制造化学家Live是一次会议，旨在强调影响制药行业的当前标准和法规。它还回顾了最新的生产协议。该活动于2022年5月25日至26日在英国伯明翰举行。
图片来源：弗里曼技术
请与Freeman Technology的运营总监Jamie Clayton一起进行“Investigating the Influence of Powder Flow Properties on DPI Dosator Performance” 5月25日16:15 BST。
Due to the small particle size of most Active Pharmaceutical Ingredients (APIs) for Dry Powder Inhalers (DPIs), the bulk powder tends to be highly cohesive. An excipient, for example lactose monohydrate, is required as a transport medium for the API. As the drug formulation is ejected from the inhaler the carrier is stripped away as the API continues to the deep lung. The selection of the carrier excipient will not only influence the ejection of the powder from the inhaler, and subsequent detachment of the API, but also the filling of capsule and blister packs during the manufacturing process.
Dosator technology is routinely used to dispense controlled but miniscule quantities of API. Dosators operate by being inserted into the powder bed, which forces powder into their cavity. Dosators are suited to a limited range of powders, demanding the need to match powder properties to dosator design.
In this presentation, Freeman Technology investigates the relationship between excipient and dosing performance. Five grades of lactose with varying particle sizes were processed through a lab-scale dosator (3P Innovation, Warwickshire) using outlets of progressively smaller size. For each combination of dosator outlet size and excipient, the standard deviation was measured for target doses of 50 mg. This was repeated across 30 runs with a target relative standard deviation (RSD) of 2%. The excipients were also evaluated using an FT4 Powder Rheometer® to quantify dynamic flow, bulk and shear properties.
这项研究的结果表明，即使是粉末性能的较小变化也可能导致剂量性能不合格，因此，重要的是将粉末与所使用的剂量匹配。显示动态流程测试可支持更容易处理的DPI公式的开发以及将更加一致地提供所需剂量的工艺设备的选择。app亚博体育