Handbook of Pharmaceutical Wet Granulation: Theory and Practice in a Quality by Design Paradigm

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 high shear wet granulation (HSWG), low shear wet granulation (LSWG) and fluid bed granulation (FBG)Examines the modern evolution of wet granulation through current topics such as established and novel process analytical technologies (PATs), product development and scale-up paradigms in batch processes, continuous manufacturing paradigms, and more Written for scientists working within the pharmaceutical industry, as well as academics, regulatory officials and equipment vendors that provide PAT tools and granulation equipment INDICE: 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

• ISBN: 9780128104606
• Editorial: Academic Press
• Encuadernacion: Rústica
• Páginas: 1008
• Fecha Publicación: 01/06/2018
• Nº Volúmenes: 1
• Idioma: Inglés