Manufacturing and Bioprocessing – Chemical
2019 PharmSci 360
Formulation and processing strategies for continuous melt granulation of gabapentine (GABA) using twin-screw extrusion process is presented. GABA a thermal liable drug substance and it degrades upon melting. Both PEG 3350 and Klucel were investigated as thermal binders. A systematic approach to select thermal binder and processing parameters is discussed. The correlation between the level of GABA degradant and system parameters was established.