Chemical Engineering in the Pharmaceutical Industry, R & d to Manufacturing [2nd ed] 9781119285519, 1119285518, 9781119285502, 9781119285496

Table of contents :
Content: Intro
TITLE PAGE
COPYRIGHT PAGE
CONTENTS
LIST OF CONTRIBUTORS
PREFACE
UNIT CONVERSIONS
PART I INTRODUCTION
CHAPTER 1 CHEMICAL ENGINEERING IN THE PHARMACEUTICAL INDUSTRY
1.1 GLOBAL IMPACT OF THE INDUSTRY
1.2 INVESTMENTS IN PHARMACEUTICAL R 1.3 BEST SELLERS
1.4 PHARMACEUTICAL RESEARCH AND DEVELOPMENT EXPENDITURES
1.5 RECENT TRENDS FOR PHARMACEUTICAL DRUG AND MANUFACTURING
1.6 CHEMICAL ENGINEERS SKILLED TO IMPACT FUTURE OF PHARMACEUTICAL INDUSTRY
REFERENCES
PART II DRUG PRODUCT DESIGN, DEVELOPMENT, AND MODELING
CHAPTER 2 DESIGN OF SOLID DOSAGE FORMULATIONS
2.1 INTRODUCTION 2.2 UNDERSTANDING DRUG SUBSTANCE2.3 EXCIPIENTS
2.4 DRUG-EXCIPIENT COMPATIBILITY STUDY
2.5 PROCESSING OF FORMULATIONS
2.6 TABLET FORMULATION DESIGN
2.7 TABLET CHARACTERISTICS
2.8 USING DISSOLUTION TO DETERMINE CQAs
2.9 DRUG PRODUCT STABILITY
2.10 PROCESS OPERATIONS AND SCALABILITY OF DOSAGE FORM
2.11 CONCLUDING REMARKS
REFERENCES
CHAPTER 3 POWDER PROCESS CHALLENGES AND SOLUTIONS
3.1 INTRODUCTION
3.2 COMMON POWDER-HANDLING EQUIPMENT
3.3 POWDER FLOW AND SEGREGATION CONCERNS
3.4 MEASUREMENT OF FLOW PROPERTIES 3.5 TROUBLE-SHOOTING POWDER-HANDLING PROBLEMS AND EQUIPMENT DESIGN METHODSREFERENCES
CHAPTER 4 DESIGN AND SCALE-UP OF DRY GRANULATION PROCESSES
4.1 OVERVIEW OF THE DRY GRANULATION PROCESS
4.2 GENERAL CONSIDERATIONS FOR ROLLER COMPACTION OPERATIONS AND EQUIPMENT
4.3 MATERIAL BEHAVIOR, QUALITY ATTRIBUTES, AND TESTING
4.4 PRINCIPLES OF OPERATION
4.5 SCALE-UP OF ROLLER COMPACTION
4.6 SUMMARY
REFERENCES
CHAPTER 5 MODEL-BASED DEVELOPMENT OF ROLLER COMPACTION PROCESSES
5.1 INTRODUCTION
5.2 ROLL COMPACTION
5.3 MILLING 5.4 PROPERTY FUNCTIONS FOR MODEL-BASED DEVELOPMENT OF ROLLER COMPACTION5.5 CONNECTING PROCESS AND PROPERTY MODELS
5.6 SUMMARY
5.7 NOTATION
REFERENCES
CHAPTER 6 WET GRANULATION PROCESSES
6.1 INTRODUCTION
6.2 MECHANISMS IN WET GRANULATION
6.3 SCALE-UP
6.4 FUTURE DIRECTIONS
REFERENCES
CHAPTER 7 TOWARD A GENERIC MODEL FOR TWIN-SCREW WET GRANULATION
7.1 INTRODUCTION
7.2 EXPERIMENTAL DATA COLLECTION
7.3 GRANULE SIZE DISTRIBUTIONS AT DIFFERENT LOCATIONS
7.4 PBM MODEL DEVELOPMENT
7.5 PBM MODEL CALIBRATION
7.6 RESULTS FOR THE WETTING ZONE 1
7.7 RESULTS FOR THE FIRST KNEADING ZONE 3 7.8 RESULTS FOR THE SECOND KNEADING ZONE 67.9 RESULTS OF DIRECT SIMULATION FROM PREBLEND TO FINAL GRANULES AT TSG OUTLET (ZONES 1-6)
7.10 OUTLOOK
REFERENCES
CHAPTER 8 MODELING A DOSATOR CAPSULE FILLING PROCESS FOR HARD-SHELL CAPSULES
8.1 OVERVIEW OF THE DOSATOR CAPSULE FILLING PROCESS
8.2 DEM MODEL OF THE DOSATOR PROCESS
8.3 MODELING RESULTS FOR THE DOSATOR FILLING PROCESS
8.4 CASE STUDY: PREDICTION OF OPTIMAL INSERTION DEPTH INTO THE POWDER BED DURING A DOSATOR FILLING PROCESS
8.5 SUMMARY
REFERENCES
CHAPTER 9 POWDER COMPACTION
9.1 INTRODUCTION

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