JP2008518724A - 医薬分析の装置および方法 - Google Patents
医薬分析の装置および方法 Download PDFInfo
- Publication number
- JP2008518724A JP2008518724A JP2007540075A JP2007540075A JP2008518724A JP 2008518724 A JP2008518724 A JP 2008518724A JP 2007540075 A JP2007540075 A JP 2007540075A JP 2007540075 A JP2007540075 A JP 2007540075A JP 2008518724 A JP2008518724 A JP 2008518724A
- Authority
- JP
- Japan
- Prior art keywords
- dosage form
- force
- solvent
- cylinder
- gastrointestinal tract
- 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.)
- Pending
Links
Images
Classifications
-
- G—PHYSICS
- G09—EDUCATION; CRYPTOGRAPHY; DISPLAY; ADVERTISING; SEALS
- G09B—EDUCATIONAL OR DEMONSTRATION APPLIANCES; APPLIANCES FOR TEACHING, OR COMMUNICATING WITH, THE BLIND, DEAF OR MUTE; MODELS; PLANETARIA; GLOBES; MAPS; DIAGRAMS
- G09B23/00—Models for scientific, medical, or mathematical purposes, e.g. full-sized devices for demonstration purposes
- G09B23/28—Models for scientific, medical, or mathematical purposes, e.g. full-sized devices for demonstration purposes for medicine
-
- 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
- G01N13/02—Investigating surface tension of liquids
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
- B01F21/00—Dissolving
- B01F21/20—Dissolving using flow mixing
- B01F21/22—Dissolving using flow mixing using additional holders in conduits, containers or pools for keeping the solid material in place, e.g. supports or receptacles
- B01F21/221—Dissolving using flow mixing using additional holders in conduits, containers or pools for keeping the solid material in place, e.g. supports or receptacles comprising constructions for blocking or redispersing undissolved solids
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
- B01F25/00—Flow mixers; Mixers for falling materials, e.g. solid particles
- B01F25/40—Static mixers
- B01F25/45—Mixers in which the materials to be mixed are pressed together through orifices or interstitial spaces, e.g. between beads
- B01F25/451—Mixers in which the materials to be mixed are pressed together through orifices or interstitial spaces, e.g. between beads characterised by means for moving the materials to be mixed or the mixture
- B01F25/4511—Mixers in which the materials to be mixed are pressed together through orifices or interstitial spaces, e.g. between beads characterised by means for moving the materials to be mixed or the mixture with a rotor surrounded by a stator provided with orifices
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
- B01F25/00—Flow mixers; Mixers for falling materials, e.g. solid particles
- B01F25/40—Static mixers
- B01F25/45—Mixers in which the materials to be mixed are pressed together through orifices or interstitial spaces, e.g. between beads
- B01F25/452—Mixers in which the materials to be mixed are pressed together through orifices or interstitial spaces, e.g. between beads characterised by elements provided with orifices or interstitial spaces
- B01F25/4521—Mixers in which the materials to be mixed are pressed together through orifices or interstitial spaces, e.g. between beads characterised by elements provided with orifices or interstitial spaces the components being pressed through orifices in elements, e.g. flat plates or cylinders, which obstruct the whole diameter of the tube
- B01F25/45211—Mixers in which the materials to be mixed are pressed together through orifices or interstitial spaces, e.g. between beads characterised by elements provided with orifices or interstitial spaces the components being pressed through orifices in elements, e.g. flat plates or cylinders, which obstruct the whole diameter of the tube the elements being cylinders or cones which obstruct the whole diameter of the tube, the flow changing from axial in radial and again in axial
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
- B01F27/00—Mixers with rotary stirring devices in fixed receptacles; Kneaders
- B01F27/80—Mixers with rotary stirring devices in fixed receptacles; Kneaders with stirrers rotating about a substantially vertical axis
- B01F27/91—Mixers with rotary stirring devices in fixed receptacles; Kneaders with stirrers rotating about a substantially vertical axis with propellers
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
- B01F31/00—Mixers with shaking, oscillating, or vibrating mechanisms
- B01F31/44—Mixers with shaking, oscillating, or vibrating mechanisms with stirrers performing an oscillatory, vibratory or shaking movement
- B01F31/441—Mixers with shaking, oscillating, or vibrating mechanisms with stirrers performing an oscillatory, vibratory or shaking movement performing a rectilinear reciprocating movement
-
- 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
-
- 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
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
-
- G—PHYSICS
- G09—EDUCATION; CRYPTOGRAPHY; DISPLAY; ADVERTISING; SEALS
- G09B—EDUCATIONAL OR DEMONSTRATION APPLIANCES; APPLIANCES FOR TEACHING, OR COMMUNICATING WITH, THE BLIND, DEAF OR MUTE; MODELS; PLANETARIA; GLOBES; MAPS; DIAGRAMS
- G09B23/00—Models for scientific, medical, or mathematical purposes, e.g. full-sized devices for demonstration purposes
- G09B23/28—Models for scientific, medical, or mathematical purposes, e.g. full-sized devices for demonstration purposes for medicine
- G09B23/30—Anatomical models
-
- 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
Abstract
Description
Claims (19)
- 胃腸管内での剤形からの活性剤の放出を分析するための溶解デバイスであって、
開端部を有し、溶媒を収容する容器と、
剤形を支持し該溶媒と流体連絡するチャンバ、および力付与機構を有する加力システムとを備え、該力付与機構が、胃腸管内の状態を模擬するために剤形に圧迫力を加える、デバイス。 - 加力システムが、開端部に連結され、それによって溶媒内に配置される、請求項1記載のデバイス。
- チャンバがシリンダであり、力付与機構がピストンを備え、該ピストンが動力源に動作可能に連結される、請求項1記載のデバイス。
- 加力システムが、剤形と力付与機構との間に配置されたパッドを有する、請求項1記載のデバイス。
- パッドがシリコーンである、請求項4記載のデバイス。
- 剤形に加えられる圧迫の頻度、持続時間、または大きさのうちの少なくとも1つを制御するために、ピストンに動作可能に連結される制御装置をさらに備える、請求項3記載のデバイス。
- 溶媒を循環させるインペラをさらに備える、請求項3記載のデバイス。
- 分析のために溶媒の試料を獲得するサンプラをさらに備える、請求項7記載のデバイス。
- シリンダが、該シリンダ内およびそこを通って溶媒が流れるようにする1つまたは複数のスロットを有する、請求項3記載のデバイス。
- シリンダが、該シリンダの底部に沿ってメッシュスクリーンを有する、請求項9記載のデバイス。
- シリンダが、該シリンダの底部に沿った第1のメッシュスクリーンと、該第1のメッシュスクリーンの上方にあり剤形を定位置で挟む第2のメッシュスクリーンとを有する、請求項3記載のデバイス。
- 加力システムが、少なくとも部分的に、電解研磨されたステンレス鋼で製作される、請求項1記載のデバイス。
- 胃腸管内での剤形からの活性剤放出を分析する方法であって、
剤形を溶媒中に配置し、
溶媒を循環させ、
胃腸管内の状態を模擬するために剤形に圧迫を加え、
剤形からの活性剤の放出を表す第1のデータを収集することを含む、方法。 - 剤形に加えられる圧迫の頻度を制御することをさらに含む、請求項13記載の方法。
- 剤形に加えられる圧迫の持続時間を制御することをさらに含む、請求項13記載の方法。
- 剤形に加えられる圧迫の大きさを制御することをさらに含む、請求項13記載の方法。
- 剤形が、剤形に圧迫を加えるために締付けられる袋内に配置される、請求項13記載の方法。
- 剤形のインビボでの胃排出時間を表す第2のデータを収集することをさらに含む、請求項13記載の方法。
- 第2のデータは、幽門括約筋と同様のサイズの固定されまたは変調された開口を有するチャンバ内に剤形が保持される、時間を監視することによって収集される、請求項18記載の方法。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US62562004P | 2004-11-05 | 2004-11-05 | |
PCT/US2005/039991 WO2006052742A2 (en) | 2004-11-05 | 2005-11-03 | Pharmaceutical analysis apparatus and method |
Publications (1)
Publication Number | Publication Date |
---|---|
JP2008518724A true JP2008518724A (ja) | 2008-06-05 |
Family
ID=36337025
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2007540075A Pending JP2008518724A (ja) | 2004-11-05 | 2005-11-03 | 医薬分析の装置および方法 |
Country Status (9)
Country | Link |
---|---|
US (1) | US8043270B2 (ja) |
EP (1) | EP1811974A4 (ja) |
JP (1) | JP2008518724A (ja) |
KR (1) | KR20070083989A (ja) |
CN (1) | CN101087594B (ja) |
AU (1) | AU2005304889A1 (ja) |
CA (1) | CA2586447C (ja) |
NZ (1) | NZ554829A (ja) |
WO (1) | WO2006052742A2 (ja) |
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2013501947A (ja) * | 2009-08-07 | 2013-01-17 | ネーデルランドセ・オルガニサティ・フォール・トゥーヘパスト−ナトゥールウェテンスハッペライク・オンデルズーク・テーエヌオー | 消化管内における剤形の崩壊を評価する方法、装置及びコンピュータプログラム製品 |
JP2014142535A (ja) * | 2013-01-25 | 2014-08-07 | National Agriculture & Food Research Organization | 胃モデル装置 |
JP2016133460A (ja) * | 2015-01-21 | 2016-07-25 | テルモ株式会社 | 消化管運動シミュレータおよび検査用消化物の採取方法 |
Families Citing this family (10)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20080076977A1 (en) * | 2006-09-26 | 2008-03-27 | Nellcor Puritan Bennett Inc. | Patient monitoring device snapshot feature system and method |
US20090064768A1 (en) * | 2007-03-13 | 2009-03-12 | Emad Alkhawam | Devices for Determining the Release Profile of Macromolecules and Methods of Using the Same |
US20100126287A1 (en) | 2007-05-04 | 2010-05-27 | Burke Matthew D | Pharmaceutical analysis apparatus and method |
AU2008335355A1 (en) * | 2007-12-06 | 2009-06-18 | Pain Therapeutics, Inc. | Dissolution test equipment and methods for testing |
DE102008044342B9 (de) | 2008-12-04 | 2010-10-21 | Ernst-Moritz-Arndt Universität Greifswald, Anstalt des öffentlichen Rechts | Wirkstofffreisetzungsvorrichtung und Verfahren zur Ermittlung des Freisetzungsverhaltens peroraler Arzneiformen |
ES2361983B1 (es) * | 2009-06-05 | 2012-05-03 | Asociación De Investigación De La Industria Agroalimentaria (Ainia) | Equipo modular de digestión in vitro. |
WO2011081857A1 (en) * | 2009-12-14 | 2011-07-07 | Cephalon, Inc. | Container and device for dissolution testing |
US20220178901A1 (en) * | 2019-04-08 | 2022-06-09 | Shionogi & Co., Ltd. | Mesh for dissolution test |
CN111544051B (zh) * | 2020-05-21 | 2023-08-01 | 郑州工业应用技术学院 | 一种利用肠道推动力的自取样装置及方法 |
CA3203419A1 (en) | 2020-12-30 | 2022-07-07 | Maria Carolina Parodi Davila | Portable modular gastrointestinal simulator system that quantifies bioaccesibility of metals in a sample remotely and in real time, and method |
Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPH09501238A (ja) * | 1993-08-06 | 1997-02-04 | チバ−カイギー アクチエンゲゼルシャフト | 医薬投与成形品の形状変化、崩壊挙動及び溶解挙動、並びに有効成分放出に与える生体の効果をシミュレーションするための装置 |
JP2001108668A (ja) * | 1999-07-30 | 2001-04-20 | Shimadzu Corp | 溶出試験機 |
Family Cites Families (14)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3802272A (en) * | 1973-01-24 | 1974-04-09 | Dow Chemical Co | Automatic dissolution rate determinator |
US4576604A (en) * | 1983-03-04 | 1986-03-18 | Alza Corporation | Osmotic system with instant drug availability |
GB2136123B (en) * | 1983-03-04 | 1986-10-29 | Akbar Noormohammadi | Dissolution testing machine |
CN87216306U (zh) * | 1987-12-19 | 1988-10-05 | 天津市医药器械研究所 | 液压举升机头药物溶出仪 |
US4855821A (en) * | 1988-02-16 | 1989-08-08 | Swon James E | Video timing device for pharmaceutical tablet testing |
US5062841A (en) * | 1988-08-12 | 1991-11-05 | The Regents Of The University Of California | Implantable, self-regulating mechanochemical insulin pump |
US5443459A (en) * | 1991-01-30 | 1995-08-22 | Alza Corporation | Osmotic device for delayed delivery of agent |
US5395366A (en) * | 1991-05-30 | 1995-03-07 | The State University Of New York | Sampling capsule and process |
US5412979A (en) * | 1993-05-03 | 1995-05-09 | Temple University - Of The Commonwealth System Of Higher Education | Method and apparatus for dissolution testing of a dosage form |
CN1177742A (zh) * | 1996-09-20 | 1998-04-01 | 胡幼圃 | 全自动模拟胃肠道体外溶离试验的装置及方法 |
DE19725015C2 (de) * | 1997-06-13 | 2002-02-14 | Bayer Ag | Sinker zur Bestimmung der Freisetzungsgeschwindigkeit von Wirkstoffen |
US6726678B1 (en) * | 2001-02-22 | 2004-04-27 | Isurgical, Llc | Implantable reservoir and system for delivery of a therapeutic agent |
US7470545B2 (en) * | 2001-11-05 | 2008-12-30 | Rohm And Haas Company | Buccal dissolution of active substances |
JP3965372B2 (ja) * | 2002-07-29 | 2007-08-29 | エーザイ・アール・アンド・ディー・マネジメント株式会社 | 試料錠崩壊装置、それを用いた崩壊試験装置及び崩壊・溶出試験システム、ならびに試料錠崩壊試験方法 |
-
2005
- 2005-11-03 EP EP05823305A patent/EP1811974A4/en not_active Withdrawn
- 2005-11-03 WO PCT/US2005/039991 patent/WO2006052742A2/en active Application Filing
- 2005-11-03 NZ NZ554829A patent/NZ554829A/en not_active IP Right Cessation
- 2005-11-03 CA CA2586447A patent/CA2586447C/en not_active Expired - Fee Related
- 2005-11-03 AU AU2005304889A patent/AU2005304889A1/en not_active Abandoned
- 2005-11-03 KR KR1020077010224A patent/KR20070083989A/ko not_active Application Discontinuation
- 2005-11-03 CN CN2005800442805A patent/CN101087594B/zh not_active Expired - Fee Related
- 2005-11-03 US US11/718,541 patent/US8043270B2/en active Active
- 2005-11-03 JP JP2007540075A patent/JP2008518724A/ja active Pending
Patent Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPH09501238A (ja) * | 1993-08-06 | 1997-02-04 | チバ−カイギー アクチエンゲゼルシャフト | 医薬投与成形品の形状変化、崩壊挙動及び溶解挙動、並びに有効成分放出に与える生体の効果をシミュレーションするための装置 |
JP2001108668A (ja) * | 1999-07-30 | 2001-04-20 | Shimadzu Corp | 溶出試験機 |
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2013501947A (ja) * | 2009-08-07 | 2013-01-17 | ネーデルランドセ・オルガニサティ・フォール・トゥーヘパスト−ナトゥールウェテンスハッペライク・オンデルズーク・テーエヌオー | 消化管内における剤形の崩壊を評価する方法、装置及びコンピュータプログラム製品 |
JP2014142535A (ja) * | 2013-01-25 | 2014-08-07 | National Agriculture & Food Research Organization | 胃モデル装置 |
JP2016133460A (ja) * | 2015-01-21 | 2016-07-25 | テルモ株式会社 | 消化管運動シミュレータおよび検査用消化物の採取方法 |
Also Published As
Publication number | Publication date |
---|---|
CA2586447A1 (en) | 2006-05-18 |
CN101087594B (zh) | 2011-08-03 |
US20080020468A1 (en) | 2008-01-24 |
WO2006052742A2 (en) | 2006-05-18 |
CN101087594A (zh) | 2007-12-12 |
WO2006052742A3 (en) | 2006-09-14 |
KR20070083989A (ko) | 2007-08-24 |
US8043270B2 (en) | 2011-10-25 |
EP1811974A2 (en) | 2007-08-01 |
CA2586447C (en) | 2013-10-01 |
EP1811974A4 (en) | 2012-03-07 |
NZ554829A (en) | 2008-10-31 |
AU2005304889A1 (en) | 2006-05-18 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
JP2008518724A (ja) | 医薬分析の装置および方法 | |
JP5701596B2 (ja) | 医薬分析の装置および方法 | |
US5827984A (en) | Apparatus for simulating the effect of the living organism on the change in shape, the disintegration and dissolution behaviour and the active-ingredient release of a pharmaceutical dosage form | |
JP5406193B2 (ja) | 哺乳動物の咀嚼動作を擬態する装置 | |
AU2005211392A1 (en) | Tablet holder device and methods for immersion testing | |
ES2665891T3 (es) | Método, dispositivo y producto de programa informático para evaluar la desintegración de una forma de dosificación en el tracto gastrointestinal | |
CN109298149B (zh) | 一种高效的自动释放率取样系统 | |
JPH02502576A (ja) | 試料を機械処理するための方法および装置 | |
US20160370253A1 (en) | Powder segregation testing apparatus and method of using | |
DE102008044342B9 (de) | Wirkstofffreisetzungsvorrichtung und Verfahren zur Ermittlung des Freisetzungsverhaltens peroraler Arzneiformen | |
EP2320227B1 (en) | Dissolution apparatus comprising beads and process | |
WO2009012923A1 (en) | Dissolution apparatus | |
JP2010520995A (ja) | 医薬分析装置および方法 | |
EP1576189A1 (en) | Vessel, method and apparatus for dissolution testing of an annular pharmaceutical delivery device | |
SI22853A (sl) | Mešalna naprava za testiranje raztapljanja, ki posnema peristaltično gibanje |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
A621 | Written request for application examination |
Free format text: JAPANESE INTERMEDIATE CODE: A621 Effective date: 20080701 |
|
A131 | Notification of reasons for refusal |
Free format text: JAPANESE INTERMEDIATE CODE: A131 Effective date: 20110628 |
|
A601 | Written request for extension of time |
Free format text: JAPANESE INTERMEDIATE CODE: A601 Effective date: 20110927 |
|
A602 | Written permission of extension of time |
Free format text: JAPANESE INTERMEDIATE CODE: A602 Effective date: 20111004 |
|
A601 | Written request for extension of time |
Free format text: JAPANESE INTERMEDIATE CODE: A601 Effective date: 20111027 |
|
A602 | Written permission of extension of time |
Free format text: JAPANESE INTERMEDIATE CODE: A602 Effective date: 20111104 |
|
A601 | Written request for extension of time |
Free format text: JAPANESE INTERMEDIATE CODE: A601 Effective date: 20111125 |
|
A602 | Written permission of extension of time |
Free format text: JAPANESE INTERMEDIATE CODE: A602 Effective date: 20111202 |
|
A521 | Written amendment |
Free format text: JAPANESE INTERMEDIATE CODE: A523 Effective date: 20111228 |
|
A131 | Notification of reasons for refusal |
Free format text: JAPANESE INTERMEDIATE CODE: A131 Effective date: 20120424 |
|
A02 | Decision of refusal |
Free format text: JAPANESE INTERMEDIATE CODE: A02 Effective date: 20121002 |