Batch vs. continuous direct compression – a comparison of material processability and final tablet quality

IF 5.2 2区 医学 Q1 PHARMACOLOGY & PHARMACY
B. Bekaert , P.H.M. Janssen , S. Fathollahi , D. Vanderroost , T. Roelofs , B.H.J. Dickhoff , C. Vervaet , V. Vanhoorne
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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.

Abstract Image

批量直接压缩与连续直接压缩--材料加工性与最终片剂质量的比较
在这项研究中,使用类似的压缩装置对批量和连续直接压缩进行了深入比较。对材料的整体加工性和最终片剂质量进行了比较和评估。通过多变量数据分析,得出了材料特性、工艺参数和最终片剂特性之间的相关性。总共加工了 10 种低剂量(1% w/w)和 10 种高剂量(40% w/w)配方,使用了 10 种不同的填料/填料组合。试验结果表明,填料类型、药量或工艺设置对间歇式和连续式直接压制的影响相似。间歇式和连续式的主要区别在于操作系统中的流动动态,其中与流动、可压缩性和渗透性有关的特性起着至关重要的作用。间歇式工艺中流动的一致性较差,导致压片机内部(σCF)和片剂质量反应(σMass、σTS)的可变性明显较高。不过,批量加工前的混合程序得到了更好的控制,这体现在原料药浓度变化更加一致。总之,比较显示了选择适当的辅料和工艺设置以实现特定结果的益处,同时牢记两种工艺之间的一些关键区别。
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来源期刊
International Journal of Pharmaceutics: X
International Journal of Pharmaceutics: X Pharmacology, Toxicology and Pharmaceutics-Pharmaceutical Science
CiteScore
6.60
自引率
0.00%
发文量
32
审稿时长
24 days
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