热熔挤压非晶态环孢素A长丝3D打印片剂的制备与表征。

IF 2.6 4区 医学 Q2 PHARMACOLOGY & PHARMACY
Jin-Hyuk Jeong, Chang-Soo Han, Ji-Hyun Kang, Kwang-Hwi Yoo, Woong-Young Jung, Yun-Sang Park, Dong-Wook Kim, Chun-Woong Park
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引用次数: 0

摘要

3D打印技术作为下一代药物配方方法正受到关注。在3D打印技术中,熔融沉积建模具有成本效益,但严重依赖于合适的细丝。热熔挤压通过将环孢素A等水溶性较差的药物掺入聚合物中形成固体分散体来生产长丝。然而,由于诸如片剂崩解不足或药物在聚合物基质内的包裹等问题,利用3D打印技术实现立即释放的配方仍然具有挑战性。本研究的目的是开发和评价使用HME长丝的3d打印环孢素A片的立即释放性。在3D打印过程中修改了三个参数:不同的填充速度、填充密度和通道长度。采用Kollidon®VA 64和HPC-SSL(1:1)组成的细丝进行片剂的打印。固态分析证实环孢素A在Xylisorb®300中的无定形状态和部分结晶度。溶解研究表明,较低的填充密度(30%)和较少的壁通过增加内部空隙空间和降低硬度来促进药物释放。相反,更大的片剂高度(通道长度)延迟溶出。这些发现强调了几何设计在药物释放中的关键作用,展示了3D打印的潜力,通过优化结构参数来创建个性化的剂型,以满足患者的需求。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Preparation and characterization of immediate release 3D printed tablets using hot melt extruded amorphous cyclosporine a filament.

3D printing technology is gaining attention as a next-generation approach to drug formulation. Among 3D printing techniques, fused deposition modeling is cost-effective but depends heavily on suitable filaments. Hot melt extrusion enables filament production by incorporating poorly water-soluble drugs like cyclosporine A into polymers to form solid dispersions. However, achieving immediate release formulations with 3D printing remains challenging due to issues such as inadequate tablet disintegration or drug entrapment within the polymer matrix. This study aimed to develop and evaluate immediate release 3D-printed cyclosporine A tablets using HME filaments. Three parameters were modified in the 3D printing process: varying fill speeds, infill densities, and channel lengths. Filaments composed of Kollidon® VA 64 and HPC-SSL (1:1) were used to print tablets. Solid-state analysis confirmed cyclosporine A 's amorphous state and partial crystallinity in Xylisorb® 300. Dissolution studies revealed that lower infill densities (30%) and fewer walls enhanced drug release by increasing internal void space and reducing hardness. Conversely, greater tablet height (channel length) delayed dissolution. These findings emphasize the critical role of geometric design in drug release, showcasing the potential of 3D printing to create personalized dosage forms tailored to patient needs by optimizing structural parameters.

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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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