Chemical Engineering in the Pharmaceutical Industry: R&D to ManufacturingDavid J. am Ende This book deals with various unique elements in the drug development process within chemical engineering science and pharmaceutical R&D. The book is intended to be used as a professional reference and potentially as a text book reference in pharmaceutical engineering and pharmaceutical sciences. Many of the experimental methods related to pharmaceutical process development are learned on the job. This book is intended to provide many of those important concepts that R&D Engineers and manufacturing Engineers should know and be familiar if they are going to be successful in the Pharmaceutical Industry. These include basic analytics for quantitation of reaction components– often skipped in ChE Reaction Engineering and kinetics books. In addition Chemical Engineering in the Pharmaceutical Industry introduces contemporary methods of data analysis for kinetic modeling and extends these concepts into Quality by Design strategies for regulatory filings. For the current professionals, in-silico process modeling tools that streamline experimental screening approaches is also new and presented here. Continuous flow processing, although mainstream for ChE, is unique in this context given the range of scales and the complex economics associated with transforming existing batch-plant capacity. The book will be split into four distinct yet related parts. These parts will address the fundamentals of analytical techniques for engineers, thermodynamic modeling, and finally provides an appendix with common engineering tools and examples of their applications. |
Contents
Chemical Engineering Principles in Biologics | |
Designinga Sustainable Pharmaceutical Industry | |
Scientific OpportunitiesThrough Quality | |
Reaction Kinetics and Characterization | |
UnderstandingRate Processes in Catalytic | |
References | |
Characterizationand | |
Solubility by Unknown More Stable Form | |
Toward aRational Solvent Selection | |
Molecular Thermodynamics for Pharmaceutical | |
the Development and Manufacturing of Active | |
Quality by Design for Analytical Methods | |
References | |
Quantitative | |
ExperimentalDesignfor Pharmaceutical | |
Reactions | |
Modeling Optimization and Applications | |
Design of Distillation and Extraction Operations | |
Crystallization Designand ScaleUp | |
ScaleUpofMixing Processes APrimer | |
Stirred Vessels Computational Modeling | |
Current Challenges andOpportunities in the Pharmaceutical Industry | |
3Organic SolventNanofiltration inPharmaceutical Industry | |
Chapter | |
The Design and Economics of LargeScale | |
Chapter | |
ProcessSafetyand Reaction Hazard Assessment | |
Process ScaleUp and Assessment | |
Chapter | |
ScaleUpDosand | |
References | |
Process Development and Case Studies | |
6 | |
Pharma | |
References | |
Prediction of Polymorphic Systems | |
4Fractional Factorials 32 5DesignProjection | |
Development | |
Chapter | |
Process Design and Development for Novel | |
Design ofSolid Dosage Formulations | |
ControlledRelease Technologyand Design | |
Chapter | |
3Material Behavior Attribute Testingand Process Sensors | |
4Principles | |
5ScaleUp | |
References | |
Chapter | |
Spray Atomization Modeling for Tablet Film | |
The FreezeDrying Process The Use | |
Achieving a Hot Melt Extrusion Design Space | |
ContinuousProcessing in Secondary Production | |
Pharmaceutical Manufacturing TheRole | |
References | |
Characterization | |
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Chemical Engineering in the Pharmaceutical Industry: R&D to Manufacturing David J. am Ende No preview available - 2010 |
Common terms and phrases
achieve activity addition agitation applications approach batch calculated catalyst cell characteristics characterization chemical chemical engineering chromatography coefficient complete component composition concentration considered constant continuous cooling crystallization dependent described determine discussed dispersion distillation distribution effect energy equation equilibrium equipment estimation example experimental experiments factor Figure filtration flow fluid force function growth heat heat transfer higher hydrogenation impeller important increase industry inthe kinetics laboratory limit liquid manufacturing mass transfer material measured mechanism membrane method mixing mixture needed observed ofthe operation parameters particle performance pervaporation pharmaceutical phase plot predicted pressure reaction reactor reduce relative represents scale scaleup selectivity separation shown shows similar simulations solid solubility solution solvent specific speed step stirred surface suspension Table temperature turbulent typically understanding values vessel volume