Format:
1 Online-Ressource (444 Seiten)
ISBN:
9780128134801
,
9780128134795
Series Statement:
Expertise in Pharmaceutical Process Technology Ser
Note:
Front Cover -- How to Design and Implement Powder-to-Tablet Continuous Manufacturing Systems -- How to Design and Implement Powder-to-Tablet Continuous Manufacturing Systems -- Copyright -- Dedication -- Contents -- Contributors -- About the Expertise in Pharmaceutical Process Technology Series -- Format -- Subject matter -- Target audience -- Foreword -- 1 - Introduction -- 1. Foreword-our journey in CM -- 2. The many benefits of continuous solid dose manufacturing -- 2.1 Improving product quality -- 2.2 Faster product and process development -- 2.3 Faster responses to shortages and emergencies -- 2.4 Potential for reducing drug prices -- 3. The engineering toolbox, applied to pharmaceutical manufacturing process design -- References -- 2 - Characterization of material properties -- 1. Introduction -- 2. Summary of the characterization techniques and their description -- 2.1 Bulk density test -- 2.2 Particle size distribution test -- 2.3 Powder flow measurements -- 2.4 Powder hydrophobicity/wettability measurements -- 2.5 Electrostatic measurement (impedance test) -- 3. Developing a material property database -- 4. Multivariate analysis -- 4.1 Principal component analysis -- 4.2 Clustering analysis -- 5. Application of material property databases -- 5.1 Identifying similar materials as surrogates for process development -- 5.2 Predicting process performance using material property databases -- 6. Conclusions -- References -- 3 - Loss-in-weight feeding -- 1. Introduction -- 2. Characterization of loss-in-weight feeders -- 2.1 Gravimetric feeding performance -- 2.1.1 Materials and equipment -- 2.1.2 Methodology -- 2.1.3 Experimental setup -- 2.1.4 General volumetric test run procedure -- 2.1.5 General gravimetric test run procedure -- 2.1.6 Analysis and filtering -- 2.1.7 Results and discussion -- 2.2 Ideal design space for loss-in-weight feeders
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2.2.1 Materials and experimental setup -- 2.2.2 Methods -- 2.3 Feed rate deviation caused by hopper refill -- 2.3.1 Operation during hopper refill -- 2.3.2 Quantifying deviation -- 2.3.3 Effect of refill level -- 2.3.4 Investigation of refill method -- 3. Effect of material flow properties on loss-in-weight feeding -- 4. Modeling of loss-in-weight feeders -- 5. Conclusions -- References -- 4 - Continuous powder mixing and lubrication -- 1. Fundamentals of powder mixing -- 1.1 Type of mixtures -- 1.1.1 Perfect mixture -- 1.1.2 Random mixture -- 1.1.3 Ordered mixtures -- 1.1.4 Textured (segregated) mixtures -- 1.2 Quantifying mixtures -- 1.3 Sampling -- 1.3.1 Sample size -- 1.3.2 Number of samples -- 1.3.3 Sampling in batch versus continuous blenders -- 1.4 Mixing mechanisms -- 2. Modes of powder mixing -- 2.1 Batch powder blenders -- 2.2 Continuous powder blenders -- 3. Mixing in continuous tubular blenders -- 3.1 Residence time distribution in continuous powders blenders -- 3.2 Choosing an appropriate mixer configuration -- 4. Lubrication in continuous tubular blenders -- 4.1 Role of lubricant -- 4.2 Measuring lubricity -- 4.3 Lubricant mixing in continuous blenders -- 4.4 Lubricant mixing in continuous versus batch systems -- 5. Role of delumping in continuous powder mixing -- 6. Other topics -- 6.1 Modeling in continuous blenders -- 6.2 Blending of segregating ingredients in continuous blenders -- 7. Conclusions -- References -- 5 - Continuous dry granulation -- 1. Introduction -- 2. Roller compaction -- 3. Milling -- 3.1 Types of mill -- 3.1.1 Impact mill -- 3.1.2 Shear-compression mill -- 4. Roller compaction characterization and micromechanical modeling -- 4.1 Near-infrared spectroscopy-information on chemical composition and physical properties -- 4.1.1 Near-infrared spectroscopy in monitoring roller compaction
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4.2 Computational modeling of compaction -- 5. Granule characterization after milling -- 5.1 Sieve analysis -- 5.2 Laser diffraction -- 5.3 Laser diffraction (Insitec) -- 5.4 Dynamic image analysis -- 5.5 Focused beam reflectance measurement -- 5.6 Bulk density -- 5.7 Tap density -- 5.8 Compressibility index and Hausner ratio -- 5.9 Friability -- 5.10 Porosity -- 6. Models for milling -- 6.1 Population balance models -- 6.2 Mechanistic models -- 7. Conclusions -- References -- 6 - A modeling, control, sensing, and experimental overview of continuous wet granulation -- 1. Introduction -- 2. Experimental design -- 2.1 Residence time distribution in continuous wet granulation -- 3. Process modeling -- 4. Case studies -- 4.1 Twin screw granulator -- 4.2 High shear granulator -- 5. Conclusions -- References -- 7 - Continuous fluid bed processing -- 1. Introduction -- 2. Basics of fluidized beds -- 3. Drying background and theory -- 4. Granulation drying background and theory -- 5. Commercial application -- 6. Why batch -- 7. Continuous processes in other industries -- 8. Traditional continuous fluid bed design -- 9. Adaptation to pharmaceutical processing -- 10. Traceability -- 11. Other continuous granulation methods -- 12. Summary and conclusion -- 8 - Continuous tableting -- 1. Fundamentals of tableting -- 2. Phenomenological modeling of compaction -- 3. Characterization of compaction operations -- 4. Characterization of tablets in continuous manufacturing -- 4.1 Models for composition -- 4.2 Models for hardness prediction -- 4.2.1 Ultrasound testing -- 4.2.2 Infrared thermography -- 4.2.3 Models for dissolution prediction -- 5. Control -- 5.1 Inbuilt tablet press control strategy -- 5.2 Advanced model predictive control system -- 5.3 Design of an advanced model predictive control system for a tablet press
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5.4 Implementation of advanced model predictive control system into tablet press -- 5.5 Supervisory control system to integrate tablet press with CM line -- 6. Designing an experimental plan for continuous tableting -- 7. Conclusions -- References -- 9 - Continuous film coating within continuous oral solid dose manufacturing -- 1. Fundamentals of continuous coating within continuous manufacturing -- 2. Goals of continuous film coating -- 2.1 Cosmetic coatings -- 2.2 Functional coatings -- 2.3 Basics of the film coating process -- 2.3.1 The process (recipe) -- 2.3.2 The platform (coater) -- 2.3.2.1 Application of the film solution -- 2.3.2.2 Drying the tablets -- 2.3.2.3 Mixing the tablets -- 2.3.3 The formulation (solution/suspension) -- 2.3.3.1 Solutions for cosmetic film coating -- 2.3.3.2 Solutions and suspensions for enteric coating -- 3. Expectations of continuous coaters -- 3.1 Change in manufacturing strategies -- 3.2 Supporting factors -- 3.3 Partnering on the continuous manufacturing coating projects -- 3.4 Special demands of the continuous coating process -- 4. Types of batch and continuous coaters used in continuous processes -- 4.1 Traditional "batch" coaters in continuous manufacturing -- 4.2 The GEA ConsiGma coater -- 4.3 Classic high-throughput continuous coaters -- 4.4 A hybrid: Driaconti-T multichambered continuous coater -- 4.5 Overall comparison -- 4.6 Considerations for production and other aspects -- 5. Controls and process analytical technology -- 5.1 Simulation and modeling of the process -- 6. Conclusions -- References -- Further reading -- 10 - Role of process analytical technology in continuous manufacturing -- 1. Introduction/background -- 2. Method development and life cycle considerations for PAT in CM -- 2.1 Instrument, sampling, reference values, multivariate analysis, sensitivity
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2.2 Sensor location and placement for calibration model building -- 2.2.1 Sampling volume -- 2.3 PAT method validation overview in CM -- 2.4 Maintenance overview -- 3. PAT in a CM commercial control strategy -- 4. Case studies -- 4.1 Continuous blending -- 4.2 Granulation -- 4.3 Residence time distribution determination in feeders and blenders -- 4.3.1 Feeders -- 4.3.2 Blenders -- 4.4 Tablets: dissolution alternatives -- 4.5 Chemical imaging: offline uniformity, API distribution -- 5. Conclusions -- References -- 11 - Developing process models of an open-loop integrated system -- 1. Introduction -- 2. Loss-in-weight feeder -- 3. Continuous blender -- 4. Roller compactor -- 5. Continuous wet granulator -- 6. Fluidized bed dryer -- 7. Conical screen mill -- 8. Tablet press -- 9. Integration -- 10. Conclusions -- References -- 12 - Integrated process control -- 1. Introduction -- 2. Design of the control architecture -- 3. Develop integrated model of closed-loop system -- 4. Implementation and verification of the control framework -- 5. Characterize and verify closed-loop performance -- 6. Conclusions -- Acknowledgment -- References -- 13 - Applications of optimization in the pharmaceutical process development -- 1. Introduction -- 2. Optimization objectives in pharmaceutical process development -- 2.1 Single-objective optimization -- 2.2 Multiobjective optimization -- 3. Applications of data-driven models in optimization -- 3.1 Sampling plans -- 3.2 Building a data-driven model -- 3.3 Response surface methodology -- 3.4 Partial least squares -- 3.5 Artificial neural network -- 3.6 Kriging -- 3.7 Model validation -- 3.8 Data-driven models in support of optimization needs -- 4. Optimization methods in pharmaceutical processes -- 4.1 Derivative-based methods -- 4.2 Successive quadratic programming -- 4.3 Derivative-free methods
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4.4 Direct search methods
Additional Edition:
Erscheint auch als Druck-Ausgabe Muzzio, Fernando How to Design and Implement Powder-To-Tablet Continuous Manufacturing Systems San Diego : Elsevier Science & Technology,c2022 ISBN 9780128134795
Language:
English
