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Summary
The Third Edition presents all pharmaceutical industry personnel and those in academia with critical updates on the recent advances in granulation technology and changes in FDA regulatory guidelines. Addressing precisely how these recent innovations and revisions affect unit operation of particle generation and granulation, this text assists the reader in selecting the ideal technology for his/her company's particular drug delivery system. This knowledge helps ensure that regulatory guidelines are followed and met in a cost-effective manner.In addition, all chapters in the Handbook of Pharmaceutical Granulation Technology explore the fundamentals of powder characterization, granulation, and state-of-the-art technologies, modeling, application of expert systems, and manufacturing optimization.
Author Biography
Dilip M. Parikh is President, DPharma Group Inc., Ellicott City, Maryland, USA. As an industrial pharmacist, he has more than 35 years of experience in product development and manufacturing, process engineering, and operational management of pharmaceutical facilities. He is an invited speaker at various scientific conferences worldwide on solid dosage manufacturing technologies, modified release dosage forms, fluid bed and spray drying technologies, quality by design implementation, and outsourcing pharmaceutical development and manufacturing. He serves on the editorial board of Contract Pharma Journal. The author of many scientific journal articles and book chapters, he is also the editor of the first and Second Edition of Handbook of Pharmaceutical Granulation Technology.
Table of Contents
| Preface | p. ix |
| Contributors | p. xv |
| Introduction | p. 1 |
| Theory of Granulation: An Engineering Perspective | p. 6 |
| Particle Formation | |
| Drug Substance and Excipient Characterization | p. 59 |
| Binders in Pharmaceutical Granulation | p. 78 |
| Spray Drying and Pharmaceutical Applications | p. 98 |
| Supercritical Fluid Technology | p. 126 |
| Pharmaceutical Applications of Nanoengineering | p. 138 |
| Granulation Processes | |
| Roller Compaction Technology | p. 163 |
| Wet Granulation in Low- and High-Shear Mixers | p. 183 |
| Batch Fluid Bed Granulation | p. 204 |
| Single-Pot Processing | p. 261 |
| Extrusion-Spheronization as a Granulation Technique | p. 281 |
| Continuous Granulation | p. 308 |
| Product Oriented Granulations | |
| Effervescent Granulation | p. 323 |
| Granulation Approaches in Biotech Industry | p. 338 |
| Granulation of Plant Products and Nutraceuticals | p. 349 |
| Granulation Approaches for Modified Release Products | p. 364 |
| Granulation of Poorly Water-Soluble Drugs | p. 381 |
| Granulation Approaches for Orally Disintegrating Formulations | p. 401 |
| Melt Granulation | p. 435 |
| Characterization and Scale-up | |
| Sizing of Granulation | p. 449 |
| Granulation Characterization | p. 469 |
| Bioavailability and Granule Properties | p. 487 |
| Granulation Process Modeling | p. 498 |
| Scale-Up Considerations in Granulation | p. 538 |
| Advances in Process Controls and End-Point Determination | p. 567 |
| Optimization Strategies, Tools and Regulatory Considerations | |
| Expert Systems and Their Use in Pharmaceutical Applications | p. 578 |
| Regulatory Issues in Granulation: The Pharmaceutical Quality for the 21st Century-A Risk-Based Approach | p. 597 |
| Quality by Design and Process Analytical Technology in Granulation | p. 617 |
| Index | p. 637 |
| Table of Contents provided by Ingram. All Rights Reserved. |
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