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

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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
Application number
PCT/US1997/011791
Other languages
French (fr)
Other versions
WO1997046860A2 (en
WO1997046860A9 (en
Inventor
Kurt Roinestad
Frank S Cheng
Philip J Palermo
Kevin Bynum
Original Assignee
Euro Celtique Sa
Kurt Roinestad
Frank S Cheng
Philip J Palermo
Kevin Bynum
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, Kurt Roinestad, Frank S Cheng, Philip J Palermo, Kevin Bynum filed Critical Euro Celtique Sa
Priority to AU43262/97A priority Critical patent/AU729814B2/en
Priority to CA002257106A priority patent/CA2257106C/en
Priority to EP97941329A priority patent/EP0938657A4/en
Priority to JP1998500947A priority patent/JP3380864B6/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
Priority to US09/707,498 priority patent/US6558957B1/en

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

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 WO1997046860A2 (en)

Priority Applications (6)

Application Number Priority Date Filing Date Title
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
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
JP1998500947A JP3380864B6 (en) 1996-06-04 1997-06-04 Improvements in detection systems and methods for predicting dissolution curves of drugs from pharmaceutical formulations
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 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)

Families Citing this family (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1210583A4 (en) * 1999-08-30 2004-08-11 Delphian Technology Inc 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
IT1319655B1 (en) 2000-11-15 2003-10-23 Eurand Int PANCREATIC ENZYME MICROSPHERES WITH HIGH STABILITY AND RELATIVE PREPARATION METHOD.
US7470545B2 (en) * 2001-11-05 2008-12-30 Rohm And Haas Company Buccal dissolution of active substances
MY163469A (en) 2007-02-20 2017-09-15 Allergan Therapeutics LLC Stable digestive enzyme compositions
WO2009109856A2 (en) 2008-03-07 2009-09-11 Axcan Pharma Inc. Method for detecting infectious parvovirus in pharmaceutical preparations
PL2621476T5 (en) 2010-10-01 2022-06-06 Société des Produits Nestlé S.A. Enteric coated, low-strength pancrelipase formulations
RU2016119726A (en) 2011-08-08 2018-11-02 Апталис Фарма Лтд. The method of conducting a test for the dissolution of solid compositions containing digestive enzymes
AU2014306222A1 (en) 2013-08-09 2016-02-18 Aptalis Pharma Ltd. Digestive enzyme composition suitable for enteral administration
EP3157568A1 (en) 2014-06-19 2017-04-26 Aptalis Pharma Limited Methods for removing viral contaminants from pancreatic extracts
FI127992B (en) * 2014-08-29 2019-07-15 Svanbaeck Sami Method and system for determining dissolution properties of matter
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
CN117783459A (en) * 2024-02-28 2024-03-29 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

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP0938657A4 *

Also Published As

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

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