三维(3D)打印技术的使用在制造口服缓释制剂中很普遍;然而,缺乏对3D打印渗透泵片的研究。基于苯扎贝特吸收快、半衰期短的特点,研制了一种3D打印核壳结构的苯扎贝特渗透泵片,利用半固体挤出(SSE)3D打印技术。首先,研究了不同壳材料的性能,以确定壳的组成,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。基于印刷性能和释放行为来定义片芯的配方。配方由苯扎贝特组成,无水乳酸,碳酸氢钠,海藻酸钠,聚环氧乙烷,和十二烷基硫酸钠的比例为400:400:300:80:50:50。该片剂能够实现零级释放。还表征了物理化学性质。药代动力学数据分析表明,3D打印片剂与参考上市药物之间的药代动力学参数没有统计学上的显着差异。3D打印片剂的体外和体内结果之间存在很强的相关性。结果表明,SSE印刷是制造渗透泵片剂的实用方法。
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.