Forster Seth P, Dippold Erin, Haser Abbe, Emanuele Daniel, Meier Robin
Merck & Co., Inc., West Point, PA 19486, USA.
Organon & Co., Inc., Jersey City, NJ 07302, USA.
Pharmaceutics. 2023 Sep 14;15(9):2317. doi: 10.3390/pharmaceutics15092317.
The pharmaceutical industry is in the midst of a transition from traditional batch processes to continuous manufacturing. However, the challenges in making this transition vary depending on the selected manufacturing process. Compared with other oral solid dosage processes, wet granulation has been challenging to move towards continuous processing since traditional equipment has been predominantly strictly batch, instead of readily adapted to material flow such as dry granulation or tablet compression, and there have been few equipment options for continuous granule drying. Recently, pilot and commercial scale equipment combining a twin-screw wet granulator and a novel horizontal vibratory fluid-bed dryer have been developed. This study describes the process space of that equipment and compares the granules produced with batch high-shear and fluid-bed wet granulation processes. The results of this evaluation demonstrate that the equipment works across a range of formulations, effectively granulates and dries, and produces granules of similar or improved quality to batch wet granulation and drying.
制药行业正处于从传统间歇工艺向连续制造的转型过程中。然而，实现这一转型的挑战因所选制造工艺而异。与其他口服固体制剂工艺相比，湿法制粒向连续加工转变一直具有挑战性，因为传统设备主要是严格的间歇式，而非像干法制粒或压片那样易于适应物料流动，并且连续颗粒干燥的设备选择很少。最近，已经开发出了结合双螺杆湿法制粒机和新型卧式振动流化床干燥机的中试和商业规模设备。本研究描述了该设备的工艺范围，并将其生产的颗粒与间歇式高剪切和流化床湿法制粒工艺生产的颗粒进行了比较。该评估结果表明，该设备适用于一系列配方，能有效地制粒和干燥，并且生产出的颗粒质量与间歇式湿法制粒和干燥工艺生产的颗粒相当或更优。
