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Development and Scale-Up of a Continuous Reaction for Production of an Active Pharmaceutical Ingredient Intermediate
Organic Process Research & Development ( IF 3.4 ) Pub Date : 2018-08-06 00:00:00 , DOI: 10.1021/acs.oprd.8b00192
Jonathan P. McMullen 1 , Christopher H. Marton 1 , Benjamin D. Sherry 1 , Glenn Spencer 1 , Joseph Kukura 1 , Natalie S. Eyke 1
Affiliation  

Examples of continuous flow reactions in the laboratory setting are becoming commonplace in pharmaceutical drug substance research. Developing these processes for robust commercialization and identifying the scale-up parameters remains a challenge. An aldol reaction in the formation of an active pharmaceutical ingredient intermediate was developed in flow at the milliliter scale. Research focused on identifying conditions that led to robust and stable operating conditions. Desired reaction performance was achieved in various mixers across reactor scales by identifying conditions that led to similar flow regimes. Conditions from the lab were transferred to the pilot plant to successfully process ∼200 kg of the starting material.

中文翻译:

用于生产活性药物成分中间体的连续反应的开发和规模放大

实验室环境中连续流动反应的例子在药物原料药研究中正变得司空见惯。开发这些过程以实现稳健的商业化并确定放大参数仍然是一个挑战。以毫升为单位发展了形成活性药物成分中间体的醛醇缩合反应。研究重点在于确定导致稳定可靠的运行条件的条件。通过确定导致相似流态的条件,可以在各种混合器中在反应器规模上实现所需的反应性能。来自实验室的条件已转移至中试工厂,以成功加工约200千克的原料。
更新日期:2018-08-06
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