JP2023509570A - 経口吸入製剤のためのインビトロ放出試験(ivrt)装置 - Google Patents
経口吸入製剤のためのインビトロ放出試験(ivrt)装置 Download PDFInfo
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/15—Medicinal preparations ; Physical properties thereof, e.g. dissolubility
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D63/00—Apparatus in general for separation processes using semi-permeable membranes
- B01D63/08—Flat membrane modules
- B01D63/087—Single membrane modules
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D69/00—Semi-permeable membranes for separation processes or apparatus characterised by their form, structure or properties; Manufacturing processes specially adapted therefor
- B01D69/10—Supported membranes; Membrane supports
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N13/00—Investigating surface or boundary effects, e.g. wetting power; Investigating diffusion effects; Analysing materials by determining surface, boundary, or diffusion effects
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D2313/00—Details relating to membrane modules or apparatus
- B01D2313/02—Specific tightening or locking mechanisms
- B01D2313/025—Specific membrane holders
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D2325/00—Details relating to properties of membranes
- B01D2325/02—Details relating to pores or porosity of the membranes
- B01D2325/0283—Pore size
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N13/00—Investigating surface or boundary effects, e.g. wetting power; Investigating diffusion effects; Analysing materials by determining surface, boundary, or diffusion effects
- G01N2013/006—Dissolution of tablets or the like
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- Food Science & Technology (AREA)
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Abstract
【選択図】図7
Description
ホルダー150の外形寸法とピッチは、ガラス容器内で容器の曲率に対して水平に位置するように設計されている。これにより、容器内のセルの正しい高さを制御できるようになり、セル表面が液浸セル装置のスターラーパドルに対して確実に位置合わせされる。
Claims (11)
- 経口吸入製剤品のためのインビトロ放出試験(IVRT)装置であって、
当該装置は、IVRT機器で使用されるものであり、
経口吸入製剤の用量を表す粒子状物質が堆積される空気透過性のフィルター(F)と、上部フィルター支持要素(130、230、330)と、下部フィルター支持要素(140、240、340)と、フィルターカバー(120、220、320)と、フィルターカバーリテーナ(110、210、310)と、を備え、
前記上部フィルター支持要素(130、230、330)と前記下部フィルター支持要素(140、240、340)との間に前記フィルター(F)の周囲が保持され、
前記フィルターカバー(120、220、320)は、前記粒子状物質が堆積されるフィルター(F)の上面を覆い、
前記フィルターカバーリテーナ(110、210、310)は、当該IVRT装置を組み立ておよびシールするために設けられている
ことを特徴するIVRT装置。 - 前記下部フィルター支持要素(140、240)を受けるとともに、当該IVRT装置のシールアセンブリのために前記フィルターカバーリテーナ(110、210)と協働するホルダー(150、250)をさらに含むことを特徴とする請求項1に記載の装置。
- 前記下部フィルター支持要素(140、240)と前記フィルター(F)との間にメッシュ(145)が設けられ、前記フィルターの下面を覆うことを特徴とする請求項2に記載の装置。
- 前記フィルターカバーリテーナ(110、210)は、前記ホルダー(150、250)上にバヨネットタイプのフィッティングを提供する脚部を備えることを特徴とする請求項2または3に記載の装置。
- 前記フィルターカバーリテーナ(310)は、当該IVRT装置のシールアセンブリのために、前記下部フィルター支持要素(340)と直接協働することを特徴とする請求項1に記載の装置。
- 前記フィルター(F)は、織布、不織布、メッシュおよび空気透過性フィルムから選択されることを特徴とする請求項1~5のいずれか1項に記載の装置。
- 前記フィルター(F)は、ガラスマイクロファイバー、合成セルロース系の材料、または、ポリカーボネート、ポリエステル、ポリオレフィン、ポリアミド、ポリ塩化ビニルおよびポリエーテルエーテルケトンから選択される高分子材料のフィラメントから形成される布を含むことを特徴とする請求項6に記載の装置。
- 前記フィルター(F)は、金属メッシュ、例えば、ステンレス鋼メッシュを含むことを特徴とする請求項6に記載の装置。
- 前記フィルター(F)は、5μm以下、好ましくは3μm以下の孔径を有することを特徴とする請求項1~8のいずれか1項に記載の装置。
- 前記フィルター(F)は、少なくとも1μmの孔径を有することを特徴とする請求項1~9のいずれか1項に記載の装置。
- 前記フィルター(F)は、フィルターがない場合と比較して、20%以下、好ましくは15%以下、より好ましくは10%以下の流量の減少を生成するような空気透過性を有することを特徴とする請求項1~10のいずれか1項に記載の装置。
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
PCT/EP2019/081551 WO2021093979A1 (en) | 2019-11-15 | 2019-11-15 | In vitro release testing (ivrt) device for orally inhaled drug products |
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JP2023509570A true JP2023509570A (ja) | 2023-03-09 |
JP7427781B2 JP7427781B2 (ja) | 2024-02-05 |
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JP2022528180A Active JP7427781B2 (ja) | 2019-11-15 | 2019-11-15 | 経口吸入製剤のためのインビトロ放出試験(ivrt)装置 |
Country Status (6)
Country | Link |
---|---|
US (1) | US20220404326A1 (ja) |
EP (1) | EP4058800B1 (ja) |
JP (1) | JP7427781B2 (ja) |
CN (1) | CN114868019A (ja) |
AU (1) | AU2019474706A1 (ja) |
WO (1) | WO2021093979A1 (ja) |
Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2000046597A1 (en) * | 1999-02-05 | 2000-08-10 | Dermik Laboratories, Inc. | Dissolution test sample holder |
JP2014531601A (ja) * | 2011-10-05 | 2014-11-27 | コミッサリア ア レネルジー アトミーク エ オ ゼネルジ ザルタナテイヴ | エアロゾルに含まれるナノ物体をその分析のためにサンプリング及び輸送する装置 |
WO2017051180A1 (en) * | 2015-09-22 | 2017-03-30 | Nanopharm Limited | Apparatus and method for determination of the fine particle dose of a powder inhalation formulation |
Family Cites Families (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6929782B1 (en) * | 1999-02-05 | 2005-08-16 | Aventis Pharmaceuticals Inc. | Dissolution test sample holder |
US20080223116A1 (en) * | 2007-03-13 | 2008-09-18 | Emad Alkhawam | Drug Release Cell and a Method for Testing the Drug Release of a Suspension in a Liquid Utilizing the Same |
CN101820967B (zh) * | 2007-10-04 | 2013-03-20 | Emd密理博公司 | 过滤装置 |
HUP0900073A2 (en) * | 2009-02-06 | 2010-11-29 | Egis Gyogyszergyar Nyilvanosan Muekoedoe Reszvenytarsasag | Process and equipment for inquiry medical product on dermal surface |
JP5576337B2 (ja) * | 2010-06-30 | 2014-08-20 | ローム アンド ハース カンパニー | 医薬剤形を溶出試験装置に分配するための送達装置 |
GB201515531D0 (en) * | 2015-09-02 | 2015-10-14 | Yip Lydia | Filtration device |
CN105784952A (zh) * | 2016-05-25 | 2016-07-20 | 延边大学 | 简易型流通池溶出度试验装置 |
-
2019
- 2019-11-15 EP EP19813426.4A patent/EP4058800B1/en active Active
- 2019-11-15 US US17/776,670 patent/US20220404326A1/en active Pending
- 2019-11-15 JP JP2022528180A patent/JP7427781B2/ja active Active
- 2019-11-15 AU AU2019474706A patent/AU2019474706A1/en active Pending
- 2019-11-15 WO PCT/EP2019/081551 patent/WO2021093979A1/en active Search and Examination
- 2019-11-15 CN CN201980102185.8A patent/CN114868019A/zh active Pending
Patent Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2000046597A1 (en) * | 1999-02-05 | 2000-08-10 | Dermik Laboratories, Inc. | Dissolution test sample holder |
JP2014531601A (ja) * | 2011-10-05 | 2014-11-27 | コミッサリア ア レネルジー アトミーク エ オ ゼネルジ ザルタナテイヴ | エアロゾルに含まれるナノ物体をその分析のためにサンプリング及び輸送する装置 |
WO2017051180A1 (en) * | 2015-09-22 | 2017-03-30 | Nanopharm Limited | Apparatus and method for determination of the fine particle dose of a powder inhalation formulation |
Also Published As
Publication number | Publication date |
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CN114868019A (zh) | 2022-08-05 |
WO2021093979A1 (en) | 2021-05-20 |
AU2019474706A1 (en) | 2022-06-02 |
JP7427781B2 (ja) | 2024-02-05 |
US20220404326A1 (en) | 2022-12-22 |
EP4058800B1 (en) | 2023-10-25 |
EP4058800A1 (en) | 2022-09-21 |
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