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Manufacturing & Analytical Characterization
Chalk Talk

Case study: Leveraging Hot Melt Extrusion to Improve Bioavailability, Reduce Pill Burden, and Increase Shelf Life

Monday, October 21, 2024
11:15 AM – 12:00 PM MT
Location:Spotlight Stage B, Aisle 1100, Exhibit Hall

Sponsored By 

A pharma company launched a 1st-generation formulation of a poorly soluble drug, with a heavy pill burden, short shelf life, and requiring storage under refrigeration. In parallel, the company initiated an engagement with AbbVie Contract Manufacturing to develop a 2nd-generation formulation -- an amorphous solid dispersion (ASD) produced by hot melt extrusion (HME). The new formulation was successfully developed, approved and launched, with patient benefits (improved bioavailability, reduced dose, reduced pill burden, no food effect) and business benefits (increased shelf life).

Learning Objectives:

  • Leveraging hot melt extrusion (HME) to produce amorphous solid dispersions (ASD)
  • Improving bioavailability, reducing pill burden, increasing shelf life
  • Reformulating an on-market product of a poorly soluble drug