Handbook of Pharmaceutical Granulation Technology

The Handbook of Pharmaceutical Granulation Technology is a comprehensive guide on pharmaceutical granulation technology and techniques. Granulation is the process of creating granules from powders, and it is an important step in the production of solid dosage forms like tablets and capsules. This guidebook covers pharmaceutical granulation theory and practice, including granule characterization, process optimization, and equipment design.

The first section of the Handbook covers the basics of granulation, including the principles of particle size distribution, granule formation, and the mechanisms of consolidation. This section also covers the various types of granulation processes, such as wet granulation, dry granulation, and melt granulation. Wet granulation is the most commonly used method for producing pharmaceutical granules, but dry granulation and melt granulation are gaining popularity due to their ability to produce granules with unique properties.

The second section of the Handbook covers the equipment used in pharmaceutical granulation, including mixers, granulators, dryers, and mills. These machines are critical to the granulation process, as they enable the production of uniform, high-quality granules. The section also covers the design and validation of granulation equipment, which is critical to ensuring consistent and reliable performance.

The third portion of the Handbook delves into the process of granule characterization, which involves assessing granules' physical and chemical characteristics. This section discusses granule characterization techniques such as particle size analysis, bulk density measurement, and moisture content assessment. Characterization of granules is crucial to ensure that they fulfill the standards for their intended usage.

The fourth section of the Handbook covers process optimization, which is the process of maximizing the efficiency and effectiveness of the granulation process. This section covers the various techniques used for process optimization, such as design of experiments (DOE), process analytical technology (PAT), and quality by design (QbD). These techniques enable pharmaceutical companies to optimize their granulation processes to ensure that they produce high-quality granules consistently.

The Handbook's last part discusses pharmaceutical granulation applications, such as the use of granules in tablet and capsule manufacture, as well as various drug delivery methods such as powders and pellets. This section also discusses the many legal and quality standards for pharmaceutical granulation, including as current good manufacturing practices (cGMP) and International Conference on Harmonization (ICH) recommendations.

Overall, the Handbook of Pharmaceutical Granulation Technology is an essential reference for anyone involved in the development and manufacturing of solid dosage forms. It provides a comprehensive overview of the theory and practical aspects of pharmaceutical granulation, including the equipment used, the process of granule characterization, and the applications of pharmaceutical granulation. This handbook is an excellent resource for researchers, engineers, and production personnel in the pharmaceutical industry, as well as for students studying pharmaceutical technology and related fields.

Handbook of Pharmaceutical Granulation Technology

The Second 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.

Here are just a few of the new topics discussed in this revised and expanded handbook:

Spray drying
Nanotechnology
Biotechnologically derived drugs
Nutraceuticals
Controlled release drugs
Particle engineering
Supercritical fluids
Concepts of design space
Process optimization
Regulation harmonization by global health authorities
Process control expert systems
Process Analytical Technology (PAT)
Regulatory issues in granulation

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.