Improvements to biorelevant dissolution testing: lyophilized media, buffer alternatives and miniaturized apparatus
Gespeichert in:
| 1. Verfasser: | |
|---|---|
| Format: | Abschlussarbeit Buch |
| Sprache: | English |
| Veröffentlicht: |
Göttingen
Cuvillier
2009
|
| Ausgabe: | 1. Aufl. |
| Schlagworte: | |
| Online-Zugang: | Inhaltstext Inhaltsverzeichnis |
| Beschreibung: | [16], 194 S. Ill., graph. Darst. |
| ISBN: | 9783869550794 |
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| 245 | 1 | 0 | |a Improvements to biorelevant dissolution testing |b lyophilized media, buffer alternatives and miniaturized apparatus |c von Julia Elisabeth Boni |
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Datensatz im Suchindex
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IMAGE 1
TABLE OF CONTENTS
I OVERVIEW - GENERAL INTRODUCTION 1
1 HISTORY OF DISSOLUTION 3
2 DISSOLUTION TODAY 4
3 BIORELEVANCE IN DISSOLUTION TESTING 6
3.1 THE GL TRACT 6
3.2 SIMULATION OF IN VIVO CONDITIONS 10
II AIMS OF THESIS 13
1 IMPROVEMENT OF PREPARATION OF BIORELEVANT MEDIA 13
2 USE OF PHYSIOLOGIC BUFFER SYSTEMS 14
3 MINIATURIZATION OF DISSOLUTION TESTING 14
III MANUFACTURE OF "INSTANT' BIORELEVANT MEDIA BY FREEZE- DRYING 15
1 INTRODUCTION 15
1.1 REASONS FOR LYOPHILISATION 15
1.2 REQUIREMENTS FOR FREEZE-DRYING COMPONENTS 17
1.3 FREEZE DRYING OF BIORELEVANT MEDIA 19
1.4 LYOPHILISATION - PHYSICAL BASICS 21
1.4.1 PROCESS OF LYOPHILISATION 21
1.4.2 FREEZING POINT 22
1.4.3 FREEZING PROCESS OF SOLUTIONS 24
1.4.4 FREEZING TIME 26
1.4.5 PRIMARY DRYING / SUBLIMATION 26
1.4.6 SECONDARY DRYING / DESORPTION 27
1.5 LYOPHILISATION - TECHNICAL BASICS 28
2 MATERIALS AND METHODS 30
2.1 MATERIALS 30
2.1.1 CHEMICALS AND FORMULATIONS 30
2.1.2 DEVICES FOR PRODUCTION AND TESTING 32
BIBLIOGRAFISCHE INFORMATIONEN HTTP://D-NB.INFO/996542787
DIGITALISIERT DURCH
IMAGE 2
TABLE OF CONTENTS
2.2 METHODS 34
2.2.1 COMPOSITIONS OF SOLUTIONS FOR FREEZE-DRYING 34
2.2.2 PREPARATION 35
2.2.3 FREEZE-DRYING 38
2.2.4 PACKAGING AND STORAGE 40
2.2.5 RECONSTITUTION 42
2.2.6 CHARACTERIZATION OF PHYSICOCHEMICAL PROPERTIES 42
2.2.7 COMPARISON OF COMMERCIALLY AVAILABLE AND FREEZE-DRIED INSTANT
MEDIA 45
3 RESULTS 47
3.1 PREPARATION AND LYOPHILISATION OF CONCENTRATED SOLUTIONS 47
3.1.1 PREPARATION 47
3.1.2 LYOPHILISATION OF VARIOUS CONCENTRATES 52
3.1.3 FREEZE-DRYING PROCESS 53
3.1.4 PACKAGING 54
3.1.5 RECONSTITUTION 55
3.2 CHARACTERIZATION OF LYOPHILISATES 56
3.2.1 APPEARANCE 56
3.2.2 SEM (SCANNING ELECTRON MICROSCOPY) 57
3.2.3 HYGROSCOPICITY 59
3.2.4 KARL-FISCHER-TITRATION 60
3.2.5 DSC (DIFFERENTIAL SCANNING CALORIMETRY) 63
3.3 PROPERTIES OF RECONSTITUTED VS FRESHLY PREPARED MEDIA 63
3.4 CHARACTERIZATION OF THE REDISSOLVED MEDIA AFTER STORAGE 67
3.4.1 OPTICAL APPEARANCE 68
3.4.2 PHYSICOCHEMICAL PROPERTIES 68
3.5 COMPARISON OF COMMERCIALLY AVAILABLE AND FREEZE-DRIED INSTANT MEDIA
76
3.5.1 PHYSICOCHEMICAL CHARACTERIZATION 76
3.5.2 DISSOLUTION RESULTS 78
4 DISCUSSION 81
4.1 PREPARATION OF THE LYOPHILISED MEDIA 81
4.1.1 PREPARATION AND FREEZE-DRYING OF CONCENTRATED SOLUTIONS 81
4.1.2 COMPARISON OF FREEZE-DRIED WITH FRESHLY PREPARED MEDIA 89
4.1.3 CHARACTERIZATION OF THE LYOPHILISATE 90
4.1.4 CHARACTERIZATION OF REDISSOLVED MEDIA 91
4.1.5 STABILITY, STORAGE AND PACKAGING 94
4.1.6 APPLICABILITY IN AN INDUSTRIAL SETTING 95
IMAGE 3
TABLE OF CONTENTS
4.2 COMPARISON OF COMMERCIALLY AVAILABLE AND FREEZE-DRIED INSTANT MEDIA
95
5 SUMMARY AND CONCLUSION 97
6 ACKNOWLEDGEMENT 97
7 STANDARD OPERATION PROCEDURE (SOP) FOR THE PREPARATION OF FREEZE DRIED
FASSIF AND FESSIF 98
7.1 COMPOSITION 98
7.2 INSTANT MEDIA 98
7.3 PREPARATION 98
7.4 STORAGE 99
IV IMPROVEMENT OF BIORELEVANCE BY SUBSTITUTING CONVENTION BUFFER SALT
FOR BICARBONATE BUFFER IN BIORELEVANT MEDIA FASSIF AND FESSIF 101
1 INTRODUCTION 101
2 MATERIALS AND METHODS 104
2.1 MATERIALS 104
2.1.1 CHEMICALS AND FORMULATIONS 104
2.1.2 MEDIA 104
3 METHODS 107
3.1.1 DISSOLUTION TESTS 107
3.1.2 STATISTICAL METHODS 108
4 RESULTS AND DISCUSSION 109
4.1 PREPARATION OF BICARBONATE BUFFERS 109
4.1.1 MCNAMARA METHOD 109
4.1.2 MODIFIED METHOD 110
4.2 REPRODUCIBILITY OF DISSOLUTION PROFILES IN MEDIA BASED ON
BICARBONATE AND
PHOSPHATE BUFFERS 112
4.3 ABILITY OF BICARBONATE AND PHOSPHATE BUFFERS TO RESIST PH CHANGE 115
4.4 BIORELEVANT MEDIA COMPOSED WITH BICARBONATE VS. PHOSPHATE 118
4.5 STATISTICAL ANALYSIS 119
5 CONCLUSION 120
6 ACKNOWLEDGEMENT 120
IMAGE 4
TABLE OF CONTENTS
V MINIATURIZATION OF DISSOLUTION DEVICES 121
1 INTRODUCTION 121
1.1 DISSOLUTION IN THE PHARMACEUTICAL INDUSTRIES 121
1.2 STANDARD DISSOLUTION TESTING 123
1.3 PHYSIOLOGICAL SMALL VOLUME DISSOLUTION TESTING 124
1.3.1 CHOICE OF VOLUME 124
1.3.2 BUFFER TYPE AND STRENGTH 125
1.3.3 PH VALUE 125
1.3.4 MINI-PADDLE APPARATUS 126
1.3.5 SAMPLE REMOVAL WITH THE MINI-PADDLE APPARATUS 126
1.4 SMALL SCALE DISSOLUTION TESTING 126
1.4.1 MANUAL VIAL METHOD 127
1.4.2 AUTOMATED VIAL SYSTEM 127
1.4.3 BL MINIDISS 128
1.5 WELL-PLATE METHOD 129
1.6 COMPATIBILITY OF THE VARIOUS METHODS 131
1.7 CORRELATION OF IN VITRO AND IN VIVO RELEASE 131
2 MATERIALSAND METHODS 133
2.1 MATERIALS 133
2.1.1 CHEMICALS AND FORMULATIONS 133
2.1.2 DISSOLUTION MEDIA FOR COMPATIBILITY TESTS 135
2.1.3 DISSOLUTION MEDIA FOR BUFFER SCREENING 136
2.1.4 DEVICES FOR DISSOLUTION AND TESTING 136
2.2 DISSOLUTION METHODS 137
2.2.1 MODIFIED USP APPARATUS 139
2.2.2 MANUAL VIAL METHOD 140
2.2.3 AUTOMATED VIAL METHOD 140
2.2.4 BL MINIDISS 140
2.2.5 WELL PLATE 141
2.3 USE OF BL MINIDISS FOR BUFFER SCREENING OF BL 20 FOR THE FORMULATION
CHARACTERIZATION 141
2.4 IVIVR 141
3 RESULTS 143
3.1 COMPATIBILITY OF METHODS 143
IMAGE 5
TABLE OF CONTENTS
3.1.1 VIAL METHODS 143
3.1.2 MODIFIED USP VS. AUTOMATED VIAL METHOD 144
3.1.3 MODIFIED USP VS. BL MINIDISS 145
3.1.4 BL MINIDISS VS. WELL-PLATE METHOD 146
3.2 BUFFER SCREENING 152
3.3 IVIVR 155
3.3.1 RESULTS FOR BIBF 155
3.3.2 RESULTS OF BIXX 157
4 DISCUSSION 158
4.1 COMPATIBILITY OF METHODS 159
4.1.1 VIAL METHODS 159
4.1.2 MODIFIED USP VS. VIAL METHOD 159
4.1.3 MODIFIED USP VS. BL MINIDISS 160
4.1.4 BL MINIDISS VS. WELL-PLATE METHOD 160
4.2 BUFFER EFFECTS 162
4.3 IVIVR 163
4.3.1 RESULTS OF BIBF 163
4.3.2 RESULTS OF BIXX 164
5 CONCLUSION 165
VI SUMMARY 167
VII ZUSAMMENFASSUNG 171
VIM APPENDIX 174
IX REFERENCES 175
X CURRICULUM VITAE 192 |
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| author | Boni, Julia Elisabeth 1978- |
| author_GND | (DE-588)139166521 |
| author_facet | Boni, Julia Elisabeth 1978- |
| author_role | aut |
| author_sort | Boni, Julia Elisabeth 1978- |
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| bvnumber | BV026748902 |
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| dewey-full | 615.7040287 |
| dewey-hundreds | 600 - Technology (Applied sciences) |
| dewey-ones | 615 - Pharmacology and therapeutics |
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| dewey-search | 615.7040287 |
| dewey-sort | 3615.7040287 |
| dewey-tens | 610 - Medicine and health |
| discipline | Biologie Medizin |
| edition | 1. Aufl. |
| format | Thesis Book |
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| spelling | Boni, Julia Elisabeth 1978- Verfasser (DE-588)139166521 aut Improvements to biorelevant dissolution testing lyophilized media, buffer alternatives and miniaturized apparatus von Julia Elisabeth Boni 1. Aufl. Göttingen Cuvillier 2009 [16], 194 S. Ill., graph. Darst. txt rdacontent n rdamedia nc rdacarrier Frankfurt (Main), Univ., Diss., 2009 Wirkstofffreisetzung (DE-588)4190018-2 gnd rswk-swf Arzneimittelprüfung (DE-588)4128030-1 gnd rswk-swf Arzneiform (DE-588)4068874-4 gnd rswk-swf Bioverfügbarkeit (DE-588)4145660-9 gnd rswk-swf (DE-588)4113937-9 Hochschulschrift gnd-content Arzneiform (DE-588)4068874-4 s Bioverfügbarkeit (DE-588)4145660-9 s Wirkstofffreisetzung (DE-588)4190018-2 s Arzneimittelprüfung (DE-588)4128030-1 s DE-604 http://deposit.dnb.de/cgi-bin/dokserv?id=3351401&prov=M&dok_var=1&dok_ext=htm Inhaltstext DNB Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=022286431&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Boni, Julia Elisabeth 1978- Improvements to biorelevant dissolution testing lyophilized media, buffer alternatives and miniaturized apparatus Wirkstofffreisetzung (DE-588)4190018-2 gnd Arzneimittelprüfung (DE-588)4128030-1 gnd Arzneiform (DE-588)4068874-4 gnd Bioverfügbarkeit (DE-588)4145660-9 gnd |
| subject_GND | (DE-588)4190018-2 (DE-588)4128030-1 (DE-588)4068874-4 (DE-588)4145660-9 (DE-588)4113937-9 |
| title | Improvements to biorelevant dissolution testing lyophilized media, buffer alternatives and miniaturized apparatus |
| title_auth | Improvements to biorelevant dissolution testing lyophilized media, buffer alternatives and miniaturized apparatus |
| title_exact_search | Improvements to biorelevant dissolution testing lyophilized media, buffer alternatives and miniaturized apparatus |
| title_full | Improvements to biorelevant dissolution testing lyophilized media, buffer alternatives and miniaturized apparatus von Julia Elisabeth Boni |
| title_fullStr | Improvements to biorelevant dissolution testing lyophilized media, buffer alternatives and miniaturized apparatus von Julia Elisabeth Boni |
| title_full_unstemmed | Improvements to biorelevant dissolution testing lyophilized media, buffer alternatives and miniaturized apparatus von Julia Elisabeth Boni |
| title_short | Improvements to biorelevant dissolution testing |
| title_sort | improvements to biorelevant dissolution testing lyophilized media buffer alternatives and miniaturized apparatus |
| title_sub | lyophilized media, buffer alternatives and miniaturized apparatus |
| topic | Wirkstofffreisetzung (DE-588)4190018-2 gnd Arzneimittelprüfung (DE-588)4128030-1 gnd Arzneiform (DE-588)4068874-4 gnd Bioverfügbarkeit (DE-588)4145660-9 gnd |
| topic_facet | Wirkstofffreisetzung Arzneimittelprüfung Arzneiform Bioverfügbarkeit Hochschulschrift |
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