JP2020073510A - 経鼻投与 - Google Patents
経鼻投与 Download PDFInfo
- Publication number
- JP2020073510A JP2020073510A JP2019230957A JP2019230957A JP2020073510A JP 2020073510 A JP2020073510 A JP 2020073510A JP 2019230957 A JP2019230957 A JP 2019230957A JP 2019230957 A JP2019230957 A JP 2019230957A JP 2020073510 A JP2020073510 A JP 2020073510A
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- JP
- Japan
- Prior art keywords
- nasal
- patient
- optionally
- sumatriptan
- delivering
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
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Abstract
Description
図2(a)および図2(b)が、粉末エアロゾルをもたらす(deliver,配送する)ように動作することができるブレスパワー(Breath Powered)(商標)粉末送出装置(powder delivery device,粉末配送装置)を示している。
研究の目的は、中程度〜激しい偏頭痛の患者の処置におけるブレスパワースマトリプタン粉末の効能および安全性を偽薬と比較することにある。経口トリプタンを摂取する患者は、一般的に、不満の理由として遅い作用の発現、不充分な痛みの緩和、および副作用に言及し、吐き気または嘔吐も使用の障壁となり得る。「トリプタン作用」として知られる副作用は、最も頻繁には、より高い血漿中濃度を生じる処方物および投与量に関係する。小さな試験において、ブレスパワー装置によってもたらされた少ない投与量のスマトリプタン粉末が、付随の副作用を伴うことなく、注射においてすでに報告された率に近い頭痛緩和率を生じた。
120分の時点(主要)および120分までの複数の時点における頭痛反応(軽微または皆無と評価される痛み)。
120分までの複数の時点における完全な痛みの解放(頭痛の苦痛からの自由)。
有意な緩和までの時間(頭痛の苦痛の反応の解釈の患者による報告)。
臨床の無力および偏頭痛関連の症状(光恐怖症、音声恐怖症、吐き気、および嘔吐)。
救急薬の使用。
反応の持続/痛みの解放の持続(120分の時点において頭痛について効果があり/痛みが完全に消え、投与後24および48hまで再発生または救急薬の使用がない)。
Claims (40)
- 患者を治療的に処置するための装置または方法であって、
第1のステップにおいて治療薬を投与することと、
第2のステップにおいて患者の鼻道の内部の位置に治療量の二酸化炭素またはpH調節物質の少なくとも一方を配送することと
を含んでおり、
前記第1のステップが、前記第2のステップの前、後、前後、および/または前記第2のステップと同時に実行される、装置または方法。 - 前記第1のステップは、前記第2のステップの前に実行される、請求項1に記載の装置または方法。
- 前記第1のステップは、前記第2のステップの後に実行される、請求項1に記載の装置または方法。
- 前記第2のステップは、前記第1のステップの前および後の両方において実行され、かつ/または前記第1のステップは、前記第2のステップと同時に実行される、請求項1に記載の装置または方法。
- 前記位置は、鼻道の上後領域を含む、請求項1に記載の装置または方法。
- 前記治療薬は、任意選択でコハク酸スマトリプタンの形態であり、任意選択で粉末エアロゾルとして投与されるスマトリプタンを含む、請求項1に記載の装置または方法。
- 前記治療薬は、任意選択でフルチカゾンであり、任意選択でプロピオン酸フルチカゾンの形態であり、任意選択で液体エアロゾルとして投与される、局所ステロイドを含む、請求項1に記載の装置または方法。
- 前記治療薬は、少なくとも100ugの量で、任意選択で1日に2回配送される、請求項7に記載の装置または方法。
- 前記治療薬は、少なくとも200ugの量で、任意選択で1日に2回配送される、請求項8に記載の装置または方法。
- 前記治療薬は、少なくとも400ugの量で、任意選択で1日に2回配送される、請求項9に記載の装置または方法。
- 前記配送する行為は、
マウスピースを患者の口に配置し、前記マウスピースに連通したノーズピースを患者の鼻孔に配置することと、
患者が前記マウスピースに息を吐き出し、前記ノーズピースから出る流体の流れを生成することと
を含んでおり、
経鼻投与されるときの前記治療薬は、前記配送する行為によらずに経鼻投与されるときの50ugの前記治療薬の全身バイオアベイラビリティと比べて同等またはそれ以下の全身バイオアベイラビリティまたは薬物動態(PK)プロフィルを有する、請求項8に記載の装置または方法。 - 前記第2のステップは、前記鼻道の位置におけるpHを、約0.01〜約0.5pH単位の範囲の量だけ調節する、請求項1に記載の装置または方法。
- 前記量は、約0.1〜約0.2pH単位の範囲である、請求項12に記載の装置または方法。
- 前記第2のステップは、二酸化炭素が約1%vol/vol〜約10%vol/volの二酸化炭素濃度を配送するステップを含む、請求項1に記載の装置または方法。
- 前記二酸化炭素濃度は、二酸化炭素が約5%〜約6%vol/volである、請求項14に記載の装置または方法。
- 前記配送する行為は、
マウスピースを患者の口に配置し、ノーズピースを患者の鼻孔に配置することと、
患者が前記マウスピースに息を吐き出し、前記ノーズピースから出る流体の流れを生成することと、
前記流体の流れを鼻道の内部の前記位置に導くことと
を含む、請求項1に記載の装置または方法。 - 前記配送する行為は、前記流体の流れを制御することによって前記位置におけるpHを調節することをさらに含む、請求項16に記載の方法。
- 前記流体の流れの制御は、前記流体の流れの継続時間、流量、圧力、および組成の少なくとも1つを制御することを含む、請求項17に記載の装置または方法。
- 前記流体の流れの継続時間を約2〜約3秒の範囲となるように制御することを含む、請求項18に記載の装置または方法。
- 前記流体の流れの流量を、少なくとも10L/分、任意選択で少なくとも20L/分、および任意選択で少なくとも30L/分に制御することを含む、請求項19に記載の装置または方法。
- 前記配送する行為は、
前記ノーズピースを患者の第2の鼻孔に配置することと、
患者が前記マウスピースに息を吐き出し、前記ノーズピースから出る第2の流体の流れを生成することと、
前記第2の流体の流れを第2の鼻道の内部の第2の位置に導くことと
を含む、請求項16に記載の装置または方法。 - 患者に配送される医薬品の治療効果を高めるための装置または方法であって、
鼻道の後方領域に約5%〜約6%vol/volの二酸化炭素を配送するように患者の鼻道に流体の流れを配送することと、
前記医薬品を患者に投与することと
を含む装置または方法。 - 鼻道の前記後方領域のpHを下げること
をさらに含む、請求項22に記載の装置または方法。 - 前記医薬品は、任意選択でコハク酸スマトリプタンの形態であり、任意選択で粉末エアロゾルとして投与される、スマトリプタンを含む、請求項22に記載の装置または方法。
- 前記医薬品は、任意選択でフルチカゾンであり、任意選択でプロピオン酸フルチカゾンの形態であり、任意選択で液体エアロゾルとして投与される、局所ステロイドを含む、請求項22に記載の装置または方法。
- 前記医薬品は、少なくとも100ugの量で、任意選択で1日に2回配送される、請求項25に記載の装置または方法。
- 前記医薬品は、少なくとも200ugの量で、任意選択で1日に2回配送される、請求項26に記載の装置または方法。
- 前記医薬品は、少なくとも400ugの量で、任意選択で1日に2回配送される、請求項27に記載の装置または方法。
- 前記配送する行為は、
マウスピースを患者の口に配置し、前記マウスピースに連通したノーズピースを患者の鼻孔に配置することと、
患者が前記マウスピースに息を吐き出し、前記ノーズピースから出る流体の流れを生成することと
を含んでおり、
経鼻投与されるときの前記医薬品は、前記配送する行為によらずに経鼻投与されるときの50ugの前記医薬品の全身バイオアベイラビリティまたは薬物動態(PK)プロフィルと比べて同等またはそれ以下の全身バイオアベイラビリティまたは薬物動態(PK)プロフィルを有する、請求項26に記載の装置または方法。 - 患者を処置するための装置または方法であって、
治療的または薬物動態的な効果をもたらすべく少なくとも約0.1pH単位だけ鼻道の上後領域のpHを下げるために患者の鼻孔に約5%〜約6%vol/volの濃度の二酸化炭素を配送すること
を含む装置または方法。 - 治療薬を患者に経口、経鼻、静脈内、および皮下の少なくとも1つにて投与すること
をさらに含む、請求項30に記載の装置または方法。 - 1回分のスマトリプタン粉末を経鼻投与すること
をさらに含む、請求項30に記載の装置または方法。 - 前記少量が、20mg未満のスマトリプタン粉末、任意選択で約16mgのスマトリプタン粉末を含み、任意選択でコハク酸スマトリプタンの形態である、請求項32に記載の装置または方法。
- 任意選択でフルチカゾンであり、任意選択でプロピオン酸フルチカゾンの形態であり、任意選択で液体エアロゾルとして投与される、局所ステロイドを投与すること
をさらに含む、請求項30に記載の装置または方法。 - 前記ステロイドは、少なくとも100ugの量で、任意選択で1日に2回配送される、請求項34に記載の装置または方法。
- 前記ステロイドは、少なくとも200ugの量で、任意選択で1日に2回配送される、請求項35に記載の装置または方法。
- 前記ステロイドは、少なくとも400ugの量で、任意選択で1日に2回配送される、請求項36に記載の装置または方法。
- 前記配送する行為は、
マウスピースを患者の口に配置し、前記マウスピースに連通したノーズピースを患者の鼻孔に配置することと、
患者が前記マウスピースに息を吐き出し、前記ノーズピースから出る流体の流れを生成することと
を含んでおり、
経鼻投与されるときの前記ステロイドは、前記配送する行為によらずに経鼻投与されるときの50ugの前記ステロイドの全身バイオアベイラビリティまたは薬物動態(PK)プロフィルと比べて同等またはそれ以下の全身バイオアベイラビリティまたは薬物動態(PK)プロフィルを有する、請求項30に記載の装置または方法。 - 前記治療的または薬物動態的な効果は、偏頭痛およびアレルギ性鼻炎の少なくとも一方を処置する、請求項30に記載の装置または方法。
- 前記配送する段階において患者の軟口蓋を実質的に閉じること
をさらに含む、請求項30に記載の装置または方法。
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