Abstract：
This study focuses on the combination of three-dimensional printing (3DP) and amorphous solid dispersion (ASD) technologies for the manufacturing of gastroretentive floating tablets. Employing hot melt extrusion (HME) and fused deposition modeling (FDM), the study investigates the development of drug-loaded filaments and 3D printed (3DP) tablets containing felodipine as model drug and hydroxypropyl methylcellulose (HPMC) as the polymeric carrier. Prior to fabrication, solubility parameter estimation and molecular dynamics simulations were applied to predict drug-polymer interactions, which are crucial for ASD formation. Physical bulk and surface characterization complemented the quality control of both drug-loaded filaments and 3DP tablets. The analysis confirmed a successful amorphous dispersion of felodipine within the polymeric matrix. Furthermore, the low infill percentage and enclosed design of the 3DP tablet allowed for obtaining low-density systems. This structure resulted in buoyancy during the entire drug release process until a complete dissolution of the 3DP tablets (more than 8 h) was attained. The particular design made it possible for a single polymer to achieve a zero-order controlled release of the drug, which is considered the ideal kinetics for a gastroretentive system. Accordingly, this study can be seen as an advancement in ASD formulation for 3DP technology within pharmaceutics.
摘要：
本研究的重点是结合三维打印（3DP）和无定形固体分散体（ASD）技术制造胃滞留漂浮片剂。采用热熔挤出（HME）和熔融沉积成型（FDM），该研究调查了含有非洛地平作为模型药物和羟丙基甲基纤维素（HPMC）作为聚合物载体的载药长丝和3D打印（3DP）片剂的开发。在制造之前，应用溶解度参数估计和分子动力学模拟来预测药物-聚合物相互作用，这对ASD的形成至关重要。物理体积和表面表征补充了载药长丝和3DP片剂的质量控制。分析证实非洛地平在聚合物基质中的成功无定形分散。此外，3DP片剂的低填充百分比和封闭设计允许获得低密度系统。这种结构在整个药物释放过程中产生浮力，直到3DP片剂完全溶解（超过8小时）。特殊的设计使得单一聚合物实现药物的零级控制释放成为可能，这被认为是胃滞留系统的理想动力学。因此，这项研究可以被视为3DP技术在制药中ASD配方的进步。
