Development of fenofibrate solid dispersion via hot melt extrusion and 3D printing technologies.

IF 2.6 4区 医学 Q2 PHARMACOLOGY & PHARMACY
Janhavi Deshmukh, Kavish Sanil, Achref Cherif, Eman A Ashour
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引用次数: 0

Abstract

This study aimed to develop an amorphous solid dispersion (ASD) of fenofibrate using Hot Melt Extrusion (HME) and 3D printing to evaluate the impact of preparation methods on ASD properties. Fenofibrate (10% w/w) was processed with Soluplus® and Polyethylene oxide-N80 to produce HME filaments. These filaments were either used as feedstock for Fused Deposition Modeling (FDM) 3D printing to fabricate tablets with 90%, 70%, and 50% infill densities or milled and filled into gelatin capsules. Printability was assessed via a three-point bend test. The fenofibrate formulations were evaluated for drug content, physical state, surface morphology, and release profile. The SEM images of pure fenofibrate showed large cylindrical crystals while the 3D-printed tablets showed a smooth surface with no record of any crystals. This observation is in line with the DSC results and confirms the conversion of fenofibrate from crystalline to an amorphous state. The in- vitro drug release for the 3D printed tablets and capsules was increased 2-fold as compared to pure fenofibrate. Statistical comparisons further supported these findings, highlighting infill density as a tunable parameter for modulating release kinetics.

利用热熔挤压和3D打印技术研制非诺贝特固体分散体。
本研究旨在利用热熔挤压(HME)和3D打印技术制备非诺贝特非晶态固体分散体(ASD),以评估制备方法对非诺贝特非晶态固体分散体性能的影响。非诺贝特(10% w/w)用Soluplus®和聚乙烯氧化物- n80处理,以生产HME长丝。这些细丝要么用作熔融沉积建模(FDM) 3D打印的原料,以制造填充密度为90%、70%和50%的片剂,要么研磨并填充到明胶胶囊中。通过三点弯曲试验评估印刷性。评估了非诺贝特制剂的药物含量、物理状态、表面形态和释放谱。纯非诺贝特的SEM图像显示出大的圆柱形晶体,而3d打印的片剂表面光滑,没有任何晶体记录。这一观察结果与DSC结果一致,证实了非诺贝特从结晶到非晶态的转化。与纯非诺贝特相比,3D打印片剂和胶囊的体外药物释放量增加了2倍。统计比较进一步支持了这些发现,强调填充密度是调节释放动力学的可调参数。
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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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