Department of Pharmaceutics and Drug Delivery, The University of Mississippi, University, MS, USA.
Pii Center for Pharmaceutical Innovation and Instruction, The University of Mississippi, University, MS, USA.
J Pharm Pharmacol. 2021 Mar 4;73(2):152-160. doi: 10.1093/jpp/rgaa037.
The aim of this study was to couple fused deposition modelling 3D printing with melt extrusion technology to produce core-shell-structured controlled-release tablets with dual-mechanism drug-release performance in a simulated intestinal fluid medium. Coupling abovementioned technologies for personalized drug delivery can improve access to complex dosage formulations at a reasonable cost. Compared with traditional pharmaceutical manufacturing, this should facilitate the following: (1) the ability to manipulate drug release by adjusting structures, (2) enhanced solubility and bioavailability of poorly water-soluble drugs and (3) on-demand production of more complex structured dosages for personalized treatment.
Acetaminophen was the model drug and the extrusion process was evaluated by a series of physicochemical characterizations. The geometries, morphologies, and in vitro drug-release performances were compared between directly compressed and 3D-printed tablets.
Initially, 3D-printed tablets released acetaminophen more rapidly than directly compressed tablets. Drug release became constant and steady after a pre-determined time. Thus, rapid effectiveness was ensured by an initially fast acetaminophen release and an extended therapeutic effect was achieved by stabilizing drug release.
The favourable drug-release profiles of 3D-printed tablets demonstrated the advantage of coupling HME with 3D printing technology to produce personalized dosage formulations.
本研究旨在将熔融挤出 3D 打印技术与融合沉积建模技术相结合,以在模拟肠液介质中生产具有双重机制药物释放性能的核壳结构控释片剂。将上述技术用于个性化药物输送可以以合理的成本提高对复杂剂量配方的可及性。与传统制药相比,这应该具有以下优势:(1)通过调整结构来操纵药物释放的能力,(2)提高难溶性药物的溶解度和生物利用度,以及(3)按需生产更复杂结构的剂量以用于个性化治疗。
对乙酰氨基酚为模型药物,并通过一系列物理化学特性评估挤出工艺。比较了直接压片和 3D 打印片剂的几何形状、形态和体外药物释放性能。
最初,3D 打印片剂比直接压片释放的对乙酰氨基酚更快。经过预定时间后,药物释放变得稳定且恒速。因此,通过快速释放对乙酰氨基酚来确保快速起效,通过稳定药物释放来实现延长的治疗效果。
3D 打印片剂的有利药物释放曲线证明了将 HME 与 3D 打印技术相结合生产个性化剂量配方的优势。