Institute of Pharmaceutics and Biopharmaceutics, Heinrich-Heine-University, 40225, Duesseldorf, Germany.
Novartis AG, WSJ-027.4.015, Novartis Campus, 4002, Basel, Switzerland.
Pharm Res. 2018 Jun 25;35(8):167. doi: 10.1007/s11095-018-2451-0.
It was investigated if continuous wet granulation and drying could be combined in a twin-screw granulator with the aim to provide (pre-)dried granules in a single-step process, i.e. in-barrel-drying.
To have a consistent and robust material propulsion mechanism, a twin-screw granulator was divided into two compartments. One compartment was operated at lower temperature to granulate and to pre-heat the material, while another compartment was operated at very high temperature to evaporate the granulation liquid as rapidly as possible. Design of experiments was used to investigate the in-barrel-drying process in detail. The process was further investigated for twin-screw wet granulation with API suspension feed, and compared against traditional fluidised-bed drying. Granule and compact properties were evaluated to study the process impact on the product quality.
In-barrel-drying was demonstrated as feasible and yielded completely dried and granulated material at specific settings. The evaporation zone temperature and the processed mass of water were identified as key parameters to balance the evaporation capacity of the process and the material throughput. Granules and compacts showed an acceptable product quality.
In-barrel-drying can be used to condense the wet granulation and drying process steps into one piece of equipment, thereby limiting or even omitting downstream drying process steps.
研究是否可以在双螺杆造粒机中将连续湿法制粒和干燥结合起来，以期在一步法（即筒内干燥）中提供（预）干燥颗粒。
为了具有一致且稳健的物料推进机制，将双螺杆造粒机分为两个腔室。一个腔室在较低温度下运行以造粒和预热物料，而另一个腔室在非常高的温度下运行以尽可能快速地蒸发造粒液。设计实验用于详细研究筒内干燥过程。进一步研究了 API 悬浮液进料的双螺杆湿法造粒，并与传统流化床干燥进行了比较。评估了颗粒和压缩物的特性，以研究该工艺对产品质量的影响。
筒内干燥被证明是可行的，并在特定条件下产生完全干燥和造粒的物料。蒸发区温度和处理的水量被确定为平衡过程蒸发能力和物料吞吐量的关键参数。颗粒和压块显示出可接受的产品质量。
筒内干燥可用于将湿法制粒和干燥工艺步骤凝结到一台设备中，从而限制甚至省略下游干燥工艺步骤。
