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Effects of Comilling on Final API Physical Attributes

机译：联磨对最终API物理属性的影响

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摘要

Severe operational challenges were experienced during the delumping (via comilling) of a shear-sensitive active pharmaceutical ingredient (API) during a pilot plant campaign. During the in-line comilling operation from the dryer, the API melted and blinded the screen, which compromised the equipment and called the batch fitness for formulation into question. These challenges instigated the investigation of comilling parameters and API physical properties and their respective effects on delumping performance as well as the final API attributes. Comil impeller speed, impeller type, screen hole size, and screen hole type were studied at both pilot plant and lab scale. The unique properties of the API were also studied in order to understand how this solid differed from others. Because solids with similar physical properties to the API in question are likely to behave in a similar way, the experimental approach described here for Comil and solid characterization should be applicable to other projects as well. The optimal comilling conditions for the API were determined and demonstrated robustly at pilot scale.
机译：在试点工厂活动期间，在剪切敏感活性药物成分（API）的分散（通过蒸煮）过程中遇到了严峻的操作挑战。在干燥机的在线精馏操作过程中，API熔化并遮蔽了筛网，这损害了设备，并使得配料的批次适应性受到质疑。这些挑战促使人们研究混合参数和API物理属性，以及它们各自对分流性能以及最终API属性的影响。在中试规模和实验室规模下研究了Comil叶轮的速度，叶轮类型，筛孔尺寸和筛孔类型。为了了解这种固体与其他固体之间的差异，还研究了API的独特性质。由于与所讨论的API具有相似物理特性的固体的行为方式可能相似，因此此处针对Comil和固体表征所述的实验方法也应适用于其他项目。确定了API的最佳混合条件，并在中试规模上得到了有力的证明。

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