Drug Product Science and Technology, Bristol-Myers Squibb , New Brunswick , NJ , USA.
Pharm Dev Technol. 2019 Dec;24(10):1250-1257. doi: 10.1080/10837450.2019.1658775. Epub 2019 Sep 9.
Using instrumented roll technology, statistical models relating process parameters such as hydraulic pressure, roll speed and screw speed of Vector TF mini roller compactor to ribbon normal stress and density were developed for placebo blends. Normal stress was found to be directly proportional to hydraulic pressure, roll speed and inversely to screw to roll speed ratio. A power-law relationship between ribbon density and normal stress was observed for placebo blends. Models developed for placebo were found to predict ribbon densities of active blends with good accuracy. Standard optimization of roller compaction process parameters involves the investment of a large amount of time and active ingredient. These models can, therefore, be utilized to predict starting instrument settings required to generate a ribbon of desired solid fraction during early-stage development where material availability & time is limited.
利用仪器化的压辊技术，为 Vector TF 迷你压辊机的安慰剂混合物建立了与工艺参数（如液压、压辊速度和螺杆速度）相关的统计模型，以研究带状物的法向应力和密度。研究发现，法向应力与液压、压辊速度成正比，与螺杆与压辊速度比成反比。对于安慰剂混合物，观察到带状物密度与法向应力之间存在幂律关系。研究发现，为安慰剂混合物开发的模型可以很好地预测活性混合物的带状物密度。压辊制粒工艺参数的标准优化需要投入大量的时间和活性成分。因此，在物料供应和时间有限的早期开发阶段，这些模型可用于预测在生成所需的固体分数的带状物时所需的起始仪器设置。
