3D打印药物释放速率控制研究基于模型结构调整的3D打印药物释放速率控制研究。

IF 2.6 4区 医学 Q2 PHARMACOLOGY & PHARMACY
Ruyue Dong, Xiaolu Han, Zhiqiang Tang, Xiaoxuan Hong, Hui Zhang, Nan Liu, Kun Wan, Mingyuan Li, Zengming Wang, Aiping Zheng
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引用次数: 0

摘要

作为一项新兴技术,3D打印促进了复杂制剂的制造,并使药物释放可控。本研究结合半固态挤压(SSE)和熔融沉积模型(FDM),开发了具有不同释放特性的核壳结构缓释片(CSRT),探索结构设计如何影响释放行为。选择盐酸心得安为模型药物。采用SSE法制备了不同填充率的载药岩心,并对其外观、硬度、XRD和释药性能进行了表征。采用FDM技术制备了具有不同释放窗口的壳体。随后,组装壳和芯。采用Micro-CT进行微观结构表征,同时评估药物分析和释放特性。结果表明,岩心形貌良好,SSE工艺对晶体类型没有影响。调节填充率允许轻微调节药物释放,而外壳结构有效地延长药物释放。CSRT没有显示出明显的内部缺陷,该分析符合美国药典-国家处方2024 (USP-NF 2024)的要求。调节释放窗可获得8 ~ 24 h的缓释,释放曲线符合一级动力学(R2值为0.961 ~ 0.999)。这些发现为控制药物释放速度提供了可行的策略。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Study on controlling 3D printed drug release rates based on model structural adjustment.

As an emerging technology, 3D printing facilitates the fabrication of complex preparations and enables controlled drug release. This study integrated semi-solid extrusion (SSE) and fused deposition modeling (FDM) to develop core-shell structured sustained-release tablets (CSRT) with varying release profiles, exploring how structural design influences release behavior. Propranolol hydrochloride was selected as the model drug. Drug-loaded cores with different filling rates were prepared using SSE and characterized for appearance, hardness, XRD, and release properties. Shells with varying release windows were fabricated using FDM. Subsequently, shells and cores were assembled. Micro-CT was employed for microstructural characterization, while drug assay and release properties were assessed. The results indicated that cores exhibited a good appearance, and the SSE process had no effect on the crystal type. Adjusting the filling rate allowed for slight modulation of drug release while the shell structure effectively prolonged drug release. The CSRT displayed no significant internal defects, and the assay met the United States Pharmacopoeia-National Formulary 2024 (USP-NF 2024) requirements. Adjusting release windows resulted in a sustained release ranging from 8 to 24 h, with the release profile conforming to first-order kinetics (R2 values ranging from 0.961 to 0.999). These findings provide practical strategies for controlling drug release rates.

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来源期刊
CiteScore
5.90
自引率
2.90%
发文量
82
审稿时长
1 months
期刊介绍: Pharmaceutical Development & Technology publishes research on the design, development, manufacture, and evaluation of conventional and novel drug delivery systems, emphasizing practical solutions and applications to theoretical and research-based problems. The journal aims to publish significant, innovative and original research to advance the frontiers of pharmaceutical development and technology. Through original articles, reviews (where prior discussion with the EIC is encouraged), short reports, book reviews and technical notes, Pharmaceutical Development & Technology covers aspects such as: -Preformulation and pharmaceutical formulation studies -Pharmaceutical materials selection and characterization -Pharmaceutical process development, engineering, scale-up and industrialisation, and process validation -QbD in the form a risk assessment and DoE driven approaches -Design of dosage forms and drug delivery systems -Emerging pharmaceutical formulation and drug delivery technologies with a focus on personalised therapies -Drug delivery systems research and quality improvement -Pharmaceutical regulatory affairs This journal will not consider for publication manuscripts focusing purely on clinical evaluations, botanicals, or animal models.
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