The melt-extrusion process is utilized in the pharmaceutical arena for the manufacturing\nof a variety of dosage forms and formulations, including solid dispersions. This technology is\nconsidered an efficient and continuous dosage form manufacturing method. However, there are\npotential challenges mainly because, during hot-melt extrusion, polymers are subject to mechanical\nand thermal degradation. Mechanical degradation may be induced by the shear effects imposed\nby the rotating screw. Thermal degradation results from high temperatures and includes random\nscission, scission from the ends of the polymer and unzipping of substitute groups. This paper\nendeavors to understand the impact of thermal and/or mechanical components of the melt-extrusion\nprocess on the stability of a pH sensitive polymer, namely Shellac. Correlation between the screw\nspeeds and processing temperature profile was examined in the context of the overall degradation\nprofile of the polymer. The results suggest that the processing stability of Shellac was reliant on\noptimization of screw speed (rpm) and process temperature.
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