Biorelevant dissolution test methods for modified release dosage forms:
Saved in:
| Main Author: | |
|---|---|
| Format: | Thesis Book |
| Language: | English |
| Published: |
Aachen
Shaker
2005
|
| Series: | Berichte aus der Pharmazie
|
| Subjects: | |
| Online Access: | Inhaltsverzeichnis |
| Physical Description: | XXIV, 312 S. Ill., graph. Darst. |
| ISBN: | 3832242767 |
Staff View
MARC
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Record in the Search Index
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| adam_text | IMAGE 1
BERICHTE AUS DER PHARMAZIE
SANDRA KLEIN
BIORELEVANT DISSOLUTION TEST METHODS FOR MODIFIED RELEASE DOSAGE FORMS
SHAKER VERLAG AACHEN 2005
IMAGE 2
TABLE OF CONTENTS
TABLE OF CONTENTS
TABLE OF CONTENTS I
LIST OF FIGURES V
LIST OF TABLES XIII
ABBREVIATIONS XXI
1 INTRODUCTION 1
1.1 ORAL MODIFIED-RELEASE (MR) DOSAGE FORMS 1
1.2 RELEVANT ANATOMY OF THE GASTROINTESTINAL TRACT 7
1.3 RELEVANT PHYSIOLOGY OF THE GASTROINTESTINAL TRACT 10
1.3.1 UPPER GL TRACT: STOMACH 11
1.3.2 UPPER GL TRACT: SMALL INTESTINE 25
1.3.3 COLON 37
1.4 DISSOLUTION METHODS FOR MODIFIED-RELEASE DOSAGE FORMS 42
1.4.1 DRUG DISSOLUTION AND BIOAVAILABILITY 42
1.4.2 OFFICIAL TEST METHODS 45
1.4.3 OBJECTIVES FOR IMPROVING THE BIORELEVANCE OF DISSOLUTION
METHODS... 48
1.4.4 USP APPARATUS 3 50
1.5 BIORELEVANT DISSOLUTION MEDIA 55
7.5./ MEDIA TO SIMULATE GASTRIC CONDITIONS IN THE FASTED STATE 56
1.5.2 MEDIA TO SIMULATE PROXIMAL SMALL INTESTINAL CONDITIONS IN THE
FASTED STATE 58
1.5.3 MEDIA TO SIMULATE GASTRIC CONDITIONS IN THE FED STATE 61
1.5.4 MEDIA TO SIMULATE PROXIMAL SMALL INTESTINAL CONDITIONS IN THE
FED STATE 64
2 AIMS OF THE THESIS 67
F
IMAGE 3
TABLE OF CONTENTS
3 DISSOLUTION MEDIA TO SIMULATE THE POSTPRANDIAL
STOMACH 69
3.1 BACKGROUND 69
3.2 MATERIALS AND METHODS 71
3.2.1 MEAL COMPOSITION 71
3.2.2 MATERIALS 72
3.2.3 MEAL AND MEDIA PREPARATION 72
3.2.4 CHARACTERIZATION OF THE PHVSICOCHEMICAL PROPERTIES 73
3.2.5 STATISTICAL ANALYSIS 74
3.3 RESULTS AND DISCUSSION 75
3.3.1 ADJUSTMENT OF THE VISCOSITY 75
3.4 CONCLUSION 81
3.5 ACKNOWLEDGEMENT 81
4 DISSOLUTION MODELS TO PREDICT THE IN VIVO
BEHAVIOR OF MODIFIED RELEASE DOSAGE FORMS 83
4.1 STANDARD MATERIALS AND EQUIPMENT 83
4.1.1 STANDARD MATERIALS 84
4.1.2 STANDARD EQUIPMENT 85
4.2 COMPOSITION OF STANDARD DISSOLUTION MEDIA 87
4.2.1 STANDARD DISSOLUTION MEDIA FOR SIMULATING GASTRIC CONDITIONS 87
4.2.2 MEDIA TO SIMULATE SMALL INTESTINAL CONDITIONS 89
4.2.3 MEDIA TO SIMULATE COLONIC CONDITIONS 94
4.3 IN VITRO DISSOLUTION PROFILE COMPARISON 95
4.3.1 CALCULATION OF DIFFERENCE FACTOR F, 95
4.3.2 F 2 FACTOR CALCULATION 96
4.3.3 CRITERIA FOR F, ANDF 2 CALCULATION IN THE PRESENT THESIS 97
4.4 COMPARISON OF DRUG RELEASE FROM METOPROLOL MR DOSAGE
FORMS IN SINGLE BUFFERVERSUS A PH-GRADIENT DISSOLUTION TEST 99
4.4.1 METOPROLOL 99
LI
IMAGE 4
TABLE OF CONTENTS
4.4.2 BACKGROUND 100
4.4.3 MATERIALS AND METHODS 102
4.4.4 RESULTS AND DISCUSSION 107
4.4.5 SUMMARY 116
4.4.6 ACKNOWLEDGEMENT 116
4.5 EVOLUTION OF B I O D I S* METHODOLOGY: SELECTION OF ADEQUATE
INSTRUMENT PARAMETERS 1 17
4.5.1 BACKGROUND. 117
4.5.2 MATERIALS AND METHODS 118
4.5.3 RESULTS AND DISCUSSION 121
4.5.4 SUMMARY 127
4.6 DEVELOPING A DISSOLUTION SYSTEM TO PREDICT DRUG RELEASE FROM
DRUG DELIVERY SYSTEMS INTENDED FOR SITE-SPECIFIC RELEASE 1 29
4.6.1 MESALAZINE 130
4.6.2 BUDESONIDE 131
4.6.3 BACKGROUND 132
4.6.4 MATERIALS AND METHODS 137
4.6.5 RESULTS 148
4.6.6 DISCUSSION 165
4.6.7 CONCLUSION 170
4.6.8 ACKNOWLEDGEMENT 170
4.7 PREDICTING FOOD EFFECTS ON DRUG RELEASE FROM EXTENDED- RELEASE ORAL
DOSAGE FORMS: THEOPHYLLINE 171
4.7.1 THEOPHYLLINE 171
4.7.2 BACKGROUND. 173
4.7.3 MATERIALS AND METHODS 177
4.7.4 RESULTS AND DISCUSSION 190
4.7.5 SUMMARY 214
4.8 PREDICTING THE IN VIVO RELEASE BEHAVIOR OF A NOVEL P H- AND
TIME-BASED MULTI-UNIT COLONIC DELIVERY SYSTEM 2 17
_
IMAGE 5
TABLE OF CONTENTS
4.8.1 SELECTION OF CAFFEINE AS A MARKER MOLECULE 218
4.8.2 BACKGROUND 219
4.8.3 MATERIALS AND METHODS 221
4.8.4 RESULTS AND DISCUSSION 226
4.8.5 ACKNOWLEDGEMENT 234
5 SUMMARY 235
6 ZUSAMMENFASSUNG 239
7 APPENDICES 249
7.1 EXPERIMENTAL DATA 249
8 LITERATURE 284
|
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| discipline | Medizin |
| format | Thesis Book |
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| id | DE-604.BV026540054 |
| illustrated | Illustrated |
| indexdate | 2024-07-09T23:14:30Z |
| institution | BVB |
| isbn | 3832242767 |
| language | English |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-022103930 |
| oclc_num | 76776892 |
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| physical | XXIV, 312 S. Ill., graph. Darst. |
| publishDate | 2005 |
| publishDateSearch | 2005 |
| publishDateSort | 2005 |
| publisher | Shaker |
| record_format | marc |
| series2 | Berichte aus der Pharmazie |
| spelling | Klein, Sandra Verfasser aut Biorelevant dissolution test methods for modified release dosage forms Sandra Klein Aachen Shaker 2005 XXIV, 312 S. Ill., graph. Darst. txt rdacontent n rdamedia nc rdacarrier Berichte aus der Pharmazie Zugl.: Frankfurt (Main), Univ., Diss., 2005 Gastrointestinaltrakt (DE-588)4074445-0 gnd rswk-swf Depotpräparat (DE-588)4126500-2 gnd rswk-swf Wirkstofffreisetzung (DE-588)4190018-2 gnd rswk-swf In vivo (DE-588)4250700-5 gnd rswk-swf (DE-588)4113937-9 Hochschulschrift gnd-content Gastrointestinaltrakt (DE-588)4074445-0 s Depotpräparat (DE-588)4126500-2 s Wirkstofffreisetzung (DE-588)4190018-2 s In vivo (DE-588)4250700-5 s DE-604 GBV Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=022103930&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Klein, Sandra Biorelevant dissolution test methods for modified release dosage forms Gastrointestinaltrakt (DE-588)4074445-0 gnd Depotpräparat (DE-588)4126500-2 gnd Wirkstofffreisetzung (DE-588)4190018-2 gnd In vivo (DE-588)4250700-5 gnd |
| subject_GND | (DE-588)4074445-0 (DE-588)4126500-2 (DE-588)4190018-2 (DE-588)4250700-5 (DE-588)4113937-9 |
| title | Biorelevant dissolution test methods for modified release dosage forms |
| title_auth | Biorelevant dissolution test methods for modified release dosage forms |
| title_exact_search | Biorelevant dissolution test methods for modified release dosage forms |
| title_full | Biorelevant dissolution test methods for modified release dosage forms Sandra Klein |
| title_fullStr | Biorelevant dissolution test methods for modified release dosage forms Sandra Klein |
| title_full_unstemmed | Biorelevant dissolution test methods for modified release dosage forms Sandra Klein |
| title_short | Biorelevant dissolution test methods for modified release dosage forms |
| title_sort | biorelevant dissolution test methods for modified release dosage forms |
| topic | Gastrointestinaltrakt (DE-588)4074445-0 gnd Depotpräparat (DE-588)4126500-2 gnd Wirkstofffreisetzung (DE-588)4190018-2 gnd In vivo (DE-588)4250700-5 gnd |
| topic_facet | Gastrointestinaltrakt Depotpräparat Wirkstofffreisetzung In vivo Hochschulschrift |
| url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=022103930&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
| work_keys_str_mv | AT kleinsandra biorelevantdissolutiontestmethodsformodifiedreleasedosageforms |