Kooperativer Bibliotheksverbund

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Format: 1 online resource (444 pages)

ISBN: 0-12-813480-1

Series Statement: Expertise in Pharmaceutical Process Technology

Content: "How to Design and Implement Powder-to-Tablet Continuous Manufacturing Systems provides a comprehensive overview on the considerations necessary for the design of continuous pharmaceutical manufacturing processes. The book covers both the theory and design of continuous processing of associated unit operations, along with their characterization and control. In addition, it discusses practical insights and strategies that the editor and chapter authors have learned. Chapters cover Process Analytical Technology (PAT) tools and the application of PAT data to enable distributed process control. With numerous case studies throughout, this valuable guide is ideal for those engaged in, or learning about, continuous processing in pharmaceutical manufacturing."--

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. , 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. , 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. , 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. , 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. , 4.4 Direct search methods.

Additional Edition: Print version: Muzzio, Fernando How to Design and Implement Powder-To-Tablet Continuous Manufacturing Systems San Diego : Elsevier Science & Technology,c2022 ISBN 9780128134795

Language: English