Abstract
The clinical application of Sinomenine hydrochloride (SH) oral solid formulation is limited due to its short half-life and gastrointestinal side effects. The novel whirlwind fluidized bed was first applied to develop the sustained-release pellet of SH, so as to mitigate the side effects. The formulation of drug-loaded layer was optimized by full factorial design. Additionally, Box–Behnken experimental design was used to optimize the operating parameters and the formulation of sustained-release layer. Compared to the conventional fluidized bed, the whirlwind fluidized bed significantly improved the quality of pellets. According to the design spaces, the yield of pellets and SH encapsulation efficiency were greater than 96% and 90%, respectively. The in vitro release results demonstrated the sustained-release time was over 12 h and the dissolution behavior of different batches of samples was stable. Findings in current study suggest that the whirlwind fluidized bed is a promising approach to develop pellets.
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