Table III.
Solid-State Characterization, Performance, and Process Summary of ASD of Compound X Prepared by HME Process
| API:PVP VA64 (1:2) | API:PVP VA64:SDS (1:2:0.5) | API:PVP VA64:tartaric acid (1:1.5:2) | API:PVP K12 (1:3) | |
|---|---|---|---|---|
| Formulation no./characterization | 3a | 3e | 5b | 7a |
| Extrusion temperature (°C) | 190 | 165–170 | 165–170 | 195 |
| PLM | No birefringence | No birefringence | No birefringence | No birefringence |
| XRPD | Amorphous | Amorphous | Amorphous | Amorphous |
| T g (°C) | 94 | 61.5 | 81 | 75.2 |
| Dissolution | 70% | 85–90% | 90–95% | 60–70% |
| Total impurity | 0.17 | 9.27 | 10.08 | 0.20 |
| Physical stability | +++ | + | + | ++ |
| Processability | ++ | +++ | +++ | ++ |
PLM polarized light microscopy, XRPD X-ray powder diffraction, T g glass transition temperature