JP2012521220A - レーザ回折装置用の吸入器アダプタおよび粒径分布を測定するための方法 - Google Patents
レーザ回折装置用の吸入器アダプタおよび粒径分布を測定するための方法 Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M15/00—Inhalators
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M11/00—Sprayers or atomisers specially adapted for therapeutic purposes
- A61M11/001—Particle size control
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M15/00—Inhalators
- A61M15/0065—Inhalators with dosage or measuring devices
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N15/00—Investigating characteristics of particles; Investigating permeability, pore-volume or surface-area of porous materials
- G01N15/02—Investigating particle size or size distribution
- G01N15/0205—Investigating particle size or size distribution by optical means
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N15/00—Investigating characteristics of particles; Investigating permeability, pore-volume or surface-area of porous materials
- G01N15/02—Investigating particle size or size distribution
- G01N15/0205—Investigating particle size or size distribution by optical means
- G01N15/0211—Investigating a scatter or diffraction pattern
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N15/00—Investigating characteristics of particles; Investigating permeability, pore-volume or surface-area of porous materials
- G01N15/06—Investigating concentration of particle suspensions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2202/00—Special media to be introduced, removed or treated
- A61M2202/06—Solids
- A61M2202/064—Powder
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2209/00—Ancillary equipment
- A61M2209/02—Equipment for testing the apparatus
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N15/00—Investigating characteristics of particles; Investigating permeability, pore-volume or surface-area of porous materials
- G01N15/02—Investigating particle size or size distribution
- G01N15/0205—Investigating particle size or size distribution by optical means
- G01N2015/025—Methods for single or grouped particles
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Abstract
Description
[0001]本出願は、米国特許法第119条(e)項に基づき、2009年3月18日出願の米国仮特許出願第61/161,379号の利益を主張するものであり、その内容は、その全体が参照により本明細書に組み込まれる。
実施例
[0050]米国特許第7,305,986号、同第7,464,706号、および米国特許出願第12/484,129(2009/0308391)号に記載されるものなどの吸入器システム上に取り付けられた、カートリッジ内に供給されたミリグラム(mg)単位の様々な量のインスリンおよびフマリルジケトピペラジン(fumaryl diketopiperazine)粒子の製剤の、レーザ回折装置(Helosレーザ回折センサ、Sympatec GmbH)に適合された装置の一実施形態を用いた粒径分布の測定が行われた。アダプタ装置は、Helos装置上に取り付けられる。装置の一端部が、流量計(TSI,Inc.Model4043)および圧縮空気源からの圧力または流れを調節するための弁に適合された、管機構に取り付けられる。図5に示すような吸入器は、装置に適合され、吸入器はまた、ドライパウダ製剤を収容するカートリッジを収容する。作動され、レーザビームの噴煙測定準備ができると、空気弁が作動されて、粉末が吸入器から吐出されることを可能にする。レーザシステムは、自動的に所定の測定条件に基づいて、吸入器装置から出る噴煙を測定する。レーザ回折システムは、装置と一体化されたソフトウェアによって動作させられ、コンピュータプログラムによって制御される。様々な量の粉末および様々な粉末を収容するサンプルの測定が行われた。測定条件は以下の通りである。
測定中の流量設定は、最大流量10〜40リットル/分である。
レーザ測定開始トリガ状態:特定の検出器チャネル上で0.6%より高いレーザ強度が検出されるとき。
レーザ測定終了トリガ状態:特定の検出器チャネル上で0.4%より低いレーザ強度が検出されるとき。
真空源は、250ミリバール、または30リットル/分より大きい流量に設定される。
真空源と吸入器チャンバとの間の距離は、約9.525cmである。
Claims (20)
- レーザ回折装置に適合されるように構成された装置であって、
マウスピースおよび本体を有し息により動かされるドライパウダ吸入器を取り囲むように構成されたチャンバであって、空洞と、入口ポートと、出口ポートとを画成する遠位端および近位端を備えるチャンバと、
前記入口ポートおよび/または前記出口ポートに適合するように構成された、1つまたは複数の端部キャップであって、前記入口ポートが正圧源を受けるように構成されている、端部キャップと、
装置取付け手段とを備え、
前記吸入器取付け手段内に設置された息により動かされるドライパウダ吸入器の本体が、前記チャンバ内に取り囲まれ、前記チャンバ空洞とチャンバなしのかつ/または周囲の環境との間に空気通路を形成する装置。 - 開口部を有し、吸入器マウスピースを前記開口部内の定位置に保持するように構成された吸入器取付け手段をさらに備える、請求項1に記載の装置。
- 前記1つまたは複数の端部キャップが第1の端部キャップと、第2の端部キャップとを含み、前記第1の端部キャップは前記チャンバの前記遠位端に位置決めされ、管機構を受けるように構成された開口部を有し、前記チャンバの前記近位端に位置決めされ、前記第2の端部キャップは前記吸入器の前記マウスピースを受けるように構成された開口部を有する、請求項1に記載の装置。
- 弁または注射器ポンプを有する流量制御システムをさらに備える、請求項1に記載の装置。
- 前記チャンバが、前記装置取付け手段から取り外し可能である、請求項1に記載の装置。
- 1つまたは複数のガスケットをさらに備える、請求項1に記載の装置。
- 1つまたは複数のOリングをさらに備える、請求項1に記載の装置。
- 前記チャンバを前記装置取付け手段に固定するためのクランプ機構をさらに備える、請求項1に記載の装置。
- 前記チャンバ内に挿入可能なスペーサをさらに備える、請求項1に記載の装置。
- レーザ回折装置に適合されるように構成された装置であって、
息により動かされるドライパウダ吸入器を取り囲むように構成され、遠位端および近位端を有するチャンバと、
前記遠位端に適合するように構成された第1の端部キャップと、前記近位端に適合するように構成された第2の端部キャップとを備え、前記第1の端部キャップが、流量制御装置および正圧源に連結される管機構を受けるように構成された開口部を有し、前記近位端が、前記息により動かされるドライパウダ吸入器を保持するように構成されたマウスピース取付け手段を有するように構成されている装置。 - 前記マウスピース取付け手段が、前記第1の端部キャップに適合されるように構成されている、請求項10に記載の装置。
- 弁または注射器ポンプを有する流量制御システムをさらに備える、請求項10に記載の装置。
- レーザ回折装置を用いて少なくとも1つの粒子の特徴を測定する方法であって、
チャンバを備える装置であって、本体を有しドライパウダ製剤を備える息により動かされるドライパウダ吸入器を、閉じた環境内で保持するように構成された装置を提供するステップと、
前記ドライパウダ吸入器の前記本体が前記チャンバ内に取り囲まれるように、前記息により動かされる吸入器を前記チャンバ内に設置するステップと、
前記ドライパウダ製剤の粒子を吐出するために、前記ドライパウダ吸入器を通る空気または気体の流れを生み出すように、前記装置の前記チャンバ内に正圧をもたらすステップと、
前記レーザ回折装置を用いて前記少なくとも1つの粒子特徴を測定するステップとを含み、
前記粒子が、前記吸入器からチャンバなしのかつ/または周囲の環境内へと放出される方法。 - 前記少なくとも1つの粒子特徴が、粒子密度である、請求項13に記載の方法。
- 前記少なくとも1つの粒子特徴が、粒径分布である、請求項13に記載の方法。
- 前記息により動かされるドライパウダ吸入器が、マウスピースを備える、請求項13に記載の方法。
- 前記マウスピースが、前記チャンバから前記チャンバなしのかつ/または周囲の環境へと空気通路を形成する、請求項16に記載の方法。
- 前記チャンバ内に正圧をもたらす前記ステップが、弁または注射器ポンプを備える流量制御システムからの加圧された気体の供給源によって達成される、請求項13に記載の方法。
- 加えられる前記正圧が、1kPaより大きい、請求項13に記載の方法。
- レーザ回折装置を用いて測定する前記ステップが、前記吸入器からの粒子の放出と同時に生じる、請求項13に記載の方法。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
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US16137909P | 2009-03-18 | 2009-03-18 | |
US61/161,379 | 2009-03-18 | ||
PCT/US2010/027880 WO2010108046A1 (en) | 2009-03-18 | 2010-03-18 | Inhaler adaptor for a laser diffraction apparatus and method for measuring particle size distribution |
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JP5671519B2 JP5671519B2 (ja) | 2015-02-18 |
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EP (1) | EP2408499B1 (ja) |
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KR (1) | KR20110139737A (ja) |
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CA (2) | CA2755514C (ja) |
DK (1) | DK2408499T3 (ja) |
IL (1) | IL215149A (ja) |
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JP5078014B2 (ja) | 2004-08-20 | 2012-11-21 | マンカインド コーポレイション | ジケトピペラジン合成の触媒反応 |
HUE025151T2 (en) | 2004-08-23 | 2016-01-28 | Mannkind Corp | Diceto-piperazine salts for drug delivery |
EP1928423B1 (en) | 2005-09-14 | 2015-12-09 | Mannkind Corporation | Method of drug formulation based on increasing the affinity of active agents for crystalline microparticle surfaces |
EP1986679B1 (en) | 2006-02-22 | 2017-10-25 | MannKind Corporation | A method for improving the pharmaceutic properties of microparticles comprising diketopiperazine and an active agent |
US8485180B2 (en) | 2008-06-13 | 2013-07-16 | Mannkind Corporation | Dry powder drug delivery system |
KR101558026B1 (ko) | 2008-06-13 | 2015-10-06 | 맨카인드 코포레이션 | 건조 분말 흡입기 및 약물 투여 시스템 |
CA2728523C (en) | 2008-06-20 | 2020-03-10 | Mannkind Corporation | An interactive apparatus and method for real-time profiling of inhalation efforts |
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KR20110139737A (ko) | 2011-12-29 |
IL215149A0 (en) | 2011-12-29 |
US9041925B2 (en) | 2015-05-26 |
EP2408499B1 (en) | 2014-03-05 |
BRPI1008998A2 (pt) | 2016-03-22 |
SG174345A1 (en) | 2011-11-28 |
US20130308130A1 (en) | 2013-11-21 |
CN102355918A (zh) | 2012-02-15 |
CA2755514A1 (en) | 2010-09-23 |
CA2755514C (en) | 2018-03-13 |
AU2010226547B2 (en) | 2013-09-26 |
US20100238457A1 (en) | 2010-09-23 |
US8508732B2 (en) | 2013-08-13 |
IL215149A (en) | 2015-04-30 |
MX2011009682A (es) | 2011-10-17 |
US20150226656A1 (en) | 2015-08-13 |
CA2992927A1 (en) | 2010-09-23 |
US9347866B2 (en) | 2016-05-24 |
CN102355918B (zh) | 2014-07-16 |
EP2408499A1 (en) | 2012-01-25 |
DK2408499T3 (da) | 2014-05-12 |
JP5671519B2 (ja) | 2015-02-18 |
AU2010226547A1 (en) | 2011-09-22 |
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