Development of a Novel Screening Methodology for the Assessment of the Risk of Particle Size Attrition during Agitated Drying,Organic Process Research & Development

当前位置： X-MOL 学术 › Org. Process Res. Dev. › 论文详情

Our official English website, www.x-mol.net, welcomes your feedback! (Note: you will need to create a separate account there.)

Development of a Novel Screening Methodology for the Assessment of the Risk of Particle Size Attrition during Agitated Drying
Organic Process Research & Development ( IF 3.1 ) Pub Date : 2020-02-12 , DOI: 10.1021/acs.oprd.9b00502
Charles D. Papageorgiou ₁ , Christopher Mitchell ₁ , Justin L. Quon ₁ , Marianne Langston ₁ , Suzanna Borg ₁ , Frederick Hicks ₁ , David am Ende ₂ , Mark Breault ₂

Affiliation

A material-sparing screening methodology has been developed for assessing the risk of particle size attrition of active pharmaceutical ingredients (APIs) during agitated drying using a single-ball mill process assisted by resonant acoustic mixing. This method requires only gram quantities of material and provides a critical particle fragility assessment that can be used to identify suitable agitation protocols that minimize attrition during at-scale manufacturing. The impact of initial particle size, as well as physical properties such as hardness, aspect ratio, and thickness, on particle breakage was assessed for both Takeda APIs and a range of commercially available compounds. Two models were developed and validated using both laboratory-scale and plant-scale agitated filter dryers, and a suitable workflow for the application of the developed methodology is proposed.

中文翻译：

新型筛分方法的开发，用于评估搅拌干燥过程中颗粒磨损的风险

已经开发了一种节省材料的筛选方法，用于评估在共振干燥下使用单球磨机工艺在搅拌干燥过程中活性药物成分（API）粒度磨损的风险。该方法仅需要克量的材料，并提供了关键的颗粒脆性评估，可用于确定合适的搅拌方案，从而在大规模生产过程中将磨损降至最低。对于武田API和一系列市售化合物，均评估了初始粒径以及诸如硬度，长宽比和厚度等物理性能对颗粒破损的影响。使用实验室规模和工厂规模的搅拌式过滤干燥机开发并验证了两种模型，

更新日期：2020-02-13

点击分享查看原文

点击收藏

阅读更多本刊最新论文本刊介绍/投稿指南11