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
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
Ajit S. Narang works for the Bristol-Myers Squibb, Co. in New Brunswick, New Jersey, in the biopharmaceutical aspects of drug delivery. He has more than eight years of experience in the pharmaceutical industry in the development of oral dosage forms and drug delivery platforms. In addition to the Bristol-Myers Squibb, Co., he has worked for Ranbaxy Research Labs (currently a subsidiary of Daiichi Sankyo, Japan) in Gurgaon, India, and Morton Grove Pharmaceuticals (currently a subsidiary of Wockhardt USA LLC, Parsippany, New Jersey) in Vernon Hills, Illinois. He has more than 35 publications and three pending patent applications, and has contributed to the development of several marketed drug products.
Badawy, Sherif I.F.
Sherif Badawy, Ph.D., is a Research Fellow in the Drug product Science and Technology of the Bristol-Myers Squibb Company. He received his B.S. in Pharmacy and M.S. in Pharmaceutics from Cairo University, and his Ph.D. in Pharmaceutics from Duquesne University. He has more than 20 years of industrial experience in drug product development. His current responsibilities at Bristol-Myers Squibb include formulation and process development and scale-up of commercial oral solid and liquid dosage forms. His areas of research interest include high shear wet granulation, tablet compaction, stability of solid dosage forms and bioavailability enhancement of poorly water-soluble compounds. He authored more than 40 manuscripts and numerous abstracts and presentations in those areas.