Gupta Anshu, Austin John, Davis Sierra, Harris Michael, Reklaitis Gintaras
FRNY Hall of Chemical Engineering, Purdue University, West Lafayette, Indiana, 40907.
J Pharm Sci. 2015 May;104(5):1787-94. doi: 10.1002/jps.24409. Epub 2015 Mar 9.
Control of particulate processes is hard to achieve because of the ease with which powders tend to segregate. Thus, proper sensing methods must be employed to ensure content uniformity during operation. The role of sensing schemes becomes even more critical while operating the process continuously as measurements are essential for implementation of feedback control (Austin et al. 2013. J Pharm Sci 102(6):1895-1904; Austin et al. 2014. Anal Chim Acta 819:82-93). A microwave sensor was developed and shown to be effective in online measurement of active pharmaceutical ingredient (API) concentration in a powder blend. During powder transport and hopper storage before processing, powder blends may segregate and cause quality deviations in the subsequent tableting operation. Therefore, it is critical to know the API concentration in the ribbons as the content uniformity is fixed once the ribbon is processed. In this study, a novel microwave sensor was developed that could provide measurement of a roller compacted ribbon's API concentration online, along with its density and moisture content. The results indicate that this microwave sensor is capable of increased accuracy compared with a commercially available near-IR probe for the determination of content uniformity and density in roller compacted ribbons online.
由于粉末易于分离，颗粒过程的控制很难实现。因此，必须采用适当的传感方法来确保操作过程中的含量均匀性。在连续操作过程中，传感方案的作用变得更加关键，因为测量对于反馈控制的实施至关重要（奥斯汀等人，2013年。《药物科学杂志》102(6):1895 - 1904；奥斯汀等人，2014年。《分析化学学报》819:82 - 93）。一种微波传感器被开发出来，并证明在在线测量粉末混合物中的活性药物成分（API）浓度方面是有效的。在粉末运输和加工前的料斗储存过程中，粉末混合物可能会分离，并在随后的压片操作中导致质量偏差。因此，由于一旦条带被加工，其含量均匀性就固定了，所以了解条带中的API浓度至关重要。在本研究中，开发了一种新型微波传感器，它可以在线测量辊压条带的API浓度及其密度和水分含量。结果表明，与市售近红外探头相比，这种微波传感器在在线测定辊压条带的含量均匀性和密度方面能够提高准确性。
