Handbook of Pharmaceutical Granulation Technology, Third Edition,9780824726478

Handbook of Pharmaceutical Granulation Technology, Third Edition

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Edition: 2nd
ISBN13: 9780824726478
ISBN10: 0824726472
Format: Hardcover
Pub. Date: 2005-08-30
Publisher(s): Informa Healthc
Availability: This title is currently not available.
List Price: $299.95

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Summary

Applying basic theories to industrial practices in pharmaceutical development, this Second Edition explains how new and emerging technologies are utilized in the production of pharmaceutical granulation-demonstrating cost-effective strategies to manufacture solid-dosage forms with consistent physical properties while complying with current regulatory requirements.

Table of Contents

Preface vii
Contributors xv
Introduction
1(6)
Dilip M. Parikh
References
6(1)
Theory of Granulation: An Engineering Perspective
7(72)
Bryan J. Ennis
Introduction
7(12)
Wetting
19(15)
Granule Growth and Consolidation
34(21)
Granule Strength and Breakage
55(5)
Controlling Granulation Processes
60(19)
References
77(2)
Drug Substance and Excipient Characterization
79(30)
L. W. Chan
P. W. S. Heng
Introduction
79(1)
Particle Shape, Size, and Surface Area
80(9)
Solubility
89(6)
Crystal Properties and Polymorphism
95(5)
Other Physical Properties
100(2)
Commonly Used Excipients in Granulation
102(1)
Compatibility of Drug and Excipient
103(2)
Conclusion
105(4)
References
106(3)
Binders and Solvents
109(20)
Ehab Hamed
Derek Moe
Raj Khankari
John Hontz
Introduction
109(1)
Types of Binders
109(6)
Factors Influencing Binder Efficiency
115(4)
Processing Parameters for Commonly Used Binders
119(10)
References
125(4)
Spray Drying and Pharmaceutical Applications
129(30)
Metin Celik
Susan C. Wendel
Introduction
129(1)
Spray Drying Process Stages
130(8)
Process Layouts
138(1)
Theory of Spray Drying Fundamentals
139(7)
Spray Drying Applications
146(8)
Conclusion
154(5)
References
155(4)
Roller Compaction Technology
159(32)
Ronald W. Miller
Introduction
159(1)
Powder Granulation and Compaction
159(1)
Background
160(1)
Benefits of Roller Compaction
161(1)
Compaction Theory
162(4)
Design Features of Roller Compactors
166(1)
Roll Configuration
167(3)
Feed Screw Design
170(2)
Future Trends in Granulation Technology
172(1)
New Findings
173(5)
Deaeration Theory
178(4)
Roller Compaction and Near-Infrared Spectroscopy
182(3)
Roller Compaction and PAT
185(6)
References
188(3)
High-Shear Granulation
191(38)
Rajeev Gokhale
Yichun Sun
Atul J. Shukla
Introduction
191(1)
High-Shear Granulators
192(3)
High-Shear Granulation Process
195(5)
Mechanism of High Shear Wet Granulation
200(4)
Factors Affecting the Granulation Process and Granule Properties
204(8)
Granulation End-Point Determination
212(5)
Formulation Development (Optimization)
217(2)
Process Scale-Up
219(5)
Conclusion
224(5)
References
224(5)
Low-Shear Granulation
229(18)
Tom Chirkot
Cecil Propst
Introduction
229(2)
Mechanical Agitator Granulators
231(4)
Rotating Shape Granulators
235(5)
Scale-Up
240(3)
End-Point Determination and Control
243(1)
Conclusions
244(3)
References
244(3)
Batch Fluid Bed Granulation
247(64)
Dilip M. Parikh
Martin Mogavero
Introduction
247(1)
Fluidization Theory
248(3)
System Description
251(10)
Particle Agglomeration and Granule Growth
261(4)
Fluid Bed Drying
265(3)
Process and Variables in Granulation
268(8)
Process Controls and Automation
276(6)
Process Scale-Up
282(4)
Safety in Fluid Bed
286(5)
Material Handling Options
291(3)
Fluid Bed Technology Progress
294(17)
References
304(7)
Single-Pot Processing
311(22)
Harald Stahl
Griet Van Vaerenbergh
Introduction
311(2)
Typical Single-Pot Process
313(2)
Drying Methods for Single-Pot Processors
315(6)
Other Processes and Applications
321(3)
Scale-Up of Drying Processes
324(2)
Cleaning
326(1)
Product Stability
326(1)
Regulatory Considerations
326(1)
Validation of Single-Pot Processors
327(1)
Control Systems and Data Acquisition Systems
328(1)
Safety
328(2)
Conclusion
330(3)
References
330(3)
Extrusion/Spheronization as a Granulation Technique
333(32)
Ketan A. Mehta
Gurvinder Singh Rekhi
Dilip M. Parikh
Introduction
333(2)
Applications
335(1)
General Process Description
336(1)
Equipment Description and Process Parameters
337(15)
Formulation Variables
352(5)
Compression of Pellets
357(2)
Conclusions
359(6)
References
360(5)
Effervescent Granulation
365(20)
Guia Bertuzzi
Introduction
365(1)
The Effervescent Reaction
366(1)
Formulation
366(1)
Raw Materials
367(4)
Manufacturing of Effervescent Forms
371(14)
References
382(3)
Melt Granulation and Pelletization
385(22)
T. W. Wong
W. S. Cheong
P. W. S. Heng
Introduction
385(4)
Mechanism of Melt Agglomeration
389(4)
Factors Affecting Melt Agglomeration
393(2)
Control of Melt Agglomeration
395(5)
Conclusions
400(7)
References
401(6)
Rapid Release Granulation
407(24)
P. W. S. Heng
Anthony Yolande
Lee Chin Chiat
Introduction
407(2)
Formulation-Related Factors
409(8)
Granulation-Related Factors
417(2)
Solid Dispersion
419(4)
Conclusions
423(8)
References
424(7)
Continuous Granulation Technologies
431(28)
Rudolf Schroeder
Klaus-Jurgen Steffens
Introduction
431(1)
Comparison of Different Modes of Processing
431(2)
Fluid Bed Systems
433(4)
Mechanical Wet Granulation Systems
437(4)
Roller Extrusion System
441(18)
References
456(3)
Scale-Up Considerations in Granulation
459(32)
Y. He
L. X. Liu
J. D. Litster
Introduction
459(1)
General Considerations in Process Scale-Up: Dimensional Analysis and the Principle of Similarity
460(2)
Analysis of Granulation Rate Processes and Implications for Scale-Up
462(11)
Scale-Down, Formulation Characterization, and Formulation Design in Pharmaceutical Granulation
473(2)
Scale-Up of Fluidized Bed Granulators
475(5)
Scale-Up of High-Shear Mixer Granulators
480(7)
Concluding Remarks
487(4)
Nomenclature
487(1)
References
488(3)
Sizing of Granulation
491(22)
Gurvinder Singh Rekhi
Richard Sidwell
Introduction
491(1)
Theory of Comminution or Size Reduction
492(1)
Properties of Feed Materials Affecting the Sizing Process
493(1)
Criteria for Selection of a Mill
494(1)
Classification of Mills
495(4)
Wet Milling
499(3)
Variables Affecting the Sizing Process
502(5)
Scale-Up
507(2)
Case Studies
509(1)
List of Equipment Suppliers
510(3)
References
511(2)
Granulation Characterization
513(22)
Raj Birudaraj
Sanjay Goskonda
Poonam G. Pande
Introduction
513(1)
Physical and Chemical Characterization of Granules
513(18)
Conclusion
531(4)
References
531(4)
Bioavailability and Granule Properties
535(10)
Sunil S. Jambhekar
Introduction
535(1)
Bioavailability Parameters
536(5)
Conclusion
541(4)
References
542(1)
Recommended Reading
543(2)
Process Analytical Technology
545(10)
D. Christopher Watts
Ajaz S. Hussain
Introduction
545(1)
Background
546(2)
PAT and Process Understanding
548(1)
PAT Tools and Their Application
549(3)
Conclusion
552(3)
References
552(3)
Granulation Process Modeling
555(40)
I. T. Cameron
F. Y. Wang
Modeling of Granulation Systems
555(5)
Key Factors in Granulation Modeling
560(2)
Representing Granulation Processes Through Population Balances
562(8)
Solving and Using Population Balances
570(7)
Application of Modeling Techniques
577(13)
Conclusion
590(5)
References
591(4)
Regulatory Issues in Granulation
595(20)
Prasad Kanneganti
Introduction
595(1)
Pharmaceutical Quality Management
595(2)
Postapproval Change Considerations
597(12)
Validation of Granulation Processes
609(4)
Conclusion
613(2)
References
613(2)
Index 615

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