Application and limitations of thermogravimetric analysis to delineate the hot melt extrusion chemical stability processing window

摘要: Abstract Thermogravimetric analysis (TGA) is frequently used to define the threshold of acceptable processing temperatures for hot melt extrusion. Herein, evaluation chemical stability amorphous drug and polymer systems was assessed by a critical TGA nonisothermal isothermal methods. Nonisothermal three crystalline APIs high glass-forming ability (posaconazole, indomethacin, bicalutamide), as well six common polymers, identified degradation onset temperature that ranged from 52 170 °C, depending on heating rate detection method employed. In particular, tangent significantly overestimated levels degradation, while weight loss criteria were more suitable. Isothermal provided direct indication stability, however neat materials are likely recrystallize. By forming an solid dispersion, can stabilize against recrystallization, enabling degradation. However, mass volatiles should be considered only approximate indicator actual potency higher; this confirmed performance liquid chromatographic samples. methods selected generate highly sensitive outcomes, caution applied when extrapolating suitability conditions.