Skip to main content
CRS 2026 Annual Meeting & Exposition Main banner

Oral Delivery (Focus Group – OrD)

Improving the Drug Loading Capacity and Downstream Processing of HPMCAS using Gelucire® 48/16 in Hot-Melt Extrusion

Masumi Dave – Senior Application Lab Manager, Pharmaceutical Division, Gattefossé USA; Nicholas DiFranco – Senior Marketing Manager, Pharmaceutical Division, Gattefossé USA; Inayet Ellis – Director, Scientific Innovation and Application, Gattefossé USA
Introduction:

Improving the drug loading capacity and downstream processability of Hydroxypropyl Methylcellulose Acetate Succinate (HPMCAS, Shin-Etsu AQOAT®) in hot-melt extrusion-based amorphous solid dispersions (ASDs) is necessary to reduce the pill burden and optimize drug release and tablet properties. In this work, we evaluated the co-processing of a lipid surfactant, Gelucire® 48/16, polyoxyl-32 stearate (G4816) with HPMCAS in ASD formulations of nifedipine (NIF) and fenofibrate (FF) (1-3).

Learning Objectives:

  • Co-processing of G4816 (10%) with AS-MMP and NIF in HME improves the drug release and maintenance of supersaturation.
  • Co-processing of G4816 (20%) with AS-MMP and FF in HME reduces torque and improves downstream processing of HPMCAS.