Patel Sarsvatkumar, Kaushal Aditya Mohan, Bansal Arvind Kumar
Department of Pharmaceutical Technology (Formulations), National Institute of Pharmaceutical Education and Research (NIPER), SAS Nagar, Punjab-160 062, India.
AAPS PharmSciTech. 2007 Oct 26;8(4):E89. doi: 10.1208/pt0804089.
The aim of this study was to investigate the lubrication potential of 2 grades of magnesium stearate (MS) blended with a mix of dicalcium phosphate dihydrate and microcrystalline cellulose. Force-displacement, force-time, and ejection profiles were generated using an instrumented rotary tablet press, and the effect of MS mixing time (10, 20, and 30 minutes) and tableting speed (10.7, 13.8, and 17.5 rpm) was investigated. The packing index (PI), frictional index (FI), and packing energy (PE) derived from the force-displacement profiles showed that MS sample I performed better than sample II. At higher lubricant mixing times, the values of PI were observed to increase, and values of FI and PE were observed to decrease for both MS samples. Lower values of area under the curve (AUC) calculated from force-time compression profiles also showed sample I to be superior to sample II in lubrication potential. For both the samples, the values of AUC were observed to decrease with higher lubricant mixing times. Tapping volumetry that simulates the initial particle rearrangement gave values of parameter a and C(max) that were higher for sample I than sample II and also increased with lubricant mixing time. The superior lubrication potential of sample I was also established by the lower values of peak ejection force encountered in the ejection profile. Lower ejection forces were also found to result from higher tableting speeds and longer lubricant mixing times. The difference in lubrication efficacy of the 2 samples could be attributed to differences in their solid-state properties, such as particle size, specific surface area, and d-spacing.
本研究的目的是研究两种硬脂酸镁(MS)与二水磷酸氢钙和微晶纤维素混合物混合后的润滑潜力。使用仪器化旋转压片机生成力-位移、力-时间和顶出曲线,并研究了MS混合时间(10、20和30分钟)和压片速度(10.7、13.8和17.5转/分钟)的影响。从力-位移曲线得出的堆积指数(PI)、摩擦指数(FI)和堆积能量(PE)表明,MS样品I的性能优于样品II。在较高的润滑剂混合时间下,观察到两个MS样品的PI值均增加,而FI和PE值均降低。从力-时间压缩曲线计算出的曲线下面积(AUC)较低的值也表明样品I在润滑潜力方面优于样品II。对于两个样品,观察到AUC值随着润滑剂混合时间的增加而降低。模拟初始颗粒重排的振实体积法得出的参数a和C(max)值,样品I高于样品II,并且也随润滑剂混合时间增加。样品I的卓越润滑潜力还通过顶出曲线中遇到的较低顶出力峰值得到证实。还发现较高的压片速度和较长的润滑剂混合时间会导致较低的顶出力。两个样品润滑效果的差异可归因于它们的固态性质差异,如粒径、比表面积和d间距。