Staniforth J N, Rees J E
J Pharm Pharmacol. 1983 Sep;35(9):549-54. doi: 10.1111/j.2042-7158.1983.tb04331.x.
The effect of different drug/excipient concentrations on the segregation tendency of three ordered powder mixes was studied. In addition, the influence of vibration frequency on the segregation intensity and mechanisms of segregation was also studied. Differences in content uniformity of the powders were measured by comparing samples from regions at different depths between the upper exposed powder surface and the base of the cylindrical container. Ordered mixes containing recrystallized lactose excipient and fine-particle potassium chloride as a model drug were found to be least susceptible to segregation at most vibration conditions for all potassium chloride concentrations. Dipac excipient/potassium chloride particles were most susceptible to segregation under all test conditions. In general, segregation intensity was most marked in conditions where high potassium chloride concentrations, above 2% w/w, were subjected to low-frequency vibration, below 100 Hz. Segregation mechanisms were considered to be mainly dependent on vibration conditions, although carrier excipient type markedly modified mechanisms and influenced segregation intensity.
研究了不同药物/辅料浓度对三种有序粉末混合物偏析倾向的影响。此外,还研究了振动频率对偏析强度和偏析机制的影响。通过比较圆柱形容器上部暴露粉末表面与底部不同深度区域的样品,测量了粉末含量均匀性的差异。发现在所有氯化钾浓度下,在大多数振动条件下,含有重结晶乳糖辅料和细颗粒氯化钾作为模型药物的有序混合物最不易发生偏析。在所有测试条件下,Dipac辅料/氯化钾颗粒最易发生偏析。一般来说,在高于2%w/w的高氯化钾浓度且低于100Hz的低频振动条件下,偏析强度最为明显。尽管载体辅料类型显著改变了偏析机制并影响偏析强度,但偏析机制主要被认为取决于振动条件。