Takeuchi Hirofumi, Nagira Shinsuke, Yamamoto Hiromitsu, Kawashima Yoshiaki
Department of Pharmaceutical Engineering, Gifu Pharmaceutical University, 5-6-1 Mitahora-higashi, Gifu 502-8585, Japan.
Int J Pharm. 2004 Apr 15;274(1-2):131-8. doi: 10.1016/j.ijpharm.2004.01.008.
The aim of this study was to evaluate the compaction property of several pharmaceutical materials by measuring the die wall pressure. The profile of die wall force during tabletting process was measured with the compaction process analyzer (TabAll). Several compaction parameters such as maximum die wall pressure (MDP), residual die wall pressure (RDP) and pressure transmission ratio (PTR) from upper punch to lower punch were calculated. The ejection pressure (EP) of tablet compacted was also measured as a parameter for sticking property of the compacts. The profile of die wall force observed was classified to the typical two types, a small type and a large one. Partly pre-gelatinized starch (PCS), cornstarch and low substituted hydroxypropylcellulose (L-HPC) were the small type, while crystalline lactose, ascorbic acid and potassium chloride were the large type. The die wall force of crystalline lactose remarkably increased at the ejection of tablet and then capping was observed. RDP value of PCS, cornstarch, L-HPC was smaller than that of crystalline lactose, ascorbic acid, potassium chloride. As the higher pressure transmission ratio from upper punch to lower punch means a good compressing property of the powder, we proposed that RDP/MDP is a useful parameter for evaluating the compaction property of powders. Although potassium chloride which is strongly plastic deformable powder showed the highest RDP value among the powders tested, the RDP/MDP value was lower than that of crystalline lactose or ascorbic acid and the tensile strength of resultant tablet of potassium chloride was much higher than these powders.
本研究的目的是通过测量模壁压力来评估几种药用材料的压实性能。使用压实过程分析仪（TabAll）测量压片过程中模壁力的变化曲线。计算了几个压实参数，如最大模壁压力（MDP）、残余模壁压力（RDP）以及上冲头到下冲头的压力传递比（PTR）。还测量了压片的顶出压力（EP），作为片剂粘着性能的一个参数。观察到的模壁力变化曲线可分为典型的两种类型，即小类型和大类型。部分预胶化淀粉（PCS）、玉米淀粉和低取代羟丙基纤维素（L-HPC）属于小类型，而结晶乳糖、抗坏血酸和氯化钾属于大类型。结晶乳糖的模壁力在片剂顶出时显著增加，随后观察到裂片现象。PCS、玉米淀粉、L-HPC的RDP值小于结晶乳糖、抗坏血酸、氯化钾的RDP值。由于从上冲头到下冲头的压力传递比越高意味着粉末的压缩性能越好，我们提出RDP/MDP是评估粉末压实性能的一个有用参数。尽管在测试的粉末中，强塑性变形粉末氯化钾显示出最高的RDP值，但其RDP/MDP值低于结晶乳糖或抗坏血酸，并且氯化钾制成的片剂的抗张强度远高于这些粉末。
