Garcia T P, Taylor M K, Pande G S
Process Science and Technology, Glaxo Wellcome Inc., Research Triangle Park, North Carolina 27709, USA.
Pharm Dev Technol. 1998 Feb;3(1):7-12. doi: 10.3109/10837459809028474.
The objective of this study was to compare the performance of two sample thieves (plug and grain) to determine the content uniformity of a powder blend. The powder blend was prepared by mixing 2% drug substance with the remaining excipients in a tumble blender for 30 min. Samples were taken at 10 locations in the blender using both thieves. The performance of each sample thief was assessed based on the respective content uniformity values and relative standard deviations obtained for each device, as well as the content uniformity values reported following analysis of the resulting compressed tablets. The relative standard deviation values for blend samples taken with the plug thief were approximately half of those obtained using the grain thief. The superior performance of the plug thief in this study is attributed to the static charge acquired by the microcrystalline cellulose, which leads to poor flow characteristics. This impeded the flow of the blend into the sample chamber of the grain thief resulting in segregation and variable content uniformity results. The plug thief, which does not require powder flow to obtain a sample, performs better for this formulation. The selection of a sampling thief should be assessed on a case-by-case basis. Superior performance is expected for the plug thief when poor flowing, compressible blends are sampled.
本研究的目的是比较两种取样器（塞式和粒式）的性能，以确定粉末混合物的含量均匀性。粉末混合物是通过在转鼓式混合器中将2%的原料药与其余辅料混合30分钟制备而成。使用两种取样器在混合器中的10个位置取样。根据每个设备获得的各自含量均匀性值和相对标准偏差，以及对所得压制片剂分析后报告的含量均匀性值，评估每个取样器的性能。用塞式取样器采集的混合样品的相对标准偏差值约为使用粒式取样器获得的值的一半。本研究中塞式取样器的优越性能归因于微晶纤维素获得的静电荷，这导致流动性较差。这阻碍了混合物流入粒式取样器的样品室，导致分离和含量均匀性结果的变化。塞式取样器不需要粉末流动就能获取样品，因此对该制剂表现更好。取样器的选择应逐案评估。当对流动性差、可压缩的混合物进行取样时，预计塞式取样器性能优越。
