选择性激光烧结阿托西汀片:一种小规模、个性化生产的创新方法。

IF 5.5 3区 医学 Q1 PHARMACOLOGY & PHARMACY
Gordana Stanojević, Ivana Adamov, Snežana Mugoša, Veselinka Vukićević, Svetlana Ibrić
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引用次数: 0

摘要

背景/目的:对个性化医疗日益增长的兴趣加速了三维(3D)打印技术在制药应用中的探索。本研究探讨了选择性激光烧结(SLS)作为一种灵活的、小规模的针对个性化治疗的阿托西汀片制造方法的潜力,并将其与传统的直接压缩进行了比较。方法:采用不同激光扫描速度的SLS 3D打印生产阿托莫西汀片剂,并与压实模拟器制作的片剂进行比较。配方以羟丙基甲基纤维素(HPMC)为主要基质前体。对其物理性质、药物含量、崩解时间和溶出度进行了评价。利用扫描电镜(SEM)、红外光谱(FTIR)、DSC和XRPD对其结构和化学完整性进行了评估。结果:SLS片的力学性能和药物含量与压实法相当。较低的激光速度产生的片剂较硬,崩解较慢,而较高的激光速度产生的片剂多孔性更强,药物释放速度超快(15分钟内释放约85%)。所有片剂均符合欧洲药典溶出度标准。未发现明显的药物-赋形剂相互作用或结晶度变化。结论:SLS印刷是传统片剂生产的可行替代方案,可通过调整参数控制药物释放曲线。该技术支持高质量、患者特异性剂型的开发,并有望在个性化药物治疗中得到更广泛的应用。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Selective Laser Sintering of Atomoxetine Tablets: An Innovative Approach for Small-Scale, Personalized Production.

Background/Objectives: The growing interest in personalized medicine has accelerated the exploration of three-dimensional (3D) printing technologies in pharmaceutical applications. This study investigates the potential of selective laser sintering (SLS) as a flexible, small-scale manufacturing method for atomoxetine tablets tailored for individualized therapy, comparing it with conventional direct compression. Methods: Atomoxetine tablets were produced using SLS 3D printing with varying laser scanning speeds and compared to tablets made via a compaction simulator. Formulations were based on hydroxypropyl methylcellulose (HPMC) as the primary matrix former. The physical properties, drug content, disintegration time, and dissolution profiles were evaluated. The structural and chemical integrity were assessed using SEM, FTIR, DSC, and XRPD. Results: The SLS tablets exhibited comparable mechanical properties and drug content to those made by compaction. Lower laser speeds produced harder tablets with slower disintegration, while higher speeds yielded more porous tablets with ultra-rapid drug release (>85% in 15 min). All tablets met the European Pharmacopoeia dissolution criteria. No significant drug-excipient interactions or changes in crystallinity were detected. Conclusions: SLS printing is a viable alternative to traditional tablet manufacturing, offering control over drug release profiles through parameter adjustment. The technique supports the development of high-quality, patient-specific dosage forms and shows promise for broader implementation in personalized pharmaceutical therapy.

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来源期刊
Pharmaceutics
Pharmaceutics Pharmacology, Toxicology and Pharmaceutics-Pharmaceutical Science
CiteScore
7.90
自引率
11.10%
发文量
2379
审稿时长
16.41 days
期刊介绍: Pharmaceutics (ISSN 1999-4923) is an open access journal which provides an advanced forum for the science and technology of pharmaceutics and biopharmaceutics. It publishes reviews, regular research papers, communications,  and short notes. Covered topics include pharmacokinetics, toxicokinetics, pharmacodynamics, pharmacogenetics and pharmacogenomics, and pharmaceutical formulation. Our aim is to encourage scientists to publish their experimental and theoretical details in as much detail as possible. There is no restriction on the length of the papers. The full experimental details must be provided so that the results can be reproduced.
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