Pharmaceutical Based Granulation by Extrusion

药物挤出造粒

• 批准号: 249687-2012
• 负责人: Thompson, Michael
• 金额: $ 2.11万
• 依托单位: McMaster University
• 依托单位国家: 加拿大
• 项目类别: Discovery Grants Program - Individual
• 财政年份: 2016
• 资助国家: 加拿大
• 起止时间: 2016-01-01 至 2017-12-31
• 项目状态: 已结题
• 来源: https://www.nserc-crsng.gc.ca/ase-oro/Details-Detailles_eng.asp?id=594313
• 关键词: Pharmaceutical; Based; Granulation; Extrusion

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.

制粒涉及粉末状固体的团聚，目的是在制造工厂内轻松流动、保护工人免受有害粉尘的影响以及改善用这些材料制成的产品的最终性能。在高科技制药市场，造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。本研究计划旨在研究制药领域正在开发的一种新的创新挤出机技术，以连续粉碎粉末状固体。挤出被发现提供了一个实质性的一步，在造粒的行业，因为它可以提供一个水平的一致性，环境控制和产品质量不可能通过传统的工艺。挤出也是除了流化床之外唯一能够在生产操作中提供必要水平的灵活性的技术，其与关于用作多个产品制造平台的单件设备的药物制造的未来愿景相匹配（AAPS新闻杂志，2001年8月11日，第16-20页）。作为一项新技术，没有对挤出机内造粒机理的基础研究，也没有为工业用户提供工艺故障排除，设备放大或设计方面的任何指导。这项发现补助金的研究计划旨在解决这种知识的缺乏。该计划的目标是根据不同的粘合剂类型对造粒的微观力学进行建模，设计新的螺杆元件以增加鲁棒性，并开发工具以帮助加拿大的工业通过这种方法建立更多的制造能力。