮エアロゾルを投与することを含む、項目1〜34のうちのいずれかに記載の方法。
(項目38)
前記投与は、前記少なくとも1つの薬学的抗不整脈薬を含む組成物を投与することを含み、前記組成物は、凝縮エアロゾルではない、項目1〜34のうちのいずれかに記載の方法。
(項目39)
前記経肺投与は、前記少なくとも1つの薬学的抗不整脈薬を含む溶液を噴霧することを含む、項目1〜34のうちのいずれかに記載の方法。
(項目40)
前記噴霧は、振動メッシュ噴霧器を用いて噴霧することを含む、項目39に記載の方法。
(項目41)
前記噴霧は、ジェット噴霧器を用いて噴霧することを含む、項目39に記載の方法。
(項目42)
前記噴霧は、10μm未満の空気動力学的中央粒子径を有する液滴を形成することを含む、項目39に記載の方法。
(項目43)
前記経肺投与は、前記少なくとも1つの薬学的抗不整脈薬を含む乾燥粉末を投与することを含む、項目1〜34のうちのいずれかに記載の方法。
(項目44)
前記乾燥粉末は、10μm未満の空気動力学的中央粒子径を有する粒子を含む、項目43に記載の方法。
(項目45)
前記乾燥粉末は、能動乾燥粉末吸入器を介して投与される、項目43に記載の方法。
(項目46)
前記乾燥粉末は、受動乾燥粉末吸入器を介して投与される、項目43に記載の方法。
(項目47)
前記経肺投与は、前記少なくとも1つの薬学的抗不整脈薬を、定量吸入器を介して投与することを含む、項目1〜34のうちのいずれかに記載の方法。
(項目48)
前記定量吸入器は、10μm未満の空気動力学的中央粒子径を有する粒子を形成する、項目47に記載の方法。
(項目49)
前記定量吸入器は、ヒドロフルオロアルカンおよびクロロフルオロカーボンから選択される担体中に製剤化された前記少なくとも1つの薬学的抗不整脈薬を含む、項目47に記載の方法。
(項目50)
前記治療は、心房性不整脈の検出後の急性治療を含む、項目1〜49のうちのいずれかに記載の方法。
(項目51)
前記患者は、前記投与の開始から10分以内に正常洞律動を有する、項目1〜50のうちのいずれかに記載の方法。
(項目52)
心房性不整脈を治療する方法であって、
有効量の少なくとも1つの薬学的抗不整脈薬を、それを必要とする患者に吸入によって投与することを含み、前記少なくとも1つの薬学的抗不整脈薬の量は、前記投与の開始から10秒〜30分の時点で、心臓の冠状静脈洞内でピークに達する、方法。
(項目53)
心臓の冠状静脈洞内の前記少なくとも1つの薬学的抗不整脈薬の前記量は、前記投与の開始から2分〜8分の時点でピークに達する、項目52に記載の方法。
(項目54)
心臓の冠状静脈洞内の前記少なくとも1つの薬学的抗不整脈薬の前記量は、投与の開始後2.5分で、0.1mg/L〜60mg/Lの範囲である、項目52および53のうちのいずれかに記載の方法。
(項目55)
心臓の冠状静脈洞内の前記少なくとも1つの薬学的抗不整脈薬の前記量は、投与の開始後30分で、0.1mg/L未満である、項目52〜54のうちのいずれかに記載の方法。
(項目56)
前記有効量は、心臓の1回のみの通過に対する有効量である、項目52〜55のうちのいずれかに記載の方法。
(項目57)
前記投与された少なくとも1つの薬学的抗不整脈薬の名目投与量の10%〜60%が冠状静脈洞に到達する、項目52〜56のうちのいずれかに記載の方法。
(項目58)
投与された薬学的抗不整脈薬が前記患者の体内に侵入する量は、0.1mg〜200mgの範囲である、項目52〜57のうちのいずれかに記載の方法。
(項目59)
吸入を介して投与された前記少なくとも1つの薬学的抗不整脈薬の名目量は、腕に静脈内投与された同一薬学的抗不整脈薬の量以下であり、冠状静脈洞内で同一量を達成する、項目52〜58のうちのいずれかに記載の方法。
(項目60)
前記投与は、1〜6回の吸入を含む、項目52〜59のうちのいずれかに記載の方法。
(項目61)
前記少なくとも1つの薬学的抗不整脈薬は、クラスIa、クラスIb、クラスIc、クラスII、クラスIII、クラスIV、およびクラスV抗不整脈薬から選択される少なくとも1つのメンバーを含む、項目52〜60のうちのいずれかに記載の方法。
(項目62)
前記少なくとも1つの薬学的抗不整脈薬は、少なくとも1つのクラスIa抗不整脈薬を含む、項目52〜61のうちのいずれかに記載の方法。
(項目63)
前記少なくとも1つの薬学的抗不整脈薬は、キニジン、プロカインアミド、およびジソピラミドから選択される、少なくとも1つのクラスIa抗不整脈薬を含む、項目52〜62のうちのいずれかに記載の方法。
(項目64)
前記少なくとも1つの薬学的抗不整脈薬は、少なくとも1つのクラスIb抗不整脈薬を含む、項目52〜63のうちのいずれかに記載の方法。
(項目65)
前記少なくとも1つの薬学的抗不整脈薬は、リドカイン、トカイニド、フェニトイン、モリシジン、およびメキシレチンから選択される、少なくとも1つのクラスIb抗不整脈薬を含む、項目52〜64のうちのいずれかに記載の方法。
(項目66)
前記少なくとも1つの薬学的抗不整脈薬は、少なくとも1つのクラスIc抗不整脈薬を含む、項目52〜65のうちのいずれかに記載の方法。
(項目67)
前記少なくとも1つの薬学的抗不整脈薬は、フレカイニド、プロパフェノン、およびモリシジンから選択される、少なくとも1つのクラスIc抗不整脈薬を含む、項目52〜66のうちのいずれかに記載の方法。
(項目68)
前記少なくとも1つの薬学的抗不整脈薬は、少なくとも1つのクラスII抗不整脈薬を含む、項目52〜67のうちのいずれかに記載の方法。
(項目69)
前記少なくとも1つの薬学的抗不整脈薬は、プロパノロール、アセブトロール、ソルタロール、エスモロール、チモロール、メトプロロール、およびアテノロールから選択される、少なくとも1つのクラスII抗不整脈薬を含む、項目52〜68のうちのいずれかに記載の方法。
(項目70)
前記少なくとも1つの薬学的抗不整脈薬は、少なくとも1つのクラスIII抗不整脈薬を含む、項目52〜69のうちのいずれかに記載の方法。
(項目71)
前記少なくとも1つの薬学的抗不整脈薬は、アミオダロン、ソタロール、ブレチリウム、イブチジド、メタンスルホンアミド、ベルナカラント、およびドフェチリドから選択される、少なくとも1つのクラスIII抗不整脈薬を含む、項目52〜70のうちのいずれかに記載の方法。
(項目72)
前記少なくとも1つの薬学的抗不整脈薬は、少なくとも1つのクラスIV抗不整脈薬を含む、項目52〜71のうちのいずれかに記載の方法。
(項目73)
前記少なくとも1つの薬学的抗不整脈薬は、ベプリジル、ニトレンジピン、アムロジピン、イスラジピン、ニフェジピン、ニカルジピン、ベラパミル、およびジルチアゼムから選択される、少なくとも1つのクラスIV抗不整脈薬を含む、項目52〜72のうちのいずれかに記載の方法。
(項目74)
前記少なくとも1つの薬学的抗不整脈薬は、少なくとも1つのクラスV抗不整脈薬を含む、項目52〜73のうちのいずれかに記載の方法。
(項目75)
前記少なくとも1つの薬学的抗不整脈薬は、ジゴキシンおよびアデノシンから選択される、少なくとも1つのクラスV抗不整脈薬を含む、項目52〜74のうちのいずれかに記載の方法。
(項目76)
前記心房性不整脈は、頻拍を含む、項目52〜75のうちのいずれかに記載の方法。
(項目77)
前記心房性不整脈は、上室性頻拍症を含む、項目52〜75のうちのいずれかに記載の方法。
(項目78)
前記心房性不整脈は、発作性上室性頻拍を含む、項目52〜75のうちのいずれかに記載の方法。
(項目79)
前記心房性不整脈は、心房細動を含む、項目52〜75のうちのいずれかに記載の方法。
(項目80)
前記心房性不整脈は、発作性心房細動を含む、項目52〜75のうちのいずれかに記載の方法。
(項目81)
前記心房性不整脈は、持続性および永久的な心房細動における急性発作を含む、項目52〜75のうちのいずれかに記載の方法。
(項目82)
前記心房性不整脈は、心房粗動を含む、項目52〜75のうちのいずれかに記載の方法。
(項目83)
前記心房性不整脈は、発作性心房粗動を含む、項目52〜75のうちのいずれかに記載の方法。
(項目84)
前記心房性不整脈は、孤立性心房細動を含む、項目52〜75のうちのいずれかに記載の方法。
(項目85)
前記投与は、前記少なくとも1つの薬学的抗不整脈薬を含む液体を投与することを含む、項目52〜84のうちのいずれかに記載の方法。
(項目86)
前記投与は、前記少なくとも1つの薬学的抗不整脈薬を含む粉末を投与することを含む、項目52〜84のうちのいずれかに記載の方法。
(項目87)
前記投与は、前記少なくとも1つの薬学的抗不整脈薬を含む凝縮エアロゾルを投与することを含む、項目52〜84のうちのいずれかに記載の方法。
(項目88)
前記投与は、前記少なくとも1つの薬学的抗不整脈薬を含む組成物を投与することを含み、前記組成物は、凝縮エアロゾルではない、項目52〜84のうちのいずれかに記載の方法。
(項目89)
前記経肺投与は、前記少なくとも1つの薬学的抗不整脈薬を含む溶液を噴霧することを含む、項目52〜84のうちのいずれかに記載の方法。
(項目90)
前記噴霧は、振動メッシュ噴霧器を用いて噴霧することを含む、項目89に記載の方法。
(項目91)
前記噴霧は、ジェット噴霧器を用いて噴霧することを含む、項目89に記載の方法。
(項目92)
前記噴霧は、10μm未満の空気動力学的中央粒子径を有する液滴を形成することを含む、項目89に記載の方法。
(項目93)
前記経肺投与は、前記少なくとも1つの薬学的抗不整脈薬を含む乾燥粉末を投与することを含む、項目52〜84のうちのいずれかに記載の方法。
(項目94)
前記乾燥粉末は、10μm未満の空気動力学的中央粒子径を有する粒子を含む、項目93に記載の方法。
(項目95)
前記乾燥粉末は、能動乾燥粉末吸入器を介して投与される、項目93に記載の方法。
(項目96)
前記乾燥粉末は、受動乾燥粉末吸入器を介して投与される、項目93に記載の方法。
(項目97)
前記経肺投与は、前記少なくとも1つの薬学的抗不整脈薬を、定量吸入器を介して投与することを含む、項目52〜84のうちのいずれかに記載の方法。
(項目98)
前記定量吸入器は、10μm未満の空気動力学的中央粒子径を有する粒子を形成する、項目97に記載の方法。
(項目99)
前記定量吸入器は、ヒドロフルオロアルカンおよびクロロフルオロカーボンから選択される担体中に製剤化された前記少なくとも1つの薬学的抗不整脈薬を含む、項目97に記載の方法。
(項目100)
前記治療は、心房性不整脈の検出後の急性治療を含む、項目52〜99のうちのいずれかに記載の方法。
(項目101)
前記患者は、前記投与の開始から30分以内に正常洞律動を有する、項目52〜100のうちのいずれかに記載の方法。
(項目102)
前記患者は、前記投与の開始から10分以内に正常洞律動を有する、項目52〜100のうちのいずれかに記載の方法。
(項目103)
心房性不整脈を自己診断および自己治療する方法であって、
息切れ、心臓動悸、および正常値を超える心拍数のうちの少なくとも1つを検出することによって、心房性不整脈を自己診断することと、
有効量の少なくとも1つの薬学的抗不整脈薬を、前記自己診断の2時間以内に吸入によって自己投与することと、を含む、方法。
(項目104)
前記自己投与は、前記自己診断の1時間以内に起こる、項目103に記載の方法。
(項目105)
前記自己投与は、前記自己診断の30分以内に起こる、項目103に記載の方法。
(項目106)
前記自己投与は、前記自己診断の15分以内に起こる、項目103に記載の方法。
(項目107)
前記自己投与は、前記患者が、息切れ、心臓動悸、および正常値を超える心拍数のうちの前記少なくとも1つを検出しなくなるまで継続する、項目103に記載の方法。
(項目108)
心房性不整脈を治療する方法であって、
有効量の少なくとも1つの薬学的抗不整脈薬を、それを必要とする患者に吸入によって投与することを含み、電気生理学的効果は、心電図検査法を介して、前記投与の開始から10秒〜30分の時点で観察される、方法。
(項目109)
前記電気生理学的効果は、不整脈から正常洞律動への移行を含む、項目108に記載の方法。
(項目110)
前記電気生理学的効果は、P波の非存在からP波の存在への移行を含む、項目108に記載の方法。
(項目111)
心房性不整脈を治療する方法であって、
有効量の少なくとも1つの薬学的抗不整脈薬を、それを必要とする患者に吸入によって投与することを含み、不整脈検出アルゴリズムを実装しているモニタからの心臓スコアは、前記投与の開始から10秒〜30分の時点で、前記患者内の不整脈状態から正常洞律動への移行を示す、方法。
(項目112)
前記モニタは、ホルターモニタを含む、項目111に記載の方法。
(項目113)
心房性不整脈を治療する方法であって、
有効量の少なくとも1つの薬学的抗不整脈薬を、それを必要とする患者に吸入によって投与することを含み、前記患者のSF36クオリティオブライフのスコアは、前記投与の開始から10秒〜30分の時点で改善する、方法。
(項目114)
単位用量レセプタクルと、
前記単位用量レセプタクル内の組成物であって、
前記冠状静脈洞内で最小有効量を達成するように、腕に静脈内投与された同一の少なくとも1つの薬学的抗不整脈薬以下の量で、少なくとも1つの薬学的抗不整脈薬を含む、組成物と、
薬学的に許容される賦形剤と、を含む、単位用量。
(項目115)
前記組成物は、溶液を含む、項目114に記載の単位用量。
(項目116)
前記組成物は、等張から生理学的等張性までの張性を有する溶液を含む、項目114に記載の単位用量。
(項目117)
前記組成物は、水溶液を含む、項目114〜116のうちのいずれかに記載の単位用量。
(項目118)
前記組成物は、非水溶液を含む、項目114〜116のうちのいずれかに記載の単位用量。
(項目119)
前記組成物は、pH緩衝剤をさらに含む、項目114〜118のうちのいずれかに記載の単位用量。
(項目120)
前記組成物は、クエン酸、リン酸、フタル酸、および乳酸から選択される、pH緩衝剤をさらに含む、項目114〜119のうちのいずれかに記載の単位用量。
(項目121)
前記組成物は、本質的に、前記少なくとも1つの薬学的抗不整脈薬および水で構成される、項目114に記載の単位用量。
(項目122)
前記組成物は、本質的に、前記少なくとも1つの薬学的抗不整脈薬、水、およびpH緩衝剤で構成される、項目114に記載の単位用量。
(項目123)
前記組成物は、3.5〜8.0のpHを有する、項目114に記載の単位用量。
(項目124)
前記薬学的に許容される賦形剤は、ヒドロフルオロアルカンを含む、項目114に記載の単位用量。
(項目125)
前記薬学的に許容される賦形剤は、クロロフルオロアルカンを含む、項目114に記載の単位用量。
(項目126)
前記組成物は、実質的に保存剤を含まない、項目114〜125のうちのいずれかに記載の単位用量。
(項目127)
前記少なくとも1つの薬学的抗不整脈薬は、クラスIa、クラスIb、クラスIc、クラスII、クラスIII、クラスIV、およびクラスV抗不整脈薬から選択される少なくとも1つのメンバーを含む、項目114〜126のうちのいずれかに記載の単位用量。
(項目128)
前記少なくとも1つの薬学的抗不整脈薬は、少なくとも1つのクラスIa抗不整脈薬を含む、項目114〜127のうちのいずれかに記載の単位用量。
(項目129)
前記少なくとも1つの薬学的抗不整脈薬は、キニジン、プロカインアミド、およびジソピラミドから選択される、少なくとも1つのクラスIa抗不整脈薬を含む、項目114〜128のうちのいずれかに記載の単位用量。
(項目130)
前記少なくとも1つの薬学的抗不整脈薬は、少なくとも1つのクラスIb抗不整脈薬を含む、項目114〜129のうちのいずれかに記載の単位用量。
(項目131)
前記少なくとも1つの薬学的抗不整脈薬は、リドカイン、トカイニド、フェニトイン、モリシジン、およびメキシレチンから選択される、少なくとも1つのクラスIb抗不整脈薬を含む、項目114〜130のうちのいずれかに記載の単位用量。
(項目132)
前記少なくとも1つの薬学的抗不整脈薬は、少なくとも1つのクラスIc抗不整脈薬を含む、項目114〜131のうちのいずれかに記載の単位用量。
(項目133)
前記少なくとも1つの薬学的抗不整脈薬は、フレカイニド、プロパフェノン、およびモリシジンから選択される、少なくとも1つのクラスIc抗不整脈薬を含む、項目114〜132のうちのいずれかに記載の単位用量。
(項目134)
前記少なくとも1つの薬学的抗不整脈薬は、少なくとも1つのクラスII抗不整脈薬を含む、項目114〜133のうちのいずれかに記載の単位用量。
(項目135)
前記少なくとも1つの薬学的抗不整脈薬は、プロパノロール、アセブトロール、ソルタロール、エスモロール、チモロール、メトプロロール、およびアテノロールから選択される、少なくとも1つのクラスII抗不整脈薬を含む、項目114〜134のうちのいずれかに記載の単位用量。
(項目136)
前記少なくとも1つの薬学的抗不整脈薬は、少なくとも1つのクラスIII抗不整脈薬を含む、項目114〜135のうちのいずれかに記載の単位用量。
(項目137)
前記少なくとも1つの薬学的抗不整脈薬は、アミオダロン、ソタロール、ブレチリウム、イブチジド、メタンスルホンアミド、ベルナカラント、およびドフェチリドから選択される、少なくとも1つのクラスIII抗不整脈薬を含む、項目114〜136のうちのいずれかに記載の単位用量。
(項目138)
前記少なくとも1つの薬学的抗不整脈薬は、少なくとも1つのクラスIV抗不整脈薬を含む、項目114〜137のうちのいずれかに記載の単位用量。
(項目139)
前記少なくとも1つの薬学的抗不整脈薬は、ベプリジル、ニトレンジピン、アムロジピン、イスラジピン、ニフェジピン、ニカルジピン、ベラパミル、およびジルチアゼムから選択される、少なくとも1つのクラスIV抗不整脈薬を含む、項目114〜138のうちのいずれかに記載の単位用量。
(項目140)
前記少なくとも1つの薬学的抗不整脈薬は、少なくとも1つのクラスV抗不整脈薬を含む、項目114〜139のうちのいずれかに記載の単位用量。
(項目141)
前記少なくとも1つの薬学的抗不整脈薬は、ジゴキシンおよびアデノシンから選択される、少なくとも1つのクラスV抗不整脈薬を含む、項目114〜140のうちのいずれかに記載の単位用量。
(項目142)
前記レセプタクルは、0.1mg〜200mgの前記少なくとも1つの薬学的抗不整脈薬を含む、項目114〜141のうちのいずれかに記載の単位用量。
(項目143)
前記単位用量は、実質的に無味である、項目114〜142のうちのいずれかに記載の単位用量。
(項目144)
10μm未満の空気動力学的中央粒子径を有する粒子を含むエアロゾルであって、前記粒子は、
冠状静脈洞内で最小有効量を達成する、腕に静脈内投与される同一の少なくとも1つの薬学的抗不整脈薬の量以下の量の少なくとも1つの薬学的抗不整脈薬と、
薬学的に許容される賦形剤と、を含む、エアロゾル。
(項目145)
前記粒子は、噴霧される溶液を含む、項目144に記載のエアロゾル。
(項目146)
前記粒子は、噴霧される水溶液を含む、項目144に記載のエアロゾル。
(項目147)
前記粒子は、pH緩衝剤をさらに含む、項目144〜146のうちのいずれかに記載のエアロゾル。
(項目148)
前記粒子は、クエン酸、リン酸、フタル酸、および乳酸から選択されるpH緩衝剤をさらに含む、項目144〜146のうちのいずれかに記載のエアロゾル。
(項目149)
前記粒子は、本質的に、前記少なくとも1つの薬学的抗不整脈薬および水で構成される、項目144〜146のうちのいずれかに記載のエアロゾル。
(項目150)
前記粒子は、本質的に、前記少なくとも1つの薬学的抗不整脈薬、水、およびpH緩衝剤で構成される、項目144〜147のうちのいずれかに記載のエアロゾル。
(項目151)
前記粒子は、3.5〜8.0の範囲のpHを有する、項目144に記載のエアロゾル。
(項目152)
前記粒子は、実質的に保存剤を含まない、項目144〜151のうちのいずれかに記載のエアロゾル。
(項目153)
前記少なくとも1つの薬学的抗不整脈薬は、クラスIa、クラスIb、クラスIc、クラスII、クラスIII、クラスIV、およびクラスV抗不整脈薬から選択される少なくとも1つのメンバーを含む、項目144〜152のうちのいずれかに記載のエアロゾル。
(項目154)
前記少なくとも1つの薬学的抗不整脈薬は、少なくとも1つのクラスIa抗不整脈薬を含む、項目144〜153のうちのいずれかに記載のエアロゾル。
(項目155)
前記少なくとも1つの薬学的抗不整脈薬は、キニジン、プロカインアミド、およびジソピラミドから選択される、少なくとも1つのクラスIa抗不整脈薬を含む、項目144〜154のうちのいずれかに記載のエアロゾル。
(項目156)
前記少なくとも1つの薬学的抗不整脈薬は、少なくとも1つのクラスIb抗不整脈薬を含む、項目144〜155のうちのいずれかに記載のエアロゾル。
(項目157)
前記少なくとも1つの薬学的抗不整脈薬は、リドカイン、トカイニド、フェニトイン、モリシジン、およびメキシレチンから選択される、少なくとも1つのクラスIb抗不整脈薬を含む、項目144〜156のうちのいずれかに記載のエアロゾル。
(項目158)
前記少なくとも1つの薬学的抗不整脈薬は、少なくとも1つのクラスIc抗不整脈薬を含む、項目144〜157のうちのいずれかに記載のエアロゾル。
(項目159)
前記少なくとも1つの薬学的抗不整脈薬は、フレカイニド、プロパフェノン、およびモリシジンから選択される、少なくとも1つのクラスIc抗不整脈薬を含む、項目144〜158のうちのいずれかに記載のエアロゾル。
(項目160)
前記少なくとも1つの薬学的抗不整脈薬は、少なくとも1つのクラスII抗不整脈薬を含む、項目144〜159のうちのいずれかに記載のエアロゾル。
(項目161)
前記少なくとも1つの薬学的抗不整脈薬は、プロパノロール、アセブトロール、ソルタロール、エスモロール、チモロール、メトプロロール、およびアテノロールから選択される、少なくとも1つのクラスII抗不整脈薬を含む、項目144〜160のうちのいずれかに記載のエアロゾル。
(項目162)
前記少なくとも1つの薬学的抗不整脈薬は、少なくとも1つのクラスIII抗不整脈薬を含む、項目144〜161のうちのいずれかに記載のエアロゾル。
(項目163)
前記少なくとも1つの薬学的抗不整脈薬は、アミオダロン、ソタロール、ブレチリウム、イブチジド、メタンスルホンアミド、ベルナカラント、およびドフェチリドから選択される、少なくとも1つのクラスIII抗不整脈薬を含む、項目144〜162のうちのいずれかに記載のエアロゾル。
(項目164)
前記少なくとも1つの薬学的抗不整脈薬は、少なくとも1つのクラスIV抗不整脈薬を含む、項目144〜163のうちのいずれかに記載のエアロゾル。
(項目165)
前記少なくとも1つの薬学的抗不整脈薬は、ベプリジル、ニトレンジピン、アムロジピン、イスラジピン、ニフェジピン、ニカルジピン、ベラパミル、およびジルチアゼムから選択される、少なくとも1つのクラスIV抗不整脈薬を含む、項目144〜164のうちのいずれかに記載のエアロゾル。
(項目166)
前記少なくとも1つの薬学的抗不整脈薬は、少なくとも1つのクラスV抗不整脈薬を含む、項目144〜165のうちのいずれかに記載のエアロゾル。
(項目167)
前記少なくとも1つの薬学的抗不整脈薬は、ジゴキシンおよびアデノシンから選択される、少なくとも1つのクラスV抗不整脈薬を含む、項目144〜166のうちのいずれかに記載のエアロゾル。
(項目168)
前記エアロゾルは、実質的に無味である、項目144〜167のうちのいずれかに記載のエアロゾル。
(項目169)
少なくとも1つの薬学的抗不整脈薬を含有する容器と、
エアロゾル化デバイスと、を含む、キット。
(項目170)
前記エアロゾル化デバイスは、噴霧器を備える、項目169に記載のキット。
(項目171)
前記エアロゾル化デバイスは、振動メッシュ噴霧器を備える、項目169に記載のキット。
(項目172)
前記エアロゾル化デバイスは、ジェット噴霧器を備える、項目169に記載のキット。
(項目173)
前記エアロゾル化デバイスは、乾燥粉末吸入器を備える、項目169に記載のキット。
(項目174)
前記エアロゾル化デバイスは、能動乾燥粉末吸入器を備える、項目169に記載のキット。
(項目175)
前記エアロゾル化デバイスは、受動乾燥粉末吸入器を備える、項目169に記載のキット。
(項目176)
前記エアロゾル化デバイスは、定量吸入器を備える、項目169に記載のキット。
(項目177)
前記少なくとも1つの薬学的抗不整脈薬の量は、心臓を最小で1回通過するだけで、電気生理学的効果をもたらすのに十分である、項目1〜113のうちのいずれかに記載の方法。
(項目178)
前記少なくとも1つの薬学的抗不整脈薬の前記有効量は、全体血液量によって希釈される場合、治療量以下である、項目1〜113のうちのいずれかに記載の方法。
ベラパミルおよびリドカインを伴う予言的分析モデル
公開された薬物動態および薬力学的モデル(図4)は、冠血中の薬物濃度と所望の冠動脈作用との関係を示す。IV薬物情報は、公開された文献から使用した。HARRISON et al.,「Effect of Single Doses of Inhaled Lignocaine on FEV1 and Bronchial Reactivity in Asthma,」Respir Med.,12:1359−635(Dec 1992)。吸入薬物情報は、肺小分子吸収に関する周知の特性に基づいてシミュレートした。
実施例2
誘発型心房細動および上室性心室頻拍症(SVT)を有するイヌの心室応答に対する抗不整脈化合物の気管内(IT)投与の効果
実施例3
エアロゾルとして投与した場合の抗不整脈薬剤の溶解性および味の事前評価
1.可視的エアロゾル特性の試験溶液は、相互に類似するが、水よりも密度が低かった。
2.酢酸フレカイニド:両ボランティアからの味フィードバックは極めて類似していた。
a.味:下の奥でわずかな苦味が感じられた。
b.後味:吸入操作から5分後、後味はほとんどなかった。
3.塩酸ジルチアゼム:水を吸入して、フレカイニド残渣をすべて洗浄した。両ボランティアからの味フィードバックは極めて類似していた。
a.味:下の奥でわずかな苦味が感じられた。
b.後味:吸入操作から5分後、後味はほとんどなかった。
4.他の観察:
a.口、喉、または肺に焼けるような感覚は感じられなかった。
b.目に見える有害事象は観察されなかった。両ボランティアは、投与後60分間安静にした。
Claims (18)
- 心房性不整脈の処置を必要とする患者において心房性不整脈を処置するための組成物であって、フレカイニドが最初に肺静脈を通って前記患者の心臓に入り、冠状静脈洞に到達するようなフレカイニドの有効量を含み、フレカイニドは噴霧器を用いた吸入により投与され、前記フレカイニドの有効量は0.1mg〜600mgの総量であり、前記フレカイニドの量が、投与の開始から10秒〜30分の範囲の時点で、心臓の冠状静脈洞内でピークに達する、水溶液の形態である組成物。
- 前記患者の肺に送達されるフレカイニドの前記有効量が、0.5〜150mgの全体用量である、請求項1に記載の組成物。
- 前記患者が投与の開始から30分以内に正常洞律動を有し、ここで、心臓の冠状静脈洞におけるフレカイニドの濃度が、投与開始後2.5分で0.1mg/L〜60mg/Lの範囲であるか、または、心臓の冠状静脈洞におけるフレカイニドの濃度が、投与開始後30分で0.1mg/L未満である、請求項1または2に記載の組成物。
- 前記組成物が1〜6回の吸入で投与される、請求項1〜3のいずれかに記載の組成物。
- 前記心房性不整脈が、頻拍、例えば上室性頻拍症、発作性上室性頻拍、心房細動、発作性心房細動、持続性および永久的心房細動における急性発作、心房粗動、発作性心房粗動、または孤立性心房細動を含む、請求項1〜4のいずれかに記載の組成物。
- フレカイニドを含む噴霧される溶液を含む請求項1〜5のいずれかに記載の組成物であって、噴霧された液滴が10μm未満の空気動力学的中央粒子径を有する、組成物。
- 電気生理学的効果が、心電図検査法を介して、前記投与の開始から10秒〜30分の範囲の時点で観察される、請求項1〜6のいずれかに記載の組成物。
- 前記電気生理学的効果が、不整脈から正常洞律動への移行を含む、請求項7に記載の組成物。
- 前記電気生理学的効果が、P波の非存在からP波の存在への移行を含む、請求項7または8に記載の組成物。
- フレカイニドの前記有効量が、全体血液量によって希釈される場合、治療量以下である、請求項1〜9のいずれかに記載の組成物。
- 前記噴霧器がジェット噴霧器である、請求項1〜10のいずれかに記載の組成物。
- 前記噴霧器が息で作動する噴霧器である、請求項1〜11のいずれかに記載の組成物。
- フレカイニドの薬学的に許容される塩を含む、請求項1〜12のいずれか一項に記載の組成物。
- 酢酸フレカイニドまたは塩化フレカイニドを含む、請求項13に記載の組成物。
- pH緩衝剤をさらに含む、請求項1〜14のいずれか一項に記載の組成物。
- 前記pH緩衝剤が、酢酸、クエン酸、乳酸、または、アスコルビン酸の有機酸塩を含む、請求項15に記載の組成物。
- 5.0〜6.5の範囲のpHを有する、請求項1〜16のいずれか一項に記載の組成物。
- さらにシクロデキストリンを含む、請求項1〜17のいずれか一項に記載の組成物。
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PL2413902T3 (pl) | 2020-01-31 |
WO2010107964A1 (en) | 2010-09-23 |
EP2413902B1 (en) | 2019-07-17 |
EP2413902A4 (en) | 2014-02-19 |
CA2755809C (en) | 2014-02-18 |
JP7071949B2 (ja) | 2022-05-19 |
CA2835771C (en) | 2017-01-24 |
CA2835771A1 (en) | 2010-09-23 |
US20190060230A1 (en) | 2019-02-28 |
JP2017160268A (ja) | 2017-09-14 |
EP3552602A1 (en) | 2019-10-16 |
US20180296480A1 (en) | 2018-10-18 |
US20180318213A1 (en) | 2018-11-08 |
CA2755809A1 (en) | 2010-09-23 |
JP2012520890A (ja) | 2012-09-10 |
ES2750359T3 (es) | 2020-03-25 |
EP2413902A1 (en) | 2012-02-08 |
DK2413902T3 (da) | 2019-10-07 |
JP2015193657A (ja) | 2015-11-05 |
JP2019203032A (ja) | 2019-11-28 |
US8974828B2 (en) | 2015-03-10 |
US20150313842A1 (en) | 2015-11-05 |
US20120003318A1 (en) | 2012-01-05 |
JP2019019139A (ja) | 2019-02-07 |
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