CA2257106C - Ameliorations apportees a des systemes de detection et a des procedes de prediction de la courbe de dissolution d'un medicament d'une forme galenique pharmaceutique - Google Patents
Ameliorations apportees a des systemes de detection et a des procedes de prediction de la courbe de dissolution d'un medicament d'une forme galenique pharmaceutique Download PDFInfo
- Publication number
- CA2257106C CA2257106C CA002257106A CA2257106A CA2257106C CA 2257106 C CA2257106 C CA 2257106C CA 002257106 A CA002257106 A CA 002257106A CA 2257106 A CA2257106 A CA 2257106A CA 2257106 C CA2257106 C CA 2257106C
- Authority
- CA
- Canada
- Prior art keywords
- dissolution
- dosage form
- fiber optic
- active agent
- processor
- 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.)
- Expired - Fee Related
Links
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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
La présente invention concerne une amélioration apportée à un système de détection utilisé pour mesurer en continu la libération d'un médicament d'une forme galénique pharmaceutique. Ce système comprend un récipient unique ou plusieurs récipients de dissolution contenant un milieu de dissolution, et un dispositif de mesure servant à détecter la quantité de médicament libéré à un moment donné. Ce système amélioré comprend une tige de mélange et une sonde placée dans la tige de mélange ou à l'extérieur des récipients de dissolution, la sonde pouvant mesurer les caractéristiques de dissolution selon des techniques de spectroscopie aux ultraviolets, aux infrarouges, aux infrarouges proches, à fluorescence, électroniques et Raman. La présente invention concerne également un procédé de prédiction de la courbe de dissolution obtenue par une forme galénique pharmaceutique régulée, ce procédé consistant à prendre des mesures en continu de la dose de médicament libéré d'une forme galénique sur une durée pendant laquelle il est prévu que le médicament se libère, et à calculer le reste de la courbe de dissolution en fonction des valeurs obtenues.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US1894496P | 1996-06-04 | 1996-06-04 | |
| US60/018,944 | 1996-06-04 | ||
| PCT/US1997/011791 WO1997046860A2 (fr) | 1996-06-04 | 1997-06-04 | Ameliorations apportees a des systemes de detection et a des procedes de prediction de la courbe de dissolution d'un medicament d'une forme galenique pharmaceutique |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2257106A1 CA2257106A1 (fr) | 1997-12-11 |
| CA2257106C true CA2257106C (fr) | 2002-04-23 |
Family
ID=21790557
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002257106A Expired - Fee Related CA2257106C (fr) | 1996-06-04 | 1997-06-04 | Ameliorations apportees a des systemes de detection et a des procedes de prediction de la courbe de dissolution d'un medicament d'une forme galenique pharmaceutique |
Country Status (4)
| Country | Link |
|---|---|
| EP (1) | EP0938657A4 (fr) |
| AU (1) | AU729814B2 (fr) |
| CA (1) | CA2257106C (fr) |
| WO (1) | WO1997046860A2 (fr) |
Families Citing this family (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1210583A4 (fr) * | 1999-08-30 | 2004-08-11 | Delphian Technology Inc | Procedes in situ de mesure de la liberation d'une substance a partir d'une forme posologique |
| SE0000522D0 (sv) * | 2000-02-17 | 2000-02-17 | Astrazeneca Ab | Mixing apparatus |
| IT1319655B1 (it) | 2000-11-15 | 2003-10-23 | Eurand Int | Microsfere di enzimi pancreatici con elevata stabilita' e relativometodo di preparazione. |
| US7470545B2 (en) * | 2001-11-05 | 2008-12-30 | Rohm And Haas Company | Buccal dissolution of active substances |
| SG186648A1 (en) | 2007-02-20 | 2013-01-30 | Aptalis Pharma Ltd | Stable digestive enzyme compositions |
| US10087493B2 (en) | 2008-03-07 | 2018-10-02 | Aptalis Pharma Canada Ulc | Method for detecting infectious parvovirus in pharmaceutical preparations |
| UA111726C2 (uk) | 2010-10-01 | 2016-06-10 | Апталіс Фарма Лімітед | Препарат панкреліпази низької сили з кишковорозчинним покриттям |
| EP2741766B1 (fr) | 2011-08-08 | 2015-10-07 | Aptalis Pharma Limited | Procédé de test de dissolution de compositions solides contenant des enzymes digestives |
| US10993996B2 (en) | 2013-08-09 | 2021-05-04 | Allergan Pharmaceuticals International Limited | Digestive enzyme composition suitable for enteral administration |
| CA2947998A1 (fr) | 2014-06-19 | 2015-12-23 | Aptalis Pharma Ltd. | Procedes d'elimination de contaminants viraux dans des extraits pancreatiques |
| FI127992B (fi) | 2014-08-29 | 2019-07-15 | Svanbaeck Sami | Menetelmä ja järjestelmä aineen liukenemisominaisuuksien määrittämiseksi |
| 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 (zh) * | 2024-02-28 | 2024-05-07 | 沈阳科惠生物医药科技有限公司 | 一种药物的溶出曲线测定方法及系统 |
Family Cites Families (4)
| 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 |
| FR2655874B1 (fr) * | 1989-12-20 | 1992-03-13 | Prolabo Sa | Cellule de dissolution pour solides et appareil d'etude de la cinetique de dissolution la comportant. |
| US5133892A (en) * | 1990-10-17 | 1992-07-28 | Lever Brothers Company, Division Of Conopco, Inc. | Machine dishwashing detergent tablets |
| CA2161224C (fr) * | 1994-02-25 | 1999-02-02 | Gerald Brinker | Appareil pour mesurer la dissolution |
-
1997
- 1997-06-04 WO PCT/US1997/011791 patent/WO1997046860A2/fr active Application Filing
- 1997-06-04 CA CA002257106A patent/CA2257106C/fr not_active Expired - Fee Related
- 1997-06-04 EP EP97941329A patent/EP0938657A4/fr not_active Withdrawn
- 1997-06-04 AU AU43262/97A patent/AU729814B2/en not_active Ceased
Also Published As
| Publication number | Publication date |
|---|---|
| EP0938657A4 (fr) | 1999-10-27 |
| AU4326297A (en) | 1998-01-05 |
| AU729814B2 (en) | 2001-02-08 |
| CA2257106A1 (fr) | 1997-12-11 |
| JPH11514088A (ja) | 1999-11-30 |
| WO1997046860A3 (fr) | 1998-02-19 |
| WO1997046860A2 (fr) | 1997-12-11 |
| EP0938657A2 (fr) | 1999-09-01 |
| JP3380864B2 (ja) | 2003-02-24 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request | ||
| MKLA | Lapsed |