UNDERSTANDING EFFECT OF LASER SPEED AND FORMULATION FACTORS ON PRINTABILITY AND CHARACTERISTICS OF SLS IRBESARTAN TABLETS- APPLICATION OF DECISION TREE MODEL 2021ICCBIKG (2021)

Marijana Madžarević, S. Ibrić
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Abstract

Selective laser sintering (SLS) is a rapid prototyping technique for the production of 3D objects through selectively sintering powder-based layers materials by combinations of energy from the laser beam and the heated chamber of the printer. The aim of the study was to investigate the effect of laser speed and formulation factors on printability and characteristics of SLS irbesartan tablets. Physical mixtures of hydroxypropylmethylcellulose (46-91%), Candurin® Gold Sheen (3%), colloidal silicon dioxide (1%), and irbesartan (5%) were prepared. Afterward, crospovidone (1-5%), Kollidon®VA 64 Fine (20%), and/or lactose monohydrate (20-45%) were added. Sintratec Kit SLS printer (Sintratec AG, Switzerland) was used for printing tablets. The decision tree model was applied to classify printability factors. Characterization of tablets was done in terms of physicochemical, mechanical and biopharmaceutical characteristics. Correlation between formulation factors, laser speed, and printability was obtained using decision tree model with an accuracy of 80%. FTIR results revealed that there was no interaction between irbesartan and applied excipients. DSC indicated that irbesartan was present in an amorphous form in printed tablets. It was observed that laser speed had a negative effect on weight. Tuning the drug release by laser speed was possible although lactose monohydrate reduced its impact because it was required higher energy for the sintering process. Results suggest that decision tree could be useful tool for predicting the printability of pharmaceutical formulations. Tailoring characteristics of SLS irbesartan tablets by laser speed is possible, however, it needs to be governed by the composition of the whole formulation.
了解激光速度和配方因素对SLS厄贝沙坦片印刷性和特性的影响——决策树模型2021icchbikg(2021)的应用
选择性激光烧结(SLS)是一种快速成型技术,通过结合激光束和打印机加热腔的能量,选择性烧结粉末基层材料,生产3D物体。研究激光速度和处方因素对SLS型厄贝沙坦片印刷性和特性的影响。制备了羟丙基甲基纤维素(46-91%)、Candurin®Gold Sheen(3%)、胶体二氧化硅(1%)和厄贝沙坦(5%)的物理混合物。随后,加入交叉维酮(1-5%)、Kollidon®VA 64 Fine(20%)和/或一水乳糖(20-45%)。使用Sintratec Kit SLS打印机(瑞士Sintratec AG)打印片剂。采用决策树模型对印刷适性因素进行分类。从理化、力学和生物制药等方面对片剂进行了表征。利用决策树模型获得了配方因素、激光速度和印刷适性之间的相关性,准确率为80%。FTIR结果显示厄贝沙坦与外用辅料之间没有相互作用。DSC表明厄贝沙坦在印刷片剂中以无定形存在。观察到激光速度对体重有负面影响。通过激光速度调整药物释放是可能的,尽管一水乳糖降低了它的影响,因为它在烧结过程中需要更高的能量。结果表明,决策树可作为预测制剂可印刷性的有效工具。利用激光速度对SLS厄贝沙坦片的特性进行裁剪是可能的,但这需要由整个配方的组成来决定。
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