Suppr超能文献

将压片工艺从压实模拟器扩展到旋转压片机——关注子过程

Scaling Tableting Processes from Compaction Simulator to Rotary Presses-Mind the Sub-Processes.

作者信息

Wünsch Isabell, Friesen Irene, Puckhaber Daniel, Schlegel Thomas, Finke Jan Henrik

机构信息

Institute for Particle Technology, TU Braunschweig, Volkmaroder Str. 5, 38104 Braunschweig, Germany.

Center of Pharmaceutical Engineering-PVZ, TU Braunschweig, Franz-Liszt-Str. 35A, 38106 Braunschweig, Germany.

出版信息

Pharmaceutics. 2020 Mar 31;12(4):310. doi: 10.3390/pharmaceutics12040310.

Abstract

Compaction simulators are frequently used in the formulation and process development of tablets, bringing about the advantages of flexibility, low material consumption, and high instrumentation to generate the most possible process understanding. However, their capability of resembling general aspects of rotary press compaction and their precision in simulating or mimicking sub-processes such as feeding and filling need to be systematically studied. The effect of material deformation behavior, blend composition, and feeding on tensile strength and simulation precision as compared with rotary presses of different scales is evaluated in this study. Generally, good simulation performance was found for the studied compaction simulator. Compaction profile-sensitivity was demonstrated for highly visco-plastic materials while shear-sensitivity in feeding was demonstrated for lubricated blends of ductile particles. Strategies for the compensation of both in compaction simulator experiments are presented by careful investigation of the compaction stress over time profiles and introduction of a compaction simulator-adapted shear number approach to account for differences in layout and operation mode between compaction simulator and rotary press, respectively. These approaches support the general aim of this study to provide a more straightforward determination of scaling process parameters between rotary press and compaction simulator and facilitate a quicker and more reliable process transfer.

摘要

压片模拟器在片剂的配方和工艺开发中经常被使用,具有灵活性、低物料消耗和高仪器化程度等优点,有助于尽可能深入地理解工艺过程。然而,它们模拟旋转压片一般过程的能力以及在模拟或模仿进料和填充等子过程方面的精度,需要进行系统研究。本研究评估了物料变形行为、混合组成和进料对拉伸强度的影响,以及与不同规模旋转压片机相比的模拟精度。总体而言,所研究的压片模拟器表现出良好的模拟性能。对于高粘塑性材料,展示了压实曲线敏感性;对于韧性颗粒的润滑混合物,展示了进料过程中的剪切敏感性。通过仔细研究压实应力随时间的变化曲线,并分别引入适用于压片模拟器的剪切数方法来考虑压片模拟器和旋转压片机在布局和操作模式上的差异,提出了在压片模拟器实验中补偿这两种情况的策略。这些方法支持了本研究的总体目标,即更直接地确定旋转压片机和压片模拟器之间的放大工艺参数,并促进更快、更可靠的工艺转移。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7d46/7238235/8aa14d633eb4/pharmaceutics-12-00310-g001.jpg

文献AI研究员

20分钟写一篇综述,助力文献阅读效率提升50倍。

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索

文档翻译

学术文献翻译模型,支持多种主流文档格式。

立即体验