JP2020505113A - 吸入器、及び、そのための空気流アダプタ - Google Patents
吸入器、及び、そのための空気流アダプタ Download PDFInfo
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- JP2020505113A JP2020505113A JP2019538350A JP2019538350A JP2020505113A JP 2020505113 A JP2020505113 A JP 2020505113A JP 2019538350 A JP2019538350 A JP 2019538350A JP 2019538350 A JP2019538350 A JP 2019538350A JP 2020505113 A JP2020505113 A JP 2020505113A
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- Prior art keywords
- inhaler
- outlet
- air
- powder medicament
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Abstract
Description
図1は、本開示に係る空気流アダプタの実施形態を示し、特に、吸入器で使用するための空気流アダプタ200の末端2010を示す。空気流アダプタは、第1の周囲フランジ206を有するコンジット2020を備える。コンジット2020は、円形の断面を有する;しかし、コンジットは、例えば、円形、正方形、または三角形など、任意の断面形状を有してよい。
図6および7のような吸入マウスピース(「ハイフローデバイス」として知られている)が、バイパス開口202、203、204、205、210、211、212を通るバイパス流路がないことを除いて同じマウスピース(スタンダードデバイスとして知られている)に対して試験された。デバイスは、活性成分としてアルブテロールを用い、「Copley Scientific-Quality Solutions for Inhaler Testing - 2012 Edition」に記載されているように、Copley Scientific Next Generation Impactor (NGI) testerを用いて試験された。
アルブテモール MDPI90mcg/用量 200用量(硫酸サルブタモール)、充填重量0.65g、プライミング50l/分。
500Hzで動作する高速カメラを使用し、Oxford Lasersによって提供されるFireFLYレーザによって形成される光シートを通って移動する同じタイプのハイフローデバイスおよびスタンダードデバイスからの製剤粒子の画像を、(上下)および予想される出口流の方向に対して垂直(また上下)(すなわち、マウスピース出口/周囲フランジ206に対して垂直)に沿った照明面で取り込み、取り込まれた画像は、デバイスからのプルームジオメトリおよびスプレーパターンに関する詳細なデータを提供するためにアプリケーションソフトウェア、Oxford Lasers Envision Patternateによって処理された。ソフトウェアは、Oxford Laserから購入することができる。
Claims (29)
- パウダー薬剤の吸入のための吸入器であって、前記吸入器は、ボディ、および、パウダー薬剤を収容する少なくとも1つのリザーバを有し、前記ボディは、空気入口、および、パウダー薬剤と前記空気入口を通って前記ボディに入る空気との患者への伝達のための出口を有し、前記出口は、前記空気入口の総断面積の80%より大きいフロー用の総断面積を有する、吸入器。
- 前記出口の前記総断面積は、前記入口の前記総断面積の85%より大きく;任意選択で125%未満、例えば90〜100%であり、一例では約95%である、請求項1に記載の吸入器。
- 前記出口は、空気中に引き入れられたドライパウダー薬剤の伝達のための主出口、および、薬剤を含まない空気だけのバイパス流の伝達のための少なくとも1つの副出口を備える、請求項1に記載の吸入器。
- 前記主出口は、実質的に円形である、請求項3に記載の吸入器。
- 前記主出口は、30〜50mm2、典型的には35〜45mm2、一例では約38.50mm2の断面積を有する、請求項3または請求項4に記載の吸入器。
- 全ての前記副出口の総断面積は、5〜15mm2、典型的には8〜12mm2、一例では約10.00 mm2である、請求項3、請求項4または請求項5に記載の吸入器。
- 前記入口の総断面積は、40〜60mm2、典型的には45〜55mm2、一例では約50.80mm2である、請求項1、請求項2または請求項3に記載の吸入器。
- 前記空気入口は、概ね楕円形状であり、楕円である少なくともその上縁部または下縁部を有し;前記空気入口は、好ましくは、前記空気入口の前記概ね楕円形状の長軸に平行にそれを横切って延在する少なくとも1つの格子部材を含む、請求項1から請求項7に記載の吸入器。
- 前記吸入器は、旋回チャンバを有する脱凝集器を含み、前記旋回チャンバは、パウダー薬剤を含まない空気のための少なくとも1つの入口ポート、および、パウダー薬剤を含む空気のための薬剤入口を有し、前記薬剤入口と合算した前記少なくとも1つの入口ポートを通るフローの面積は、合算した断面積を有し、前記合算した断面積は、前記ボディへの前記入口の前記総断面積より小さく;好ましくは(a)前記出口の前記断面積より小さい、および/または、(b)約40mm2である、請求項1から請求項8のいずれかに記載の吸入器。
- 前記合算した断面積は、全ての前記副出口の総断面積より3〜5倍大きく、例えば約4倍大きい、請求項3に従属する請求項9に記載の吸入器。
- 前記出口は、前記吸入器のマウスピースに形成されている、請求項1から請求項10に記載の吸入器。
- 前記吸入器によって放出された物質のプルームの円錐角が、35度未満である、請求項1から請求項11のいずれかに記載の吸入器。
- 前記吸入器から放出された物質のプルームの吸入器出口から3cm離れたところでの断面積は、6cm2未満、任意選択で5cm2未満、例えば約4.5cm2未満である、請求項1から請求項12のいずれかに記載の吸入器。
- 吸入器出口から3cm離れたところにおいて、前記吸入器から放出された物質のプルームの最大断面寸法の最小断面寸法に対する比は、1.8未満、任意選択で1.7未満、または1.6未満であり、一例では1.55である、請求項1から請求項13のいずれかに記載の吸入器。
- ドライパウダー薬剤を含む、請求項1から請求項14に記載の吸入器。
- 前記主ポートおよび前記副ポートは、Copley Scientific Next Generation Impactor試験で2kPa、4kPaおよび6kPaの圧力降下でのステージ4の粒子の送達が粒子の最大重量と粒子の最小重量との間で変動し、粒子の前記最大重量が前記最小重量の50%増より小さいように、任意選択で35%増より小さいまたは30%増より小さいように、一例では約25%増より小さいように、構成されている、請求項3または請求項3に従属する任意の先行する請求項に記載の吸入器。
- 前記主ポートおよび前記副ポートは、Copley Scientific Next Generation Impactor試験で2kPa、4kPaおよび6kPaの圧力降下でのステージ5の粒子の送達が粒子の最大重量と粒子の最小重量との間で変動し、粒子の前記最大重量が前記最小重量の20%増より小さいように、任意選択で17.5%増より小さいまたは15%増より小さいように、一例では約14%増より小さいように、構成されている、請求項3または請求項3に従属する任意の先行する請求項に記載の吸入器。
- パウダー薬剤の吸入のための吸入器であって、前記吸入器は、ボディ、および、パウダー薬剤を収容する少なくとも1つのリザーバを有し、前記ボディは、空気入口、および、パウダー薬剤と前記空気入口を通って前記ボディに入る空気との患者への伝達のための出口を有し、前記出口は、空気中に引き入れられたドライパウダー薬剤の伝達のための主出口、および、空気のバイパス流の伝達のための少なくとも1つの副出口を備え、前記主出口および前記副出口は、前記吸入器によって放出された微粒物質のプルームであってその円錐角が35度未満であるプルームを生成するように構成されている、吸入器。
- パウダー薬剤の吸入のための吸入器であって、前記吸入器は、ボディ、および、パウダー薬剤を収容する少なくとも1つのリザーバを有し、前記ボディは、空気入口、および、パウダー薬剤と前記空気入口を通って前記ボディに入る空気との患者への伝達のための出口を有し、前記出口は、空気中に引き入れられたドライパウダー薬剤の伝達のための主出口、および、空気のバイパス流の伝達のための少なくとも1つの副出口を備え、前記主出口および副出口は、吸入器出口から3cm離れた平面で6cm2未満の断面積を有する、前記吸入器によって放出された微粒物質のプルームを生成するように構成されている、吸入器。
- パウダー薬剤の吸入のための吸入器であって、前記吸入器は、ボディ、および、パウダー薬剤を収容する少なくとも1つのリザーバを有し、前記ボディは、空気入口、および、パウダー薬剤と前記空気入口を通って前記ボディに入る空気との患者への伝達のための出口を有し、前記出口は、空気中に引き入れられたドライパウダー薬剤の伝達のための主出口、および、空気のバイパス流の伝達のための少なくとも1つの副出口を備え、前記主出口および前記副出口は、吸入器出口から3cm離れた平面における最大断面寸法の最小断面寸法に対する比が1.8未満である、前記吸入器から放出された微粒物質のプルームを生成するように構成されている、吸入器。
- パウダー薬剤の吸入のための吸入器であって、前記吸入器は、ボディ、パウダー薬剤を収容する少なくとも1つのリザーバ、および、前記パウダー薬剤を脱凝集するための旋回チャンバを有し、前記ボディは、空気入口、および、パウダー薬剤と前記空気入口を通って前記ボディに入る空気との患者への伝達のための出口を有し、前記出口は、空気中に引き入れられたドライパウダー薬剤の伝達のための主出口、および、空気のバイパス流の伝達のための少なくとも1つの副出口を備え、前記主出口および前記副出口は、約95度から約100度のプルーム角を有する、前記吸入器によって放出された微粒物質のプルームを生成するように構成されている、吸入器。
- 呼吸器の疾患または障害を治療する方法であって、治療有効量の1つまたは複数の活性成分を投与するために請求項1から請求項21のいずれか1項に記載の吸入器を作動させることを含む、方法。
- 前記吸入器は、ドライパウダー吸入器であり、前記吸入器を作動させるステップは、前記吸入器を通じて吸入することを含む、請求項22に記載の方法。
- 前記呼吸器の疾患または障害は、喘息である請求項22に記載の方法。
- 前記呼吸器の疾患または障害は、慢性閉塞性肺疾患である、請求項22に記載の方法。
- 前記1つまたは複数の活性成分は、ブデソニドおよび/またはフマル酸フォルモテロールを含む、請求項22に記載の方法。
- 前記1つまたは複数の活性成分は、アルブテロールまたは硫酸サルブタモールを備える、請求項22に記載の方法。
- 前記1つまたは複数の活性成分は、プロピオン酸フルチカゾンとサルメテロールとの組合せを備える、請求項22に記載の方法。
- 前記サルメテロールは、サルメテロールキシナフォエートである、請求項28に記載の方法。
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GBGB1700727.9A GB201700727D0 (en) | 2017-01-16 | 2017-01-16 | Inhalers and airflow adaptors therefor |
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PCT/EP2018/051036 WO2018130727A1 (en) | 2017-01-16 | 2018-01-16 | Inhalers and airflow adaptors therefor |
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GB2614774A (en) * | 2022-07-14 | 2023-07-19 | Copley Scient Ltd | Inhaler testing apparatus |
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