Preparation and Optimizing Formulation of Simvastatin Tablets by 3D Printing
ZENG Qing-yuan1,2, YANG Meng-ru2, GU Yi-ping3, WU Jian-hong3*
1. Third Hospital of Wuhan,Wuhan 430074, China; 2. Hubei University of Chinese Medicine, Wuhan 430065, China; 3. Wuhan Institute for Drug and Medical Device Control, Wuhan 430075, China
Abstract：OBJECTIVE To prepare simvastatin tablets and optimize its formulation by 3D printing technology. METHODS A cylindrical tablet with a radius of 4 mm and a thickness of 4.8 mm were prepared by a 3D printer. The dosage of the adjuvant povidone 30(PVP K30), lactose/microcrystalline cellulose (MCC) and absolute ethanol were taken as an investigation factor, the cumulative dissolution rate of 5, 15 and 30 min were used as an evaluation index,and the central composite design-response surface method was used to optimize the formulation and verify, the effect of dissolution were researched by compared with the traditional preparation. RESULTS The optimal formulation value: the ratio of PVP K30 was 30%, the mass ratio of lactose/MCC was 2.5, the ratio of absolute ethanol was 74%, and the cumulative dissolution in vitro of the printed tablets at 5, 15, 30 min was (45.7±0.5)%, (70.9±0.7)%, (89.7±2.3)% respectively, the deviation between the verification result and the predicted value were less than 5%. The preparation of dissolutioncurve is similar with commercially available formulations. CONCLUSION The successful preparation of 3D printed simvastatin tablets is simple and the mathematical model is predictive.
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2020, Vol. 55 
