Sugar-based surfactants for pharmaceutical protein formulations:
Gespeichert in:
| 1. Verfasser: | |
|---|---|
| Format: | Abschlussarbeit Buch |
| Sprache: | English |
| Veröffentlicht: |
Göttingen
Cuvillier
2011
|
| Ausgabe: | 1. Aufl. |
| Schlagworte: | |
| Online-Zugang: | Inhaltsverzeichnis |
| Beschreibung: | 156, 1 S. graph. Darst. 21 cm |
| ISBN: | 9783869558325 |
Internformat
MARC
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| 245 | 1 | 0 | |a Sugar-based surfactants for pharmaceutical protein formulations |c Lars |
| 250 | |a 1. Aufl. | ||
| 264 | 1 | |a Göttingen |b Cuvillier |c 2011 | |
| 300 | |a 156, 1 S. |b graph. Darst. |c 21 cm | ||
| 336 | |b txt |2 rdacontent | ||
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| 502 | |a Zugl.: München, Univ., Diss., 2011 | ||
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Datensatz im Suchindex
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| adam_text | IMAGE 1
TABLE OF CONTENTS:
CHAPTER 1: INTRODUCTION
1.1. FORMULATION CHALLENGES WITH BIOLOGICALS 1
1.1.1. GENERAL CONSIDERATIONS 1
1.1.2. PHYSICAL INSTABILITY 3
1.1.3. CHEMICAL INSTABILITY: 4
1.2. STABILIZING ADDITIVES IN PHARMACEUTICAL PROTEIN FORMULATION 6
1.2.1. OTHER EXCIPIENTS THAN SURFACTANTS 7
1.2.2. SURFACE ACTIVE AGENTS (SURFACTANTS) IN PARENTERAL FORMULATIONS OF
PROTEIN PHARMACEUTICALS: 9
1.2.2.1. PHYSICOCHEMICAL ASPECTS OF SURFACTANTS IN PROTEIN FORMULATIONS
9
1.2.2.2. SURFACE COMPETITION 10
1.2.2.3. MOLECULAR INTERACTIONS BETWEEN PROTEINS AND SURFACTANTS 11
1.2.2.4. SURFACTANTS IN PHARMACEUTICAL PRODUCTS 12
1.2.2.5. PROBLEMS WITH SURFACTANTS IN PROTEIN FORMULATION 13
1.2.2.6. APPROACHES TO UNDERSTAND INTERACTION OF PROTEINS AND
SURFACTANTS 14
1.2.2.6.1. ISOTHERMAL TITRATION CALORIMETRY 15
1.2.2.6.2. TWO-DIMENSIONAL NMR SPECTROSCOPY 17
1.2.2.6.3. FLUORESCENCE CORRELATION SPECTROSCOPY 17
1.2.2.6.4. ELECTRON PARAMAGNETIC RESONANCE SPECTROSCOPY 20
1.2.2.6.5. VISCOMETRY 20
1.2.2.6.6. SMALL ANGLE X-RAY SCATTERING 21
1.2.2.6.7. SURFACE TENSION MEASUREMENTS 21
1.2.2.6.8. ATOMIC FORCE MICROSCOPY 22
1.2.2.6.9. EQUILIBRIUM DIALYSIS 23
1.2.2.6.10. FLOURESCENCE SPECTROSCOPY 23
1.2.2.6.11. OTHER 24
BIBLIOGRAFISCHE INFORMATIONEN HTTP://D-NB.INFO/1014054206
DIGITALISIERT DURCH
IMAGE 2
1.3. OBJECTIVE OF THIS THESIS 24
1.4. REFERENCES: 26
CHAPTER 2: PHYSICOCHEMICAL CHARACTERIZATION OF TECHNICAL MIXTURES OF
SUGAR BASED
SURFACTANTS
2.1. INTRODUCTION 38
2.2. MATERIALS AND METHODS 44
2.2.1 MATERIALS 44
2.2.2 METHODS 44
2.2.2.1 SOLUBILITY TESTING 44
2.2.2.2 TENSIOMETRY 45
2.2.2.3 PYRENE INTERACTION FLUORESCENCE 46
2.2.2.4 HEMOLYTIC ACTIVITY 47
2.2.2.5 PHOTON CORRELATION SPECTROSCOPY (PCS) 48
2.2.2.6 VISCOMETRY 48
2.2.2.7 ELEMENTAL ANALYSIS 48
2.2.2.8 REVERSED-PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY (RP-HPLC)
49
2.2.2.9 CONTENT OF PEROXIDES 49
2.2.2.10 MASS SPECTROMETRY 50
2.3. RESULTS AND DISCUSSION 50
2.3.1 POORLY SOLUBLE SURFACTANTS 53
2.3.1.1. POORLY SOLUBLE SUGAR ESTERS 53
2.3.1.2. HARDLY SOLUBLE ALKYL GLUCOSIDES 57
2.3.2. SOLUBLE SURFACTANTS 59
2.3.2.1 WATER SOLUBLE SUGAR ESTERS 59
2.3.2.2. WATER SOLUBLE ALKYL GLUCOSIDES (PLUS ANALYSIS ON PS 20 AND PS
80) 60
2.3.2.3. NV 10 64
2.4. CONCLUSIONS 68
2.5. REFERENCES: 71
IMAGE 3
CHAPTER 3: SYNTHESIS, CHARACTERIZATION AND ASSESSMENT OF SUITABILITY OF
TREHALOSE
FATTY ACID ESTERS AS ALTERNATIVES FOR POLYSORBATES IN PROTEIN
FORMULATION
3.1. INTRODUCTION 73
3.2. MATERIALS AND METHODS 75
3.2.1 MATERIALS 75
3.2.1.1 PREPARATION OF 2,3,4,6,2 ,3 ,4 ,6 -OCTA-O-(TRIMETHYLSILYL)
TREHALOSE (1) 75
3.2.1.2. PREPARATION OF
2,3,4,2 ,3 ,4 -HEXA-O-(TRIRNETHYLSILYL)-A,A-TREHALOSE (2) 76
3.2.1.3 PREPARATION OF 6-0-MONOPALMITOYL-, 6-0-MONOLAUROYL- AND 6 -O-
MONOCAPRINOYL-2,3,4,2 ,3 ,4 -HEXA-O-(TRIRNETHYLSILYL)-A,A-TREHALOSE (3A,
3B, 3C) 77
3.2.1.4 PREPARATION OF 6-O-MONOPALMITOYL-, 6-O-MONOLAUROYL- AND 6-O-
MONOCAPRINOYL-A,A-TREHALOSE (4A, 4B, 4C) 78
3.2.1.5 INSTRUMENTS USED FOR IDENTIFICATION OF THE SYNTHESIZED PRODUCTS
81
3.2.2. METHODS 81
3.2.2.1 TENSIOMETRY 81
3.2.2.2 PYRENE INTERACTION FLUORESCENCE 82
3.2.2.3 HEMOLYTIC ACTIVITY 82
3.2.2.4 PHOTON CORRELATION SPECTROSCOPY (PCS) 82
3.2.2.5 VISCOMETRY 83
3.2.2.6 DIFFERENTIAL SCANNING CALORIMETRY (DSC) 83
3.2.2.7 AGITATION STRESSING OF HUMAN GROWTH HORMONE FORMULATIONS 83
3.2.2.8 SIZE EXCLUSION CHROMATOGRAPHY (SEC) 84
3.2.2.9 TURBIDITY MEASUREMENT 84
3.2.2.10 LIGHT OBSCURATION 84
3.2.2.11 VISUAL INSPECTION 85
3.3. RESULTS AND DISCUSSION 85
3.3.1 SYNTHESIS OF SUGAR BASED SURFACTANTS MONO-PT, MONO-LT UND
MONO-CT... 85
3.3.2 PHYSICAL CHARACTERIZATION 87
3.3.2.1 SURFACE TENSION AND CRITICAL MICELLE CONCENTRATION 87
IMAGE 4
3.3.2.2 MICELLE SIZE CHARACTERIZATION AND RHEOMETRY 88
3.3.2.3 DSC CHARACTERIZATION 90
3.3.2.4 HEMOLYTIC ACTIVITY 90
3.3.3 AGITATION STRESS OF HUMAN GROWTH HORMONE 91
3.3.3.1 PARTICLE FORMATION 92
3.3.3.2 SIZE EXCLUSION CHROMATOGRAPHY 94
3.4. CONCLUSIONS 95
3.5. REFERENCES: 97
CHAPTER 4: STRESS TEST OF PROTEIN FORMULATIONS WITH DIFFERENT NONIONIC
SURFACTANTS
4.1 .INTRODUCTION 101
4.2.MATERIALS AND METHODS 102
4.2.1. MATERIAL 102
4.2.2. METHODS 102
4.2.2.1. STRESS TESTS 102
4.2.2.1.1. AGITATION STRESS TEST OF HGH CONTAINING FORMULATIONS 102
4.2.2.1.2. STRESS TESTS WITH 11-11 CONTAINING FORMULATIONS 103
4.2.2.2. SIZE EXCLUSION CHROMATOGRAPHY 104
4.2.2.3. TURBIDITY MEASURMENTS 104
4.2.2.4. LIGHT OBSCURATION MEASUREMENTS 104
4.2.2.5. VISUAL INSPECTION 105
4.2.2.6. SDS-PAGE 105
4.2.2.7. REVERSED PHASE HPLC 105
4.3.RESULTS AND DISCUSSION 107
4.3.1. STRESS TESTING OF 11-11 107
4.3.1.1. THERMAL STRESS 107
4.3.1.2. AGITATION STRESS 112
4.3.2. STRESS TESTING OF HGH 113
4.3.2.1. AGITATION STRESS 113
IMAGE 5
4.3.2.2. ADSORPTION AT CONTAINER SURFACES DURING STORAGE 115
4.4 CONCLUSIONS 118
4.5.REFERENCES 120
CHAPTER 5: STUDIES ON THE BINDING INTERACTIONS BETWEEN NONIONIC
SURFACTANTS AND
PROTEINS IN LIQUID FORMULATIONS
5.1. INTRODUCTION 123
5.1. MATERIAL AND METHODS 126
5.1.1. MATERIAL 126
5.1.2. TENSIOMETRY 126
5.1.3. PYRENE INTERACTION FLUORESCENCE SPECTROSCOPY 126
5.1.4. ISOTHERMAL TITRATION CALORIMETRY 127
5.1.5. NUCLEAR MAGNETIC RESONANCE (NMR) SPECTROSCOPY 127
5.2. RESULTS AND DISCUSSION 128
5.2.1. CMC DETERMINATION 128
5.2.2. ITC MEASUREMENTS 128
5.3. NMR - SPECTROSCOPY 137
5.4. CONCLUSIONS 139
5.5. REFERENCES: 141
CHAPTER 6: DETERMINATION OF THE INTERACTION BETWEEN NONIONIC SURFACTANTS
AND HUMAN
GROWTH HORMONE WITH THE HELP OF FLUORESCENCE CORRELATION SPECTROSCOPY
6.1. INTRODUCTION 145
6.2 .MATERIAL AND METHODS 146
6.2.1. MATERIAL 146
6.2.2. METHODS 146
6.2.2.1. SIZE EXCLUSION CHROMATOGRAPHY 146
6.2.2.2. OPTIMIZATION OF THE BINDING PROTOCOL 147
6.2.2.3. FLUORESCENCE CON-ELATION SPECTROSCOPY 147
IMAGE 6
6.3. RESULTS AND DISCUSSION 148
6.3.1. OPTIMIZATION OF THE BINDING PROTOCOL 148
6.3.2. FLUORESCENCE CORRELATION SPECTROSCOPY 150
6.4.CONCLUSIONS 152
6.5. REFERENCES 154
CHAPTER 7: SUMMARY OF THE THESIS 155
|
| any_adam_object | 1 |
| author | Schiefelbein, Lars Kurt Johann 1980- |
| author_GND | (DE-588)1014295467 |
| author_facet | Schiefelbein, Lars Kurt Johann 1980- |
| author_role | aut |
| author_sort | Schiefelbein, Lars Kurt Johann 1980- |
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| building | Verbundindex |
| bvnumber | BV039692639 |
| ctrlnum | (OCoLC)767771451 (DE-599)DNB1014054206 |
| dewey-full | 615.19 |
| dewey-hundreds | 600 - Technology (Applied sciences) |
| dewey-ones | 615 - Pharmacology and therapeutics |
| dewey-raw | 615.19 |
| dewey-search | 615.19 |
| dewey-sort | 3615.19 |
| dewey-tens | 610 - Medicine and health |
| discipline | Medizin |
| edition | 1. Aufl. |
| format | Thesis Book |
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| indexdate | 2024-07-10T00:09:06Z |
| institution | BVB |
| isbn | 9783869558325 |
| language | English |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-024541368 |
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| physical | 156, 1 S. graph. Darst. 21 cm |
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| spelling | Schiefelbein, Lars Kurt Johann 1980- Verfasser (DE-588)1014295467 aut Sugar-based surfactants for pharmaceutical protein formulations Lars 1. Aufl. Göttingen Cuvillier 2011 156, 1 S. graph. Darst. 21 cm txt rdacontent n rdamedia nc rdacarrier Zugl.: München, Univ., Diss., 2011 Glykoside (DE-588)4021359-6 gnd rswk-swf Stabilität (DE-588)4056693-6 gnd rswk-swf Pharmazeutische Technologie (DE-588)4045699-7 gnd rswk-swf Proteinpräparat (DE-588)4247384-6 gnd rswk-swf Grenzflächenaktiver Stoff (DE-588)4158138-6 gnd rswk-swf (DE-588)4113937-9 Hochschulschrift gnd-content Proteinpräparat (DE-588)4247384-6 s Stabilität (DE-588)4056693-6 s Grenzflächenaktiver Stoff (DE-588)4158138-6 s Glykoside (DE-588)4021359-6 s Pharmazeutische Technologie (DE-588)4045699-7 s DE-604 DNB Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=024541368&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Schiefelbein, Lars Kurt Johann 1980- Sugar-based surfactants for pharmaceutical protein formulations Glykoside (DE-588)4021359-6 gnd Stabilität (DE-588)4056693-6 gnd Pharmazeutische Technologie (DE-588)4045699-7 gnd Proteinpräparat (DE-588)4247384-6 gnd Grenzflächenaktiver Stoff (DE-588)4158138-6 gnd |
| subject_GND | (DE-588)4021359-6 (DE-588)4056693-6 (DE-588)4045699-7 (DE-588)4247384-6 (DE-588)4158138-6 (DE-588)4113937-9 |
| title | Sugar-based surfactants for pharmaceutical protein formulations |
| title_auth | Sugar-based surfactants for pharmaceutical protein formulations |
| title_exact_search | Sugar-based surfactants for pharmaceutical protein formulations |
| title_full | Sugar-based surfactants for pharmaceutical protein formulations Lars |
| title_fullStr | Sugar-based surfactants for pharmaceutical protein formulations Lars |
| title_full_unstemmed | Sugar-based surfactants for pharmaceutical protein formulations Lars |
| title_short | Sugar-based surfactants for pharmaceutical protein formulations |
| title_sort | sugar based surfactants for pharmaceutical protein formulations |
| topic | Glykoside (DE-588)4021359-6 gnd Stabilität (DE-588)4056693-6 gnd Pharmazeutische Technologie (DE-588)4045699-7 gnd Proteinpräparat (DE-588)4247384-6 gnd Grenzflächenaktiver Stoff (DE-588)4158138-6 gnd |
| topic_facet | Glykoside Stabilität Pharmazeutische Technologie Proteinpräparat Grenzflächenaktiver Stoff Hochschulschrift |
| url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=024541368&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
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