Handbook of Pharmaceutical Wet Granulation: Theory and Practice in a Quality by Design Paradigm offers a single and comprehensive reference dedicated to all aspects of pharmaceutical wet granulation. This book takes a holistic approach to pharmaceutical wet granulation by combining introductory principles with practical solutions and an in-depth look at the current state of research and practice in this area. In chapters written by international experts across industry, academic and regulatory settings, this book covers a wide spectrum of relevant and contemporary wet granulation topics, techniques and processes. Its focus on process analytical technology, quality by design principles, granulation equipment, modeling, scale-up, control and real time release makes it a timely and valuable resource for all those involved in pharmaceutical wet granulation.
Section I: Physicochemical Principles and Fundamentals of Wet Granulation Section II: Critical Quality Attributes of Drug Products and Process Design Solutions Section III: Process-Stability Interactions and Optimization Section IV: Material Attributes Critical to Wet Granulation Process Performance Section V: Process Modeling Section VI: Scale-up Section VII: Process Development and Process Analytical Technology Applications Section VIII: Real-Time Release, Real-time Release Testing, and Drug Product Control Strategy Development