Traciann Scirbona (Process Engineer, Hovione LLC)
Date: Tuesday, April 24
Time: 4:15pm - 4:35pm
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Vault Recording: TBD
Top 5 takeaways from the session:
- Amorphous solids dispersions can be leveraged to improve drug solubility.
- Hot melt extrusion is a viable option to obtain amorphous solid dispersions. When compared to spray drying, extrusion can decrease overall expense by utilizing a higher throughput, removing cost of process solvents and reducing manufacturing time due to eliminating post- drying requirements.
- Formulation development often involves screening polymers to analyze drug compatibility to determine both miscibility and sustainability. An ideal screening process utilizes minimal amounts of the active pharmaceutical ingredient when compared to directly starting at the extrusion process.
- After the formulation is successfully extruded in laboratory scale equipment, the process can be scaled up to larger extruders in order to meet manufacturing requirements. Process scale-up of extrusion equipment is performed using scale-independent variables with design space studies.
- Ternary systems can be used to resolve formulation miscibility and bioavailability challenges in order to achieve an optimal formulation. This allows for an amorphous solid dispersion that maximizes drug/polymer miscibility, drug supersaturation and drug bioavailability