Pharmaceutical Based Granulation by Extrusion

造粒包括为便于在制造厂内流动而聚集粉末固体，保护工人免受有害粉尘的伤害，以及改善用这些材料形成的产品的最终性能。在高科技药品市场，制粒是生产片剂的必要步骤-片剂是加拿大人和世界各地最受欢迎的药物剂型。这项研究计划致力于研究制药领域正在开发的一种新的创新挤压机技术，以连续造粒粉状固体。人们发现，挤压造粒为制粒工业向前迈进了一大步，因为它可以提供传统工艺无法实现的一致性、环境控制和产品质量。除了流态化床外，挤压也是唯一一种能够在生产操作中提供必要水平的灵活性的技术，这种灵活性能够与制药制造的未来愿景相匹配，因为单一设备被用作多产品制造平台(AAPS News Magazine，2001年8月11日，16-20页)。作为一项新技术，目前还没有关于挤出机内造粒机理的基础性研究，也没有任何关于工艺故障排除、设备放大或设计的指导意见。探索基金的研究项目旨在解决这种知识匮乏的问题。该计划的目标是根据不同的粘结剂类型对造粒的微观机制进行建模，设计新的螺杆元件以增加坚固性，并开发工具以帮助加拿大工业通过这种方法建立更多的制造能力。

Granulation involves the agglomeration of powdered solids for the purpose of easy flow inside a manufacturing plant, protection of workers from hazardous dust, and the improvement of end properties of products formed with these materials. In the high-tech pharmaceutical market, granulation is a necessary step in the production to tablets - the most popular dosage form of drugs for Canadians and world-wide. This research proposal is intent on studying a new innovative extruder technology being developed in the pharmaceutical field to granulate powdered solids on a continuous basis. Extrusion is being found to offer a substantial step forward in granulation for the industry since it can give a level of consistency, environmental control and product quality not possible by traditional processes. Extrusion is also the only technology besides fluidized beds which is capable of providing the necessary level of flexibility in production operation that matches the future vision of pharmaceutical manufacturing in regards to single pieces of equipment being used as multiple product manufacturing platforms (AAPS News Magazine, Aug 11, 2001 pp 16-20). Being a new technology there are no fundamental studies on the mechanism of granulation within the extruder nor is there any guidance to be given to industrial users on process troubleshooting, equipment scale-up, or design. The research program of this Discovery grant intends to address this lack of knowledge. The goals of the program are to model the micromechanics of granulation based on different binder types, design new screw elements to increase robustness, and to develop tools to aid Canada's industry in building up more manufacturing capacity by this approach.