PDF(Pubmed)
Abstract：
In this study, an in-depth comparison was made between batch and continuous direct compression using similar compression set-ups. The overall material processability and final tablet quality were compared and evaluated. Correlations between material properties, process parameters and final tablet properties were made via multivariate data analyses. In total, 10 low-dosed (1% w/w) and 10 high-dosed (40% w/w) formulations were processed, using a total of 10 different fillers/filler combinations. The trials indicated that the impact of filler type, drug load or process settings was similar for batch and continuous direct compression. The main differentiator between batch and continuous was the flow dynamics in the operating system, where properties related to flow, compressibility and permeability played a crucial role. The less consistent flow throughout a batch process resulted in a significantly higher variability within the tablet press (σCF) and for the tablet quality responses (σMass, σTS). However, the better controlled blending procedure prior to batch processing was reflected in a more consistent API concentration variability. Overall, the comparison showed the benefits of selecting appropriate excipients and process settings to achieve a specific outcome, keeping in mind some key differentiators between both processes.
摘要：
在这项研究中,使用类似的压缩设置，在分批和连续直接压缩之间进行了深入比较。比较和评价总体材料加工性能和最终片剂质量。材料属性之间的相关性，工艺参数和最终片剂的性质是通过多变量数据分析。总的来说,处理10个低剂量（1％w/w）和10个高剂量（40％w/w）制剂，使用总共10种不同的填料/填料组合。试验表明，填料类型的影响，批量和连续直接压缩的载药量或工艺设置相似.间歇和连续之间的主要区别是操作系统中的流动动力学，其中与流相关的属性，可压缩性和渗透性起了至关重要的作用。整个批处理过程中的一致性较低，导致压片机内的可变性（σCF）和片剂质量响应（σMass，σTS）。然而,在批量处理之前更好地控制混合程序反映在更一致的API浓度变异性中.总的来说,比较显示了选择合适的赋形剂和工艺设置以实现特定结果的好处，记住这两个过程之间的一些关键区别。
