三维打印的替硝唑片剂与熔融挤压技术相结合,用于配制儿童友好型药品。

IF 4.4 2区 医学 Q1 PHARMACOLOGY & PHARMACY
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引用次数: 0

摘要

本研究探讨了利用热熔挤出(HME)和熔融沉积建模(FDM)技术制造聚(1-乙烯基-2-吡咯烷酮)(Kollidon®25)长丝的可行性,以生产装载替硝唑(TNZ)的可定制儿童友好型片剂(具有不同的形状和大小)。Kollidon®25因其能够提高TNZ(BCS二类药物)的溶解度而被选中,通过汉森溶解度、极性和相互作用参数分析,对Kollidon®25的聚合物与药物相容性进行了评估,证实了TNZ与Kollidon®25之间良好的混溶性和亲和性。使用 HME 制备了不同比例的安慰剂和 TNZ 长丝,然后通过 FDM 开发了 3D 打印片剂。对制成的安慰剂和 TNZ 三维片剂进行了表征,发现它们的平均重量变化分别为 270.41 ± 7.44 mg 和 270.87 ± 9.33 mg,硬度分别为 155.01 ± 11.79 N 和 265.3 ± 7.62 N,易碎性分别为 0.1583 ± 0.0011 % 和 0.2254 ± 0.0013 %。差示扫描量热法(DSC)和粉末 X 射线衍射(PXRD)分析证实了这种材料的非晶化现象。扫描电子显微镜(SEM)显示片剂表面有一层一层的微小裂缝,这增强了介质的渗透性,从而改善了溶出曲线。TNZ 的释放曲线显示,在胃酸介质中 2.0 小时内完全释放了 100%。这些研究结果证明了 Kollidon®25 的潜力,它可以为 TNZ 的给药创造出可定制的、适合儿童的、具有不同形状和大小的 3D 打印剂型,为儿科用药提供了一种独特的方法。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

3D printed tinidazole tablets coupled with melt-extrusion techniques for formulating child friendly medicines

3D printed tinidazole tablets coupled with melt-extrusion techniques for formulating child friendly medicines

This study investigates the feasibility of fabrication of poly(1-vinyl-2-pyrrolidone) (Kollidon®25)-mediated filaments for producing tinidazole (TNZ)-loaded, customizable, child-friendly tablets (with varying shapes and sizes) using hot melt extrusion (HME) coupled with fused deposition modeling (FDM) technology. Kollidon®25, chosen for its ability to enhance the dissolution of TNZ (a BCS Class II drug), was evaluated for polymer-drug compatibility through Hansen solubility, polarity, and interaction parameter analyses, confirming good miscibility and affinity between TNZ and Kollidon®25. Placebo- and TNZ-loaded filaments were prepared in different ratios using HME, followed by the development of 3D-printed tablets via FDM. The fabricated batches of placebo and TNZ-loaded 3D tablets were characterized, and it was found that they had an average weight variation of 270.41 ± 7.44 mg and 270.87 ± 9.33 mg, hardness of 155.01 ± 11.79 N and 265.3 ± 7.62 N, and friability of 0.1583 ± 0.0011 % and 0.2254 ± 0.0013 %. Amorphization was confirmed by differential scanning calorimetry (DSC) and powder X-ray diffraction (PXRD) analysis. Scanning electron microscopy (SEM) revealed a layer-by-layer pattern with tiny fractures on the tablet surfaces, which enhanced media penetration, resulting in improved dissolution profiles. The TNZ release profile showed complete 100 % release within 2.0 h in a gastric acidic medium. These findings support the potential of Kollidon®25 to create customizable, child-friendly, 3D-printed dosage forms with different shapes and sizes for TNZ delivery, offering a unique approach to paediatric medications.

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来源期刊
CiteScore
8.80
自引率
4.10%
发文量
211
审稿时长
36 days
期刊介绍: The European Journal of Pharmaceutics and Biopharmaceutics provides a medium for the publication of novel, innovative and hypothesis-driven research from the areas of Pharmaceutics and Biopharmaceutics. Topics covered include for example: Design and development of drug delivery systems for pharmaceuticals and biopharmaceuticals (small molecules, proteins, nucleic acids) Aspects of manufacturing process design Biomedical aspects of drug product design Strategies and formulations for controlled drug transport across biological barriers Physicochemical aspects of drug product development Novel excipients for drug product design Drug delivery and controlled release systems for systemic and local applications Nanomaterials for therapeutic and diagnostic purposes Advanced therapy medicinal products Medical devices supporting a distinct pharmacological effect.
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