Stability and repeatability of a continuous twin screw granulation and drying system
Stability and repeatability of a continuous twin screw granulation and drying system
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DOI：
10.1016/j.ejpb.2013.05.002
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发表时间：
2013-11-01
影响因子：
4.9
通讯作者：
Vervaet, C.
中科院分区：
文献类型：
--
作者：
Vercruysse, J.;Delaet, U.;Vervaet, C.
本研究的目的是研究将一种商用产品从目前的间歇沸腾造粒和干燥生产方法转移到一条以双螺杆造粒为中间造粒步骤的创新的连续运行的“从粉末到片剂”生产线上。通过监测工艺结果(扭矩、制粒机夹套入口处的水温、干燥机过滤器上的压差、温度研磨筛)以及颗粒和片剂的质量随工艺时间的变化，确定了长时间生产过程中的稳定性和重复性。使用ConsiGma(TM)-25系统(Gea Pharma Systems，Collette(TM)，Wemmelgem，比利时)进行了连续5 h的从粉剂到片剂的生产。用蒸馏水将两种活性成分--纤维素粉、玉米淀粉、预糊化淀粉和乙醇酸钠淀粉制成预混料。干燥研磨后(1000um m和800rpm)，将颗粒与硬脂酸镁在线混合，并使用Modul(TM)P型压片机(片剂重量：430 mg，主压缩力：12kN)直接压片。对颗粒剂(干燥损失、粒度分布、脆碎度、流动性)和片剂(重量均匀度、硬度、厚度、脆碎度、含量均匀度、崩解时间和溶出度)的质量进行了工艺时间的评估。对于每个记录的工艺结果，需要一个稳定期以达到稳定状态。由于磨机筛网的初始分层，在启动过程中观察到磨粒的粒度分布和脆性结果略有偏差。片剂质量与炮制时间的函数关系不存在偏差，在多小时内，颗粒剂和片剂的质量与炮制时间的函数关系不变。此外，流程数据趋势具有很高的重复性。因此，ConsiGma(TM)-25系统可以被认为是通过湿法制粒连续生产片剂的稳定和可重复的系统。(C)2013爱思唯尔B.V.保留所有权利。
The aim of this study was to investigate the process transfer of a commercially available product from the current batch fluid bed granulation and drying production method to an innovative continuously operating "from powder to tablet" production line using twin screw granulation as an intermediate granulation step. By monitoring process outcomes (torque, water temperature at the granulator jacket inlet, differential pressure over the dryer filters, and temperature mill screen) and granule and tablet quality in function of process time, the stability and repeatability during long production runs were determined.Three consecutive 5 h "from powder to tablet" production runs were performed using the ConsiGma (TM)-25 system (GEA Pharma Systems, Collette (TM), Wommelgem, Belgium). A premix of two active ingredients, powdered cellulose, maize starch, pregelatinized starch, and sodium starch glycolate was granulated with distilled water. After drying and milling (1000 mu m and 800 rpm), granules were in-line blended with magnesium stearate and directly compressed using a Modul (TM) P tablet press (tablet weight: 430 mg, main compression force: 12 kN). Granule (loss on drying, particle size distribution, friability, flow) and tablet (weight uniformity, hardness, thickness, friability, content uniformity, disintegration time, and dissolution) quality was evaluated in function of process time.For each of the logged process outcomes, a stabilization period was needed to reach steady-state conditions. Slightly deviating particle size distribution and friability results for milled granules were observed during start-up due to initial layering of the mill screen. However, no deviating tablet quality was detected in function of process time.For multiple hours, granule and tablet quality was constant in function of process time. Furthermore, process data trends were highly repeatable. Consequently, the ConsiGma (TM)-25 system can be considered as a stable and repeatable system for the continuous production of tablets via wet granulation. (C) 2013 Elsevier B.V. All rights reserved.