Institute of Pharmaceutics and Biopharmaceutics, Heinrich-Heine-University, Duesseldorf, Germany.
AAPS PharmSciTech. 2012 Mar;13(1):94-100. doi: 10.1208/s12249-011-9726-7. Epub 2011 Dec 9.
In recent years, extrusion technology has shifted the focus of pharmaceutical research due to versatile applications like pelletization, bioavailability improvement or manipulation of solid-state properties of drugs, continuous granulation, and the development of novel solid dosage forms. Meanwhile, a major effort has been devoted to the miniaturization of equipment in pharmaceutical extrusion technology, particularly with regard to the requirements of the development of new chemical entities and formulations. In the present study, a lab-scale twin-screw extruder was investigated in order to determine the limitations imposed by the feeding systems. The wet extrusion process was considered as challenging because both a powder and a liquid feeder have to be considered. Initially, the accuracy and uniformity of the powder and liquid feeder were tested independently of the extrusion process. After modification of the powder feeder, both feeders were investigated in conjunction with extrusion. Based on this, an optimization of the liquid feeder was required and completed. Both feeder modifications reduced the variability of the moisture content in the extrudates 10-fold. This led to a reliable small-scale extrusion process.
近年来，挤出技术由于在颗粒化、生物利用度改善或药物固态性质的操纵、连续造粒和新型固体制剂的开发等方面的多功能应用，成为了药物研究的焦点。同时，人们也在努力实现药物挤出技术设备的小型化，特别是在开发新的化学实体和制剂方面。在本研究中，我们研究了一台实验室规模的双螺杆挤出机，以确定供料系统的限制。湿挤出工艺具有挑战性，因为必须同时考虑粉末和液体供料器。最初，在不考虑挤出过程的情况下，独立测试了粉末和液体供料器的准确性和均匀性。在对粉末供料器进行修改后，我们结合挤出过程对两个供料器进行了研究。在此基础上，需要并完成了液体供料器的优化。这两个供料器的改进使挤出物的水分含量的变化降低了 10 倍。这使得可靠的小规模挤出过程成为可能。
