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崩解剂对速释制剂SSE 3D打印中流变学性质和可打印性的影响。

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

作者信息

Aina Morenikeji, Kuznyetsova Darya, Baillon Fabien, Sescousse Romain, Sanchez-Ballester Noelia M, Begu Sylvie, Soulairol Ian, Sauceau Martial

机构信息

RAPSODEE, IMT Mines Albi, CNRS, University of Toulouse, 81013 Albi, France.

RAPSODEE, IMT Mines Albi, CNRS, University of Toulouse, 81013 Albi, France.

出版信息

Eur J Pharm Sci. 2025 Mar 1;206:107017. doi: 10.1016/j.ejps.2025.107017. Epub 2025 Jan 21.

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 × 3 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.

摘要

本研究调查了崩解剂羟丙基淀粉甘醇醚(SSG)和交联聚维酮(CP)对基于琼脂和羟丙基甲基纤维素(HPMC)的半固体挤出制剂的可打印性、流变学性质及崩解时间的影响。通过测量手动挤出长丝的尺寸精度来评估可打印性。使用振荡测量进行流变学分析。主成分分析(PCA)和Spearman相关性分析确定了三个关键成分(相角、临界应变和弹性模量),它们解释了流变学数据集中的总方差。采用2×3析因设计来评估CP、SSG和HPMC对这些流变学参数以及对可打印性和崩解时间的影响。结果表明,含有HPMC和SSG的制剂通常表现出更好的可打印性。仅当包含SSG或HPMC时,含有CP的制剂才能实现令人满意的可打印性。含有5%CP和10%SSG的制剂实现了最佳的可打印性和流变学性质。线性回归模型将模型的几何体积与打印物体的真密度体积相关联,验证表明预测质量在各种形状测量值的95%置信区间内。所有制剂均表现出速释特性,证实了使用半固体挤出技术成功制备了个性化速释剂型。

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