Drug Substance Development - Material Science, GlaxoSmithKline, 1250 S, Collegeville Rd, Collegeville, PA, 19426, United States of America.
Department of Material Science and Engineering, Drexel University, 3141 Chestnut St., Philadelphia, PA, 19104, United States of America.
AAPS PharmSciTech. 2023 Nov 21;24(8):237. doi: 10.1208/s12249-023-02694-6.
"Sticking" during tablet manufacture is the term used to describe the accumulation of adhered tablet material on the punch over the course of several compaction cycles. The occurrence of sticking can affect tablet weight, image, and structural integrity and halt manufacturing operations. The earlier the risk of sticking is detected during R&D, the more options are available for mitigation and the less potential there is for significant delays and costs. The detection osf sticking, however, during the early stages of drug development is challenging due to the limitations of available material quantity. In this work, single tablet multi-compaction (STMC) and a highly sensitive laser reflection sensor are used to detect the propensity of sticking with ibuprofen powder blends. STMC can differentiate the various formulations and replicates the trends of sticking at different punch speeds. The results demonstrate the potential for STMC to be used as an extremely material sparing (requiring very few tablets) methodology for the assessment of sticking during early-stage development.
“黏冲”是指在多个压片循环过程中，片剂物料黏附在冲头表面的现象。黏冲会影响片剂的重量、外观和结构完整性，并导致生产中断。在研发阶段越早发现黏冲的风险，就有更多的缓解选择，潜在的重大延迟和成本也就越低。然而，由于可用物料数量的限制，在药物开发的早期阶段检测黏冲存在挑战。在这项工作中，采用了单压片多次压缩（STMC）和高灵敏度激光反射传感器来检测布洛芬粉末混合物发生黏冲的趋势。STMC 可以区分不同的配方，并复制在不同冲头速度下黏冲的趋势。结果表明，STMC 有可能成为一种非常节省物料（仅需很少片剂）的方法，用于评估早期开发阶段的黏冲情况。
