直接压片辅料-Cellactose80的粉体学性能评价

 目的考察Cellactose80的直接压片性能。方法测定Cellactose80的休止角、卡氏指数、屈张压力、润滑敏感率、稀释潜力等粉体学基本性质,并将Cellactose80应用于4种模型药物的粉末直接压片工艺中。结果和喷雾干燥单水乳糖以及微晶纤维素相比,复合型辅料Cellactose80的休止角最小,Heckel曲线显示了典型的塑性变型特征。该辅料对硬脂酸镁是敏感的,对可压性差的药物具有很大的稀释作用。结论Cellactose80改变了单水乳糖的物理压缩性质,由脆性变型转换成塑性变型,显著增强了流动性和可压性,更加适合于粉末直接压片工艺。

Study on Compressibility and Tablet-Forming Ability of Cellactose?80

OBJECTIVE To investigate the compression behaviour and tablet-forming ability of Cellactose80. METHODS Cellactose80 was characterized with respect to the angle of repose, aerated bulk density, packed bulk density, carr’s index, the lubricant sensitivity ratio and dilution potential. The tensile strength of the tablet formed at a series of applied pressures was determined and compression parameters were derived from the Heckel equations. RESULTS Being compared with Tablettose80 and Avicel PH102, cellactose80 underment plastic deformation as a result of the presence of cellulose and exhibited excellent dilution potential. Tablets prepared using low dosage drugs (zolmitriptan and phentolamine mesylate) and poorly compressible and poorly flowing drug (metformin HCl and acetaminophen) were satisfactory. CONCLUSION The flowability and compressibility of Cellactose80 are significantly superior to those of lactose monohydrate, and it was suitable for direct compression.