The book offers a comprehensive overview of the unit operations involved in the manufacturing process of solid and liquid dosage forms, along with the scale-up of each operation. This book is a valuable resource for professionals working in the pharmaceutical industry and researchers seeking to develop a comprehensive understanding of the various aspects of the manufacturing process.
The book is divided into four sections, covering a range of topics. Section I provide readers with a comprehensive understanding of the basic principles behind the manufacturing process of solid and liquid dosage forms.
Section II covers the different unit operations involved in the production of solid dosage forms, including mixing, granulation, drying, compression, coating, and size reduction. This section includes case studies to provide readers with practical insights into the scale-up principles involved in the manufacturing process.Section III focuses on the manufacturing and scale-up of liquid formulations, covering topics such as mixing, filtration, and scale-up of liquid mixing process. This section offers a comprehensive understanding of the various aspects of the manufacturing process, including the challenges and opportunities associated with the scale-up of liquid formulations.
Finally, Section IV includes two chapters that describe the manufacturing and scale-up of advanced drug delivery systems, including the manufacturing and scale-up of nanoparticles and biotechnology-derived products. This section provides readers with insights into the development of innovative drug delivery systems and the challenges involved in their scale-up.Overall, the book is an essential guide for professionals and researchers seeking a deeper understanding of the manufacturing process. The case studies and practical examples offer valuable insights into the challenges and opportunities involved in the scale-up process, making it an indispensable resource for those involved in the pharmaceutical industry.
- Only book that is dedicated to pharmaceutical process engineering and scale-up;
- Contain numerous case studies for easy reference;
- Covers solid, liquid, and advanced dosage forms.
Author(s): Anil B. Jindal
Series: AAPS Introductions in the Pharmaceutical Sciences, 13
Publisher: Springer-AAPS
Year: 2023
Language: English
Pages: 227
City: Arlington
Preface
Acknowledgements
Contents
Contributors
Part I: General Considerations
Chapter 1: Properties of Solids
1.1 Introduction
1.2 Particle Size and Particle Size Distribution
1.3 Particle Shape
1.4 Particle Density
1.5 Surface Area
1.6 Porosity
1.7 Surface Charge
1.8 Powder Flow
1.9 Cohesiveness
1.10 Conclusion
References
Part II: Solid Dosage Forms: Pharmaceutical Process Engineering and Scale Up
Chapter 2: Mixing
2.1 Introduction
2.2 Factors Affecting the Powder Mixing Process
2.3 Mechanism of the Mixing Process
2.4 Kinetics of the Mixing Process
2.5 The Perfect and Acceptable Mixture
2.6 Mixing Equipment
2.7 Mixing Problems
2.7.1 Milling of Active Ingredients
2.7.2 Mixing of Poor-Flowing Cohesive Materials
2.7.3 Geometric Mixing
2.8 Scale-Up Approaches for the Mixing Process
2.8.1 Froude Number Approach
2.8.2 Limitations of the Froude Number Approach
2.8.3 Tip Speed Approach
2.8.4 Limitations of the Tip Speed Approach
2.8.5 Number of Revolution Approach
2.8.6 Limitations of the Number of Revolution Approach
2.9 Conclusion
References
Chapter 3: Rapid Mixer Granulator
3.1 Introduction
3.2 Need of Powder Granulation
3.3 Types of Granulations
3.3.1 Dry Granulation
3.3.2 Wet Granulation
3.3.3 Hot Melt Granulation
3.4 Mechanism of Granule Formation
3.4.1 Wetting and Nucleation
3.4.2 Consolidation and Growth
3.4.3 Attrition and Breakage
3.5 Rapid Mixer Granulator
3.5.1 End Point Determination in RMG
3.6 Types of RMG
3.7 Scale-Up of Wet Granulation Process in RMG
3.7.1 Height of the Raw Materials in the Bowl
3.7.2 Binder Solution Spray/Addition Rate
3.7.3 Chopper Speed
3.7.4 Impeller Speed
3.8 Modelling and Simulation in RMG
3.9 Conclusion
References
Chapter 4: Fluid Bed Processing Technology
4.1 Introduction
4.2 Fluidization Theory
4.3 Components and Functionality of the Fluid Bed Processor
4.3.1 Air Handling Unit (AHU)
4.3.2 Product Container and Air Distribution Plate
4.3.3 Spray Nozzle
4.3.4 Filter Bags
4.3.5 Control Panel
4.4 Factors Affecting the Granulation Process
4.4.1 Formulation-Related Factors
4.4.2 Process-Related Factors
4.4.3 Equipment-Related Factors
4.5 Process Scale-Up
4.6 Scale-Up Principles
4.6.1 Constant Fluidization Velocity
4.6.2 Airflow Rate
4.6.3 Spray Rate
4.6.4 Droplet Size
References
Chapter 5: Drying
5.1 Introduction
5.2 Psychometry
5.3 Drying Cycle
5.3.1 Initial Adjustment Period
5.3.2 Constant Rate Period
5.3.3 First Falling Rate Period
5.3.4 Second Falling Rate Period
5.3.5 Equilibrium Moisture Content
5.4 Drying Equipment
5.4.1 Tray Dryer
5.4.2 Fluidized Bed Dryer
5.4.3 Spray Dryer
5.5 Specialized Drying Techniques
5.5.1 Freeze Drying
5.5.2 Vacuum Drying
5.6 Conclusion
References
Chapter 6: Compression
6.1 Introduction
6.2 Bulk Volume Reduction Process During Compression
6.3 Compression Under High Load
6.4 Frictional and Radial Forces During Compression
6.5 Porosity
6.6 Ejection Forces
6.7 Decompression
6.8 Compaction Profile
References
Chapter 7: Pan Coating
7.1 Introduction
7.2 Effect of Different Factors on the Pan-Coating Process
7.2.1 Thermodynamic Factors
7.2.2 Pan-Related Factors
7.2.3 Spray-Related Factors
7.3 Scale-Up of the Pan-Coating Process
7.3.1 Pan Speed
7.3.2 Spray Rate
7.3.3 Pan Load
7.3.4 Air Volume
7.3.5 Number of Spray Guns
7.3.6 Gun-to-Bed Distance
References
Chapter 8: Size Reduction
8.1 Introduction
8.2 Theoretical Consideration of Milling Process
8.2.1 Energy Requirement in the Milling
8.2.2 Kick´s Theory
8.2.3 Rittinger´s Theory
8.2.4 Bond´s Theory
8.3 Ball Mill
8.4 Hammer Mill
8.5 Fluid Energy Mill
8.6 Cutter Mill
8.7 Oscillating Granulator
8.8 Factors Affecting the Size Reduction Process
8.9 Selection of the Mill
References
Part III: Liquid Dosage Forms: Pharmaceutical Process Engineering and Scale Up
Chapter 9: Mixing and Filtration
9.1 Introduction
9.2 Types of Mixtures
9.3 Solid-Liquid Mixing
9.3.1 Pharmaceutical Suspension
9.3.1.1 Wetting of Solid
9.3.1.2 Mixing Uniformity
9.3.1.3 Mechanically Stirred Vessel
9.3.1.4 Rotor-Stator Mixing Devices
9.4 Liquid-Liquid Mixing
9.4.1 Equipment for Manufacturing of Emulsions
9.4.1.1 Mechanically Stirred Vessel
9.4.1.2 Rotor-Stator Mixing Devices
9.4.1.3 High-Pressure Homogenizers
9.5 Filtration
9.5.1 Classification of Filters
9.5.1.1 Particle/Clarifying Filters
9.5.1.2 Membrane Filters
9.5.1.3 Reverse Osmosis Membrane
9.5.1.4 Ultrafilter Membrane
9.5.1.5 Nanofilter Membrane
9.6 Rating of Membrane Filter
9.7 Applications of Sterilizing Grade Membrane Filters
9.8 Membrane Polymers
9.8.1 Hydrocarbon-Based Polymers
9.8.2 Polyamides
9.8.3 Polysulfone
9.8.4 Fluorpolymers
9.8.5 Cellulosic Polymers
9.8.6 Polycarbonates
9.9 Filter Design and Construction
9.9.1 Disc Filter
9.9.2 Cartridge Filters
9.9.3 Capsule Filters
9.10 Filter Validation
9.11 Bacterial Retention Test
9.12 Filter Integrity Testing
9.13 Conclusion
References
Chapter 10: Scale-Up of Liquid Mixing Process
10.1 Introduction
10.2 Mechanism of Liquid Mixing
10.3 Important Considerations During Liquid Mixing and Its Scale-Up
10.3.1 Flow Pattern
10.3.2 Rheology of the Fluids
10.3.3 Design of Liquid Mixing Devices
10.3.4 Mixing Baffles
10.3.5 Airjet/Jet Devices
10.3.6 Heat Transfer
10.3.7 Material Transfer
10.4 Scale-Up of Liquid Mixing Process
10.4.1 Constant Power/Volume Function
10.4.2 Principle of Geometric Similarity
10.4.3 Tip Speed Calculation
10.4.4 Scale of Agitation Approach
10.4.5 Software-Based Approach of Scale-Up of Liquid Mixing Process
10.5 Conclusion
References
Part IV: Manufacturing and Scale-Up of Specialised Pharmaceutical Formulations
Chapter 11: Manufacturing Process of Nanoparticles
11.1 Introduction
11.2 Bottom-up Methods
11.2.1 Double Emulsion Method
11.2.2 Solvent Injection Method
11.2.3 Micro Emulsion Method
11.2.4 Ultrasonication
11.2.5 Freeze-Drying Method
11.2.6 Spray-Drying Method
11.2.7 Emulsification and Solvent Evaporation
11.3 Top-Down Methods
11.3.1 Hot Homogenization Method
11.3.2 Cold Homogenization Method
11.3.3 Media Milling
11.4 Conclusion and Future Perspective
References
Chapter 12: Scale-Up of Nanoparticle Manufacturing Process
12.1 Introduction
12.2 Classification of Techniques for Preparation of Nanoparticles
12.2.1 Top-Down Approach
12.2.1.1 Mechanical Techniques
12.2.1.2 Cavitation-Based Techniques
12.2.1.3 Thermal Techniques
12.2.2 Bottom-Up Approach
12.2.2.1 Solvent Evaporation Techniques
12.2.2.2 Thermal Techniques
12.2.2.3 Chemical Techniques
12.2.2.4 Microemulsion Technique
12.2.2.5 Nanoprecipitation
12.2.2.6 Biological Techniques
12.3 Conclusion
References
Chapter 13: Manufacturing and Scale-Up of Biotechnology-Derived Products
13.1 Introduction
13.2 Manufacturing of Biotechnology-Based Pharmaceutical Products
13.2.1 Cell Culture Technology
13.2.2 Bioreactor Operations
13.2.3 Filtration and Centrifugation
13.2.4 Chromatography
13.3 Scale-Up Considerations
13.3.1 Cell Culture Process Scale-Up
13.3.2 Bioreactor Operation Scale-Up
13.3.3 Chromatography Process Scale-Up
13.4 Viral Removal
13.5 Conclusion
References
Untitled
Index
