Pharmaceutical formulation development of peptides and proteins:
Gespeichert in:
| Format: | Buch |
|---|---|
| Sprache: | English |
| Veröffentlicht: |
London [u.a.]
Taylor & Francis
2000
|
| Ausgabe: | 1. publ. |
| Schlagworte: | |
| Online-Zugang: | Inhaltsverzeichnis |
| Beschreibung: | XVIII, 238 S. graph. Darst. |
| ISBN: | 0748407456 |
Internformat
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Datensatz im Suchindex
| _version_ | 1804128250704691200 |
|---|---|
| adam_text | PHARMACEUTICAL FORMULATION DEVELOPMENT OF PEPTIDES AND PROTEINS EDITED
BY SVEN FROKJAER AND LARS HOVGAARD O *$L CONTENTS LIST OF FIGURES ,
PAGE XI LIST OF TABLES XIII CONTRIBUTORS XV PREFACE XVII 1 PEPTIDE
SYNTHESIS 1 BERNARD A. MOSS 1.1 INTRODUCTION 1 1.2 CHEMICAL SYNTHESIS OF
PEPTIDES 2 1.2.1 SOLUTION AND SOLID PHASE PEPTIDE SYNTHESIS 4 1.2.2
LARGE-SCALE PEPTIDE SYNTHESIS 6 1.3 CONCLUDING REMARKS 10 REFERENCES AND
ADDITIONAL SOURCES 10 2 BASICS IN RECOMBINANT DNA TECHNOLOGY 12 NANNI
DIN AND JAN ENGBERG 2.1 INTRODUCTION 12 2.2 GENERAL METHODS IN GENE
TECHNOLOGY 13 2.2.1 DNA CLONING TOOLS 13 2.2.2 CLONING OF CDNA 15 2.2.3
PCR CLONING AND DNA DATABASE MINING 16 2.3 EXPRESSION OF RECOMBINANT
PROTEINS 18 2.3.1 TRANSCRIPTION, TRANSLATION AND PROTEIN MODIFICATIONS
18 2.3.2 CHOICE OF EXPRESSION SYSTEM 19 2.4 PROTEIN DESIGN 22 2.4.1
PROTEIN VARIANTS 22 2.4.2 PROTEIN CHIMERAS 24 2.4.3 EPITOPE DISPLAY
LIBRARIES 24 VI CONTENTS 2.5 RECOMBINANT PROTEIN THERAPEUTICS - STATUS
AND FUTURE TRENDS 25 REFERENCES 27 3 PROTEIN PURIFICATION 29 LARS
HOVGAARD, LARS SKRIVER AND SVEN FROKJAER 3.1 INTRODUCTION 29 3.2
FRACTIONATION STRATEGIES 30 3.2.1 INITIAL FRACTIONATION STEP 30 3.2.2
INTERMEDIATE PURIFICATION STEP 31 3.2.3 FINAL POLISHING STEP 32 3.2.4
THE FINISHED PRODUCT 32 3.3 PROTEIN STABILITY IN DOWNSTREAM PROCESSING
33 3.3.1 PROTEIN CONFORMATION STABILITY 33 3.3.2 PROTEIN INSTABILITY 34
3.3.3 ESSENTIAL PROCESS-RELATED PARAMETERS 37 REFERENCES 38 4 PEPTIDE
AND PROTEIN CHARACTERIZATION 41 MIROSLAV BAUDYS AND SUNG WAN KIM 4.1
INTRODUCTION 41 4.2 CHROMATOGRAPHY 43 4.2.1 REVERSED PHASE
CHROMATOGRAPHY 43 4.2.2 HYDROPHOBIC INTERACTION CHROMATOGRAPHY 46 4.2.3
ION-EXCHANGE CHROMATOGRAPHY 47 4.2.4 SIZE-EXCLUSION CHROMATOGRAPHY 47
4.3 ELECTROPHORESIS 48 4.3.1 GEL ELECTROPHORESIS 48 4.3.2
TWO-DIMENSIONAL GEL ELECTROPHORESIS 50 4.3.3 CAPILLARY ELECTROPHORESIS
50 4.4 STRUCTURAL CHARACTERIZATION 51 4.4.1 PRIMARY STRUCTURE 52 4.4.2
MASS SPECTROMETRY 53 4.5 SECONDARY AND TERTIARY STRUCTURE 55 4.5.1
ABSORPTION AND FLUORESCENCE SPECTROSCOPY 56 4.5.2 CIRCULAR DICHROISM
SPECTROSCOPY 57 4.5.3 INFRARED SPECTROSCOPY 58 4.5.4 OTHER METHODS 59
4.6 CONCLUSION 60 REFERENCES 60 5 CHEMICAL PATHWAYS OF PEPTIDE AND
PROTEIN DEGRADATION 70 CHIMANLALL GOOLCHARRAN, MEHRNAZ KHOSSRAVI AND
RONALD T. BORCHARDT 5.1 INTRODUCTION 70 5.2 HYDROLYTIC PATHWAYS 71 5.2.1
DEAMIDATION OF ASN AND GIN RESIDUES 71 5.2.2 DEGRADATION OF ASP RESIDUES
75 CONTENTS VII 5.2.3 DEGRADATION OF N-TERMINAL SEQUENCES CONTAINING
PENULTIMATE PRO RESIDUES VIA DIKETOPIPERAZINE FORMATION 78 5.3 OXIDATION
PATHWAYS 79 5.3.1 AUTOOXIDATION 80 5.3.2 METAL-CATALYSED OXIDATION 80
5.3.3 PHOTOOXIDATION 82 5.3.4 STRATEGIES TO PREVENT OXIDATION 83 5.4
OTHER CHEMICAL PATHWAYS 84 5.4.1 (3-ELIMINATION REACTIONS 84 5.4.2
DISULPHIDE EXCHANGE REACTIONS 84 5.5 CONCLUSION 85 REFERENCES 86 6
PHYSICAL STABILITY OF PROTEINS 89 JENS BRANGE 6.1 INTRODUCTION 89 6.2
PROTEIN STRUCTURE 90 6.2.1 STABILIZING INTERACTIONS 92 6.2.2 ROLE OF
WATER IN STRUCTURE AND STABILITY 93 6.3 PROTEIN DESTABILIZATION
(DENATURATION) 94 6.3.1 UNFOLDING INTERMEDIATES (MOLTEN GLOBULE) 95
6.3.2 TEMPERATURE-INDUCED CHANGES 98 6.3.3 INFLUENCE OF PH 98 6.3.4
INFLUENCE OF PRESSURE 99 6.4 AGGREGATION AND PRECIPITATION 99 6.4.1
MECHANISMS OF AGGREGATION 100 6.4.2 PRECIPITATION AND FIBRILLATION
PHENOMENA 102 6.4.3 FACTORS INFLUENCING AGGREGATION AND PRECIPITATION
105 6.5 SURFACE ADSORPTION 106 6.6 SOLID PHASE STABILITY 107 6.6.1
LYOPHILIZATION-INDUCED AGGREGATION 107 6.7 STABILIZATION OF PROTEIN
DRUGS 107 6.7.1 STABILIZATION STRATEGIES 108 REFERENCES 109 7 PEPTIDES
AND PROTEINS AS PARENTERAL SUSPENSIONS: AN OVERVIEW OF DESIGN,
DEVELOPMENT, AND MANUFACTURING CONSIDERATIONS 1 13 MICHAEL R. DEFELIPPIS
AND MICHAEL J. AKERS 7.1 INTRODUCTION AND SCOPE 113 7.2 RATIONALE FOR
SUSPENSION DEVELOPMENT 114 7.3 TYPES OF SUSPENSIONS AND PARTICLE
FORMATION 116 7.3.1 IN SITU PARTICLE FORMATION 116 7.3.2 COMBINATION OF
PARTICLES AND VEHICLE 122 7.4 EXCIPIENT SELECTION 124 7.5 GENERAL
REQUIREMENTS FOR SUSPENSION PRODUCTS 126 7.6 TESTING AND OPTIMIZATION OF
CHEMICAL, PHYSICAL, AND MICROBIOLOGICAL PROPERTIES 127 VIII CONTENTS
7.6.1 CHEMICAL PROPERTIES 7.6.2 PHYSICAL PROPERTIES 7.6.3
MICROBIOLOGICAL PROPERTIES 7.7 TECHNIQUES FOR CHARACTERIZING AND
OPTIMIZING SUSPENSIONS 7.8 SUSPENSION MANUFACTURE 7.8.1 SCALE-UP 7.8.2
MANUFACTURING CONTROLS: SPECIAL CONSIDERATIONS FOR PEPTIDE AND PROTEIN
SUSPENSIONS 7.9 OTHER RELATED SYSTEMS 7.10 CONCLUSIONS ACKNOWLEDGEMENTS
REFERENCES 8 PEPTIDES AND PROTEINS AS PARENTERAL SOLUTIONS MICHAEL J.
AKERS AND MICHAEL R. DEFELIPPIS 8.1 OVERVIEW AND INTRODUCTION 8.2
OPTIMIZING HYDROLYTIC STABILITY 8.2.1 BUFFERS 8.2.2 IONIC STRENGTH 8.3
OPTIMIZING OXIDATIVE STABILITY 8.3.1 ANTIOXIDANTS 8.3.2 CHELATING AGENTS
8.3.3 INERT GASES 8.3.4 PACKAGING AND OXIDATION 8.3.5 OTHER CHEMICAL
STABILIZERS 8.4 OPTIMIZING PHYSICAL STABILITY 8.4.1 DENATURATION 8.4.2
PROTEIN AGGREGATION 8.4.3 ADSORPTION 8.4.4 PRECIPITATION 8.4.5
SURFACTANTS 8.4.6 CYCLODEXTRINS 8.4.7 ALBUMIN 8.4.8 OTHER PHYSICAL
COMPLEXING/STABILIZING AGENTS 8.5 OPTIMIZING MICROBIOLOGICAL ACTIVITY:
ANTIMICROBIAL PRESERVATIVES (APS) 8.6 OSMOLALITY (TONICITY) AGENTS 8.7
PACKAGING 8.8 PROCESSING 8.9 CONCLUSION REFERENCES 127 129 133 133 136
136 136 138 139 139 139 145 145 147 150 151 153 154 157 157 157 158 158
159 160 162 163 163 165 166 167 167 170 170 171 171 172 ROLES OF PROTEIN
CONFORMATION AND GLASSY STATE IN THE STORAGE STABILITY OF DRIED PROTEIN
FORMULATIONS 178 JOHN F. CARPENTER, LOTTE KREILGAARD, S. DEAN ALLISON
AND THEODORE W. RANDOLPH 9.1 INTRODUCTION 178 9.2 INFRARED SPECTROSCOPY
TO STUDY PROTEIN SECONDARY STRUCTURE 180 CONTENTS IX 9.3 PHYSICAL
FACTORS AFFECTING STORAGE STABILITY OF DRIED PROTEIN FORMULATIONS 181
9.4 SUMMARY AND CONCLUSIONS 186 ACKNOWLEDGEMENTS 186 REFERENCES 186 10
PEPTIDE AND PROTEIN DRUG DELIVERY SYSTEMS FOR NON-PARENTERAL ROUTES OF
ADMINISTRATION 189 METTE INGEMANN, SVEN FROKJAER, LARS HOVGAARD AND
HELLE BRONDSTED 10.1 INTRODUCTION 189 10.2 NON-PARENTERAL ROUTES OF
DELIVERY FOR PEPTIDES AND PROTEINS 189 10.2.1 BARRIERS TO NON-PARENTERAL
ADMINISTRATION OF PEPTIDES AND PROTEINS 191 10.2.2 GENERAL APPROACHES TO
BYPASS ENZYMATIC AND ABSORPTION BARRIERS 192 10.3 FORMULATION PRINCIPLES
FOR PEPTIDES AND PROTEINS 194 10.3.1 ENTRAPMENT AND ENCAPSULATION 194
10.3.2 COVALENT BINDING 198 10.4 IMMOBILIZED PROTEINS INTENDED FOR LOCAL
EFFECT IN THE GI TRACT - A CASE STUDY 200 10.4.1 ORAL ENZYME
SUPPLEMENTATION THERAPY - PHENYLALANINE AMMONIA-LYASE 200 10.5 FUTURE
PERSPECTIVES 202 10.6 SUMMARY 203 REFERENCES 203 11 PEPTIDE AND PROTEIN
DERIVATIVES 206 GITTE JUEL FRIIS * 11.1 INTRODUCTION 206 11.2
4-IMIDAZOLIDINONE PRODRUGS 207 11.3 PRODRUGS OF TRH 209 11.4 DERIVATIVES
OF DESMOPRESSIN 210 11.5 DERIVATIVES OF INSULIN 212 11.6 CYCLIC PRODRUGS
213 11.7 CONCLUSIONS 214 REFERENCES 215 12 CHEMICAL AND PHARMACEUTICAL
DOCUMENTATION 220 KAREN FICH AND DEIRDRE MANNION 12.1 INTRODUCTION 220
12.2 COMPOSITION 221 12.3 METHOD OF MANUFACTURE 222 12.4 CONTROL OF
STARTING MATERIALS 222 12.4.1 ACTIVE SUBSTANCES 222 12.4.2 EXCIPIENTS
226 12.4.3 PACKAGING MATERIALS 226 CONTENTS 12.5 INTERMEDIATE PRODUCTS
227 12.6 CONTROL TESTS ON THE FINISHED PRODUCT 227 12.7 STABILITY 228
12.7.1 EXPERT REPORT 230 REFERENCES 231 INDEX 232
|
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| spelling | Pharmaceutical formulation development of peptides and proteins ed. by Sven Frokjaer ... 1. publ. London [u.a.] Taylor & Francis 2000 XVIII, 238 S. graph. Darst. txt rdacontent n rdamedia nc rdacarrier Protein drugs Arzneimittel (DE-588)4003115-9 gnd rswk-swf Proteine (DE-588)4076388-2 gnd rswk-swf 1\p (DE-588)4143413-4 Aufsatzsammlung gnd-content Proteine (DE-588)4076388-2 s Arzneimittel (DE-588)4003115-9 s 2\p DE-604 Frøkjaer, Sven Sonstige oth GBV Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=009186868&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis 1\p cgwrk 20201028 DE-101 https://d-nb.info/provenance/plan#cgwrk 2\p cgwrk 20201028 DE-101 https://d-nb.info/provenance/plan#cgwrk |
| spellingShingle | Pharmaceutical formulation development of peptides and proteins Protein drugs Arzneimittel (DE-588)4003115-9 gnd Proteine (DE-588)4076388-2 gnd |
| subject_GND | (DE-588)4003115-9 (DE-588)4076388-2 (DE-588)4143413-4 |
| title | Pharmaceutical formulation development of peptides and proteins |
| title_auth | Pharmaceutical formulation development of peptides and proteins |
| title_exact_search | Pharmaceutical formulation development of peptides and proteins |
| title_full | Pharmaceutical formulation development of peptides and proteins ed. by Sven Frokjaer ... |
| title_fullStr | Pharmaceutical formulation development of peptides and proteins ed. by Sven Frokjaer ... |
| title_full_unstemmed | Pharmaceutical formulation development of peptides and proteins ed. by Sven Frokjaer ... |
| title_short | Pharmaceutical formulation development of peptides and proteins |
| title_sort | pharmaceutical formulation development of peptides and proteins |
| topic | Protein drugs Arzneimittel (DE-588)4003115-9 gnd Proteine (DE-588)4076388-2 gnd |
| topic_facet | Protein drugs Arzneimittel Proteine Aufsatzsammlung |
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