Compréhension, modélisation et optimisation de procédés de production pharmaceutique impliquant des solides divisés

固体制剂生产过程的理解、建模和优化

• 批准号: 522450-2017
• 负责人: Abatzoglou, Nicolas
• 金额: $ 16.85万
• 依托单位: Université de Sherbrooke
• 依托单位国家: 加拿大
• 项目类别: Collaborative Research and Development Grants
• 财政年份: 2019
• 资助国家: 加拿大
• 起止时间: 2019-01-01 至 2020-12-31
• 项目状态: 已结题
• 来源: https://www.nserc-crsng.gc.ca/ase-oro/Details-Detailles_eng.asp?id=694645
• 关键词: Compr; hension; mod; lisation; et

The achievements of the last 10 years in the development of analytical technologies (PAT) tools for pharmaceutical processes involving powders and granules makes it possible to foresee with great optimism their use to better understand the critical attributes of these processes. The latter is the basis of process optimization but also, in many cases, the conversion of "batch" processes into continuous ones. The advantages of continuous steady-state operation are well known in process engineering and the industrial partner of this project is strongly interested.The project primarily targets dry pharmaceutical formulation processes that involve the handling of divided solids (powders and granules) as well as semi-solids. The overall objective of the project is twofold:- Understand, model and optimize pharmaceutical processes involving powders and granules.- Design new process configurations, namely "continuous" ones, from existing scientific knowledge and batch process operation technologies.The specific objectives of the project are summarized below:- Apply developed PAT (Process Analysis technologies) tools, preferably online, to accurately and robustly measure the critical parameters of the processes studied.- Use these analyses to understand process phenomena, model and optimize these processes.- Carry out pilot scale studies of batch processes and design of continuous conversion protocols.-Test developed protocols and establish scaling criteria.This project tackles industrial issues in fields of high importance for Canada and worldwide. The proposed methodology, which combines process engineering fundamentals, use of in-situ analytical tools and first principles, will produce plus-value in industrial production, namely pharmaceutical, food, biotechnological.

过去10年在粉末和颗粒制药工艺分析技术（PAT）工具开发方面取得的成就，使人们有可能非常乐观地预见它们的使用，以更好地了解这些工艺的关键属性。后者是工艺优化的基础，而且在许多情况下，也是将“间歇”工艺转化为连续工艺的基础。连续稳态操作的优点在工艺工程中是众所周知的，该项目的工业合作伙伴对此非常感兴趣。该项目主要针对涉及处理分散固体（粉末和颗粒）以及半固体的干燥药物配制工艺。该项目的总体目标是双重的：-了解，建模和优化涉及粉末和颗粒的制药工艺。根据现有的科学知识和间歇过程操作技术，设计新的工艺配置，即“连续”工艺配置。该项目的具体目标概述如下：-应用开发的PAT（过程分析技术）工具，最好是在线，以准确和可靠地测量所研究过程的关键参数。使用这些分析来了解过程现象，建模和优化这些过程。开展间歇工艺的中试规模研究和连续转化方案的设计。测试开发的协议并建立缩放标准。该项目解决了加拿大和全球高度重要领域的工业问题。所提出的方法结合了工艺工程基础知识、原位分析工具的使用和第一原理，将在工业生产中产生附加价值，即制药、食品和生物技术。