Manufacturing and Bioprocessing – Chemical

2019 PharmSci 360

Strategies to Maintain Drug Stability during Twin Screw Melt Granulation

Speaker(s)

• 

  Feng Zhang, Ph.D.

  University of Texas at Austin
  Austin, Texas

Formulation and processing strategies for continuous melt granulation of gabapentine (GABA) using twin-screw extrusion process is presented. GABA a thermal liable drug substance and it degrades upon melting. Both PEG 3350 and Klucel were investigated as thermal binders. A systematic approach to select thermal binder and processing parameters is discussed. The correlation between the level of GABA degradant and system parameters was established.

Learning Objectives:

• Participant will learn the benefits of twin-screw extrusion as a process for melt granulation.
• Participant will learn the formulation design for twin-screw melt granulation.
• Participant will learn the process design of twin-screw melt granulation.