Design and Optimization of 3D Printing Amlodipine Besylate Chewable Tablets
HAN Xiao-lu1,2, HONG Xiao-xuan1, LIU Bo-shi1,3, ZHU Chun-xiao1, DU Yi-meng1, ZHANG Hui1, GAO Jing1, WANG Zeng-ming1*, ZHENG Ai-ping1*
1. Institute of Pharmacology and Toxicology, Academy of Military Medical Sciences, Beijing 100850, China; 2. Troops 32104 of People's Liberation Army of China, Alashan 735400, China; 3. Military Hospital 93152 of People's Liberation Army of China, Tonghua 135300, China
Abstract：OBJECTIVE To develop a semi-solid materialfor 3D printing technology based on the concept of quality by design(QbD). METHODS Amlodipine besylate was used as the model drug, CMC-NA, CMS-Na and glycerin were used as independent variables, and hardness, fragility, disintegration and dissolution were used as dependent variables. The full factor design of 23 was used to establish the design space of the prescription, and the amplification study was carried out. RESULTS The semi-solid material has good printability. In the design space, 1.0% CMC-NA, 7.0%CMS-Na and 10.0% glycerin were selected for amplification. All the indexes were close to the predicted values of the model and all met the requirements. CONCLUSION The total factorial experimental design can be used for the prescription optimization of 3D printed semi-solid materials, and the optimized prescription can meet the preparation requirements of 3D printed chewable tablets, which provides the possibility for the mass production of extruded 3D printing and the realization of personalized customized drugs.
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2021, Vol. 56 
