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基于数学函数控制的 3D 打印片剂的开发及其对药物释放的影响。

Development of Mathematical Function Control-Based 3D Printed Tablets and Effect on Drug Release.

机构信息

Department of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, University, MS, 38677, USA.

Pii Center for Pharmaceutical Technology, The University of Mississippi, University, MS, 38677, USA.

出版信息

Pharm Res. 2024 Nov;41(11):2235-2246. doi: 10.1007/s11095-024-03780-5. Epub 2024 Oct 21.

Abstract

PURPOSE

The application of 3D printing technology in drug delivery is often limited by the challenges of achieving precise control over drug release profiles. The goal of this study was to apply surface equations to construct 3D printed tablet models, adjust the functional parameters to obtain multiple tablet models and to correlate the model parameters with the in vitro drug release behavior.

METHODS

This study reports the development of 3D-printed tablets using surface geometries controlled by mathematical functions to modulate drug release. Utilizing fused deposition modeling (FDM) coupled with hot-melt extrusion (HME) technology, personalized drug delivery systems were produced using thermoplastic polymers. Different tablet shapes (T1-T5) were produced by varying the depth of the parabolic surface (b = 4, 2, 0, -2, -4 mm) to assess the impact of surface curvature on drug dissolution.

RESULTS

The T5 formulation, with the greatest surface curvature, demonstrated the fastest drug release, achieving complete release within 4 h. In contrast, T1 and T2 tablets exhibited a slower release over approximately 6 h. The correlation between surface area and drug release rate was confirmed, supporting the predictions of the Noyes-Whitney equation. Differential Scanning Calorimetry (DSC) and Scanning Electron Microscope (SEM) analyses verified the uniform dispersion of acetaminophen and the consistency of the internal structures, respectively.

CONCLUSIONS

The precise control of tablet surface geometry effectively tailored drug release profiles, enhancing patient compliance and treatment efficacy. This novel approach offers significant advancements in personalized medicine by providing a highly reproducible and adaptable platform for optimizing drug delivery.

摘要

目的

3D 打印技术在药物传递中的应用常常受到难以精确控制药物释放曲线的挑战。本研究的目的是应用表面方程构建 3D 打印片剂模型,调整功能参数以获得多个片剂模型,并将模型参数与体外药物释放行为相关联。

方法

本研究报告了使用由数学函数控制的表面几何形状来调节药物释放的 3D 打印片剂的开发。利用熔融沉积建模(FDM)与热熔挤出(HME)技术,使用热塑性聚合物生产了个性化药物传递系统。通过改变抛物面的深度(b=4、2、0、-2、-4mm)来生产不同形状的片剂(T1-T5),以评估表面曲率对药物溶解的影响。

结果

具有最大表面曲率的 T5 制剂表现出最快的药物释放,在 4 小时内实现完全释放。相比之下,T1 和 T2 片剂在大约 6 小时内释放速度较慢。表面积与药物释放速率之间的相关性得到了确认,支持了 Noyes-Whitney 方程的预测。差示扫描量热法(DSC)和扫描电子显微镜(SEM)分析分别验证了对乙酰氨基酚的均匀分散和内部结构的一致性。

结论

片剂表面几何形状的精确控制有效地调整了药物释放曲线,提高了患者的顺应性和治疗效果。这种新方法通过提供高度可重复和可适应的药物传递优化平台,在个性化医学方面取得了重大进展。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8963/11599347/9cd6494517f3/11095_2024_3780_Fig1_HTML.jpg

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