Compaction simulator use at Genentech – 5 Years Later

Ariel R. Muliadi,
Edward Yost,
Kellie Sluga,
Tim Hoogenraad,
Mohannad Awadalla,
Vincent Mazel,
Karthik Nadapudi
Small Molecule Pharmaceutical Sciences (SMPS)
Genentech Inc.

Abstract                   

This talk is a follow up to a previous presentation given at the 2018 Compaction Simulation Forum.  Here, we chronicle how our approach to oral solid dosage formulation development utilizing compaction simulation technologies has evolved in the last five years.  Specifically, we detail:

  • Our ever evolving tool for assessing the tableting risks of NMEs;
  • The experimental and computational tools we use when developing a dry-granulated FCT for a typical accelerated program at Genentech;
  • Unique novel technologies we are currently evaluating to broaden our material characterization abilities.