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.