Impact of disintegrants on rheological properties and printability in SSE 3D printing of immediate-release formulations

IF 4.7 3区 医学 Q1 PHARMACOLOGY & PHARMACY European Journal of Pharmaceutical Sciences Pub Date : 2025-03-01 Epub Date: 2025-01-21 DOI:10.1016/j.ejps.2025.107017
Morenikeji Aina , Darya Kuznyetsova , Fabien Baillon , Romain Sescousse , Noelia M. Sanchez-Ballester , Sylvie Begu , Ian Soulairol , Martial Sauceau
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Abstract

This study investigates the effects of disintegrants sodium starch glycolate (SSG) and crospovidone (CP) on the printability, rheological properties, and disintegration time of agar and hydroxypropyl methylcellulose (HPMC)-based formulations designed for semi-solid extrusion. Printability was assessed by measuring the dimensional accuracy of manually extruded filaments. Rheological analysis was performed using oscillatory measurements. Principal component analysis (PCA) and Spearman correlation analysis identified three key components (phase angle, critical strain, and elastic modulus) that explained the total variance in the rheological dataset. A 2 × 32 factorial design was employed to evaluate the impact of CP, SSG, and HPMC on these rheological parameters, as well as on printability and disintegration time. Results indicated that formulations containing HPMC and SSG generally exhibited better printability. Formulations containing CP achieved satisfactory printability only when SSG or HPMC was included. The optimal printability and rheological properties were achieved with formulations containing 5 % CP and 10 % SSG. Linear regression models correlated geometric volumes of the model and pycnometric volumes of printed objects, with validation showing that predicted masses were within a 95 % confidence interval of measured values for various shapes. All formulations demonstrated immediate-release properties, confirming the successful fabrication of personalised immediate-release dosage forms using semi-solid extrusion technology.

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崩解剂对速溶配方SSE 3D打印流变特性和可打印性的影响。
本研究考察了崩解剂淀粉乙醇酸钠(SSG)和交叉聚维酮(CP)对琼脂和羟丙基甲基纤维素(HPMC)基半固态挤出配方的可印刷性、流变性能和崩解时间的影响。通过测量手工挤出长丝的尺寸精度来评估可印刷性。流变分析采用振荡测量。主成分分析(PCA)和Spearman相关分析确定了三个关键成分(相角、临界应变和弹性模量),它们解释了流变数据集中的总方差。采用2 × 32因子设计来评估CP、SSG和HPMC对这些流变参数以及印刷性和崩解时间的影响。结果表明,含HPMC和SSG的配方普遍具有较好的印刷适性。含有CP的配方只有在含有SSG或HPMC时才能达到满意的印刷性。在含有5% CP和10% SSG的配方中获得了最佳的印刷性能和流变性能。线性回归模型将模型的几何体积与打印物体的体积相关联,验证表明预测质量在各种形状的实测值的95%置信区间内。所有配方均显示出立即释放特性,证实了使用半固体挤出技术成功制造个性化立即释放剂型。
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来源期刊
CiteScore
9.60
自引率
2.20%
发文量
248
审稿时长
50 days
期刊介绍: The journal publishes research articles, review articles and scientific commentaries on all aspects of the pharmaceutical sciences with emphasis on conceptual novelty and scientific quality. The Editors welcome articles in this multidisciplinary field, with a focus on topics relevant for drug discovery and development. More specifically, the Journal publishes reports on medicinal chemistry, pharmacology, drug absorption and metabolism, pharmacokinetics and pharmacodynamics, pharmaceutical and biomedical analysis, drug delivery (including gene delivery), drug targeting, pharmaceutical technology, pharmaceutical biotechnology and clinical drug evaluation. The journal will typically not give priority to manuscripts focusing primarily on organic synthesis, natural products, adaptation of analytical approaches, or discussions pertaining to drug policy making. Scientific commentaries and review articles are generally by invitation only or by consent of the Editors. Proceedings of scientific meetings may be published as special issues or supplements to the Journal.
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