Comparison of the performance of two sample thieves for the determination of the content uniformity of a powder blend.
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.
Garcia
T P
TP
Process Science and Technology, Glaxo Wellcome Inc., Research Triangle Park, North Carolina 27709, USA.
Taylor
M K
MK
Pande
G S
GS
D004364:Pharmaceutical Preparations / Q000032:analysis; D011208:Powders / Q000737:chemistry* / Q000592:standards; D013607:Tablets / Q000737:chemistry
D004364:Pharmaceutical Preparations; D011208:Powders; D013607:Tablets