熔融沉积成型印刷参数对片剂崩解时间影响的实验设计研究。

IF 2.1 4区 医学 Q3 PHARMACOLOGY & PHARMACY Acta Pharmaceutica Pub Date : 2023-09-01 DOI:10.2478/acph-2023-0026
Klemen Kreft, Tijana Stanić, Petra Perhavec, Rok Dreu, Zoran Lavrič
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引用次数: 0

摘要

尽管使用熔融沉积建模(FDM)技术打印固体剂型的过程参数很重要,但该领域的探索仍然很少。为了解自行研制的FDM 3D打印机的全套工艺参数及其对片剂崩解时间的影响,进行了实验设计研究。对Simplify 3D打印工艺设计软件中的9种设置进行了评估,并对填充百分比、填充模式、喷嘴直径和层高的影响进行了进一步的实验研究。充填率是影响最大的参数,充填率呈抛物线型增加,会影响崩解时间的延长。此外,更大的喷嘴直径延长片剂分解,因为在印刷过程中,更宽的喷嘴产生更厚的挤出股。选择三种填充模式进行深入分析,表明内部结构的几何形状在崩解试验中抵抗机械应力的明显重要性。最后,层高对崩解时间没有影响。建立了具有准确拟合(r2 = 0.928)和可预测性(q2 = 0.847)的统计模型。此外,只有填充模式和层高对质量均匀性和崩解时间均匀性都有影响,表明了印刷工艺的稳健性。
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Influence of fused deposition modelling printing parameters on tablet disintegration times: a design of experiments study.

Despite the importance of process parameters in the printing of solid dosage forms using fused deposition modelling (FDM) technology, the field is still poorly explored. A design of experiment study was conducted to understand the complete set of process parameters of a custom developed FDM 3D printer and their influence on tablet disintegration time. Nine settings in the Simplify 3D printing process design software were evaluated with further experimental investigation conducted on the influence of infill percentage, infill pattern, nozzle diameter, and layer height. The percentage of infill was identified as the most impactful parameter, as increasing it parabolically affected the increase of disintegration time. Furthermore, a larger nozzle diameter prolonged tablet disintegration, since thicker extruded strands are generated through wider nozzles during the printing process. Three infill patterns were selected for in-depth analysis, demonstrating the clear importance of the geometry of the internal structure to resist mechanical stress during the disintegration test. Lastly, layer height did not influence the disintegration time. A statistical model with accurate fit (R 2 = 0.928) and predictability (Q 2 = 0.847) was created. In addition, only the infill pattern and layer height influenced both the uniformity of mass and uniformity of the disintegration time, which demonstrates the robustness of the printing process.

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来源期刊
Acta Pharmaceutica
Acta Pharmaceutica PHARMACOLOGY & PHARMACY-
CiteScore
5.20
自引率
3.60%
发文量
20
审稿时长
>12 weeks
期刊介绍: AP is an international, multidisciplinary journal devoted to pharmaceutical and allied sciences and contains articles predominantly on core biomedical and health subjects. The aim of AP is to increase the impact of pharmaceutical research in academia, industry and laboratories. With strong emphasis on quality and originality, AP publishes reports from the discovery of a drug up to clinical practice. Topics covered are: analytics, biochemistry, biopharmaceutics, biotechnology, cell biology, cell cultures, clinical pharmacy, drug design, drug delivery, drug disposition, drug stability, gene technology, medicine (including diagnostics and therapy), medicinal chemistry, metabolism, molecular modeling, pharmacology (clinical and animal), peptide and protein chemistry, pharmacognosy, pharmacoepidemiology, pharmacoeconomics, pharmacodynamics and pharmacokinetics, protein design, radiopharmaceuticals, and toxicology.
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