WO1996028717A1 - Testing vessel - Google Patents

Testing vessel Download PDF

Info

Publication number
WO1996028717A1
WO1996028717A1 PCT/GB1996/000493 GB9600493W WO9628717A1 WO 1996028717 A1 WO1996028717 A1 WO 1996028717A1 GB 9600493 W GB9600493 W GB 9600493W WO 9628717 A1 WO9628717 A1 WO 9628717A1
Authority
WO
WIPO (PCT)
Prior art keywords
vessel
dissolution testing
testing
dissolution
insert
Prior art date
Application number
PCT/GB1996/000493
Other languages
English (en)
French (fr)
Inventor
Stephen George Barnwell
Stephen John Burns
Simon Higginbottom
Original Assignee
Cortecs Limited
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Cortecs Limited filed Critical Cortecs Limited
Priority to EP96904938A priority Critical patent/EP0815427A1/en
Priority to BR9607230A priority patent/BR9607230A/pt
Priority to JP8527352A priority patent/JPH11503517A/ja
Priority to AU48853/96A priority patent/AU4885396A/en
Publication of WO1996028717A1 publication Critical patent/WO1996028717A1/en
Priority to MXPA/A/1997/006805A priority patent/MXPA97006805A/xx
Priority to NO974156A priority patent/NO974156L/no
Priority to FI973639A priority patent/FI973639A0/fi

Links

Classifications

    • 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
    • G01N33/15—Medicinal preparations ; Physical properties thereof, e.g. dissolubility
    • 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

Definitions

  • This invention relates to a dissolution testing vessel, and in particular to a vessel for testing dissolution of pharmaceutical formulations, particularly buoyant pharmaceutical formulations.
  • formulations may be designed to release an initial "burst" of active ingredient followed by a steady-state release thereafter.
  • a reliable method of assessing dissolution in vivo and consequently analysing the rate of release of active ingredient (s) is required.
  • the mechanical interaction between the means, for example an insert, and the formulation provides a suitable means of mechanical erosion, whether the dosage form is a floating type or sinking type, and therefore mimics the effect of the gastrointestinal tract in vivo .
  • the formulation Unlike the paddle set to surface method described by Burns et al , 1995 ( supra) , there is little tendency for the formulation to stick to the means.
  • a dissolution study was carried out with a floating dosage form, size '0' enteric-coated capsules containing a granule preparation of salmon calcitonin with a potency of 400 iu per capsule.
  • the dissolution medium volume 900 ml, was maintained at 37°C ⁇ 1°C and contained 5.84 g.l" 1 disodium hydrogen orthophosphate, 4.61 g.l "1 potassium dihydrogen orthophosphate, 2.00 g.l 1 sodium cnolate and 1.00 g.l ' sodium deoxycholate adjusted to pH 6.8.
  • 5 ml samples of dissolution medium were removed for analysis.
  • the paddle rotation speed in both cases was 100 rpm.

Landscapes

  • Life Sciences & Earth Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Pathology (AREA)
  • General Physics & Mathematics (AREA)
  • General Health & Medical Sciences (AREA)
  • Biochemistry (AREA)
  • Analytical Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • Food Science & Technology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Medicinal Preparation (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Sampling And Sample Adjustment (AREA)
  • Devices For Use In Laboratory Experiments (AREA)
PCT/GB1996/000493 1995-03-10 1996-03-04 Testing vessel WO1996028717A1 (en)

Priority Applications (7)

Application Number Priority Date Filing Date Title
EP96904938A EP0815427A1 (en) 1995-03-10 1996-03-04 Testing vessel
BR9607230A BR9607230A (pt) 1995-03-10 1996-03-04 Vaso de teste de dissolução e uso do vaso no teste de dissolução de uma formulação farmacêutica
JP8527352A JPH11503517A (ja) 1995-03-10 1996-03-04 試験容器
AU48853/96A AU4885396A (en) 1995-03-10 1996-03-04 Testing vessel
MXPA/A/1997/006805A MXPA97006805A (en) 1995-03-10 1997-09-05 Pru container
NO974156A NO974156L (no) 1995-03-10 1997-09-09 Prövebeholder
FI973639A FI973639A0 (fi) 1995-03-10 1997-09-09 Testausastia

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB9504893.0 1995-03-10
GBGB9504893.0A GB9504893D0 (en) 1995-03-10 1995-03-10 Testing vessel

Publications (1)

Publication Number Publication Date
WO1996028717A1 true WO1996028717A1 (en) 1996-09-19

Family

ID=10771008

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB1996/000493 WO1996028717A1 (en) 1995-03-10 1996-03-04 Testing vessel

Country Status (12)

Country Link
EP (1) EP0815427A1 (fi)
JP (1) JPH11503517A (fi)
KR (1) KR19980702844A (fi)
AU (1) AU4885396A (fi)
BR (1) BR9607230A (fi)
CA (1) CA2214998A1 (fi)
FI (1) FI973639A0 (fi)
GB (1) GB9504893D0 (fi)
IL (1) IL117407A0 (fi)
NO (1) NO974156L (fi)
WO (1) WO1996028717A1 (fi)
ZA (1) ZA961920B (fi)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE19725015A1 (de) * 1997-06-13 1998-12-17 Bayer Ag Sinker zur Bestimmung der Freisetzungsgeschwindigkeit von Wirkstoffen
WO2004055209A1 (en) * 2002-12-16 2004-07-01 Akzo Nobel N.V. Vessel, method and apparatus for dissolution testing of an annular pharmaceutical delivery device
US7357046B2 (en) 2002-12-16 2008-04-15 N. V. Organon Method for dissolution testing of a pharmaceutical delivery device
DE102009042345A1 (de) 2008-10-21 2010-05-12 Levin, Felix, Dr. Testsystem und Verfahren zur schnellen und einfachen Analyse von Substanzen in Flüssikgeiten
DE202008014226U1 (de) 2008-10-21 2010-11-18 Levin, Felix, Dr. Testsystem zur schnellen und einfachen Analyse von Substanzen in Flüssigkeiten

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TW200732644A (en) * 2005-10-25 2007-09-01 Rohm & Haas Dissolution test equipment and methods for testing having improved filtration system
CN109884281B (zh) * 2019-04-12 2023-12-01 中国地质科学院岩溶地质研究所 一种在线监测碳酸盐岩溶蚀的试验装置
JP7390069B1 (ja) * 2022-09-20 2023-12-01 クラシエ株式会社 薬剤の保持具、溶出試験装置、および薬剤の溶出試験方法

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3862042A (en) * 1974-02-27 1975-01-21 Becton Dickinson Co Serum/plasma separator - piston with red-cell trapping surfaces
FR2546628A1 (fr) * 1983-05-27 1984-11-30 Univ Victor Segalen Bordeaux 2 Dispositif pour etudier la liberation-dissolution des medicaments a partir des formes pharmaceutiques pateuses
US4681858A (en) * 1986-06-19 1987-07-21 Warner-Lambert Company Dissolution cell and method for determining the in-vitro release of a drug
US5142920A (en) * 1989-12-20 1992-09-01 Prolabo Dissolution cell and apparatus for determining solids-dissolving kinetics
WO1995004923A1 (en) * 1993-08-06 1995-02-16 Ciba-Geigy Ag 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

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3862042A (en) * 1974-02-27 1975-01-21 Becton Dickinson Co Serum/plasma separator - piston with red-cell trapping surfaces
FR2546628A1 (fr) * 1983-05-27 1984-11-30 Univ Victor Segalen Bordeaux 2 Dispositif pour etudier la liberation-dissolution des medicaments a partir des formes pharmaceutiques pateuses
US4681858A (en) * 1986-06-19 1987-07-21 Warner-Lambert Company Dissolution cell and method for determining the in-vitro release of a drug
US5142920A (en) * 1989-12-20 1992-09-01 Prolabo Dissolution cell and apparatus for determining solids-dissolving kinetics
WO1995004923A1 (en) * 1993-08-06 1995-02-16 Ciba-Geigy Ag 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

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE19725015A1 (de) * 1997-06-13 1998-12-17 Bayer Ag Sinker zur Bestimmung der Freisetzungsgeschwindigkeit von Wirkstoffen
DE19725015C2 (de) * 1997-06-13 2002-02-14 Bayer Ag Sinker zur Bestimmung der Freisetzungsgeschwindigkeit von Wirkstoffen
WO2004055209A1 (en) * 2002-12-16 2004-07-01 Akzo Nobel N.V. Vessel, method and apparatus for dissolution testing of an annular pharmaceutical delivery device
US7357046B2 (en) 2002-12-16 2008-04-15 N. V. Organon Method for dissolution testing of a pharmaceutical delivery device
DE102009042345A1 (de) 2008-10-21 2010-05-12 Levin, Felix, Dr. Testsystem und Verfahren zur schnellen und einfachen Analyse von Substanzen in Flüssikgeiten
DE202008014226U1 (de) 2008-10-21 2010-11-18 Levin, Felix, Dr. Testsystem zur schnellen und einfachen Analyse von Substanzen in Flüssigkeiten

Also Published As

Publication number Publication date
FI973639A (fi) 1997-09-09
CA2214998A1 (en) 1996-09-19
BR9607230A (pt) 1997-11-11
EP0815427A1 (en) 1998-01-07
IL117407A0 (en) 1996-07-23
FI973639A0 (fi) 1997-09-09
AU4885396A (en) 1996-10-02
KR19980702844A (ko) 1998-08-05
MX9706805A (es) 1997-11-29
NO974156D0 (no) 1997-09-09
JPH11503517A (ja) 1999-03-26
ZA961920B (en) 1997-09-08
GB9504893D0 (en) 1995-04-26
NO974156L (no) 1997-09-09

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