Amorphous solid dispersions (ASD) offer a bioavailability enhancement drug delivery solution for otherwise poorly soluble crystalline APIs. Spray drying and hot melt extrusion (HME) are the two most common means of manufacturing ASDs. Hot melt extrusion has the advantage of being a higher throughput process and more environmentally friendly, yet often results in lower drug loadings and has a higher risk of degrading the API. To determine if HME is a good ASD manufacturing route, it is required to understand the achievable API loadings possible without risk of degradation. Typical HME screening methods can give misleading results by not considering the kinetic aspects of API dissolution and degradation. Thus, there is a need for an approach more representative of the extrusion process. This presentation will demonstrate a screening process to quickly assess HME feasibility. Compared to traditional approaches, this protocol yields more accurate predictions for both API loading and degradation while saving material and time.
Key Learning Objectives:
- Understand key differences between spray drying and HME, and why different feasibility screening approaches are needed
- Limitations of current small-scale HME screening techniques
- Demonstration of newly developed HME screening process with a variety of model systems