Investigations on the sustained release of fenoldopam from film coated pellets for an oral dosage form:
Gespeichert in:
| 1. Verfasser: | |
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| Format: | Abschlussarbeit Buch |
| Sprache: | English |
| Veröffentlicht: |
1996
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| Schlagworte: | |
| Online-Zugang: | Inhaltsverzeichnis |
| Beschreibung: | [6], 230 S. Ill., graph. Darst. |
Internformat
MARC
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| 100 | 1 | |a Ziegler, Iris |d 1966- |e Verfasser |0 (DE-588)115663983 |4 aut | |
| 245 | 1 | 0 | |a Investigations on the sustained release of fenoldopam from film coated pellets for an oral dosage form |c von Iris Ziegler |
| 264 | 1 | |c 1996 | |
| 300 | |a [6], 230 S. |b Ill., graph. Darst. | ||
| 336 | |b txt |2 rdacontent | ||
| 337 | |b n |2 rdamedia | ||
| 338 | |b nc |2 rdacarrier | ||
| 502 | |a München, Univ., Diss., 1996 | ||
| 650 | 0 | 7 | |a Kontrollierte Wirkstofffreisetzung |0 (DE-588)4165181-9 |2 gnd |9 rswk-swf |
| 650 | 0 | 7 | |a Orale Applikation |0 (DE-588)4202348-8 |2 gnd |9 rswk-swf |
| 650 | 0 | 7 | |a Gefäßerweiterndes Mittel |0 (DE-588)4071630-2 |2 gnd |9 rswk-swf |
| 650 | 0 | 7 | |a Fenoldopam |0 (DE-588)4491865-3 |2 gnd |9 rswk-swf |
| 655 | 7 | |0 (DE-588)4113937-9 |a Hochschulschrift |2 gnd-content | |
| 689 | 0 | 0 | |a Fenoldopam |0 (DE-588)4491865-3 |D s |
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Datensatz im Suchindex
| _version_ | 1804125818297778176 |
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| adam_text | INVESTIGATIONS ON THE SUSTAINED RELEASE OF FENOLDOPAM FROM FILM COATED
PELLETS FOR AN ORAL DOSAGE FORM DISSERTATION ZUR ERLANGUNG DES
DOKTORGRADES DER FAKULTAT FUR CHEMIE UND PHARMAZIE DER
LUDWIG-MAXIMILIANS-UNIVERSITAT MIINCHEN VORGELEGT VON IRIS ZIEGLER AUS
AUGSBURG MUNCHEN 1996 INVESTIGATIONS ON THE SUSTAINED RELEASE OF
FENOLDOPAM FROM FILM COATED PELLETS FOR AN ORAL DOSAGE FORM TABLE OF
CONTENTS A INTRODUCTION 1 I. FENOLDOPAM - AN ORALLY BIOAVAILABLE
DOPAMINE (DAI) AGONIST 1 II. PROPOSAL 2 B RESULTS 5 I. DEVELOPMENT AND
VALIDATION OF AN AUTOMATED FLOW-THROUGH DISSOLUTION SYSTEM 5 1.
FENOLDOPAM - ITS PROBLEMS IN SOLUBILITY AND STABILITY 6 2. WORKING
PRINCIPLE OF THE FLOW-THROUGH DISSOLUTION SYSTEM 8 3. STABILITY AND
DISSOLUTION RATES OF FENOLDOPAM IN DEPENDENCE OF PH AND 9 FLOW RATE OF
DISSOLUTION MEDIA 4. COMPARISON OF DISSOLUTION RATES OF UNCOATED AND
COATED PELLETS WITH 10 THOSE OBTAINED BY THE MODIFIED USP BASKET METHOD
5. QUANTIFICATION OF RELEASED FENOLDOPAM BY HPLC-UV OR SIMPLE 12
UV-SPECTROSCOPY 6. AUTOMATED FLOW-THROUGH DISSOLUTION TESTING SYSTEM AS
A 6-CHANNEL 12 WORK STATION 6.1. WORKING PRINCIPLE OF THE AUTOMATED
FLOW-THROUGH DISSOLUTION SYSTEM 15 6.2 VALIDATION OF THE AUTOMATED
SYSTEM USING A TEST BATCH OF COATED 18 FENOLDOPAM PELLETS 6.2.1.
DETERMINATION OF THE INTER-CHANNEL AND RUN TO RUN PRECISION 18 6.2.2.
INFLUENCE OF MECHANICAL STRESS ON DISSOLUTION RATES 21 6.2.3. INFLUENCE
OF THE SAMPLE WEIGHT ON DISSOLUTION RATES 22 6.2.4. INFLUENCE OF FLOW
RATES AND FILLING VOLUME OF DISSOLUTION CELLS ON 23 FENOLDOPAM RELEASE
6.2.5. STATISTICAL EVALUATION OF SIGNIFICANT DIFFERENCES OF THE RELEASE
RATES 24 CAUSED BY THE INVESTIGATED PARAMETERS 7. DISSOLUTION TESTING OF
SUSTAINED RELEASE RIBOFLAVIN AND THEOPHYLLINE 25 PELLETS IN THE NOVEL
FLOW-THROUGH SYSTEM 8. DISCUSSION 26 II. OPTIMISING THE FORMULATION AND
PROCESSING PARAMETERS FOR PELLETS WITH 31 FENOLDOPAM AND ORGANIC ACIDS
1. PELLET FORMULATIONS CONSISTING OF FENOLDOPAM MESYLATE AND ORGANIC 32
ACIDS (0-80%) 1.1. ORGANIC ACIDS AS PH-ADJ USTERS 3 3 1.2. SOLUBILITY AT
DIFFERENT PH-VALUES 33 1.3. PH-VALUES OF AQUEOUS SOLUTIONS 34 1.4.
PARTICLE SIZE OF BULK SUBSTANCE 34 2. MAXIMISING THE YIELD BY THE
INCORPORATION OF SODIUM LAURYL SULPHATE 36 3. REDUCING THE FRIABILITY OF
PELLETS BY THE ADDITION OF A SUITABLE BINDER 37 4. ADJUSTING THE WATER
CONTENT FOR DIFFERENT ORGANIC ACIDS 42 5. OPTIMISING EACH STEP OF THE
PELLETIZATION PROCESS 44 5.1. DRY POWDER MIXING 44 5.2. WET GRANULATION
45 5.3. EXTRUSION 46 5.4. SPHERONIZATION 46 5.4.1. SPHERONIZER LOAD 46
5.4.2. SPHERONIZATION TIME 47 5.4.3. SPHERONIZER SPEED 48 6. WATER AND
DRUG CONTENTS OF EXTRUDATE, SPHERES AND DIFFERENT SIEVE 49 FRACTIONS 7.
STABILITY OF FENOLDOPAM IN PELLETS DURING PELLETIZATION AND AFTER
STORAGE 53 AT ROOM TEMPERATURE 8. DISCUSSION 53 III SUSTAINED RELEASE OF
FENOLDOPAM FROM FILM COATED PELLETS CONTAINING 62 FENOLDOPAM MESYLATE
AND SUCCINIC ACID AT EQUAL PARTS 1. AQUEOUS POLYMER DISPERSIONS FOR
SUSTAINED RELEASE APPLICATIONS 62 1.1. DETERMINATION OF THE KINEMATIC
VISCOSITY OF POLYMER DISPERSIONS WITH 64 OR WITHOUT PLASTICIZER 1.2.
LASER DIFFRACTION MEASUREMENTS OF THE PARTICLE SIZE OF FILM DISPERSIONS
66 1.3. DETERMINATION OF THE GLASS TRANSITION TEMPERATURES (T G ) OF
FREE FILMS BY 66 ^.DIFFERENTIAL SCANNING CALORIMETRY (DSC) AND
THERMOMECHANICAL ANALYSIS (TMA) 2. DIFFUSION CONTROLLED DRUG RELEASE
THROUGH INSOLUBLE POLYMERS 67 2.1. DRUG RELEASE AND RELEASE PROFILES
WITH RESPECT TO COATING LEVELS 67 2.2. STORAGE STABILITY OF BATCHES AT
ROOM TEMPERATURE 68 3. FENOLDOPAM RELEASE FROM INSOLUBLE POLYMERS,
CONTAINING SOLUBLE PORE 69 FORMERS 3.1. SOLUBLE POLYMERS AS PORE FORMERS
- HPMC, PULLULAN 69 3.2. ENTERIC POLYMERS AS PH-DEPENDENT PORE FORMERS
(EUDRAGIT L-55, 70 EUDRAGIT L/S, AQUOT HF) 3.3. STORAGE STABILITY OF
BATCHES AT ROOM TEMPERATURE 71 4. LOWERING THE DISSOLUTION RATE OF
SUCCINIC ACID BY COATING THE BULK 72 MATERIAL PRIOR TO PELLETIZATION 5.
THE INFLUENCE OF THE PARTICLE SIZE OF SUCCINIC ACID ON FENOLDOPAM 73
RELEASE FROM COATED PELLETS 6. INFLUENCE OF THE PLASTICIZER AMOUNT AND
CURING TEMPERATURE ON 74 FENOLDOPAM RELEASE 7. DEPENDENCE OF FENOLDOPAM
DISSOLUTION ON THE PH-VALUE AND IONIC 75 STRENGTH OF DISSOLUTION MEDIA
8. INVESTIGATION OF FENOLDOPAM RELEASE FOR DIFFERENT PH-ADJUSTERS 75 9.
DISCUSSION 76 IV. A SIMPLE HPLC METHOD FOR THE QUANTIFICATION OF
SUCCINIC ACID AND FENOLDOPAM 83 IN DISSOLUTION MEDIA 1. A SIMPLE, NON
ION-PAIR HPLC METHOD WITH MULTIPLE-WAVELENGTH 83 DETECTION AND
COMPUTERISED QUANTIFICATION 2. METHOD VALIDATION FOR THE QUANTITATIVE
ANALYSIS OF SUCCINIC ACID AND 87 FENOLDOPAM 2.1. LINEARITY AND RANGE OF
LINEARITY 87 2.2. PRECISION 89 2.3. SELECTIVITY 89 2.4. ACCURACY 90 3.
QUANTIFICATION OF DISSOLVED FUMARIC ACID BY THE SAME HPLC-METHOD 91 4.
DISCUSSION 92 V. THE PH-INDEPENDENT RELEASE OF FENOLDOPAM FROM PELLETS
WITH INSOLUBLE FILM 95 COATS 1. THE IMPORTANCE OF THE RATIO OF SUCCINIC
ACID TO FENOLDOPAM FOR THE 96 RELEASE OF FENOLDOPAM 2. INVESTIGATION OF
EXTREMELY LOW COATING LEVELS FOR HIGH SUCCINIC ACID TO 99 DRUG RATIOS
AND SURELEASE COATS 3. COMPARISON OF SURELEASE AND CELLULOSEACETATE
COATS FOR HIGH SUCCINIC 103 ACID TO DRUG RATIOS 4. DETERMINATION OF THE
KINETICS OF FENOLDOPAM RELEASE 105 5. COMPARISON OF DISSOLUTION RATES IN
SGF PH 1.2 AND SEF PH 7.5 109 6. STORAGE STABILITY OF SURELEASE AND
CELLULOSEACETATE BATCHES AT ROOM 111 TEMPERATURE 7. DISCUSSION 112 8.
THE RELEASE OF SUCCINIC ACID FROM PELLETS WITH HIGH SUCCINIC ACID TO 117
DRUG RATIOS 8.1. DETERMINATION OF RELEASE RATES AND PROFILES FOR VARIOUS
RATIOS 118 8.2. SCANNING ELECTRON MICROSCOPY (SEM) INVESTIGATIONS OF
PELLETS WITH 120 A HIGH SUCCINIC ACID TO DRUG RATIO AND A 2.5% W/W
SURELEASE COAT 8.3. CALCULATION OF THE RATIOS BETWEEN THE RELEASE RATES
OF SUCCINIC ACID 122 AND FENOLDOPAM 8.4. CALCULATION FOR DIFFERENT
DISSOLUTION MEDIA 124 9. COMPARISON OF FENOLDOPAM RELEASE RATES AT A 5:1
RATIO AND A 2.5% 125 COATING LEVEL FOR DIFFERENT SYSTEMS 10. DISCUSSION
127 VI. INVESTIGATIONS ON THE INFLUENCE OF THE EXTRUSION METHOD ON THE
EXTRUSION 132 BEHAVIOUR OF FORMULATIONS AND THE QUALITY OF PELLETS 1.
THE DIFFERENT EXTRUDER TYPES AND THEIR WORKING PRINCIPLES 133 1.1. THE
ALEXANDERWERK GA 65 - A ROTARY CYLINDER EXTRUDER 133 1.2. THE NICA - A
RADIAL SCREW EXTRUDER 134 1.3. THE GABLER - AN AXIAL SINGLE SCREW
EXTRUDER 136 1.4. THE RAM EXTRUDER . 138 2. THE DIFFERENT FORMULATIONS
139 2.1. AVICELPH 101+WATER 139 2.2. AVICEL PH 101 + LACTOSE EP 80 +
WATER 139 2.3. AVICEL PH 101 + MANNITOL + WATER 139 2.4. AVICEL PH 101 +
SUCCINIC ACID + WATER 139 2.5. AVICEL PH 101 + FENOLDOPAM MESYLATE +
SUCCINIC ACID + WATER 140 2.6. AVICEL CL 611 + AVICEL RC 591 + LACTOSE
EP 80 + WATER 140 3. EVALUATION OF THE EXTRUSION BEHAVIOUR 140 3.1. EASE
OF EXTRUSION AND QUALITY OF THE EXTRUDATE 140 3.2. LOSS OF WATER DURING
EXTRUSION-SPHERONIZATION 144 3.3. FORCE-DISPLACEMENT PROFILES FOR THE
RAM EXTRUDER 146 4. EVALUATION OF SPHERE QUALITY 148 4.1. ORGANOLEPTICAL
EVALUATION OF PELLET SPHERICITY 148 4.2. COMPARISON OF PELLET SIZE AND %
YIELD BETWEEN 710 AND 1250 URN 153 4.3. BULK DENSITY AND TRUE DENSITY
157 4.4. SPECIFIC SURFACE AREA 160 4.5. FRIABILITY 160 4.6. HAUSNER
FACTOR 161 5. THE INFLUENCE OF EXTRUSION SPEED ON THE QUALITY OF
EXTRUDATES AND 161 SPHERES 6. DISCUSSION 162 C MATERIALS AND METHODS 171
D SUMMARY 211 E LITERATURE 217
|
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| author | Ziegler, Iris 1966- |
| author_GND | (DE-588)115663983 |
| author_facet | Ziegler, Iris 1966- |
| author_role | aut |
| author_sort | Ziegler, Iris 1966- |
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| bvnumber | BV011311378 |
| ctrlnum | (OCoLC)214927098 (DE-599)BVBBV011311378 |
| format | Thesis Book |
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| genre | (DE-588)4113937-9 Hochschulschrift gnd-content |
| genre_facet | Hochschulschrift |
| id | DE-604.BV011311378 |
| illustrated | Illustrated |
| indexdate | 2024-07-09T18:07:36Z |
| institution | BVB |
| language | English |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-007598519 |
| oclc_num | 214927098 |
| open_access_boolean | |
| owner | DE-19 DE-BY-UBM DE-29T DE-12 DE-355 DE-BY-UBR DE-11 DE-188 |
| owner_facet | DE-19 DE-BY-UBM DE-29T DE-12 DE-355 DE-BY-UBR DE-11 DE-188 |
| physical | [6], 230 S. Ill., graph. Darst. |
| publishDate | 1996 |
| publishDateSearch | 1996 |
| publishDateSort | 1996 |
| record_format | marc |
| spelling | Ziegler, Iris 1966- Verfasser (DE-588)115663983 aut Investigations on the sustained release of fenoldopam from film coated pellets for an oral dosage form von Iris Ziegler 1996 [6], 230 S. Ill., graph. Darst. txt rdacontent n rdamedia nc rdacarrier München, Univ., Diss., 1996 Kontrollierte Wirkstofffreisetzung (DE-588)4165181-9 gnd rswk-swf Orale Applikation (DE-588)4202348-8 gnd rswk-swf Gefäßerweiterndes Mittel (DE-588)4071630-2 gnd rswk-swf Fenoldopam (DE-588)4491865-3 gnd rswk-swf (DE-588)4113937-9 Hochschulschrift gnd-content Fenoldopam (DE-588)4491865-3 s Gefäßerweiterndes Mittel (DE-588)4071630-2 s Kontrollierte Wirkstofffreisetzung (DE-588)4165181-9 s Orale Applikation (DE-588)4202348-8 s DE-604 GBV Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=007598519&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Ziegler, Iris 1966- Investigations on the sustained release of fenoldopam from film coated pellets for an oral dosage form Kontrollierte Wirkstofffreisetzung (DE-588)4165181-9 gnd Orale Applikation (DE-588)4202348-8 gnd Gefäßerweiterndes Mittel (DE-588)4071630-2 gnd Fenoldopam (DE-588)4491865-3 gnd |
| subject_GND | (DE-588)4165181-9 (DE-588)4202348-8 (DE-588)4071630-2 (DE-588)4491865-3 (DE-588)4113937-9 |
| title | Investigations on the sustained release of fenoldopam from film coated pellets for an oral dosage form |
| title_auth | Investigations on the sustained release of fenoldopam from film coated pellets for an oral dosage form |
| title_exact_search | Investigations on the sustained release of fenoldopam from film coated pellets for an oral dosage form |
| title_full | Investigations on the sustained release of fenoldopam from film coated pellets for an oral dosage form von Iris Ziegler |
| title_fullStr | Investigations on the sustained release of fenoldopam from film coated pellets for an oral dosage form von Iris Ziegler |
| title_full_unstemmed | Investigations on the sustained release of fenoldopam from film coated pellets for an oral dosage form von Iris Ziegler |
| title_short | Investigations on the sustained release of fenoldopam from film coated pellets for an oral dosage form |
| title_sort | investigations on the sustained release of fenoldopam from film coated pellets for an oral dosage form |
| topic | Kontrollierte Wirkstofffreisetzung (DE-588)4165181-9 gnd Orale Applikation (DE-588)4202348-8 gnd Gefäßerweiterndes Mittel (DE-588)4071630-2 gnd Fenoldopam (DE-588)4491865-3 gnd |
| topic_facet | Kontrollierte Wirkstofffreisetzung Orale Applikation Gefäßerweiterndes Mittel Fenoldopam Hochschulschrift |
| url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=007598519&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
| work_keys_str_mv | AT ziegleriris investigationsonthesustainedreleaseoffenoldopamfromfilmcoatedpelletsforanoraldosageform |