(35e) Progress in wet granulation process development - from a pharmaceutical industry application perspective

Particle engineering is an intricate part of pharmaceutical drug product development processes involving powders. Designing for acceptable powder flowability and compactibility is often challenging and requires significant particle engineering. Although simpler routes like direct compression and dry granulation are preferred, wet granulation is often unavoidable due to the physical attributes of the powder formulation and the required drug loading in the dosage form. Owing to its wide-spread adoption, different types of wet granulation techniques have been studied extensively in literature.

This talk will review the traditional approaches towards developing wet granulation processes and present case studies on current approaches. The current approaches will highlight the faster and more innovative ways of conducting drug product process development and ensuring product quality, which fits the current business environment that emphasizes reducing the time to market in a cost-effective manner.

Bio – Maitraye Sen

Maitraye is a chemical engineer with experience in pharmaceutical process and product design, and expertise in process modeling & simulation. She completed her doctoral studies from Rutgers University, NJ, USA, followed by postdoctoral research at Purdue University, IN, USA prior to joining Eli Lilly and Company, IN, USA. Her work is on building streamlined process development workflows and control strategies by integrating different mathematical and experimental tools for speedy development of robust pharmaceutical manufacturing processes.