Stabilization of antibodies in spray-dried powders for inhalation:
Gespeichert in:
| 1. Verfasser: | |
|---|---|
| Format: | Abschlussarbeit Buch |
| Sprache: | English |
| Veröffentlicht: |
München
Hut
2006
|
| Ausgabe: | 1. Aufl. |
| Schriftenreihe: | Pharmazeutische Technologie
|
| Schlagworte: | |
| Online-Zugang: | Inhaltsverzeichnis |
| Beschreibung: | VII, 204 S. Ill., graph. Darst. 210 mm x 148 mm, 295 gr. |
| ISBN: | 9783899633719 3899633717 |
Internformat
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| 264 | 1 | |a München |b Hut |c 2006 | |
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Datensatz im Suchindex
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| adam_text | STABILIZATION OF ANTIBODIES IN SPRAY-DRIED POWDERS FOR INHALATION
DISSERTATION ZUR ERLANGUNG DES DOKTORGRADES DER FAKULTAT FUR CHEMIE UND
PHARMAZIE DER LUDWIG-MAXIMILIANS-UNIVERSITAT MIINCHEN VORGELEGT VON
STEFANIE SCHIILE AUS ERLANGEN TABLE OF CONTENTS 1 INTRODUCTION 1 1.1
ANTIBODIES 1 1.1.1 ANTIBODY STRUCTURE 2 1.1.2 DESCRIPTION OF IGG
SUBCLASSES 5 1.1.3 ROLE OF MONOCLONAL ANTIBODIES (MABS) IN CURRENT DRUG
THERAPY 7 1.1.3.1 MURINE ANTIBODIES 10 1.1.3.2 CHIMERIC ANTIBODIES 11
1.1.3.3 HUMANIZED ANTIBODIES 11 1.1.3.4 HUMAN ANTIBODIES 13 1.1.3.5
APPLICATION OF ANTIBODIES 13 1.2 PREPARATION OF ANTIBODY POWDERS FOR
INHALATION BY SPRAY-DRYING 17 1.2.1 STABILITY OF ANTIBODIES IN
SPRAY-DRIED POWDERS 19 1.2.2 POWDER PERFORMANCE OF ANTIBODIES IN
SPRAY-DRIED POWDERS 23 1.2.2.1 PARTICLE SIZE AND FINE PARTICLE FRACTION
23 1.2.2.2 ELECTROSTATIC PROPERTIES 26 1.2.2.3 HYGROSCOPICITY - THE
INFLUENCE OF MOISTURE 30 1.2.2.4 FLOWABILITY 35 2 OBJECTIVES OF THIS
THESIS 39 3 MATERIALS AND METHODS 41 3.1 * MATERIALS 41 3.1.1 HUMAN
SERUM ALBUMIN (HSA) 41 3.1.2 ANTIBODY 1 N 41 3.1.3 ANTIBODY 2 41 3.1.4
ANTIBODY 3 41 3.2 SPRAY-DRYING EXCIPIENTS 43 3.3 METHODS 45 3.3.1
PREPARATION OF SOLUTIONS FOR SPRAY-DRYING 45 TABLE OF CONTENTS 3.3.2
SPRAY-DRYING 45 3.3.3 FREEZE-DRYING 46 3.3.4 ANALYTICAL METHODS 46
3.3.4.1 CHARACTERIZATION OF PROTEIN SOLUTIONS 46 3.3.4.1.1 SIZE
EXCLUSION HIGH PERFORMANCE LIQUID CHROMATOGRAPHY (SE- HPLC) 46 3.3.4.1.2
TURBIDITY 47 3.3.4.1.3 FOURIER TRANSFORMATION INFRARED SPECTROSCOPY
(FTIR) 47 3.3.4.1.4 CIRCULAR DICHROISM SPECTROSCOPY (CD) 47 3.3.4.1.5
MICROCALORIMETRY 48 3.3.4.1.6 LASER DIFFRACTION 48 3.3.4.1.7 PHOTON
CORRELATION SPECTROSCOPY (PCS) 48 3.3.4.2 CHARACTERIZATION OF PROTEIN
POWDERS 49 3.3.4.2.1 DIFFERENTIAL SCANNING CALORIMETRY (DSC) 49
3.3.4.2.2 MODULATED DIFFERENTIAL SCANNING CALORIMETRY (MDSC) 49
3.3.4.2.3 SCANNING ELECTRON MICROSCOPY (SEM) 49 3.3.4.2.4 X-RAY POWDER
DIFFRACTION (XRD) 49 3.3.4.2.5 TIME-OF-FLIGHT MEASUREMENT (TOF) 50
3.3.4.2.6 ANDERSEN CASCADE IMPACTOR (ACI) 50 3.3.4.2.7 DYNAMIC VAPOUR
SORPTION (DVS) 51 3.3.4.2.8 KARL-FISCHER TITRATION 51 3.3.4.2.9
DETERMINATION OF THE POWDER FLOWABILITY 51 3.3.4.3 VACUUM-DRYING 52
3.3.4.4 STORAGE STABILITY 52 4 RESULTS AND DISCUSSION 53 4.1 PROTEIN
STABILITY IN SOLUTIONS 53 4.1.1 EFFECT OF SUGARS AND POLYOLS ON
AGGREGATION 53 4.1.1.1 T M -MEASUREMENTS 54 4.1.1.2 INFLUENCE OF THE
PROTEIN CONCENTRATION 56 4.1.1.3 COMPARISON OF DIFFERENT ANTIBODIES 57
4.1.2 INFLUENCE OF ATOMIZATION 58 TABLE OF CONTENTS III_ 4.1.3 SUMMARY
61 4.2 STRUCTURE ANALYSIS OF PROTEINS WITH FTIR AND CD 63 4.2.1
INFLUENCE OF SUGARS AND POLYOLS 63 4.2.1.1 INFLUENCE OF STORAGE 69
4.2.1.2 INFLUENCE OF FORCED DENATURATION 70 4.2.1.2.1 INFLUENCE OF
TEMPERATURE 70 4.2.1.2.2 INFLUENCE OF GUANIDINE 74 4.2.2 SECONDARY
STRUCTURE OF DIFFERENT ANTIBODIES 76 4.2.3 SUMMARY 78 4.3 SPRAY-DRYING
PROPERTIES OF MANNITOL 81 4.3.1 SPRAY DRY ING OF PURE MANNITOL 81 4.3.2
SPRAY DRYING OF HSA/MANNITOL * 84 4.3.3 SUMMARY 91 4.4 SPRAY-DRYING OF
ANTIBODY 1 FORMULATIONS 93 4.4.1 CHARACTERISTICS OF ANTIBODY 1/MANNITOL
FORMULATIONS AFTER SPRAY-DRYING 93 4.4.1.1 SUMMARY 102 4.4.2 STORAGE
TESTS OF ANTIBODY 1/MANNITOL POWDERS 103 4.4.2.1 STORAGE OF PRE-TREATED
ANTIBODY 1/MANNITOL POWDERS 103 4.4.2.2 STORAGE STABILITY OF POWDERS
SPRAY-DRIED AT T IN /T OU , OF 130/75C 109 4.4.2.3 SUMMARY 113 4.4.3
VARIATIONS BASED ON THE 70/30 ABL/MANNITOL FORMULATION 113 4.4.3.1
CHARACTERISTICS 115 4.4.3.2 STABILITY UPON STORAGE OF ANTIBODY
1/MANNITOL/SECOND EXCIPIENT POWDERS 120 4.4.4 VARIATIONS BASED ON THE
80/20 ABL/MANNITOL FORMULATION 125 4.4.5 SUMMARY 129 4.4.6 FTIR
SPECTROSCOPY OF ANTIBODY 1 CONTAINING POWDERS 132 4.4.6.1
FTIR-TRANSMISSION SPECTRA OF REDISSOLVED POWDERS 132 4.4.6.2 ATR-FTIR
SPECTRA OF ANTIBODY 1/MANNITOL POWDERS 134 4.4.6.3 INFLUENCE OF STORAGE
ON ATR-FTIR SPECTRA OF POWDERS 136 JV TABLE OF CONTENTS 4.4.6.4 SUMMARY
137 4.4.7 FINDING THE OPTIMUM - SPRAY-DRYING OF MODIFIED ABL/MANNITOL/
SECOND EXCIPIENT FORMULATIONS 138 4.4.7.1 POWDER CHARACTERISTICS OF
MODIFIED ABL/MANNITOL/SECOND EXCIPIENT FORMULATIONS 138 4.4.7.2 STORAGE
TESTS OF MODIFIED ABL/MANNITOL/SECOND EXCIPIENT POWDERS 143 4.4.7.2.1
STORAGE STABILITY OF MODIFIED POWDERS 143 4.4.7.2.2 AERODYNAMIC
PROPERTIES OF MODIFIED FORMULATIONS AFTER STORAGE 148 4.4.7.3 INFLUENCE
OF TOTAL SOLID ON STORAGE STABILITY 149 4.4.7.4 SUMMARY 151 4.5
COMPARISON OF DIFFERENT ANTIBODIES IN SPRAY-DRIED FORMULATIONS 153 4.5.1
CHARACTERISTICS OF SPRAY-DRIED ANTIBODY FORMULATIONS 153 4.5.1.1
AERODYNAMIC PROPERTIES 155 4.5.2 STORAGE STABILITY 156 4.5.3 SUMMARY 158
5 FINAL SUMMARY 161 6 REFERENCES 167 7 APPENDIX 185
|
| adam_txt |
STABILIZATION OF ANTIBODIES IN SPRAY-DRIED POWDERS FOR INHALATION
DISSERTATION ZUR ERLANGUNG DES DOKTORGRADES DER FAKULTAT FUR CHEMIE UND
PHARMAZIE DER LUDWIG-MAXIMILIANS-UNIVERSITAT MIINCHEN VORGELEGT VON
STEFANIE SCHIILE AUS ERLANGEN TABLE OF CONTENTS 1 INTRODUCTION 1 1.1
ANTIBODIES 1 1.1.1 ANTIBODY STRUCTURE 2 1.1.2 DESCRIPTION OF IGG
SUBCLASSES 5 1.1.3 ROLE OF MONOCLONAL ANTIBODIES (MABS) IN CURRENT DRUG
THERAPY 7 1.1.3.1 MURINE ANTIBODIES 10 1.1.3.2 CHIMERIC ANTIBODIES 11
1.1.3.3 HUMANIZED ANTIBODIES 11 1.1.3.4 HUMAN ANTIBODIES 13 1.1.3.5
APPLICATION OF ANTIBODIES 13 1.2 PREPARATION OF ANTIBODY POWDERS FOR
INHALATION BY SPRAY-DRYING 17 1.2.1 STABILITY OF ANTIBODIES IN
SPRAY-DRIED POWDERS 19 1.2.2 POWDER PERFORMANCE OF ANTIBODIES IN
SPRAY-DRIED POWDERS 23 1.2.2.1 PARTICLE SIZE AND FINE PARTICLE FRACTION
23 1.2.2.2 ELECTROSTATIC PROPERTIES 26 1.2.2.3 HYGROSCOPICITY - THE
INFLUENCE OF MOISTURE 30 1.2.2.4 FLOWABILITY 35 2 OBJECTIVES OF THIS
THESIS 39 3 MATERIALS AND METHODS 41 3.1 * MATERIALS 41 3.1.1 HUMAN
SERUM ALBUMIN (HSA) 41 3.1.2 ANTIBODY 1 N 41 3.1.3 ANTIBODY 2 41 3.1.4
ANTIBODY 3 41 3.2 SPRAY-DRYING EXCIPIENTS 43 3.3 METHODS 45 3.3.1
PREPARATION OF SOLUTIONS FOR SPRAY-DRYING 45 TABLE OF CONTENTS 3.3.2
SPRAY-DRYING 45 3.3.3 FREEZE-DRYING 46 3.3.4 ANALYTICAL METHODS 46
3.3.4.1 CHARACTERIZATION OF PROTEIN SOLUTIONS 46 3.3.4.1.1 SIZE
EXCLUSION HIGH PERFORMANCE LIQUID CHROMATOGRAPHY (SE- HPLC) 46 3.3.4.1.2
TURBIDITY 47 3.3.4.1.3 FOURIER TRANSFORMATION INFRARED SPECTROSCOPY
(FTIR) 47 3.3.4.1.4 CIRCULAR DICHROISM SPECTROSCOPY (CD) 47 3.3.4.1.5
MICROCALORIMETRY 48 3.3.4.1.6 LASER DIFFRACTION 48 3.3.4.1.7 PHOTON
CORRELATION SPECTROSCOPY (PCS) 48 3.3.4.2 CHARACTERIZATION OF PROTEIN
POWDERS 49 3.3.4.2.1 DIFFERENTIAL SCANNING CALORIMETRY (DSC) 49
3.3.4.2.2 MODULATED DIFFERENTIAL SCANNING CALORIMETRY (MDSC) 49
3.3.4.2.3 SCANNING ELECTRON MICROSCOPY (SEM) 49 3.3.4.2.4 X-RAY POWDER
DIFFRACTION (XRD) 49 3.3.4.2.5 TIME-OF-FLIGHT MEASUREMENT (TOF) 50
3.3.4.2.6 ANDERSEN CASCADE IMPACTOR (ACI) 50 3.3.4.2.7 DYNAMIC VAPOUR
SORPTION (DVS) 51 3.3.4.2.8 KARL-FISCHER TITRATION 51 3.3.4.2.9
DETERMINATION OF THE POWDER FLOWABILITY 51 3.3.4.3 VACUUM-DRYING 52
3.3.4.4 STORAGE STABILITY 52 4 RESULTS AND DISCUSSION 53 4.1 PROTEIN
STABILITY IN SOLUTIONS 53 4.1.1 EFFECT OF SUGARS AND POLYOLS ON
AGGREGATION 53 4.1.1.1 T M -MEASUREMENTS 54 4.1.1.2 INFLUENCE OF THE
PROTEIN CONCENTRATION 56 4.1.1.3 COMPARISON OF DIFFERENT ANTIBODIES 57
4.1.2 INFLUENCE OF ATOMIZATION 58 TABLE OF CONTENTS III_ 4.1.3 SUMMARY
61 4.2 STRUCTURE ANALYSIS OF PROTEINS WITH FTIR AND CD 63 4.2.1
INFLUENCE OF SUGARS AND POLYOLS 63 4.2.1.1 INFLUENCE OF STORAGE 69
4.2.1.2 INFLUENCE OF FORCED DENATURATION 70 4.2.1.2.1 INFLUENCE OF
TEMPERATURE 70 4.2.1.2.2 INFLUENCE OF GUANIDINE 74 4.2.2 SECONDARY
STRUCTURE OF DIFFERENT ANTIBODIES 76 4.2.3 SUMMARY 78 4.3 SPRAY-DRYING
PROPERTIES OF MANNITOL 81 4.3.1 SPRAY DRY ING OF PURE MANNITOL 81 4.3.2
SPRAY DRYING OF HSA/MANNITOL * 84 4.3.3 SUMMARY 91 4.4 SPRAY-DRYING OF
ANTIBODY 1 FORMULATIONS 93 4.4.1 CHARACTERISTICS OF ANTIBODY 1/MANNITOL
FORMULATIONS AFTER SPRAY-DRYING 93 4.4.1.1 SUMMARY 102 4.4.2 STORAGE
TESTS OF ANTIBODY 1/MANNITOL POWDERS 103 4.4.2.1 STORAGE OF PRE-TREATED
ANTIBODY 1/MANNITOL POWDERS 103 4.4.2.2 STORAGE STABILITY OF POWDERS
SPRAY-DRIED AT T IN /T OU , OF 130/75C 109 4.4.2.3 SUMMARY 113 4.4.3
VARIATIONS BASED ON THE 70/30 ABL/MANNITOL FORMULATION 113 4.4.3.1
CHARACTERISTICS 115 4.4.3.2 STABILITY UPON STORAGE OF ANTIBODY
1/MANNITOL/SECOND EXCIPIENT POWDERS 120 4.4.4 VARIATIONS BASED ON THE
80/20 ABL/MANNITOL FORMULATION 125 4.4.5 SUMMARY 129 4.4.6 FTIR
SPECTROSCOPY OF ANTIBODY 1 CONTAINING POWDERS 132 4.4.6.1
FTIR-TRANSMISSION SPECTRA OF REDISSOLVED POWDERS 132 4.4.6.2 ATR-FTIR
SPECTRA OF ANTIBODY 1/MANNITOL POWDERS 134 4.4.6.3 INFLUENCE OF STORAGE
ON ATR-FTIR SPECTRA OF POWDERS 136 JV TABLE OF CONTENTS 4.4.6.4 SUMMARY
137 4.4.7 FINDING THE OPTIMUM - SPRAY-DRYING OF MODIFIED ABL/MANNITOL/
SECOND EXCIPIENT FORMULATIONS 138 4.4.7.1 POWDER CHARACTERISTICS OF
MODIFIED ABL/MANNITOL/SECOND EXCIPIENT FORMULATIONS 138 4.4.7.2 STORAGE
TESTS OF MODIFIED ABL/MANNITOL/SECOND EXCIPIENT POWDERS 143 4.4.7.2.1
STORAGE STABILITY OF MODIFIED POWDERS 143 4.4.7.2.2 AERODYNAMIC
PROPERTIES OF MODIFIED FORMULATIONS AFTER STORAGE 148 4.4.7.3 INFLUENCE
OF TOTAL SOLID ON STORAGE STABILITY 149 4.4.7.4 SUMMARY 151 4.5
COMPARISON OF DIFFERENT ANTIBODIES IN SPRAY-DRIED FORMULATIONS 153 4.5.1
CHARACTERISTICS OF SPRAY-DRIED ANTIBODY FORMULATIONS 153 4.5.1.1
AERODYNAMIC PROPERTIES 155 4.5.2 STORAGE STABILITY 156 4.5.3 SUMMARY 158
5 FINAL SUMMARY 161 6 REFERENCES 167 7 APPENDIX 185 |
| any_adam_object | 1 |
| any_adam_object_boolean | 1 |
| author | Schüle, Stefanie |
| author_facet | Schüle, Stefanie |
| author_role | aut |
| author_sort | Schüle, Stefanie |
| author_variant | s s ss |
| building | Verbundindex |
| bvnumber | BV021715113 |
| ctrlnum | (OCoLC)162388494 (DE-599)BVBBV021715113 |
| 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 |
| discipline_str_mv | Medizin |
| edition | 1. Aufl. |
| format | Thesis Book |
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| index_date | 2024-07-02T15:21:43Z |
| indexdate | 2024-07-09T20:42:20Z |
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| owner | DE-19 DE-BY-UBM DE-355 DE-BY-UBR DE-29T DE-12 DE-188 |
| owner_facet | DE-19 DE-BY-UBM DE-355 DE-BY-UBR DE-29T DE-12 DE-188 |
| physical | VII, 204 S. Ill., graph. Darst. 210 mm x 148 mm, 295 gr. |
| publishDate | 2006 |
| publishDateSearch | 2006 |
| publishDateSort | 2006 |
| publisher | Hut |
| record_format | marc |
| series2 | Pharmazeutische Technologie |
| spelling | Schüle, Stefanie Verfasser aut Stabilization of antibodies in spray-dried powders for inhalation Stefanie Schüle 1. Aufl. München Hut 2006 VII, 204 S. Ill., graph. Darst. 210 mm x 148 mm, 295 gr. txt rdacontent n rdamedia nc rdacarrier Pharmazeutische Technologie München, Univ., Diss., 2005 Inhalationsmittel (DE-588)4263866-5 gnd rswk-swf Zerstäubungstrocknung (DE-588)4190759-0 gnd rswk-swf Immunglobuline (DE-588)4026626-6 gnd rswk-swf (DE-588)4113937-9 Hochschulschrift gnd-content Inhalationsmittel (DE-588)4263866-5 s Immunglobuline (DE-588)4026626-6 s Zerstäubungstrocknung (DE-588)4190759-0 s DE-604 GBV Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=014928865&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Schüle, Stefanie Stabilization of antibodies in spray-dried powders for inhalation Inhalationsmittel (DE-588)4263866-5 gnd Zerstäubungstrocknung (DE-588)4190759-0 gnd Immunglobuline (DE-588)4026626-6 gnd |
| subject_GND | (DE-588)4263866-5 (DE-588)4190759-0 (DE-588)4026626-6 (DE-588)4113937-9 |
| title | Stabilization of antibodies in spray-dried powders for inhalation |
| title_auth | Stabilization of antibodies in spray-dried powders for inhalation |
| title_exact_search | Stabilization of antibodies in spray-dried powders for inhalation |
| title_exact_search_txtP | Stabilization of antibodies in spray-dried powders for inhalation |
| title_full | Stabilization of antibodies in spray-dried powders for inhalation Stefanie Schüle |
| title_fullStr | Stabilization of antibodies in spray-dried powders for inhalation Stefanie Schüle |
| title_full_unstemmed | Stabilization of antibodies in spray-dried powders for inhalation Stefanie Schüle |
| title_short | Stabilization of antibodies in spray-dried powders for inhalation |
| title_sort | stabilization of antibodies in spray dried powders for inhalation |
| topic | Inhalationsmittel (DE-588)4263866-5 gnd Zerstäubungstrocknung (DE-588)4190759-0 gnd Immunglobuline (DE-588)4026626-6 gnd |
| topic_facet | Inhalationsmittel Zerstäubungstrocknung Immunglobuline Hochschulschrift |
| url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=014928865&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
| work_keys_str_mv | AT schulestefanie stabilizationofantibodiesinspraydriedpowdersforinhalation |