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WO1997046860A3 - Improvements in detection systems and methods for predicting the dissolution curve of a drug from a pharmaceutical dosage form - Google Patents

Improvements in detection systems and methods for predicting the dissolution curve of a drug from a pharmaceutical dosage form Download PDF

Info

Publication number
WO1997046860A3
WO1997046860A3 PCT/US1997/011791 US9711791W WO9746860A3 WO 1997046860 A3 WO1997046860 A3 WO 1997046860A3 US 9711791 W US9711791 W US 9711791W WO 9746860 A3 WO9746860 A3 WO 9746860A3
Authority
WO
WIPO (PCT)
Prior art keywords
dissolution
drug
dosage form
predicting
pharmaceutical dosage
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.)
Ceased
Application number
PCT/US1997/011791
Other languages
French (fr)
Other versions
WO1997046860A9 (en
WO1997046860A2 (en
Inventor
Kurt Roinestad
Frank S Cheng
Philip J Palermo
Kevin Bynum
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Euro Celtique SA
Original Assignee
Euro Celtique SA
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 Euro Celtique SA filed Critical Euro Celtique SA
Priority to JP1998500947A priority Critical patent/JP3380864B6/en
Priority to CA002257106A priority patent/CA2257106C/en
Priority to EP97941329A priority patent/EP0938657A4/en
Priority to AU43262/97A priority patent/AU729814B2/en
Priority to US08/915,785 priority patent/US6174497B1/en
Publication of WO1997046860A2 publication Critical patent/WO1997046860A2/en
Publication of WO1997046860A3 publication Critical patent/WO1997046860A3/en
Publication of WO1997046860A9 publication Critical patent/WO1997046860A9/en
Anticipated expiration legal-status Critical
Priority to US09/707,498 priority patent/US6558957B1/en
Ceased legal-status Critical Current

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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Immunology (AREA)
  • Pathology (AREA)
  • Physics & Mathematics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Food Science & Technology (AREA)
  • Medicinal Chemistry (AREA)
  • Investigating, Analyzing Materials By Fluorescence Or Luminescence (AREA)
  • Investigating Or Analysing Materials By Optical Means (AREA)
  • Medicinal Preparation (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

The present invention relates to an improvement in a detection system used for continuously measuring the release of a drug from a pharmaceutical dosage form comprising a singular dissolution vessel or multiple dissolution vessels containing a dissolution medium and a measuring device for detecting the amount of drug released at a given time, the improvement comprising a mixing shaft and a probe placed within the mixing shaft or outside the individual dissolution vessels, the probe capable of measuring the dissolution characteristics using UV, IR, near-IR, fluorescence, electrochemical, and Raman spectroscopy techniques. The present invention also relates to a method for predicting the dissolution curve provided by a controlled release pharmaceutical dosage form comprising taking continuous measurements of the amount of drug released from a dosage form for a portion of the time over which the drug is expected to be released and predicting the remainder of the dissolution curve based on the values obtained.
PCT/US1997/011791 1996-06-04 1997-06-04 Improvements in detection systems and methods for predicting the dissolution curve of a drug from a pharmaceutical dosage form Ceased WO1997046860A2 (en)

Priority Applications (6)

Application Number Priority Date Filing Date Title
JP1998500947A JP3380864B6 (en) 1996-06-04 1997-06-04 Improvements in detection systems and methods for predicting dissolution curves of drugs from pharmaceutical formulations
CA002257106A CA2257106C (en) 1996-06-04 1997-06-04 Improvements in detection systems and methods for predicting the dissolution curve of a drug from a pharmaceutical dosage form
EP97941329A EP0938657A4 (en) 1996-06-04 1997-06-04 Improvements in detection systems and methods for predicting the dissolution curve of a drug from a pharmaceutical dosage form
AU43262/97A AU729814B2 (en) 1996-06-04 1997-06-04 Improvements in detection systems and methods for predicting the dissolution curve of a drug from a pharmaceutical dosage form
US08/915,785 US6174497B1 (en) 1997-06-04 1997-08-21 Detection systems and methods for predicting the dissolution curve of a drug from a pharmaceutical dosage form
US09/707,498 US6558957B1 (en) 1996-06-04 2000-11-07 Detection systems and methods for predicting the dissolution curve of a drug from a pharmaceutical dosage form

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US1894496P 1996-06-04 1996-06-04
US60/018,944 1996-06-04

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US08/915,785 Continuation US6174497B1 (en) 1996-06-04 1997-08-21 Detection systems and methods for predicting the dissolution curve of a drug from a pharmaceutical dosage form

Publications (3)

Publication Number Publication Date
WO1997046860A2 WO1997046860A2 (en) 1997-12-11
WO1997046860A3 true WO1997046860A3 (en) 1998-02-19
WO1997046860A9 WO1997046860A9 (en) 1998-04-23

Family

ID=21790557

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1997/011791 Ceased WO1997046860A2 (en) 1996-06-04 1997-06-04 Improvements in detection systems and methods for predicting the dissolution curve of a drug from a pharmaceutical dosage form

Country Status (4)

Country Link
EP (1) EP0938657A4 (en)
AU (1) AU729814B2 (en)
CA (1) CA2257106C (en)
WO (1) WO1997046860A2 (en)

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9884025B2 (en) 2000-11-15 2018-02-06 Aptalis Pharma S.R.L. Microspheres of pancreatic enzymes with high stability and production method thereof
US9976171B2 (en) 2011-08-08 2018-05-22 Allergan Pharmaceuticals International Limited Method for dissolution testing of solid compositions containing digestive enzymes
US10087493B2 (en) 2008-03-07 2018-10-02 Aptalis Pharma Canada Ulc Method for detecting infectious parvovirus in pharmaceutical preparations
US10184121B2 (en) 2013-06-28 2019-01-22 Allergan Pharmaceuticals International Limited Methods for removing viral contaminants from pancreatic extracts
US10993996B2 (en) 2013-08-09 2021-05-04 Allergan Pharmaceuticals International Limited Digestive enzyme composition suitable for enteral administration
US11364205B2 (en) 2010-10-01 2022-06-21 Societe Des Produits Nestle S.A. Stable low digestive enzyme content formulation

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001016582A1 (en) * 1999-08-30 2001-03-08 Euro-Celtique S.A. In situ methods for measuring the release of a substance from a dosage form
SE0000522D0 (en) * 2000-02-17 2000-02-17 Astrazeneca Ab Mixing apparatus
US7470545B2 (en) * 2001-11-05 2008-12-30 Rohm And Haas Company Buccal dissolution of active substances
EP2079445B1 (en) 2007-02-20 2015-11-04 Aptalis Pharma Limited Stable digestive enzyme compositions
FI127992B (en) 2014-08-29 2019-07-15 Svanbaeck Sami Procedure and systems for determining dissolution properties of a substance
GB2550539A (en) 2016-03-21 2017-11-29 Res Center Pharmaceutical Engineering Gmbh Monitoring dissolution of a dosage form in progress during dissolution by low coherence interferometry
CN117783459B (en) * 2024-02-28 2024-05-07 沈阳科惠生物医药科技有限公司 Drug dissolution curve determination method and system

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4335438A (en) * 1980-04-17 1982-06-15 Smolen Victor F Method and apparatus for automatic dissolution testing of products
US5133892A (en) * 1990-10-17 1992-07-28 Lever Brothers Company, Division Of Conopco, Inc. Machine dishwashing detergent tablets
US5142920A (en) * 1989-12-20 1992-09-01 Prolabo Dissolution cell and apparatus for determining solids-dissolving kinetics
US5589649A (en) * 1994-02-25 1996-12-31 Distek, Inc. Dissolution testing apparatus

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4335438A (en) * 1980-04-17 1982-06-15 Smolen Victor F Method and apparatus for automatic dissolution testing of products
US5142920A (en) * 1989-12-20 1992-09-01 Prolabo Dissolution cell and apparatus for determining solids-dissolving kinetics
US5133892A (en) * 1990-10-17 1992-07-28 Lever Brothers Company, Division Of Conopco, Inc. Machine dishwashing detergent tablets
US5589649A (en) * 1994-02-25 1996-12-31 Distek, Inc. Dissolution testing apparatus

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9884025B2 (en) 2000-11-15 2018-02-06 Aptalis Pharma S.R.L. Microspheres of pancreatic enzymes with high stability and production method thereof
US10087493B2 (en) 2008-03-07 2018-10-02 Aptalis Pharma Canada Ulc Method for detecting infectious parvovirus in pharmaceutical preparations
US11364205B2 (en) 2010-10-01 2022-06-21 Societe Des Produits Nestle S.A. Stable low digestive enzyme content formulation
US9976171B2 (en) 2011-08-08 2018-05-22 Allergan Pharmaceuticals International Limited Method for dissolution testing of solid compositions containing digestive enzymes
US10184121B2 (en) 2013-06-28 2019-01-22 Allergan Pharmaceuticals International Limited Methods for removing viral contaminants from pancreatic extracts
US10993996B2 (en) 2013-08-09 2021-05-04 Allergan Pharmaceuticals International Limited Digestive enzyme composition suitable for enteral administration

Also Published As

Publication number Publication date
JPH11514088A (en) 1999-11-30
AU729814B2 (en) 2001-02-08
CA2257106A1 (en) 1997-12-11
CA2257106C (en) 2002-04-23
AU4326297A (en) 1998-01-05
JP3380864B2 (en) 2003-02-24
EP0938657A4 (en) 1999-10-27
EP0938657A2 (en) 1999-09-01
WO1997046860A2 (en) 1997-12-11

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