Handbook of Pharmaceutical Wet Granulation Theory and Practice in a Quality by Design Paradigm 1st Edition by Ajit Narang, Sherif Badawy 0323481038 9780323481038

Handbook of Pharmaceutical Wet Granulation Theory and Practice in a Quality by Design Paradigm 1st Edition by Ajit S. Narang, Sherif I.F. Badawy – Ebook PDF Instant Download/Delivery:  0323481038, 9780323481038 
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Product details:

ISBN 10: 0323481038 

ISBN 13: 9780323481038

Author: Ajit S. Narang, Sherif I.F. Badawy 

Handbook of Pharmaceutical Wet Granulation Theory and Practice in a Quality by Design Paradigm 1st Table of contents:

Chapter 1: Physicochemical Principles Governing Agglomeration and Growth Kinetics

1 General Introduction
Chapter 2: Microstructure and Mechanical Properties of Granules Formed in High Shear Wet Granulation
Abstract
Acknowledgments
1 Introduction
2 Characterization Techniques
3 Microstructure of Granules
4 Connection Between Granule Microstructure and Granule Strength
5 Connection Between Granule Microstructure and Granule Dissolution
6 Granule Microstructure and Granulation Process
7 Concluding Remarks
Chapter 3: Mechanistic Basis for the Effects of Process Parameters on Quality Attributes in High Shear Wet Granulation
Abstract
1 Introduction
2 Lactose Study
3 Active Pharmaceutical Ingredient (API) Studies
4 Summary and Conclusions
Chapter 4: Structures and Properties of Granules Prepared By High Shear Wet Granulation
Abstract
1 Introduction
2 Material Sciences Tetrahedron
3 Topics of Practical Importance in High Shear Wet Granulation (HSWG)
4 Evolution of Granule Structure During HSWG
5 Applications of Materials Science Tetrahedron in HSWG
6 A Formulation Strategy for Solving Overgranulation Problem During HSWG
7 Conclusion
Chapter 5: Wet Granulation and Chemical Stability of Drug Products
Abstract
1 Introduction
2 Reduced Stability by Wet Granulation
3 Enhanced Stability by Wet Granulation
4 Summary and Conclusions
Chapter 6: Material Physical Modifications Induced by Wet Granulation
Abstract
1 Introduction
2 Solid State Transformation in Wet Granulation
3 Micromeritic Changes in Wet Granulation
4 Summary and Conclusions
Chapter 7: Current Practices in Wet Granulation-Based Generic Product Development
Abstract
Acknowledgments
1 Introduction
2 Mechanism of Granule Formation
3 Granulation Methodologies
4 Application of QbD in Wet Granulation Process Development
5 Granulation End Point Determination
6 Scaleup of Wet Granulation Process
7 Conclusions and Recommendations
Part 2: Excipients and Input Material Attributes Impacting Wet Granulation
Chapter 8: Material Attributes and Their Impact on Wet Granulation Process Performance
Abstract
1 Granulation Technology
2 Excipients in Wet-Granulation Process
3 Conclusion and Future Directions
Chapter 9: Binders in Wet Granulation
Abstract
1 Introduction
2 Physical-Chemical Properties of Common Wet Granulation Binders
3 Important Considerations for Binder Selection and Use
4 Regulatory Acceptance and Supplier Reliability
Chapter 10: Effect of Binder Attributes on Granule Growth and Densification
Abstract
Acknowledgments
1 Functional Excipients and Critical Material Attributes
2 Impact of Binder Attributes on Granulation Outcomes
3 Impact of Binders on Granulation Outcomes
4 Simulation of Particle Velocities and Impaction Forces
5 Modeling Binder Mode of Addition Effects
6 Granule Consolidation Kinetics
7 Conclusion
Chapter 11: Role of Drug Substance Material Properties in the Processibility and Performance of Wet Granulated Products
Abstract
1 Introduction
2 Multivariate Study of Input Material Properties
3 Effect of Particle Size
4 Surface Area
5 Contact Angle
6 Solubility
7 Compaction Properties
8 Flow Properties
9 Summary and Conclusions
Chapter 12: Critical Material Attributes in Wet Granulation
Abstract
1 Introduction
2 Basics of Wet Granulation: Understanding the Process, the Equipment, and the Materials
3 QbD Paradigm in Wet Granulation
4 Execution of QbD Methodology in Assessing Criticality of Material Attributes
5 Conclusions
Chapter 13: Use of Mannitol as a Filler in Wet Granulation
Abstract
1 Introduction
2 Study Design
3 Characterization of Granulation and Tablets
4 Compaction Studies
5 Particle Size Distribution
6 Granulation Flow
7 Summary and Conclusions
Part 3: Process Analytical Technology, Scale-up, and Control Strategy
Chapter 14: Inline Focused Beam Reflectance Measurement During Wet Granulation
Abstract
Acknowledgments
1 Introduction
2 FBRM Probe Setup and Operation
3 Understanding Chord Length Distribution
4 Granulations That Predominantly Increase the Particle Size
5 Granulations that Predominantly Reduce Fines
6 Conclusions
Chapter 15: Principles of Drag Force Flow Sensor
Abstract
1 Introduction
2 Measurement Principle of the DFF Sensor
3 Sensing Model
4 Flow Force
5 Data Interpretation
6 2-Dimensional DFF: Direction of Particle Flow
7 Conclusions
Chapter 16: Real-Time Assessment of Granule Densification and Application to Scale-up
Abstract
1 Introduction
2 In-Line Drag Force Flow Sensor and Focused Beam Reflectance Measurements
3 Brivanib Alaninate Granulation
4 Discussion and Conclusion
Chapter 17: An Introduction to Powder Characterization
Abstract
1 The Relevance of Powder Flow for Wet Granulation
2 Considerations and Challenges in Characterizing Powder Flow
3 Defining a Powder—Fundamental Principles of Particles
4 Methods Available to the Modern Scientist
5 Practical Process Relevance—Case Studies (× 3)
6 Conclusions
Chapter 18: A Quality By Design Approach to Scale-Up of High Shear Wet Granulation Process
Abstract
1 Introduction
2 High-Shear Wet Granulation Process
3 QbD in High-Shear Wet Granulation
4 Scale-Up Principles
5 Modeling Techniques
6 Summary
Chapter 19: Wet Mass Consistency Reported by In-Line Drag Force Flow Sensor Compared With Powder Rheology and Shaft Amperage
Abstract
1 Introduction
2 Comparison of Force Pulse Magnitude With Basic Flowability Energy
3 Comparison of Force Pulse Magnitude With Shaft Amperage
4 Conclusions
Chapter 20: Integrated Application of Quality-by-Design Principles to Drug Product and Its Control Strategy Development
Abstract
1 Introduction
2 QbD Methodology
3 Physical Characterization
4 Process Analytical Technology
5 Formulation Selection and Optimization
6 Critical Quality Attributes, Process Parameters, and Material Attributes
7 Control Strategy
8 Key Considerations
9 Concluding Remarks
Chapter 21: Implementation of Pharmaceutical Quality by Design in Wet Granulation
Abstract
1 Introduction
2 Function and Popularity of Wet Granulation
3 QbD and Unit Operation Profiles for Wet Granulation
4 Quality Characterizations of Wet Granulation Product
5 Product Design and Understanding of Wet Granulation
6 Process Design and Understanding of Wet Granulation
7 QbD Tools and Wet Granulation Development
8 Summary
Part 4: Process Modeling and Emerging Trends in Wet Granulation
Chapter 22: Numerical Modeling for Wet Granulation Processes
Abstract
1 Introduction
2 Random Models
3 Population Balance Models
4 Fundamental of Discrete Element Method (DEM)
5 Analysis and Design of Granulation Processes Using DEM
6 Advanced Modeling of Particle Transformation in Wet Granulation by DEM-Related Methods
Chapter 23: Application of the Discrete Element Method to Scale-Up of High-Shear Granulation
Abstract
1 Introduction
2 What Can We Extract From the Discrete Element Modeling?
3 Application Examples
4 Summary and Outlook
Chapter 24: Twin Screw Continuous Wet Granulation
Abstract
1 Introduction
2 Challenges With Granulation and Tableting Technologies
3 Wet Granulation
4 Continuous Wet Granulation
5 Understanding Twin Screw Wet Granulation (TSWG)
6 Effects of Process Parameters on Twin Screw Wet Granulation
7 In-line Monitoring of the Twin Screw Granulation Process
8 Comparison of Twin Screw Granulation With High Shear Granulation
9 Possible Mechanism of the Effect of Twin Screw Wet Granulation on Granule Properties
10 General Issues With Twin Screw Wet Granulation
11 Some Recent Efforts in Continuous Granulation
12 Continuous Twin Screw Wet Granulation Process by Eliminating Multiple Unit Operations
13 Summary
Chapter 25: Emerging Paradigms in Pharmaceutical Wet Granulation
Abstract
1 Introduction
2 Moisture Activated Granulation
3 Technologies With Concurrent Heat and Mass Flow Dynamics
4 Foam Granulation
5 Conclusion and Future Trends

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