A high-loaded dosage form (HLDF) architecture was developed to address the challenge of large dosage form size or number of units for amorphous solid dispersions (ASDs). A drug is first spray-dried with a high glass transition temperature dispersion polymer to facilitate high drug loading while maintaining physical stability. The ASD is then granulated with a concentration sustaining polymer to extend supersaturation in solution. The HLDF platform can reduce tablet mass by at least 40% while maintaining performance, stability and manufacturability.

Case studies demonstrating the following topics will be presented:

  • HLDF architecture
  • Physical stability
  • In vitro and in vivo performance
  • Spray drying and downstream manufacturability

Who should attend: Pharmaceutical scientists and engineers from industry and academia, consultants

Benefits of attending: Gaining an understanding of how to combine two different polymers, one “inside” and one “outside” the ASD to maximize performance, physical stability, and drug loading of ASD drug products.

Featured Speaker

Deanna M. Mudie, Ph.D.

Principal Scientist
Lonza Pharma & Biotech

Dr. Mudie is a Principal Scientist in the Research and Development department at Lonza in Bend, OR. Her focus is on enabling bioavailability enhancing amorphous spray dried dispersions by designing and developing solid oral dosage form platforms, and investigating novel techniques for evaluating performance of these platforms using in vitro test methods. Prior to joining Lonza in 2016 Dr. Mudie gained two years of post-doctoral experience designing in vivo predictive dissolution methodologies to predict oral dosage form bioperformance. She earned her Ph.D. in Pharmaceutical Sciences and B.S.E. in Chemical Engineering from the University of Michigan, and has seven years of pre-doctoral experience at two large pharmaceutical companies characterizing, developing and manufacturing solid oral dosage forms from pre-clinical to commercial scale.