Madžarević Marijana, Medarević Đorđe, Pavlović Stefan, Ivković Branka, Đuriš Jelena, Ibrić Svetlana
Department of Pharmaceutical Technology and Cosmetology, Faculty of Pharmacy, University of Belgrade, Vojvode Stepe 450, 11221 Belgrade, Serbia.
Institute of Chemistry, Technology, and Metallurgy, University of Belgrade, Njegoseva 12, 11001 Belgrade, Serbia.
Pharmaceutics. 2021 Nov 20;13(11):1969. doi: 10.3390/pharmaceutics13111969.
Selective laser sintering (SLS) is a rapid prototyping technique for the production of three-dimensional objects through selectively sintering powder-based layer materials. The aim of the study was to investigate the effect of energy density (ED) and formulation factors on the printability and characteristics of SLS irbesartan tablets. The correlation between formulation factors, ED, and printability was obtained using a decision tree model with an accuracy of 80%. FT-IR results revealed that there was no interaction between irbesartan and the applied excipients. DSC results indicated that irbesartan was present in an amorphous form in printed tablets. ED had a significant influence on tablets' physical, mechanical, and morphological characteristics. Adding lactose monohydrate enabled faster drug release while reducing the possibility for printing with different laser speeds. However, formulations with crospovidone were printable with a wider range of laser speeds. The adjustment of formulation and process parameters enabled the production of SLS tablets with hydroxypropyl methylcellulose with complete release in less than 30 min. The results suggest that a decision tree could be a useful tool for predicting the printability of pharmaceutical formulations. Tailoring the characteristics of SLS irbesartan tablets by ED is possible; however, it needs to be governed by the composition of the whole formulation.
选择性激光烧结（SLS）是一种快速成型技术，通过选择性地烧结基于粉末的层状材料来生产三维物体。本研究的目的是探讨能量密度（ED）和配方因素对SLS厄贝沙坦片的可打印性和特性的影响。使用准确率为80%的决策树模型获得了配方因素、ED和可打印性之间的相关性。傅里叶变换红外光谱（FT-IR）结果显示，厄贝沙坦与所用辅料之间不存在相互作用。差示扫描量热法（DSC）结果表明，厄贝沙坦在打印片中以无定形形式存在。ED对片剂的物理、机械和形态特性有显著影响。添加一水乳糖可使药物释放更快，同时降低以不同激光速度打印的可能性。然而，含有交联聚维酮的配方在更宽的激光速度范围内均可打印。通过调整配方和工艺参数，可以生产出在不到30分钟内完全释放的含羟丙基甲基纤维素的SLS片剂。结果表明，决策树可能是预测药物制剂可打印性的有用工具。通过ED调整SLS厄贝沙坦片的特性是可行的；然而，这需要由整个配方的组成来控制。
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