Case Study 5 – Internal structure of tablets manufactured by direct compression and by hot melt extrusion

The Challenge:

The case required examining the internal structure of hot melt extrusion and direct compression tablets to determine whether the processes were equivalent.

The Acumen Approach:

Acumen formed a team of four senior academic experts and six laboratory researchers working in four different laboratories to:

  • Test the internal structure of tablets using Scanning Electron Microscopy, Energy Dispersive Spectroscopy, Raman Scanning Spectroscopy, and X-Ray Computer Tomography.
  • Test product performance and compare it to the attributes of the claimed products.
  • Articulate sound technical arguments demonstrating that the processes generated products with very different attributes.
  • Support clients in building claim construction arguments.
  • Provide deposition testimony.
The Result:

Case was settled favorably post-deposition without going to trial.