Chen Hao, Fang Dongyang, Wang Xiangyu, Gong Ye, Ji Yang, Pan Hao
School of Pharmacy, Liaoning University, 66 Chongshan Middle Road, Shenyang 110036, China; School of Pharmacy, Shenyang Pharmaceutical University, 103 Wenhua Road, Shenyang, 110016, China.
School of Pharmacy, Shenyang Pharmaceutical University, 103 Wenhua Road, Shenyang, 110016, China.
Int J Pharm. 2024 Nov 15;665:124668. doi: 10.1016/j.ijpharm.2024.124668. Epub 2024 Sep 6.
The utilization of three-dimensional (3D) printing technology is prevalent in the fabrication of oral sustained release preparations; however, there is a lack of research on 3D-printed osmotic pump tablets. A 3D-printed core-shell structure bezafibrate osmotic pump tablet was developed based on the characteristics of rapid absorption and short half-life of bezafibrate, utilizing semisolid extrusion (SSE) 3D printing technology. First, the properties of different shell materials were investigated to define the composition of the shell, and ultimately, the optimal formulation was found to be ethyl cellulose:cellulose acetate:polyethylene glycol = 2:1:2. The formulation of the tablet core was defined based on the printing performance and release behavior. The formulation consisted of bezafibrate, lactis anhydrous, sodium bicarbonate, sodium alginate, polyethylene oxide and sodium dodecyl sulfate at a ratio of 400:400:300:80:50:50. The tablet was capable of achieving zero-order release. The physicochemical properties were also characterized. The pharmacokinetic data analysis indicated that there were no statistically significant differences in the pharmacokinetic parameters between the 3D-printed tablets and the reference listed drugs. There was a strong correlation between the in vitro and in vivo results for the 3D-printed tablets. The results showed that SSE printing is a practical approach for manufacturing osmotic pump tablets.
三维（3D）打印技术在口服缓释制剂的制备中应用广泛；然而，关于3D打印渗透泵片的研究却较为匮乏。基于苯扎贝特吸收快、半衰期短的特点，利用半固体挤出（SSE）3D打印技术研制了一种3D打印的核壳结构苯扎贝特渗透泵片。首先，研究了不同包衣材料的性能以确定包衣的组成，最终发现最佳配方为乙基纤维素：醋酸纤维素：聚乙二醇 = 2:1:2。根据打印性能和释放行为确定了片芯的配方。该片芯配方由苯扎贝特、无水乳糖、碳酸氢钠、海藻酸钠、聚环氧乙烷和十二烷基硫酸钠按400:400:300:80:50:50的比例组成。该片能够实现零级释放。还对其理化性质进行了表征。药代动力学数据分析表明，3D打印片与参比上市药品之间的药代动力学参数无统计学显著差异。3D打印片的体外和体内结果之间存在很强的相关性。结果表明，SSE打印是制造渗透泵片的一种实用方法。
