Manufacturing and Bioprocessing – Chemical

2019 PharmSci 360

A Modernized Approach to Wet Granulation Process Development – Applying Granule Porosity, Regime Maps and Crystal Form Understanding

Speaker(s)

• 

  Jonathan Wade, PhD

  Eli Lilly and Company
  Indianapolis, Indiana

Wet granulation is often unfairly called an art form where we “feel” our way to the finish line. While this is historically true, a more realistic position is to argue that insufficient time is dedicated to understand and characterize the science and engineering of this common unit operation. With fundamental understanding of the mechanisms associated with granule nucleation and growth we can characterize and understand wet granulation processes thus replacing the art form with robust process control. This presentation will cover the fundamentals of granule growth, process characterization approaches, complexities associated with process induced crystal form changes, and resulting control strategy approaches.

Learning Objectives:

• Understand the importance of granule porosity.
• Appreciate the nuance of crystal form change.
• Understand process control options.