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, taking a holistic approach by combining introductory principles with practical solutions. Chapters are written by international experts across industry, academic and regulatory settings, and cover a wide spectrum of relevant and contemporary wet granulation topics, techniques and processes. The books' 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. - Discusses fundamentals of theory and current industrial practice in the field of wet granulation, including product and process design and role of material properties in wet granulation - Examines the modern evolution of wet granulation through current topics such as established and novel process analytical technologies (PATs), and product development and scale-up paradigms - Written for scientists working within the pharmaceutical industry, as well as academics, regulatory officials and equipment vendors who provide PAT tools and granulation equipment

Inhalt

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