Table 4.
Physical/Chemical Stability of MK-A Amorphous Solid Dispersions prepared by Spray Drying or Hot Melt Extrusion.
| Polymer | Condition | Initial (% Area) | 2 Weeks at 40 °C/75% RH Closed (% Area) | 2 Weeks at 40 °C/75% RH Closed Physical Form |
|---|---|---|---|---|
| MK-A (FB) | - | 98.8 | 98.8 | - |
| SDD HPMCAS-HF | 25% DL | 96.7 | 90.3 | Amorphous |
| SDD HPMCAS-HF | 40% DL | 96.8 | 89.8 | Amorphous |
| SDD HPMCAS-MF | 25% DL | 97.1 | 91.8 | Amorphous |
| SDD VA64 | 40% DL | 96.9 | 89.3 | Amorphous/Phase separation |
| SDD HPMCAS-LF | 25% DL under N2 | 98.8 | 95.4 | Amorphous |
| * SDD HPMCAS-LF | 25% DL under N2 antioxidants | 98.9 | 98.2 | Amorphous |
| HME HPMCAS-HF | 25% DL, 140 °C | 95.1 | 86.6 | Amorphous |
| HME HPMCAS-MF | 25% DL, 136 °C | 94.2 | 86.0 | Amorphous |
* Antioxidants: BHT (0.1%)/BHA (0.1%).